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

Logo ACUGEL SUSPENSION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ACUGEL SUSPENSION

COMPOSITION:
Each 10 mL of suspension contains:
Dicyclomine hydrochloride         5 mg
Compressed aluminium hydroxide gel equivalent to dried aluminium hydroxide         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 antispasmodic.

PHARMACOLOGICAL ACTION:
ACUGEL has antacid properties.

INDICATIONS:
ACUGEL is indicated as an antacid.

CONTRA-INDICATIONS:
Prostatic enlargement, paralytic ileus or pyloric stenosis where it's 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:
ACUGEL 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 due to dicyclomine include dry mouth, blurred vision, flushing and dryness of skin, tachycardia with palpitations and arrhythmias, urinary retention and constipation.
It's 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 or 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.
ACUGEL 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 suspension with peppermint odour and a sweet aromatic taste.

PRESENTATION:
Round plastic bottles of 200 mL and 350 mL, and rectangular plastic containers of 2,5 litres.

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

REGISTRATION NUMBER:
29/11.4.2/0155

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ACUPHARM (PTY) LTD
43 Richards Drive
Halfway House, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
{Undated}

First displayed on this site in October 1996
Current: September 2004
Source: Pharmaceutical Industry

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