Leaflet: information for the user

Polaramine 0.4 mg/ml syrup

dexchlorpheniramine maleate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Polaramine is and for what it is used

2. What you need to know before starting to take Polaramine

3. How to take Polaramine

4. Possible side effects

5. Storage of Polaramine

6. Contents of the pack and additional information

Dexclorfeniramina belongs to a group of medications known as antihistamines.

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

Do not take Polaramine

• if you are allergic to dexchlorpheniramine maleate or any of the other ingredients of this medication (listed in section 6).
• Polaramine should not be administered to newborns and premature infants.
• if you are under treatment with a type of antidepressant known as monoamine oxidase inhibitors (MAO) or within two weeks of discontinuing treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Polaramine.

• if you have narrow-angle glaucoma, a certain type of stomach ulcer (stenosing), pyloric obstruction, prostate disease, or urinary tract obstruction, cardiovascular diseases, including hypertension, or if you have increased intraocular pressure or thyroid disease.
• 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 have not been established in children under 2 years, so it should not be administered to these patients. Polaramine may cause nervousness and restlessness, especially in children.

Polaramine with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

A type of antidepressant known as monoamine oxidase inhibitors prolongs and intensifies the effect of antihistamines, potentially causing severe hypotension, i.e., severe drops in blood pressure.

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

Medications in the Polaramine group (antihistamines) may reduce the action of oral anticoagulants, so you should consult with your doctor before taking Polaramine.

Polaramine with food, drinks, and alcohol

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

Interaction with laboratory tests

Polaramine treatment should be discontinued at least 48 hours before any skin allergy test, as medications in the Polaramine group (antihistamines) may mask the results of these tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Polaramine should not be administered during the third trimester of pregnancy due to the risk of severe reactions in newborns and premature infants to antihistamines.

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

Breastfeeding

The excretion of Polaramine in human milk is unknown, so you should consult with your doctor if you are breastfeeding.

Driving and operating machinery

Polaramine may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.

Polaramine contains saccharose

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Polaramine contains ethanol

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

Polaramine contains sorbitol

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Polaramine contains Ponceau 4R (E-124) colorant

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

Use in children

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

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

Administration form

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

If you take more Polaramine than you should

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

If you forgot to take Polaramine

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not everyone will experience them.

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

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Polaramine

• The active principle is dexchlorpheniramine maleate. Each ml of syrup contains 0.4 mg of dexchlorpheniramine maleate.
• The other components are ethanol, sucrose, sodium citrate, sodium chloride, sorbitol, methylparaben, propylparaben, menthol, orange and peach flavors, Ponceau 4R (E-124) colorant, and purified water.

Appearance of the product and contents of the packaging

Clear syrup, red in color, and free of foreign matter.

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

A dosing syringe is included.

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing

SAG Manufacturing S.L.U.

Km. 36 National Highway I

28750 San Agustín de Guadalix

Madrid, Spain

Last review date of this leaflet: March 2007

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/