Polaramine 5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

POLARAMINE 5 mg/ml INJECTION SOLUTION

dexchlorpheniramine maleate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Polaramine 5 mg/ml injection solution is and what it is used for
2. Before you use Polaramine 5 mg/ml injection solution
3. How to use Polaramine 5 mg/ml injection solution
4. Possible side effects
5. How to store Polaramine 5 mg/ml injection solution
6. Further information

1. What POLARAMINE 5 mg/ml INJECTION SOLUTION is and what it is used for

Polaramine 5 mg/ml injection solution is presented as an injectable solution. The active substance in Polaramine is dexchlorpheniramine, which belongs to a group of medicines known as antihistamines (used to treat allergy) that compete with histamine for receptor sites on effector cells.

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

2. BEFORE USING POLARAMINE 5 mg/ml INJECTION SOLUTION

Do not use Polaramine 5 mg/ml injection solution

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

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

• if you are being treated with a special type of antidepressants known as monoamine oxidase inhibitors (MAO inhibitors), or during the two weeks following discontinuation of such treatment.

Take special care with Polaramine 5 mg/ml injection solution

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

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

A special type of antidepressants known as monoamine oxidase inhibitors (MAO inhibitors) prolong and intensify the effects of antihistamines, possibly causing severe hypotension (i.e., serious drop in blood pressure).

Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates, or other medicines acting on the central nervous system may enhance the sedative effect of dexchlorpheniramine.

Medicines in the Polaramine group (antihistamines) may reduce the effect of oral anticoagulants; therefore, you should consult your doctor before using Polaramine.

Interaction with laboratory tests

Treatment with Polaramine should be discontinued at least 48 hours before any skin allergy testing, as medicines in the Polaramine group (antihistamines) may mask the results of such tests.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Polaramine must not be administered during the third trimester of pregnancy, as newborns and premature infants may experience severe, serious reactions to antihistamines.

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

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

Driving and use of machines

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

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

Follow exactly the administration instructions for Polaramine provided 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 needs and response. The recommended dose is 5 mg (1 ampoule) administered by intravenous or deep intramuscular route. 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 fluid; administer it separately.

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

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 missed doses.

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

4. Possible adverse effects

Like all medicines, Polaramine may cause adverse effects, although not everyone experiences them.

The most common adverse effect caused by dexchloropheniramine maleate is drowsiness. Other possible adverse effects include those attributable to its anticholinergic properties, as well as those commonly observed with antihistamines, such as:

General: urticaria, drug eruption, severe allergic reactions (anaphylactic shock), photosensitivity, excessive sweating, chills, dryness of mouth, nose, and throat.
Cardiovascular: headache, palpitations, tachycardia, extrasystoles, hypotension.
Hematological: hemolytic anemia, hypoplastic anemia, thrombocytopenia, agranulocytosis.
Neurological: sedation, dizziness, vertigo, tinnitus, acute labyrinthitis, coordination disturbances, fatigue, confusion, restlessness, excitement, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, hysteria, neuritis, convulsions.

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

Genitourinary: polyuria, difficulty in urination, urinary retention, shortened menstrual cycles.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. STORAGE OF POLARAMINE 5 mg/ml INJECTION SOLUTION

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use Polaramine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Polaramine 5 mg/ml injectable solution

• The active substance is dexchlorpheniramine maleate, 5 mg per 1 ml ampoule.
• The other components are sodium hydroxide for pH adjustment, nitrogen, and water for injections.

Appearance of the product and contents of the container

Polaramine 5 mg/ml injectable solution is presented as an injectable solution. Clear, colourless solution free from foreign particles.

Type I glass ampoules. Each pack contains 5 ampoules of 1 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 leaflet was last approved in March 2007

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