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.
MAYOGEL SUSPENSION
SCHEDULING STATUS:
Not Scheduled
PROPRIETARY NAME
(and dosage form):
MAYOGEL SUSPENSION
COMPOSITION:
Each 15 mL contains:
Aluminium hydroxide gel dried equivalent to
Aluminium oxide 282,00 mg
Magnesium trisilicate equivalent to
Magnesium oxide 120,00 mg
Alcohol 3,10% v/v
Preservatives:
Methylparaben 0,20% m/v
Propylparaben 0,02% m/v
PHARMACOLOGICAL CLASSIFICATION:
Category A11.4.1 Antacids – Acid neutralisers.
PHARMACOLOGICAL ACTION:
Antacid, with the capability to neutralise the acid in the stomach.
INDICATIONS:
For the relief of gastric acidity, dyspepsia and peptic ulcers.
CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. In patients with impaired renal function. The safety of this medicine in pregnant women has not yet been established.
WARNINGS:
Do not take this product if you are presently taking a prescription antibiotic product containing any form of tetracycline. Do not use this product if you have kidney disease except under the advice and supervision of a doctor.
DOSAGE AND DIRECTIONS FOR USE:
Adults only.
Two to three medicine measures one to three hours after meals and at bedtime; according to the need of the patient.
Do not use the maximum daily dosage of this product for more than two weeks. except under the advice and supervision of a doctor.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aluminium hydroxide may cause nausea, vomiting, and constipation. Large doses may cause intestinal obstruction. Excessive doses, or even normal doses in patients with low-phosphate diets, may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia. Osteomalacia, and also encephalopathy and dementia can occur in patients with chronic renal failure who receive relatively high doses of aluminium hydroxide as a phosphate-binding agent. Magnesium trisilicate may cause diarrhoea. If renal function is impaired hypermagnesaemia may result. The symptoms of which include flushing of the skin, thirst, hypotension due to peripheral vasodilation, drowsiness, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma, and cardiac arrest.
Aluminium hydroxide and magnesium trisilicate may interfere with the absorption of other drugs when these are taken concomitantly.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Refer to ‘Side-Effects and Special Precautions’ above.
Treatment is symptomatic and supportive.
IDENTIFICATION:
White suspension with odour of peppermint.
PRESENTATION:
100 mL, 200 mL, 350 mL, 500 mL, and 2,5 L in bottles.
STORAGE INSTRUCTIONS:
Store in a cool place below 25°C in airtight containers.
KEEP OUT OF REACH OF CHILDREN.
