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

Logo RESPINOL® ELIXIR

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

RESPINOL® ELIXIR

COMPOSITION:
Each 5 mL contains:
  Phenylephrine Hydrochloride 2,5 mg
  Chlorpheniramine Maleate 1,25 mg
  Hyoscine Methylnitrate 0,5 mg
Preservative: Nipasept 0,08% m/v
PHARMACOLOGICAL CLASSIFICATION:
5.8 (Common cold remedies, decongestants and antihistaminics).

PHARMACOLOGICAL ACTION:
Phenylephrine is a sympathomimetic and produces decongestion of the mucosa;
Chlorpheniramine is an antihistamine and Hyoscine is an anticholinergic, reducing nasal secretion.

INDICATIONS:
RESPINOL ELIXIR is indicated for 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:
Phenylephrine is contra-indicated in pregnancy, hypersusceptible patients or those with hyperthyroidism, aneurism, hypertension, arteriosclerosis and cardiovascular disorders.
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 - 6 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.

Phenylephrine may produce an undesirably high blood pressure with headache, vomiting and palpitations. Reflex bradycardia may occur which can be prevented or abolished with atropine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The high blood pressure caused by Phenylephrine 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.

IDENTIFICATION:
A red, raspberry-flavoured syrup.

PRESENTATION:
Bottles of 100 mL and 50 mL.

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

REFERENCE NUMBER:
C909 (Act 101 of 1965).

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

DATE OF PUBLICATION:
2/90

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