POLARAMINE Film-coated tablet / Syrup Ref.[8573] Active ingredients: Dexchlorpheniramine

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 should be used with caution in patients with:

• narrow-angle glaucoma
• stenosing peptic ulcer
• prostatic hypertrophy

Polaramine Data Sheet

• bladder neck obstruction
• pyloroduodenal obstruction
• cardiovascular disease including hypertension
• increased intraocular pressure
• hyperthyroidism
• use with caution in patients with renal or hepatic impairment
• seizures

Polaramine may cause photosensitivity in some patients.

Paediatric Use

Children may experience paradoxical excitation with dexchlorpheniramine maleate. In children this may cause excitability.

Polaramine Syrup contains sorbitol, which may have a laxative effect or cause diarrhoea.

Use in the Elderly

The elderly may experience paradoxical excitation with dexchlorpheniramine maleate. In patients over 60 years of age, antihistamines may cause dizziness, sedation and hypotension. Also they are more likely to have central nervous system (CNS) depressive side effects, including confusion.

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
• concomitant administration with tricyclic antidepressants (TCAs) may result in additive antimuscarinic activity
• monoamine oxidase inhibitors (MAOIs) may prolong and intensify the anticholinergic and CNS depressive effects of some antihistamines and may cause a decrease in blood pressure
• oral anticoagulants may have their actions decreased by antihistamines.

Effect on laboratory tests

Antihistamines should be discontinued approximately 48 hours prior to skin testing procedures since these medicines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

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 not be used in the third trimester of pregnancy because newborn and premature infants may have severe reactions to antihistamines.

Polaramine has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects of on the foetus having been observed.

Lactation

Polaramine is excreted in breast milk. Therefore caution should be exercised when administered to nursing mothers.

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.

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, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat

Cardiovascular: Hypotension, hypertension, headache, palpitations, tachycardia, extrasystoles

Haematological: Haemolytic anaemia, hypoplastic anaemia, thrombocytopenia, agranulocytosis

Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhoea, constipation

Genitourinary: Urinary frequency, difficult urination, urinary hesitation and retention, early menses

Nervous System: Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paraesthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions, lassitude, depression, inability to concentrate, dilated pupils, hypereflexia, hyporeflexia, xerostomia, hallucinations, appetite stimulation, anxiety, facial dyskinesias and seizures

Respiratory: Thickening of bronchial secretions, tightness of chest, wheezing, nasal stuffiness

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

Not applicable.