POLARAMINE 5 mg/ml INJECTABLE SOLUTION

2. BEFORE USING POLARAMINE 5 mg/ml INJECTABLE SOLUTION

Do not use Polaramine 5 mg/ml injectable solution

• if you are allergic (hypersensitive) to dexclorfeniramine maleate or to any of the other components of Polaramine or to other antihistamines with a similar chemical structure.

• Polaramine should not be administered to children under two years of age.

• if you are under treatment with a special type of antidepressants known as monoamine oxidase inhibitors (MAOIs) or during the two weeks following the interruption of treatment.

Be careful with Polaramine 5 mg/ml injectable solution

• if you have narrow-angle glaucoma, certain types of stomach ulcers (stenosing), pyloroduodenal obstruction, prostate diseases, or urethral stricture, bronchial asthma, and increased intraocular pressure, thyroid diseases, cardiovascular diseases, including arterial hypertension.
• if you are over 60 years old, as Polaramine may cause dizziness, sedation, and hypotension in patients over 60 years old.
• Polaramine may cause excitement, especially in children.
• if you are using Polaramine, you should not engage in activities that require maximum attention, such as driving a car or operating instruments or machinery.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

A special type of antidepressant known as monoamine oxidase inhibitors (MAOIs) prolongs and intensifies the effect of antihistamines, which can cause severe hypotension, i.e., severe drops in blood pressure.

The simultaneous use of antihistamines with alcohol, tricyclic antidepressants, barbiturates, or other medications that act on the central nervous system can potentiate the sedative effect of dexclorfeniramine.

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

Interaction with laboratory tests

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Polaramine should not be administered during the third trimester of pregnancy, as 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.

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.

3. HOW TO USE POLARAMINE 5 mg/ml INJECTABLE SOLUTION

Follow exactly the administration instructions of Polaramine indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

Polaramine 5 mg/ml injectable solution should be administered by healthcare personnel.

Adults: The dose should be individualized according to the need and response of the patient. The recommended dose is 5 mg (1 ampoule) administered intravenously or by deep intramuscular injection. The maximum daily dose is 20 mg (4 ampoules). In the case of a reaction during a transfusion, do not administer Polaramine in the transfusion, but separately.

If you use more Polaramine 5 mg/ml injectable solution than you should

If you have used more Polaramine than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20.

If you forget to use Polaramine 5 mg/ml injectable solution

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

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

4. Possible side effects

Like all medications, Polaramine can cause side effects, although not everyone experiences them.

The most frequent side effect produced by dexclorfeniramine maleate is drowsiness. Other possible side effects include those attributable to its anticholinergic properties, as well as those common to antihistamines, such as:

General:urticaria, drug eruption, severe allergic reactions (anaphylactic shock), sensitivity to light, excessive sweating, chills, dry mouth, nose, and throat. Cardiovascular:headache, palpitations, tachycardia, extrasystoles, hypotension. Hematologic:hemolytic anemia, hypoplastic anemia, thrombocytopenia, agranulocytosis. Neurological:sedation, dizziness, vertigo, tinnitus, acute labyrinthitis, coordination disorders, fatigue, confusion, restlessness, excitement, nervousness, tremors, irritability, insomnia, euphoria, paresthesias, blurred vision, hysteria, neuritis, convulsions.

Gastrointestinal:epigastric pain, anorexia, nausea, vomiting, diarrhea, constipation.

Genitourinary:polyuria, difficulty urinating, urinary retention, shortening of menstrual cycles.

Respiratory:thickened bronchial secretions, chest oppression, nasal obstruction, wheezing.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of POLARAMINE 5 mg/ml INJECTABLE SOLUTION

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use Polaramine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Polaramine 5 mg/ml injectable solution

• The active ingredient is dexclorfeniramine maleate, 5 mg per 1 ml ampoule.
• The other components are sodium hydroxide for pH adjustment, nitrogen, and water for injectable preparations.

Appearance of the product and packaging content

Polaramine 5 mg/ml injectable solution is presented in the form of an injectable solution. Clear, colorless, and free of foreign particles.

Glass ampoules Type I. Each package contains 5 ampoules of 1 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid - Spain

Manufacturer:

Cenexi HSC

2, rue Louis Pasteur

14200 Hérouville Saint-Clair, France

This package leaflet was approved in March 2007

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