INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo RESPINOL® COMPOUND LINCTUS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

RESPINOL® COMPOUND LINCTUS

COMPOSITION:
Each 5 mL contains:
  Pholcodine 4 mg
  Pseudoephedrine HCl 30 mg
  Chlorpheniramine Maleate 1,25 mg
  Hyoscine Methylnitrate 0,5 mg
Preservative: Nipasept 0,01% m/v
PHARMACOLOGICAL CLASSIFICATION:
10.1 (Antitussives and expectorants).

PHARMACOLOGICAL ACTION:
Pholcodine is an effective cough suppressant and is especially useful for the treatment of unproductive coughs.

Pseudoephedrine is a bronchodilator and peripheral vasoconstrictor and acts as a nasal decongestant.

Chlorpheniramine is an antihistamine for the relief of most allergic conditions.

Hyoscine has an anticholinergic action reducing nasal secretion without affecting the central nervous system.

INDICATIONS:
RESPINOL COMPOUND LINCTUS is indicated for coughs, nasal congestion and allergic conditions associated with the common cold, for vasomotor rhinitis and sinusitis. It is also indicated in bronchial asthma in young allergic asthmatics.

CONTRA-INDICATIONS
Pseudoephedrine and Hyoscine are contra-indicated in coronary thrombosis, hypertension, and hyperthyroidism. They should be administered carefully in patients with organic heart conditions, cardiac decompensation, pain caused by cardiac exertion, or patients on digitalis.

It may cause difficulty in micturition in patients with prostatic hypertrophy. It should not be administered to patients on monoamine oxidase inhibitors, or within two weeks of stopping such treatment.

Chlorpheniramine should not be administered to epileptics as it may precipitate fits. Preparations containing Chlorpheniramine or Hyoscine should be used with care in conditions such as glaucoma and prostatic hypertrophy.

Hyoscine should not be given to patients with closed angle glaucoma.

WARNING:
The use of this medicine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol, monoamine oxidase inhibitors and tricyclic antidepressants.

DOSAGE AND DIRECTIONS FOR USE:
Children 1 - 12 years:
        Half to one medicine measure (2,5 - 5,0 mL).
Older children and adults:
        One to two medicine measures (5,0 - 10,0 mL).
Dosage may be repeated three times per day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Chlorpheniramine causes drowsiness that could lead to impaired judgement when operating machinery.

Hyoscine causes dryness of the mouth, thirst, dilation of the pupils, increased intraocular pressure, hot flushes and dry skin, bradycardia followed by tachycardia, constipation and sometimes vomiting, difficulty in micturition, as well as reduction in the tone and motility of the G.I.T.

Pholcodine may cause nausea.

Pseudoephedrine may cause undesirably high blood pressure with dizziness, headache, vomiting, perspiration, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremor, anxiety, insomnia; certain patients may exhibit these symptoms with the normal therapeutic dose. Paranoid psychosis, delusions and hallucinations may also occur. Prolonged administration has no cumulative effect, but tolerance with dependence has been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The high blood pressure caused by Pseudoephedrine can be treated with an alpha adrenergic blocker such as Phentolamine mesylate, 5 - 10 mg I/V, repeated as necessary.
Overdosage with Chorpheniramine and Hyoscine can be treated by stomach pumping. Patients should be kept calm and the convulsions controlled with diazepam.
Toxic doses of Hyoscine can produce tachycardia, rapid breathing, hyperpyrexia, restlessness, confusion and excitation.
A rash may appear on the face and upper trunk. In severe intoxication depression of the central nervous system may occur with circulatory failure and respiratory depression.

IDENTIFICATION:
A dark red liquid with a fruity odour and taste.

PRESENTATION:
Bottles of 50 and 100 mL.

STORAGE CONDITIONS:
STORE BELOW 25 °C OUT OF REACH OF CHILDREN.
Protect from light.

REGISTRATION NUMBER:
B/10.1/214

APPLICANT:
Pharmaceutical Enterprises (Pty) Ltd
Howard Studios
Howard Drive
PINELANDS
7405

DATE OF PUBLICATION:
2/90

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