POLARAMINE 0.4 mg/ml SYRUP

Introduction

Package Leaflet: Information for the User

Polaramine 0.4 mg/ml Syrup

dexclorfeniramine maleate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Polaramine and what is it used for
2. What you need to know before you take Polaramine
3. How to take Polaramine
4. Possible side effects
5. Storage of Polaramine
6. Contents of the pack and further information

1. What is Polaramine and what is it used for

Dexclorfeniramine belongs to a group of medicines known as antihistamines.

Polaramine is indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, uncomplicated mild allergic skin manifestations of urticaria and angioedema, and reactions to blood or plasma. It is also indicated in the treatment of anaphylactic reactions in conjunction with adrenaline or other appropriate measures, after controlling acute manifestations. Polaramine often relieves skin manifestations such as allergic eczema, atopic dermatitis, and contact dermatitis, insect bites, dermatographism, and drug reactions.

2. What you need to know before you take Polaramine

Do not take Polaramine

• if you are allergic to dexclorfeniramine maleate or any of the other ingredients of this medicine (listed in section 6).
• Polaramine should not be administered to newborns and premature infants.
• If you are under treatment with a special type of antidepressants known as monoamine oxidase inhibitors (MAOIs) or during the two weeks following treatment interruption.

Warnings and precautions

Consult your doctor or pharmacist before taking Polaramine

• If you have narrow-angle glaucoma, certain types of stomach ulcers (stenosing), pyloroduodenal obstruction, prostate or urethral stricture, cardiovascular diseases, including hypertension, or if you have increased intraocular pressure or thyroid diseases.
• If you are over 60 years old, as Polaramine may cause dizziness, sedation, and hypotension in patients over 60 years old.

Children

The safety and efficacy of Polaramine in children under 2 years of age have not been established, so it should not be administered to these patients. Polaramine may cause nervousness and restlessness, especially in children.

Taking Polaramine with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

A special type of antidepressants known as monoamine oxidase inhibitors (MAOIs) prolong and intensify the effect of antihistamines, which may cause severe hypotension, i.e., severe drops in blood pressure.

The simultaneous use of Polaramine with tricyclic antidepressants, barbiturates, or other medicines that act on the central nervous system may potentiate the sedative effect of Polaramine.

Medicines of the Polaramine group (antihistamines) may decrease the action of oral anticoagulants, so you should consult your doctor before taking Polaramine.

Taking Polaramine with food, drinks, and alcohol

The simultaneous use of Polaramine with alcohol may potentiate the sedative effect of Polaramine.

Interaction with laboratory tests

Treatment with Polaramine should be suspended at least 48 hours before performing any skin allergy test, as medicines of the Polaramine group (antihistamines) may mask the result of these tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Polaramine should not be administered during the third trimester of pregnancy because newborns and premature infants may have severe reactions to antihistamines.

During the first two trimesters of pregnancy, Polaramine should only be used if your doctor considers it necessary.

Breastfeeding

It is unknown whether Polaramine is excreted in human milk, so you should consult your doctor if you are breastfeeding.

Driving and using machines

Polaramine may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Polaramine contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Polaramine contains ethanol

This medicine contains 0.5% ethanol (alcohol), which corresponds to 24 mg/5 ml.

Polaramine contains sorbitol

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Polaramine contains the colorant Ponceau 4R (E-124)

This medicine may cause allergic reactions because it contains the colorant Ponceau 4R (E-124).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Polaramine

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate your individualized dose according to the needs of the disease and your response.

In adults and children from 12 years old: the recommended dose is 2 mg (5 ml) 3 or 4 times a day.

Use in children

Children from 6 to 12 years old: 1 mg (2.5 ml) 3 or 4 times a day.

Children from 2 to 6 years old: 0.5 mg (1.25 ml) 3 or 4 times a day.

Method of administration

Take the corresponding dose prescribed by your doctor with the dosing syringe.

If you take more Polaramine than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Polaramine

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The most frequently observed adverse effect with the use of Polaramine (antihistamines) is mild to moderate drowsiness. Rarely, general adverse effects such as urticaria, skin rash, severe allergic reactions (anaphylactic shock), sensitivity to light, excessive sweating, chills, dry mouth, nose, and throat have been reported.

Other adverse effects that may occur with the use of antihistamines are: cardiovascular reactions, blood reactions, nervous system reactions, gastrointestinal reactions, genitourinary reactions, and respiratory reactions.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Polaramine

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 protect the environment.

6. Contents of the pack and further information

Composition of Polaramine

• The active substance is dexclorfeniramine maleate. Each ml of syrup contains 0.4 mg of dexclorfeniramine maleate.
• The other ingredients are ethanol, sucrose, sodium citrate dihydrate, sodium chloride, sorbitol, methylparaben, propylparaben, menthol, apricot flavor, orange flavor, colorant Ponceau 4R (E-124), and purified water.

Appearance and packaging

Clear, red syrup, free of foreign matter.

High-density polyethylene plastic bottle, white opaque. Each bottle contains 60 ml of syrup.

A dosing syringe is included.

Marketing authorization holder and manufacturer

Manufacturer

SAG Manufacturing S.L.U.

Km. 36 Carretera Nacional I

28750 San Agustín de Guadalix

Madrid, Spain

Date of last revision of this leaflet: March 2007

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/