KOLANTICON GEL Per Cent Oral Suspension
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
DICYCLOMINE HYDROCHLORIDE ALUMINIUM HYDROXIDE GEL MAGNESIUM OXIDUM LEVE DIMETICONE, ACTIVATED
Available from:
Peckforton Pharmaceuticals Ltd
INN (International Name):
DICYCLOMINE HYDROCHLORIDE ALUMINIUM HYDROXIDE GEL MAGNESIUM OXIDUM LEVE DIMETICONE, ACTIVATED
Dosage:
Per Cent
Pharmaceutical form:
Oral Suspension
Authorization status:
Withdrawn
Authorization date:
2007-02-07
Summary of Product characteristics
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
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