Package Insert: Information for the User

Polaramine 2 mg Tablets

Dexchlorpheniramine Maleate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What is Polaramine and how is it used

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

3. How to take Polaramine

4. Possible adverse effects

5. Storage of Polaramine

6. Contents of the package 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 cutaneous allergic manifestations such as 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 cutaneous 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 bladder neck constriction, cardiovascular diseases, including hypertension, or if you have increased intraocular pressure or thyroid disease.
• if you are over 60 years old, as in patients over 60 years old, Polaramine may cause dizziness, sedation, and hypotension.

Children

The safety and efficacy of Polaramine have not been established in children under 6 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

The treatment with Polaramine should be suspended 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 intend to become pregnant, consult your doctor before using this medication.

Pregnancy

Polaramine should not be administered during the third trimester of pregnancy due to the fact that newborns and premature infants may have severe and serious reactions 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 through breast milk is unknown, so you should consult with your doctor if you are breastfeeding.

Driving and operating machinery

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

Polaramine contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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 one tablet 3 or 4 times a day, up to a maximum of 6 tablets a day.

Use in children

Children 6 to 12 years: a maximum total of 3 tablets divided into three doses.

Swallow the tablets with a sufficient amount of liquid – a glass of water.

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 produce 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. General adverse effects reported include urticaria, skin rash, severe allergic reactions (anaphylactic shock), light sensitivity, excessive sweating, chills, dry mouth, nose, and throat.

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 on the safety of this medication.

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

This medication does not require special storage conditions.

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.

Medications 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Polaramine

• The active principle is dexchlorpheniramine maleate. Each Polaramine tablet contains 2 mg of dexchlorpheniramine maleate.
• The other components are lactose, pregelatinized cornstarch, cornstarch, magnesium stearate, and purified water.

Appearance of the product and content of the packaging

White, round, flat, beveled edge, and scored on one of its faces tablets.

Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing

ROVI Pharma Industrial Services. S.A.

Vía Complutense, 140,

Alcalá de Henares, 28805

Madrid

Spain

Last review date of this leaflet: March 2007

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