ALU-CAP Capsules (2018)
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Περιεχόμενα
Name of the medicinal product
Alu-Cap Capsules.
Qualitative and quantitative composition
Each capsule contains 475 mg Dried Aluminium Hydroxide Gel Ph Eur as a white powder.
Pharmaceutical form
Hard gelatin capsules.
Therapeutic indications
Alu-Cap is recommended for use as a phosphate binding agent in the management of renal failure. It may also be used as an antacid.
Posology and method of administration
For phosphate binding Adults and children: The dosage must be selected in accordance with individual patient requirements, and may range from 4 to 20 capsules of Alu-Cap daily (approximately 2 to 10 g ...
Contraindications
Alu-Cap is contra-indicated in patients with hypophosphataemia and acute porphyria.
Special warnings and precautions for use
Phosphate depletion Aluminium salts may cause phosphate depletion, which is generally negligible. On prolonged treatment with large doses hypophosphataemia may occur, especially in patients with restricted ...
Interaction with other medicinal products and other forms of interaction
Reported to interfere with absorption of some drugs including tetracyclines. Penicillin, sulphonamides, iron, digoxin, indometacin, naproxen, phenylbutazone and vitamins, Aluminium hydroxide and such drugs ...
Pregnancy and lactation
There are no adequate data from the use of Aluminium hydroxide in pregnant women. Animal studies are insufficient with respects to effects on pregnancy, embryonal and foetal development, parturition and ...
Effects on ability to drive and use machines
None. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance ...
Undesirable effects
Aluminium hydroxide is astringent and may cause constipation.
Overdose
Symptoms and treatment A single massive dose of aluminium hydroxide is unlikely to have harmful sequelae, as aluminium is not absorbed systemically to any great extent. Gastric lavage should be administered, ...
Pharmacodynamic properties
In the gut, aluminium hydroxide absorbs phosphate ions. This reduces absorption of phosphate into the body, and thereby reduces serum phosphate levels. Aluminium hydroxide gel is a slow-acting antacid. ...
Pharmacokinetic properties
Aluminium hydroxide is slowly but perhaps incompletely converted to aluminium chloride in the stomach. Some absorption of soluble aluminium salts occurs from the gastro-intestinal tract with some excretion ...
Preclinical safety data
Not applicable.
List of excipients
Polyethylene Glycol 6000 Purified Talc Solka Floc BW 100, Special Capsule shell: E104, E110, E127, E131
Incompatibilities
None known.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Store the capsules below 30°C.
Nature and contents of container
Amber glass bottles with screw cap containing 120 capsules.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0156
Date of first authorization / renewal of the authorization
6 June 1974/21 November 2005
Date of revision of the text
04/2018
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