PHARMACOLOGICAL CLASSIFICATION: A.10.1 Antitussives and expectorants.
INDICATIONS: The alleviation of cough.
CONTRA-INDICATIONS: Hypersensitivity to any of the ingredients. RELIEF-COFF EXPECTORANT solution is contra-indicated in the presence of impaired hepatic or renal function and during an attack of asthma. Safety in pregnancy and lactation has not been established.
WARNINGS: The use of RELIEF-COFF EXPECTORANT solution leads to drowsiness and impaired concentration which is aggravated by the simultaneous intake of alcohol and it is unsafe to drive a vehicle or be in charge of machinery while using this medicine, as impaired decision making could lead to accidents.
DOSAGE AND DIRECTIONS FOR USE: Adults: 5 to 10 mL, every three to four hours.
Children 6 to 12 years: 2,5 to 5 mL every four hours.
The safety in children under 6 years has not been established.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The most common side-effect caused by diphenhydramine is sedation which includes drowsiness, inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination. Other side-effects include gastro-intestinal disturbances, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of mouth and tightness of chest, tingling, heaviness and weakness of the hands, constipation, diarrhoea, epigastric pain, nausea, vomiting, allergic (hypersensitivity) reactions, epileptiform seizures, euphoria, extrapyramidal effects, haemolytic anaemia, leucopenia, thrombocytopenia and photosensitisation of the skin. Symptoms of stimulation such as insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions may also occur.
RELIEF-COFF EXPECTORANT should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary oedema and toxaemia of pregnancy. It should also be used with caution in patients with cardiovascular disease, glaucoma, liver impairment, prostatic hypertrophy and patients with urinary retention.
Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects.
The positive results of skin allergy tests may be suppressed.
Side-effects that may arise from large doses of ammonium chloride are nausea, vomiting, thirst, headache, hyperventilation, progressive drowsiness, mental confusion, hyperchloraemic acidosis and hypokalaemia.
Extreme caution should be exercised by patients taking RELIEF-COFF EXPECTORANT in conjunction with nervous system depressants such as alcohol, barbiturates, hypnotics, narcotics and analgesic sedatives and tranquillizers and anticholinergic agents and tricyclic antidepressants as their effects may be enhanced by diphenhydramine.
Monoamine-oxidase inhibitors may enhance the anticholinergic effects of diphenhydramine hydrochloride.
The warning signs of damage caused by ototoxic medicines may be masked by diphenhydramine hydrochloride.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Retention of sodium leads to the accumulation of fluid, with cerebral oedema and peripheral and pulmonary oedema.
Symptoms of hypernatraemia may include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypotension, tachycardia, delirium, hyperpnoea and respiratory arrest. Other symptoms of overdosage are gastro-intestinal upset, drowsiness, hypochloraemic acidosis and hypokalaemia.
Overdosage may be fatal, especially in children in whom main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hypotension, drowsiness, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia, respiratory collapse, death may occur from respiratory failure.
Treatment is symptomatic and supportive.
IDENTIFICATION: A clear brown syrupy liquid.
PRESENTATION: 100 mL, 200 mL, 2,5L and 25 litre containers.
STORAGE INSTRUCTIONS: Store in a cool place, below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 27/10.1/0140
NAME AND BUSINESS ADDRESS OF THE APPLICANT: MDI CC
374 Anderson Street
DATE OF PUBLICATION OF THIS PACKAGE INSERT: April 1996