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Logo RINEX DIFFUCAPS (capsules)
RINEX SYRUP
RINEX PED SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

RINEX DIFFUCAPS (capsules)
RINEX SYRUP
RINEX PED SYRUP

COMPOSITION:
Rinex Diffucaps
Each capsule contains:
Chlorpheniramine maleate         12 mg
Phenylpropanolamine hydrochloride         30 mg
Phenylephrine hydrochloride         20 mg
Rinex Syrup
Each 5 mL contains:
Chlorpheniramine maleate         4 mg
Phenylpropanolamine hydrochloride         5 mg
Phenylephrine hydrochloride         5 mg
Nipasept (as preservative) 0,08% m/v
Alcohol 4,3% v/v
Rinex Ped Syrup
Each 5 mL contains:
Chlorpheniramine maleate         2 mg
Phenylpropanolamine hydrochloride         2,5 mg
Phenylephrine hydrochloride         2,5 mg
Nipasept (as preservative) 0,08% m/v
Alcohol 4,3% v/v

PHARMACOLOGICAL CLASSIFICATION:
A5.8 Preparations for the common cold, including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
The combination has antihistaminic and sympathomimetic properties.

INDICATIONS:
For the symptomatic relief of colds and flu and for the relief of symptoms associated with allergic rhinitis.

CONTRA-INDICATIONS:
Antihistamines should not be given to premature infants or neonates, and are also contra-indicated during acute attacks of asthma.
Sympathomimetics should not be given to patients being treated with monoamine oxidase inhibitors or within two weeks of stopping such treatment.
Safety in pregnancy and lactation has not been established.

WARNING:
The use of this medicine may cause drowsiness and impaired concentration, which is aggravated by the simultaneous intake of alcohol and other central nervous system depressants; patients so affected should not drive or operate machinery.

DOSAGE AND DIRECTIONS FOR USE:
Rinex Diffucaps
Adults and children 12 years and older: one capsule every 8 - 12 hours.
Rinex Syrup
Adults and children 12 years and older: one medicine measure 3 to 4 times daily.
Children 4 - 12 years: half a medicine measure 3 to 4 times daily.
NOT FOR CHILDREN UNDER 4 YEARS OF AGE.
Rinex Ped Syrup
Children 4 - 12 years: one medicine measure 3 to 4 times daily.
Children under 4 years: half a medicine measure 3 to 4 times daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effect of chlorpheniramine, an antihistamine, is sedation varying from slight drowsiness to deep sleep, and including lassitude, dizziness and inco-ordination. Sedative effects, when they occur, may diminish after a few days. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite and epigastric pain. Chlorpheniramine may also produce antimuscarinic effects including blurred vision, difficulty in micturition, dysuria, dryness of the mouth, and tightness of the chest. Other central effects include hypotension, muscular weakness, tinnitus, euphoria, and occasionally headache.
Paradoxical central nervous system stimulation may occur, especially in children, with insomnia, nervousness, tachycardia, tremors and convulsions. Blood disorders, including agranulocytosis, leucopenia and haemolytic anaemia, though rare, have been reported. Allergic reactions and cross-sensitivity to related drugs may occur, and photosensitivity has also been reported.
Chlorpheniramine should be used with care in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy. Monoamine oxidase inhibitors may enhance the antimuscarinic effects of chlorpheniramine which also has an additive antimuscarinic action with other antimuscarinic drugs such as atropine and tricyclic antidepressants. Chlorpheniramine may enhance the sedative effects of central nervous system depressants, including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquilizers. It may also suppress positive skin test results and should thus be stopped several days before the test.
Central effects of phenylpropanolamine and phenylephrine, both sympathomimetic agents, include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states.
Appetite may be reduced, and nausea and vomiting may occur. Cardiac effects include rise in blood pressure which may produce cerebral haemorrhage and pulmonary oedema, tachycardia and cardiac arrhythmias, anginal pain, palpitations and cardiac arrest; hypotension with dizziness and fainting, and flushing may occur. Other effects include difficulty in micturition and urinary retention, dyspnoea, altered metabolism including disturbances of glucose metabolism, sweating, and hypersalivation. Headache is also common.
This medicine should be used with caution in patients who may be hypersusceptible to the effects of sympathomimetics, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease; arrhythmias or tachycardia; occlusive vascular disorders, including arteriosclerosis; hypertension; or aneurysms. Anginal pain may be precipitated in patients with angina pectoris. Care is also required when sympathomimetics are given to patients with diabetes mellitus or closed-angle glaucoma. They should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as they may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if they are given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Reversal of action of many antihypertensive agents occurs in patients given sympathomimetics, and therefore special care is advisable in patients receiving antihypertensive therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The main symptoms of overdosage with chlorphenamine in infants and children include ataxia, excitement, hallucinations, muscular tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults, the usual symptoms are drowsiness, coma and convulsions. Hypotension may also occur. Elderly patients are more susceptible to these central nervous system depressant and hypotensive effects even at therapeutic doses.
Overdosage with phenylpropanolamine may cause giddiness, headache, nausea, vomiting, sweating, thirst, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia.
Overdosage with phenylephrine may cause headache, hypertension, palpitations and vomiting.
Unless contra-indications exist, the stomach should be emptied by gastric lavage. Further treatment is symptomatic and supportive.

IDENTIFICATION:
Rinex Diffucaps Transparent orange/clear capsule containing blue and white pellets.
Rinex Syrup A red flavoured syrup.
Rinex Ped Syrup A red flavoured syrup.

PRESENTATION:
Rinex Diffucaps Bottles of 16 and 100 capsules. Blister packs of 10 capsules.
Rinex Syrup Bottles of 100 mL and 2,5 litre polyethylene cans.
Rinex Ped Syrup Bottles of 50 mL, 100 mL and 350 mL and 2,5 litre polyethylene cans.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Rinex Diffucaps N/5.8/67
Rinex Syrup M/5.8/125
Rinex Ped Syrup Q/5.8/87

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
TRIOMED (Pty) Ltd
6b Phumelela Park
Montague Drive, Montague Gardens, 7441

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 September 1992

        101235                7/2000        Unified

Current: October 2002
Source: Community Pharmacy

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