COMPOSITION: Each 10 mL of the suspension contains:
Compressed Aluminium Hydroxide Gel equivalent to:
Dried Aluminium Hydroxide
Light Magnesium Oxide
0,2 % m/v
PHARMACOLOGICAL CLASSIFICATION: A 11.4 2 Acid Neutralisers with antipasmodics
PHARMACOLOGICAL ACTION: CO-GEL has antacid properties
INDICATIONS: Co-GEL is indicated as an 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.
Should not be given to children under two years.
DOSAGE AND DIRECTIONS FOR USE: Adults: Two to four medicine measure (10 - 20 mL) three to four times daily.
Children over 2 years of age: One to two medicine measure (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 arrythmias, urinary retention and constipation. Its effects may be enhanced by other drugs with anticholinergic properties. Fatigue, sedation, rash, thirst, nausea and vomiting, headache and dizziness have been reported.
Hypersensitivity may appear as conjunctivitis or a skin rash.
Preparations containing dicyclomine should be used with caution in elderly men and in conditions characterised tachycardia.
Magnesium oxide may cause diarrhoea, mucosal irritation and absorption of magnesium may occur if there is gastro-intestinal atony or obstruction. Magnesium may interfere with the absorption of tetracyclines.
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 medicines that are weak bases. Aluminium hydroxide may cause nausea, vomiting and constipation. Aluminium hydroxide absorbs phospates and excessive doses or normal doses with a low phosphate diet may lead to phosphate depletion with renal rickets or osteo-malacia. It reduces the absorption of medicines such as tetracyclines and vitamins and warfarin, quinidine, quinine, anticholinergic agents, barbiturates and digoxin. Use with care in patients with hiatal hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate the condition.
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. Treatment includes pilocarpine to counteract the effect of dicyclomine.
Further treatment is symptomatic. Large doses of aluminium hydroxide may cause intestinal obstruction.
IDENTIFICATION: A white homogenous suspension with slight peppermint flavour.
PRESENTATION: 200 mL, 350 mL and 500 mL in amber plastic bottles
STORAGE INSTRUCTIONS: Store below 25 C
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: W/11.4.2/325
NAME AND BUSINESS ADDRESS OF APPLICANT: Compu Pharmaceutical Products Limited
476 Kings Highway
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 21 July 1989