Package Insert: Information for the User

POLARAMINE 5 mg/ml INJECTABLE SOLUTION

dexclorpheniramine maleate

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

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What is Polaramine 5 mg/ml injectable solution and how it is used

2. Before using Polaramine 5 mg/ml injectable solution

3. How to use Polaramine 5 mg/ml injectable solution

4. Possible adverse effects

5. Storage of Polaramine 5 mg/ml injectable solution

6. Additional information

Polaramine 5 mg/ml injectable solution is presented in the form of an injectable solution.The active ingredient of Polaramine is dexclorfeniramina which belongs to a group of medicines known as antihistamines (used to treat allergies) that compete with histamine for receptor sites on effector cells.

Polaramine is indicated in situations where oral administration is not practicable: for the relief of allergic reactions to blood or plasma, for the treatment of anaphylactic reactions together with adrenaline and other necessary measures after controlling acute manifestations and in other immediate type uncomplicated allergic conditions when oral treatment is impossible or contraindicated.

Do not use Polaramine 5 mg/ml injectable solution

• if you are allergic (hypersensitive) to dexclorfeniramina maleate or to any of the other components of Polaramine or to other antihistamines with 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 (MAO) inhibitors or during the two weeks following the interruption of treatment.

Be especially careful with Polaramine 5 mg/ml injectable solution

• if you have narrow-angle glaucoma, a certain type of stomach ulcer (stenosing), pyloric obstruction, prostate disease or urinary bladder neck constriction, bronchial asthma and increased intraocular pressure, thyroid diseases, cardiovascular diseases, including hypertension.
• if you are over 60 years old, as in patients over 60 years old, Polaramine may cause dizziness, sedation and drops in blood pressure.
• Polaramine may cause excitement, especially in children.
• if you are using Polaramine, do not perform activities that require maximum attention, such as driving a car or operating instruments or machinery.

Use of other medications

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

A special type of antidepressants known as monoamine-oxidase inhibitors prolong and intensify the effect of antihistamines, potentially causing severe hypotension, i.e., severe drops in blood pressure.

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

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

Interaction with laboratory tests

The 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 results of these tests.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Polaramine should not be administered during the third trimester of pregnancy due to the fact that the newborn and premature children may have severe and severe reactions to antihistamines.

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

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

Driving and operating machines

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

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

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

Adults: The dose should be individualized according to the patient's need and response. The recommended dose is 5 mg (1 ampule) administered via intravenous or deep intramuscular injection. The maximum daily dose is 20 mg (4 ampules). 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, phone 91 562 04 20.

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

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

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

Like all medications, Polaramine can produce adverse effects, although not all people experience them.

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

General:urticaria, drug rash, 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, seizures.

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

Genitourinary:polyuria, difficulty urinating, urinary retention, shortened menstrual cycles.

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use Polaramine 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 the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Polaramine 5 mg/ml injectable solution

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

Appearance of the product and contents of the package

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid - Spain

Responsible for manufacturing:

Cenexi HSC

2, rue Louis Pasteur

14200 Hérouville Saint-Clair, France

This leaflet was approved in March 2007

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