POLARAMINE Film-coated tablet / Syrup (2017)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Polaramine, Tablets, film-coated – dexchlorpheniramine maleate 2 mg. Polaramine, Syrup dexchlorpheniramine maleate 2 mg/5 mL (0.4 mg/mL).

Qualitative and quantitative composition

Qualitative Composition in terms of the active ingredient: All formulations: dexchlorpheniramine maleate. Quantitative Composition in terms of the active ingredient: Polaramine Tablets: dexchlorpheniramine ...

Pharmaceutical form

Polaramine Tablets Film-coated, immediate release tablets for oral use. Off-white, round, bevelled tablets with a score-line on one side. The score line is not intended for breaking the tablet. Polaramine ...

Therapeutic indications

Polaramine is indicated for symptomatic treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, mild uncomplicated allergic skin manifestations of urticaria ...

Posology and method of administration

Polaramine Tablets Adults and children over 12 years: One tablet every 6 hours. Polaramine Syrup Adults and children over 12 years: 5 mL every 6 hours. Children 6-12 years: 2-4 mL ...

Contraindications

Polaramine is contraindicated for use in: newborns and premature infants. patients taking monoamine oxidase inhibitors (MAOIs) (see Interactions with other medicines section) patients with a history of ...

Special warnings and precautions for use

Polaramine may cause drowsiness and may add to the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided. Polaramine ...

Interaction with other medicinal products and other forms of interaction

The following interactions with Polaramine have been noted: central nervous system (CNS) depressants (alcohol, sedatives, opioid analgesics, hypnotics) may cause an increase in sedative effects of Polaramine ...

Pregnancy and lactation

Pregnancy (Category A) Safety during pregnancy has not been established. Polaramine should be used during the first two trimesters of pregnancy only if clearly needed. Dexchlorpheniramine maleate should ...

Effects on ability to drive and use machines

Polaramine may cause drowsiness and may add to the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.

Undesirable effects

Slight to moderate drowsiness is the most frequent side effect of dexchlorpheniramine maleate. Other reported reactions associated with antihistamine therapy in general include: General: Urticaria, ...

Overdose

Manifestations Antihistamine overdosage effects may vary from central nervous system depression (apnoea, arrhythmias, cardiovascular collapse, cyanosis, diminished mental alertness, sedation) to stimulation ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Antihistamines for systemic use – substituted alkylamines ATC Code: R06AB02 Mechanism of Action Dexchlorpheniramine, the d-isomer of the racemic compound chlorpheniramine, is ...

Pharmacokinetic properties

The absorption, distribution, metabolism and elimination of dexchlorpheniramine have not been specifically described. However, since dexchlorpheniramine is the primary active isomer of the racemic compound ...

List of excipients

Polaramine Tablets: Lactose, starch-maize, starch – pregelatinised maize, magnesium stearate. Polaramine Syrup: Sodium citrate, sodium chloride, sucrose, sorbitol solution (70 per cent), ...

Incompatibilities

Not applicable.

Shelf life

Polaramine Tablets: 36 months (3 years) from date of manufacture. Polaramine Syrup: 36 months (3 years) from date of manufacture.

Special precautions for storage

Tablets: Store at or below 25°C. Syrup: Store at or below 25°C.

Nature and contents of container

Polaramine Tablets: Available in blister packs of 20 and 40 tablets. Polaramine Syrup: Available in a glass bottle of 100 mL.

Special precautions for disposal and other handling

Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Marketing authorization holder

Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, Auckland 0627, P. O. Box 2825, Shortland Street, Auckland 1140, Freephone 0800 229 379

Date of first authorization / renewal of the authorization

31 December 1969

Date of revision of the text

7 December 2017

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