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

Logo GELUMEN Suspension

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

GELUMEN Suspension

COMPOSITION:
Each 10 mL of suspension contains:
  Dicyclomine hydrochloride 5 mg
  Compressed aluminium hydroxide gel equivalent to dried aluminium hydroxide gel 400 mg
  Light magnesium oxide 200 mg
PRESERVATIVES:
  Nipastat 0,2% m/v
  Chloroform 0,2% v/v
  Benzyl alcohol 0,3% v/v
PHARMACOLOGICAL CLASSIFICATION:
A 11.4.2 Acid neutralisers with antispasmodics.

PHARMACOLOGICAL ACTION:
GELUMEN SUSPENSION has antacid properties.

INDICATIONS:
GELUMEN SUSPENSION is indicated as a antacid.

CONTRA-INDICATIONS:
Prostatic enlargement, paralytic ileus or pyloric stenosis where its use may lead to obstruction, severe ulcerative colitis, myasthenia gravis, glaucoma.
Patients with renal failure. Obstructive uropathy, thyrotoxicosis cardiac failure. Sensitivity to any of the ingredients.

WARNINGS:
GELUMEN SUSPENSION should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis and cardiac insufficiency or cardiac failure.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Two to four medicine measures (10 - 20) mL three to four times daily.
Children over 2 years of age: One to two medicine measures (5 - 10) mL three to four times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects that may occur because of the dicyclomine include dry mouth, blurred vision, flushing and dryness of skin, tachycardia with palpitations and arrhthmias, urinary retention and constipation. Its effect may be enhanced by other drugs with anticholinergic properties. Fatigue, sedation, rash, thirst, nausea and vomiting, headache and dizziness have been reported.

Preparations containing dicyclomine should be used with caution in elderly men. 5 - 10% of magnesium is absorbed, and retention in patients with impaired renal function may lead to neurological, neuromuscular and cardiovascular impairment. The urine of normal persons may become alkaline which decreases excretion of drugs that are weak bases. Magnesium may cause diarrhoea and mucosal irritation. Aluminium hydroxide absorbs phosphates and excessive doses of normal doses with a low phosphate diet may lead to phosphate depletion with renal rickets or osteomalacia. Use with care in patients with hiatal hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition.

GELUMEN SUSPENSION may interfere with or reduce the absorption of anticholinergic medicines, barbiturates, digoxin, quinine, warfarin, tetracyclines and vitamins. The effects of dicyclomine hydrochloride may be enhanced by the concomitant administration of anticholinergic medicines such as antihistamines, amantadine, butyrophenones, phenothiazines and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic doses of dicyclomine cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, and hallucinations passing into delirium. A rash may appear on the face and upper trunk. In severe intoxication depression of the central nervous system may occur with hypertension or circulatory failure and respiratory depression. See further under "Side-Effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
A white homogenous suspension with slight peppermint flavour.

PRESENTATION:
In bottles containing 200 mL, 350 mL and 2,5 litre.

STORAGE INSTRUCTIONS:
Store in a cool place, below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/11.4.2/234

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
MEDPRO PHARMACEUTICA (PTY) LTD
UNIT 9 ROSEN HEIGHTS
PASITA STREET
ROSENPARK 7830

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26 January 1990.

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