Source: Health Sciences Authority (SG) Revision Year: 2011 Publisher: <u>Manufacturer:</u> Sunward Pharmaceutical Sdn. Bhd., No. 9,11&17, Jalan Kempas 4, Taman Perindustrian Tampoi Indah, 81200 Johor Bahru, Johor, Malaysia. Tel: 07-2367531, 2367967, 2367972 Fax: 07-2367532 ...
Hypersensitivity to any of its ingredients.
Do not use in the newborn, in premature infants, in nursing mothers, in patients with severe hypertension or severe coronary, artery disease or in those receiving monoamine oxidase (MAO) inhibitors.
Sympathomimetics should be used with caution in patients with hypertension, hyperthyroidism, diabetes mellitus and cardiovascular disease. Antihistamines should be used with caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy and bladder neck obstruction.
Antihistamines should not be used to treat lower respiration tract conditions including asthma. Not to be used for chronic persistent cough accompanying a disease state or for cough associated with excessive secretions.
Should be used with caution in patients with Bronchial asthma, Arrhythmias, Glaucoma, Ischemic Heart Disease and Renal Failure.
Use in children: Safety and effectiveness of this product have not been established in children below 2 years.
Use in elderly: Antihistamines may cause dizziness, sedation and hypotension in patients above 60 years. These patients are also more likely to have adverse reactions to sympathomimetics. Elderly patients may be particularly sensitive to Central Nervous system Effects.
Not recommended for children below 2 years.
Use with caution and on doctor’s/pharmacist’s advice in children 2 to 6 years of age.
Anti-histamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquillisers, antianxiety agents, etc). These drugs may potentiate the sedative effect of dexchlorpheniramine.
The action of oral anticoagulants may be inhibited by antihistamines. Monoamine oxidase inhibitors prolong and intensify the anti-cholinergic (drying) effects of antihistamines and potentiate the pressor effects of sympathomimetics. Pseudoephedrine-containing drugs should not be given to patients treated with a MAOI or within 10 days of discontinuing such treatment. Pseudoephedrine should not be used with ganglionic-blocking agents or with adrenergics-blocking agents. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis.
Safety during pregnancy has not been established.
It is not known whether this product is excreted in human milk and therefore caution should be exercised when administered to nursing mothers.
Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating machinery.
The most frequent adverse reactions are: sedation, dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness.
Other adverse reactions may include:
Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.
Cardiovascular system: Hypotension, hypertension, cardiac arrhythmias, and palpitation.
Hematologic system: Hemolytic anemia, thrombocytopenia, agranulocytosis.
Nervous system: Disturbed coordination, nervousness, tremor, irritability, insomnia, vision disturbances, convulsions, headache, euphoria and dysphoria.
Gastrointestinal system: Epigastric distress, anorexia, nausea, vomiting, diarrhoea, constipation.
Urinary system: Urinary frequency, difficult urination, and urinary retention.
Respiratory system: Tightness of chest and wheezing, shortness of breath.
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