País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
DICYCLOMINE HYDROCHLORIDE ALUMINIUM HYDROXIDE GEL MAGNESIUM OXIDUM LEVE DIMETICONE, ACTIVATED
Peckforton Pharmaceuticals Ltd
DICYCLOMINE HYDROCHLORIDE ALUMINIUM HYDROXIDE GEL MAGNESIUM OXIDUM LEVE DIMETICONE, ACTIVATED
Per Cent
Oral Suspension
Withdrawn
2007-02-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kolanticon Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Kolanticon gel is a white viscous suspension containing 2.5mg Dicycloverine Hydrochloride (Dicyclomine Hydrochloride), 200mg Aluminium Hydroxide Gel, 100mg Light Magnesium Oxide, 20mg Simethicone per 5ml. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral suspension 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the symptomatic relief of gastritis, hyperacidity and flatulence. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Two to four 5ml spoonfuls every four hours as required. 4.3 CONTRAINDICATIONS _Contra-indications: _Known idiosyncrasy to any of the ingredients. Should not be used in patients with prostatic enlargement, paralytic ileus or patients with closed angle glaucoma or those with a shallow anterior chamber. It should not be used in patients with pyrexia where the ambient temperature is high. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Precautions: _Use with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery. In the presence of renal insufficiency magnesium salts may cause central nervous system depression. Prolonged use of aluminium in patients with renal failure can cause aluminium intoxication. Aluminium hydroxide absorbs phosphate and excessive dose or low phosphate diet may lead to rickets. Aluminium hydroxide may reduce absorption of tetracyclines when given concomitantly. If symptoms do not improve, the physician should be consulted. Use with care in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate this condition. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Aluminium hydro Leia o documento completo