Meddev 10 ml Suspensions.

MEDDEV is indicated as an antacid in adults and children over 2 years of age.

Shake the bottle before use. MEDDEV should be taken at least 2 to 3 hours before or after other oral medicines.

Adults: Two to four medicine measures (10 u2013 20 ml) three to four times daily.

Children over 2 years of age: One to two medicine measures (5 u2013 10 ml) three to four times daily.

Paediatric population: MEDDEV is contraindicated in children under 2 years of age (see section 4.3).

Hypersensitivity to dicyclomine, aluminium hydroxide and magnesium oxide or to any of the ingredients of MEDDEV.

Prostatic enlargement, paralytic ileus or pyloric stenosis or other stenosis in the gut where its use may lead to obstruction, Ulcerative colitis, Myasthenia gravis, Glaucoma, Patients with renal failure.

Obstructive uropathy, Hyperthyroidism, Cardiac failure.

Should not be given to children under two years.

Infantile colic in children less than 6 months due to safety concerns.

MEDDEV should be used with caution in conditions characterised by tachycardia such as hyperthyroidism and cardiac insufficiency or cardiac failure.

MEDDEV should be used with caution in elderly men, hepatic and renal impairment and in conditions characterised by tachycardia.

5 u2013 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.

Mucosal irritation and absorption of magnesium may occur if there is gastrointestinal atony or obstruction.

Aluminium hydroxide such as MEDDEV 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 medicines such as MEDDEV may aggravate the condition.

MEDDEV contains sorbitol and may have a laxative effect.

Patients with the rare hereditary condition of sorbitol intolerance should not take MEDDEV.

Because of MEDDEVu2019s ability to change gastric or urinary pH and to adsorb or form complexes with other medicines, the rate and/or extend of absorption of other medicine may be increased or reduced when used concurrently.

Patient should be advised not to take any other oral medications within 2 to 3 hours of antacids.

Concurrent use of MEDDEV with other medicines with anticholinergic activity may intensify the anticholinergic effect.

Occurrence of gastrointestinal problems should be reported promptly since paralytic ileus may occur with concurrent therapy.

MEDDEVu2019s effects may be enhanced by other medicines with anticholinergic properties such as antihistamines, amantadine, butyrophenones, phenothiazines and tricyclic antidepressants.

Magnesium may interfere with the absorption of tetracyclines.

Aluminium hydroxide reduces the absorption of medicines such as tetracyclines and vitamins and warfarin, quinidine, quinine, anticholinergic medicines, barbiturates and digoxin.

The safety of MEDDEV in pregnancy and lactation has not been established. MEDDEV is excreted in breast milk.

The use of MEDDEV may lead to drowsiness and blurred vision which is aggravated by the simultaneous intake of alcohol and it is dangerous to drive a vehicle or be in charge of machinery while on treatment with MEDDEV.

Dicyclomine hydrochloride: The following side effects have been reported but the frequencies are unknown.

Nervous system disorders: Dizziness, headache, confusion, sedation.

Respiratory disorders: Reduced bronchial secretions.

Eye disorders: Photophobia, blurred vision, mydriasis with loss of accommodation (cycloplegia), increased intraocular pressure.

Cardiac disorders: Transient bradycardia followed by tachycardia with palpitations and dysrhythmias.

Gastrointestinal disorders: Thirst, dry mouth with difficulty in swallowing and talking, constipation, nausea and vomiting.

Skin and subcutaneous tissue disorders: Flushing, dryness of skin, rash, hypersensitivity may occur as conjunctivitis or a skin rash.

Renal and urinary disorders: Urinary retention, difficulty in micturition.

General disorders: Fatigue, hyperthermia.

Aluminium hydroxide: Gastrointestinal disorders: Frequent: chalky taste, constipation, stomach cramps. Less frequent: nausea, vomiting. Frequency unknown: faecal impaction, intestinal obstruction (large doses).

The following side effects have been reported and the frequency are unknown: Osteomalacia or adynamic bone disease, encephalopathy, dementia and microcytic hypochromic anaemia have been associated with aluminium accumulation in patients suffering from renal failure.

Excessive doses of aluminium hydroxide or even normal doses in patients on low phosphate diets may lead to phosphate depletion accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. (see u201cWarnings and Special precautionsu201d).

Magnesium oxide: Gastrointestinal disorders: Frequent: chalky taste, watery diarrhoea, gastrointestinal irritation. Less frequent: nausea, vomiting, stomach cramps, paralytic ileus. Blood disorders: Less frequent: hypermagnesaemia or other electrolyte imbalance.

Overdosage of dicyclomine cause hyperthermia, hypertension, tachycardia, rapid or stertorous respiration, nausea and vomiting. A rash may appear on the face and upper trunk. Toxic doses cause restlessness, confusion and excitement, ataxia, incoordination, paranoid and psychotic reactions, and hallucinations passing into delirium and occasionally seizures. In severe intoxication central stimulation may cause depression, coma, circulatory and respiratory failure and death. Large doses of aluminium hydroxide may cause intestinal obstruction. See u201cside effectsu201d section 4.8. Treatment is symptomatic and supportive.