Fabrazyme 5 mg, powder for concentrate for solution for infusion

Fabrazyme 5 mg powder for concentrate for solution for infusion

Agalsidase beta

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Fabrazyme is and what it is used for


• 2. Before you use Fabrazyme


• 3. How to use Fabrazyme


• 4. Possible side effects


• 5. How to store Fabrazyme


• 6. Further information

What Fabrazyme Is And What It Is Used For

Fabrazyme is used as enzyme replacement therapy in Fabry disease, where the level of α-galactosidase enzyme activity is absent or lower than normal. If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs.

Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.

Before You Use Fabrazyme

Do not use Fabrazyme

If you have experienced an allergic anaphylactic reaction to agalsidase beta or if you are allergic (hypersensitive) to any of the other ingredients of Fabrazyme.

Take special care with Fabrazyme

If you are treated with Fabrazyme, you may develop infusion associated reactions. An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (See 4 “Possible Side Effects”). If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent such reactions from occurring.

Different groups of patients using Fabrazyme

The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.

Using other medicines

There are no known interactions with other medicinal products. Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamicin due to a theoretical risk of decreased agalsidase beta activity. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Fabrazyme with food and drink

Interactions with food and drink are unlikely.

Pregnancy and breast-feeding

Use of Fabrazyme during pregnancy is not recommended. There is no experience with the use of Fabrazyme in pregnant women. Fabrazyme may get into breast milk. Use of Fabrazyme during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking this medicine.

How To Use Fabrazyme

Fabrazyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals)

Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.

The recommended dose of Fabrazyme for adults and children 8 – 16 years is 1 mg/kg body weight, once every 2 weeks. No changes in dose are necessary for patients with kidney disease.

If you use more Fabrazyme than you should

There are no cases of overdose of Fabrazyme reported. Doses up to 3 mg/kg body weight have shown to be safe.

If you forget to use Fabrazyme

If you have missed an infusion of Fabrazyme, please contact your doctor.

Possible Side Effects

Like all medicines, Fabrazyme can cause side effects, although not everybody gets them.

In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after. If you experience any serious side effect or side effects not listed, please tell your doctor immediately.

In clinical trials the following side effects were reported:

Very common (occurring in more than 1 in 10 patients):

• chills


• fever


• headache


• abnormal touch feeling (pins and needles)


• nausea


• vomiting


• feeling cold

Common (occurring in 1 in 100 to 1 in 10 patients):

• chest pain


• difficulty in breathing


• pallor


• itching


• abnormal tear secretion


• feeling weak


• tinnitus


• nasal congestion


• diarrhoea


• redness


• muscle pain


• increased blood pressure


• sudden swelling of the face or throat


• oedema in extremities


• vertigo


• stomach discomfort


• muscle spasms


• sleepiness


• increased heart beat


• abdominal pain


• back pain


• rash


• low heart rate


• lethargy


• syncope


• cough


• abdominal discomfort


• swelling face


• joint pain


• decreased blood pressure


• chest discomfort


• face oedema


• exacerbated difficulty in breathing


• muscle tightness


• fatigue


• flushing


• pain


• throat tightness


• dizziness


• palpitations


• decreased sensitivity to pain


• burning sensation


• wheezing


• urticaria


• pain at the extremities


• nasopharyngitis


• hot flush


• feeling hot


• hyperthermia


• decreased mouth sensitivity


• musculoskeletal stiffness

Uncommon (occurring in 1 in 1000 to 1 in 100 patients):

• tremor


• red eyes


• ear pain


• throat pain


• fast breathing


• itchy rash


• feeling hot and cold


• difficulty swallowing


• infusion site pain


• infusion site reaction


• itching eyes


• ear swelling


• bronchospasm


• runny nose


• heart burn


• skin discomfort


• musculoskeletal pain


• rhinitis


• influenza-like illness


• malaise


• low heart rate due to conduction disturbances


• increased sensitivity to pain


• upper respiratory tract congestion


• red rash


• (mottled purplish) skin discoloration


• coldness of the extremities


• injection site blood clotting


• skin discoloration


• oedema

Unknown frequency

• Serious allergic reactions


• serious inflammation of the vessels


• lower blood oxygen levels

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Fabrazyme

Keep out of the reach and sight of children.

Unopened vials

Store in a refrigerator (2 °C – 8 °C).

Do not use Fabrazyme after the expiry date which is stated on the labelling after the letters ‘EXP’.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Fabrazyme contains

• The active substance is agalsidase beta, one vial contains 5 mg.


• Other ingredients are:
  
  
  • Mannitol
  • Sodium phosphate monobasic, monohydrate
  • Sodium phosphate dibasic, heptahydrate.

What Fabrazyme looks like and contents of the pack

Fabrazyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted. Package sizes: 1, 5 and 10 vials per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Genzyme Europe B.V.

Gooimeer 10

NL-1411DD Naarden

The Netherlands

Manufacturer

Genzyme Ltd.

37 Hollands Road

Haverhill

Suffolk

CB9 8PU

United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom/Ireland

Genzyme Therapeutics Ltd.

United Kingdom

Tel: +44 1865 405200

This leaflet was last approved in 01/2010

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments.

Aspirin/Caffeine

Pronunciation: AS-pir-in/cah-FEEN
Generic Name: Aspirin/Caffeine
Brand Name: Examples include Anacin and P-A-C

Aspirin/Caffeine is used for:

Treating pain including, headache, muscle aches, sprains, tooth extraction and toothache, menstrual cramps, arthritis and rheumatism, and pain and fever of the common cold. It may also be used for other conditions as determined by your doctor.

Aspirin/Caffeine is a combination salicylate and stimulant. It works by blocking several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Do NOT use Aspirin/Caffeine if:

• you are allergic to any ingredient in Aspirin/Caffeine


• you are a child or teenager with influenza (flu) or chickenpox


• you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets, or you have active severe bleeding


• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)


• you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aspirin/Caffeine:

Some medical conditions may interact with Aspirin/Caffeine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day


• if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or intestinal problems (eg, ulcer, inflammation), heart problems, heartburn, upset stomach, stomach pain, hives, influenza (flu) or chickenpox, or vitamin K deficiency


• if you have anxiety, trouble sleeping, or heart problems


• if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, rheumatic disease (eg, rheumatoid arthritis), or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Aspirin/Caffeine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Aspirin/Caffeine's effectiveness


• Anticoagulants (eg, heparin, warfarin), clopidogrel, or NSAIDs (eg, ibuprofen, celecoxib) because the risk of their side effects, including risk of bleeding, may be increased by Aspirin/Caffeine


• Quinolones (eg, ciprofloxacin) because side effects, such as problems sleeping, nervousness, jitteriness, or anxiety, may occur


• Insulin or oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by Aspirin/Caffeine


• Methotrexate, theophylline, or valproic acid because the risk of their actions and side effects may be increased by Aspirin/Caffeine


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Aspirin/Caffeine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aspirin/Caffeine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aspirin/Caffeine:

Use Aspirin/Caffeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Aspirin/Caffeine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking Aspirin/Caffeine.


• Take Aspirin/Caffeine with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Aspirin/Caffeine.


• Use Aspirin/Caffeine exactly as directed on the package, unless instructed differently by your doctor. If you are taking Aspirin/Caffeine without a prescription, follow any warnings and precautions on the label.


• If you miss a dose of Aspirin/Caffeine and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aspirin/Caffeine.

Important safety information:

• Aspirin/Caffeine may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Aspirin/Caffeine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). This includes any medicines that contain caffeine.


• Aspirin/Caffeine has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Talk to your doctor before you take Aspirin/Caffeine or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Aspirin/Caffeine. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Aspirin/Caffeine with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Aspirin/Caffeine regularly may be habit-forming.


• Aspirin/Caffeine may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Aspirin has been linked to a serious illness called Reye syndrome. Do not give Aspirin/Caffeine to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.


• Diabetes patients - Aspirin/Caffeine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• If Aspirin/Caffeine has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.


• Tell your doctor or dentist that you take Aspirin/Caffeine before you receive any medical or dental care, emergency care, or surgery.


• Do not take Aspirin/Caffeine for at least 7 days after any surgery unless directed by your health care provider.


• Do not take Aspirin/Caffeine for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.


• Different brands of Aspirin/Caffeine may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aspirin/Caffeine while you are pregnant. Aspirin/Caffeine is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Aspirin/Caffeine is found in breast milk. If you are or will be breast-feeding while you use Aspirin/Caffeine, check with your doctor. Discuss any possible risks to your baby.

Some people who use Aspirin/Caffeine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Aspirin/Caffeine suddenly, you may have WITHDRAWAL symptoms including dizziness, headache, unusual tiredness, irritability, muscle tension, and nausea.

Possible side effects of Aspirin/Caffeine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; heartburn; irritability; nausea; nervousness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; drowsiness; hearing loss; ringing in the ears; severe or persistent dizziness; severe or persistent stomach pain or heartburn; shakiness; trouble sleeping; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Aspirin/Caffeine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; anxiety; confusion; fever; hearing loss; lethargy; lightheadedness, especially upon standing; muscle twitching; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; trouble sleeping; vomiting.

Proper storage of Aspirin/Caffeine:

Store Aspirin/Caffeine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aspirin/Caffeine out of the reach of children and away from pets.

General information:

• If you have any questions about Aspirin/Caffeine, please talk with your doctor, pharmacist, or other health care provider.


• Aspirin/Caffeine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Aspirin/Caffeine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Aspirin/Caffeine resources

• Aspirin/Caffeine Side Effects (in more detail)
• Aspirin/Caffeine Use in Pregnancy & Breastfeeding
• Aspirin/Caffeine Drug Interactions
• Aspirin/Caffeine Support Group
• 0 Reviews for Aspirin/Caffeine - Add your own review/rating

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• Fever
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Pentacel

Generic Name: diphtheria, tetanus, acellular pertussis, polio, hib vaccine (Intramuscular route)

dif-THEER-ee-a TOX-oyd, ad-SORBD, TET-n-us TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar, POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated, hee-MOF-i-lus B KON-joo-gate VAX-een

Commonly used brand name(s)

In the U.S.

• Pentacel

Available Dosage Forms:

• Suspension


• Powder for Suspension

Uses For Pentacel

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) combined with inactivated poliovirus and Haemophilus B conjugate vaccine (also known as IPV and Hib) is a combination vaccine that is given to protect against infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliovirus, and Haemophilus influenzae type b. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is only given to infants and children who are 6 weeks to 4 years of age, and is given before the child's 5th birthday .

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications is greater in very young children and the elderly .

Tetanus (also known as lockjaw) is a very serious illness that causes seizures and severe muscle spasms that can be strong enough to cause bone fractures of the spine. The disease continues to occur almost exclusively among people who do not get vaccinated or do not have enough protection from previous vaccines .

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis can also cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death .

Polio is a very serious infection that causes paralysis of the muscles, including the muscles that enable you to walk and breathe. A polio infection may leave a person unable to breathe without the help of a breathing machine. It may also leave a person unable to walk without leg braces or being confined to a wheelchair. There is no cure for polio .

Infection by Haemophilus influenzae type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis, which affects the brain; epiglottitis, which affects the throat and can cause death by suffocation; pericarditis, which affects the heart; pneumonia, which affects the lungs; and septic arthritis, which affects the bones and joints .

This vaccine is to be administered only by or under the supervision of your child's doctor or other authorized health care professional .

Before Using Pentacel

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of this vaccine in infants younger than 6 weeks of age and in children 5 years of age and older. Safety and efficacy have not been established .

Geriatric

This vaccine is not recommended for use in adult populations .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Disease of the brain—This includes a coma, a decreased level of consciousness, or seizures lasting a long time. Children who have these symptoms within seven days of receiving a vaccine with pertussis should not get this vaccine .

• Guillain-Barre syndrome (nerve disease that causes paralysis), history of—If your child had this condition after getting a vaccine with tetanus in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine .

• Fever, high or


• Moderate or severe illness, with or without fever—This vaccine may make these conditions worse or may increase the chance of side effects .

• Immunodeficiency disorder or


• Weakened immune system—This vaccine may not work as well in children with these conditions .

• Previous serious reaction to a vaccine—If your child had a serious reaction to this vaccine or another vaccine with pertussis in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine. Some serious reactions include being less responsive than normal, crying continuously without stopping for 3 hours or more, having a seizure with or without a fever, or having a fever that was 105 degrees F or higher .

• Progressive neurologic disorder—This includes infantile spasms, progressive brain disease, or uncontrolled seizures. This vaccine should not be given until these conditions are treated and under control .

Proper Use of Pentacel

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into one of your child's muscles .

This vaccine is usually given as a series of 4 shots. It is important that your child receive all of the shots in this series. Try to keep all scheduled appointments. If your child must miss a shot, make another appointment with the doctor as soon as possible .

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you .

Your child may also receive a medicine to help prevent or treat some of the minor side effects of the vaccine, such as fever and soreness .

Precautions While Using Pentacel

It is very important that the doctor check your child at regular visits to make sure this vaccine is working properly and to check for unwanted effects. It is very important that you return to your child's doctor for the next dose in the series .

Tell your child’s doctor about all other vaccines your child has had, especially if those vaccines were part of a series. This vaccine might be used to finish a series of vaccines .

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, polio, or Haemophilus influenzae type b, your child will need medicines to treat these infections .

Be sure to tell your child's doctor about any side effects that occur after your child receives the vaccine. This may include fainting, seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given .

Pentacel Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• chest pain


• confusion


• coughing, wheezing, or shortness of breath


• crying, persistent and inconsolable, occurring within 48 hours and lasting 3 or more hours


• decreased urination


• diarrhea


• dizziness


• dry mouth


• fainting


• fever


• increase in heart rate


• lightheadedness


• loss of appetite


• nausea


• noisy breathing


• rapid breathing


• shortness of breath


• sneezing


• sore throat


• sunken eyes


• thirst


• tightness in chest


• troubled breathing


• unusual tiredness or weakness


• weakness


• wrinkled skin

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds


• chills


• cold or flu-like symptoms


• drowsiness


• fast heartbeat


• general feeling of illness


• hives


• hoarseness


• irritation


• itching


• joint pain, stiffness, or swelling


• rash


• redness of skin


• runny nose


• severe headache


• slow breathing


• sneezing


• stiff neck and/or back


• stuffy nose


• swelling of the eyelids, face, lips, hands, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Irritability


• tenderness at the injection site


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• change in skin color at the injection site


• paleness of the skin


• sleepiness or unusual drowsiness


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Pentacel side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Pentacel resources

• Pentacel Side Effects (in more detail)
• Pentacel Use in Pregnancy & Breastfeeding
• Pentacel Drug Interactions
• Pentacel Support Group
• 0 Reviews for Pentacel - Add your own review/rating

• Pentacel Prescribing Information (FDA)


• Pentacel MedFacts Consumer Leaflet (Wolters Kluwer)


• Pentacel Consumer Overview

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aluminum chloride hexahydrate topical

Generic Name: aluminum chloride hexahydrate (topical) (al LOO min um KLOR ide hex a HYD rayt TOP ik al)

Brand Names: Drysol, Hypercare, Xerac AC

What is aluminum chloride hexahydrate?

Aluminum chloride hexahydrate is used to treat excessive sweating, also called hyperhidrosis.

Aluminum chloride hexahydrate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about aluminum chloride hexahydrate?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

This medicine is for use only on your skin. Avoid getting it in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use aluminum chloride hexahydrate topical on irritated or broken skin. Do not use the medicine on skin that has recently been shaved. Also avoid using this medication on open wounds. Do not apply any other deodorants or antiperspirants while you are using aluminum chloride hexahydrate.

This medication can stain certain types of fabric or metals that it comes in contact with. Avoid getting the medicine on surfaces you do not want to stain.

What should I discuss with my health care provider before using aluminum chloride hexahydrate?

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether aluminum chloride hexahydrate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use aluminum chloride hexahydrate?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Apply this medication only to completely dry skin. You may need to blow-dry the skin with a hair dryer before applying the medicine.

For best results, apply this medication only at bedtime, when you are less likely to sweat. You will need to leave the medicine on your skin for 6 to 8 hours after application.

To use on the underarms: Apply the medication evenly and allow it to dry. Use a hair dryer on a cool setting to dry the skin if needed. Leave a thin film of the medication on the skin. Wear a tee-shirt or short-sleeved nightgown to bed to keep the medicine from rubbing off onto your bed linens.

To use on the hands or feet: Apply the medication evenly and allow it to dry. Use a hair dryer on a cool setting to dry the skin if needed. Leave a thin film of the medication on the skin. Wrap your hands or feet in plastic wrap and cover with cotton gloves or socks. Leave the gloves or socks on while you sleep.

To use on the scalp: Apply the medication evenly and allow it to dry. Use a hair dryer on a cool setting to dry the skin if needed. Leave a thin film of the medication on the skin. Wear a plastic shower cap to bed to keep the medicine from rubbing off onto your bed linens.

The morning after you apply this medicine, remove your clothing or the plastic covering from the treated skin areas. Throw the plastic wrap away and do not reuse it. Rinse out the plastic shower cap with water and allow it to dry completely before using again.

Wash or shampoo the treated skin areas thoroughly, and towel dry.

Repeat the application of aluminum chloride hexahydrate for 2 or 3 more nights in a row, until you get the desired results of reduced sweating. Using the medication one or two times per week thereafter may be enough to keep your condition under control.

Store this medication at room temperature away from heat or open flame. Aluminum chloride hexahydrate contains alcohol and is flammable.

This medicine will evaporate quickly when exposed to air. Keep the bottle tightly closed when you are not using the medicine.

What happens if I miss a dose?

Since aluminum chloride hexahydrate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly and you miss a dose, wait until the following night and use the medicine at bedtime. Aluminum chloride hexahydrate may not be as effective if you use it during the day while you are awake.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of aluminum chloride hexahydrate applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using aluminum chloride hexahydrate?

This medicine is for use only on your skin. Avoid getting it in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use aluminum chloride hexahydrate topical on irritated or broken skin. Do not use the medicine on skin that has recently been shaved. Also avoid using this medication on open wounds. Do not apply any other deodorants or antiperspirants while you are using aluminum chloride hexahydrate.

This medication can stain certain types of fabric or metals that it comes in contact with. Avoid getting the medicine on surfaces you do not want to stain.

Aluminum chloride hexahydrate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any stinging, burning, redness, or swelling of treated skin areas.

Other less serious side effects are more likely to occur, such as tingling or itching of the treated skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect aluminum chloride hexahydrate?

There may be other drugs that can affect aluminum chloride hexahydrate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More aluminum chloride hexahydrate resources

• Aluminum chloride hexahydrate Side Effects (in more detail)
• Aluminum chloride hexahydrate Use in Pregnancy & Breastfeeding
• Aluminum chloride hexahydrate Support Group
• 162 Reviews for Aluminum chloride hexahydrate - Add your own review/rating

• Drysol Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Hypercare Prescribing Information (FDA)

Compare aluminum chloride hexahydrate with other medications

• Hyperhidrosis

Where can I get more information?

• Your pharmacist has more information about aluminum chloride hexahydrate written for health professionals that you may read.

See also: aluminum chloride hexahydrate side effects (in more detail)

Tums Plus Chewable Tablets

Pronunciation: KAL-see-uhm/si-METH-i-kone
Generic Name: Calcium/Simethicone
Brand Name: Examples include Titralac Plus and Tums Plus

Tums Plus Chewable Tablets are used for:

Treating acid indigestion, heartburn, gas, and sour stomach. It may also be used for other conditions as determined by your doctor.

Tums Plus Chewable Tablets are an antacid and antiflatulent. It works by neutralizing acid in the stomach. It also helps to break up gas bubbles in the stomach, allowing it to be passed through the system more comfortably.

Do NOT use Tums Plus Chewable Tablets if:

• you are allergic to any ingredient in Tums Plus Chewable Tablets


• you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives)


• you have a history of high blood calcium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tums Plus Chewable Tablets:

Some medical conditions may interact with Tums Plus Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have Alzheimer disease, kidney problems, appendicitis, diarrhea, a stomach blockage, or an ileostomy


• if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Tums Plus Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because the actions and side effects of Tums Plus Chewable Tablets may be increased


• Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because the actions and side effects of these medicines may be increased


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), thyroid hormones (eg, levothyroxine), or verapamil because the effectiveness of these medicines may be decreased, especially when taken at the same time as Tums Plus Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tums Plus Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tums Plus Chewable Tablets:

Use Tums Plus Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tums Plus Chewable Tablets may be taken with or without food.


• Chew thoroughly before swallowing. Drink a glass of water after swallowing.


• Do not use Tums Plus Chewable Tablets within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because Tums Plus Chewable Tablets may decrease the effectiveness of these medicines.


• If you miss a dose of Tums Plus Chewable Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tums Plus Chewable Tablets.

Important safety information:

• Do not exceed the recommended dose or use the maximum dose for more than 2 weeks without checking with your doctor.


• If your symptoms do not improve within 2 weeks or if they become worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tums Plus Chewable Tablets, discuss with your doctor the benefits and risks of using Tums Plus Chewable Tablets during pregnancy. If you are or will be breast-feeding while you are using Tums Plus Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Tums Plus Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tums Plus side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tums Plus Chewable Tablets:

Store Tums Plus Chewable Tablets in a tightly closed container at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tums Plus Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Tums Plus Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Tums Plus Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tums Plus Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tums Plus resources

• Tums Plus Side Effects (in more detail)
• Tums Plus Use in Pregnancy & Breastfeeding
• Tums Plus Drug Interactions
• Tums Plus Support Group
• 0 Reviews for Tums Plus - Add your own review/rating

Compare Tums Plus with other medications

• GERD

Pravachol

Pronunciation: PRAV-a-STAT-in
Generic Name: Pravastatin
Brand Name: Pravachol

Pravachol is used for:

Lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with an appropriate diet. It is also used in certain patients to reduce the risk of heart attack, stroke, and death due to coronary heart disease. It is also used to slow blood vessel blockage and to reduce the need for medical procedures to open blocked blood vessels. It may also be used for other conditions as determined by your doctor.

Pravachol is an HMG-CoA reductase inhibitor, also known as a "statin." It works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Pravachol if:

• you are allergic to any ingredient in Pravachol


• you have liver problems or unexplained abnormal liver function tests


• you are pregnant or breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pravachol:

Some medical conditions may interact with Pravachol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have low blood pressure, a serious infection, kidney problems, diabetes, muscle pain or tenderness, or a history of seizures


• if you have metabolism, hormonal, or electrolyte problems


• if you drink alcohol, have jaundice (yellowing of the skin or eyes), or have a history of liver problems or alcohol abuse


• if you have recently had major surgery or a serious injury


• if you have a certain type of high cholesterol (homozygous familial hypercholesterolemia)

Some MEDICINES MAY INTERACT with Pravachol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, itraconazole, ketoconazole), fibrates (eg, gemfibrozil, clofibrate), fluconazole, HIV protease inhibitors (eg, ritonavir), immunosuppressants (eg, cyclosporine), macrolides (eg, erythromycin), niacin, non-nucleoside reverse transcriptase inhibitors (eg, delavirdine), telithromycin, or voriconazole because they may increase the risk of muscle or kidney problems


• Cimetidine or spironolactone because the risk of their side effects may be increased by Pravachol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pravachol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pravachol:

Use Pravachol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pravachol by mouth with or without food.


• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Pravachol.


• Continue to take Pravachol even if you feel well. Do not miss any doses.


• If you miss a dose of Pravachol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pravachol.

Important safety information:

• Pravachol may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Pravachol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Drinking alcohol daily or in large amounts may increase the risk of liver problems with Pravachol. Check with your doctor before drinking alcohol while you are taking Pravachol.


• Follow the diet and exercise program given to you by your health care provider.


• Tell your doctor or dentist that you take Pravachol before you receive any medical or dental care, emergency care, or surgery.


• Women who may become pregnant should use effective birth control while taking Pravachol. Check with your doctor if you have questions about using birth control.


• Do NOT take more than the recommended dose without checking with your doctor.


• Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.


• Lab tests, including blood cholesterol levels and liver function tests, may be performed while you use Pravachol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Pravachol should be used with extreme caution in CHILDREN younger than 8 years old and in those who have not reached puberty; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Pravachol if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Pravachol is found in breast milk. Do not breast-feed while you are taking Pravachol.

Possible side effects of Pravachol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; heartburn.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; muscle pain, tenderness, or weakness (with or without fever or fatigue); pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pravachol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Pravachol:

Store Pravachol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pravachol out of the reach of children and away from pets.

General information:

• If you have any questions about Pravachol, please talk with your doctor, pharmacist, or other health care provider.


• Pravachol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pravachol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pravachol resources

• Pravachol Side Effects (in more detail)
• Pravachol Use in Pregnancy & Breastfeeding
• Drug Images
• Pravachol Drug Interactions
• Pravachol Support Group
• 4 Reviews for Pravachol - Add your own review/rating

• Pravachol Prescribing Information (FDA)


• Pravachol Consumer Overview


• Pravachol Monograph (AHFS DI)


• Pravachol Advanced Consumer (Micromedex) - Includes Dosage Information


• Pravastatin Prescribing Information (FDA)

Compare Pravachol with other medications

• High Cholesterol
• High Cholesterol, Familial Heterozygous
• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
• Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL
• Hyperlipoproteinemia Type IV, Elevated VLDL
• Ischemic Stroke, Prophylaxis
• Myocardial Infarction, Prophylaxis
• Revascularization Procedures, Prophylaxis

Otrivine Child Nasal Drops

1. Name Of The Medicinal Product

Otrivine^® Child Nasal Drops

2. Qualitative And Quantitative Composition

Xylometazoline Hydrochloride 0.05% w/v

For excipients see 6.1

3. Pharmaceutical Form

Nasal drops, solution

The product is a clear, colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.

4.2 Posology And Method Of Administration

Adults and elderly: Not applicable.

Otrivine Child Nasal Drops are contra-indicated in children under 6 years of age.

Children between 6 and 12 years (all indications):

1 or 2 drops, in each nostril 1 or 2 times daily.

Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Not more than 2 doses should be given in any 24 hours.

Route of administration: Nasal use

Do not exceed the stated dose

Keep out of the reach and sight of children.

4.3 Contraindications

• Known hypersensitivity to Otrivine or any of the excipients

• Concomitant use of other sympathomimetic decongestants

• Cardiovascular disease including hypertension Diabetes mellitus

• Phaeochromocytoma

• Hyperthyroidism

• Closed angle glaucoma

• Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

• Beta-blockers – (see section 4.5)

• Inflammation of the skin and/or mucosa of the nasal vestibule

• Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater

• Not to be used in children under the age of 6 years

4.4 Special Warnings And Precautions For Use

Patients are advised not to take decongestants for more than five consecutive days, without the advice of a doctor. Otrivine Child Nasal Drops like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.

• Do not exceed the recommended dosage

• Do not take with any other cough and cold medicine.

• Decongestants should not be used for more than five consecutive days. If symptoms persist consult your doctor

• If your child is receiving medication or is under a doctor's care, consult him before giving Otrivine Child Nasal Drops

• Each Otrivine Child Nasal Drops pack should be used by one person only to prevent any cross infection

• Some patients who have sensitive nasal passages may feel some local discomfort when applying nasal drops. Other side effects are very rare

• Occasionally small children may show restlessness or sleep disturbance or experience hallucinations when Otrivine Child Nasal Drops is used. If this occurs Otrivine Child Nasal Drops should be stopped

• Keep medicines out of reach and sight of children

• Expectant mothers should consult their doctors before using Otrivine Child Nasal Drops for themselves

• Use with caution in occlusive vascular disease

• Keep away from the eyes

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

MAOIs and /or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis

•Moclobemide: risk of hypertensive crisis

•Antihypertensives (including adrenergic neurone blockers & beta-blockers):

Otrivine Child Nasal Drops may block the hypotensive effects

•Cardiac glycosides: increased risk of dysrhythmias

•Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

•Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension

•Oxytocin– risk of hypertension

4.6 Pregnancy And Lactation

No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine Child Nasal Drops during pregnancy.

Label warning: Expectant mothers should consult their doctor before using Otrivine Child Nasal Drops for themselves

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.

Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Otrivine Child Nasal Drops to people with cardiovascular disease.

Oral agents

Cardiovascular effects

• Tachycardia/palpitations

• Other cardiac dysrhythmias and hypertension

•CNS effects

• Irritability

• Anxiety

• Restlessness

• Excitability

• Insomnia

• Hallucinations and paranoid delusions

Skin reactions including rash

Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics

Other reactions

• Nausea and/or vomiting

• Headache

• Urinary retention

Topical agents

• Local effects – irritation and dryness

• Nausea

• Headache

• Rebound congestion (rhinitis medicamentosa) – especially with prolonged and/or heavy use

• Tolerance with diminished effect – especially with prolonged and/or heavy use

• Cardiovascular effects (as with oral agents) particularly with prolonged and/or excessive use

• CNS effects (as with oral agents) particularly with prolonged and/or excessive use

4.9 Overdose

No cases of overdosage in adults have yet been reported. In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure, drowsiness, respiratory depression or irregularity. There is no specific treatment and appropriate supportive treatment should be initiated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Otrivine Child Nasal Drops is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. The effect of Otrivine Child Nasal Drops begins within a few minutes and lasts for up to 10 hours. Otrivine Child Nasal Drops is generally well tolerated and does not impair the function of ciliated epithelium.

In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the decongestant effect of Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

5.2 Pharmacokinetic Properties

Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.

5.3 Preclinical Safety Data

There are no findings in the preclinical testing which are of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Disodium phosphate dodecahydrate (Sodium phosphate)

Disodium edetate

Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)

Sodium chloride

Sorbitol

Hypromellose

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

Unopened: 36 months

After the container is opened for the first time: 28 days

6.4 Special Precautions For Storage

Protect from heat

6.5 Nature And Contents Of Container

Bottle: High density polyethylene

Cap: Polypropylene

Pipette rod: Low density polythene

Pipette bulb: Halogenated butyl elastomer

Carton: Cardboard

The pipette forms an integral part of the cap.

Pack size: 10 ml

6.6 Special Precautions For Disposal And Other Handling

Keep all medicines out of the reach of children

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0114

9. Date Of First Authorisation/Renewal Of The Authorisation

15 November 2003

10. Date Of Revision Of The Text

22 December 2009

Legal Category: P