SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Alu-Cap Capsules

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 475 mg Dried Aluminium Hydroxide Gel Ph Eur as a white powder.

3    PHARMACEUTICAL FORM

Hard gelatin capsules

4    CLINICAL PARTICULARS

4.1    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.

4.2    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 dried aluminium hydroxide gel), taken with meals.

AS AN ANTACID

ADULTS: One Alu-Cap four times daily and on retiring.

CHILDREN: Alu-Cap is not suitable for antacid therapy in children.

ELDERLY: No special dosage recommendations are made for elderly patients.

4.3 Contraindications

Alu-Cap is contra-indicated in patients with hypophosphataemia and acute porphyria.

4.4 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 phosphate intake. This syndrome is characterised by anorexia, malaise and muscle weakness. If left unchecked this condition may give rise to osteomalacia. osteoporosis and urinary calculi. Serum phosphate levels should be monitored regularly (bi-monthly) in patients on maintenance haemodialysis who are receiving chronic aluminium hydroxide therapy.

Renal failure: In patients with chronic renal failure. hyperaluminaemia may occur. Aluminium accumulates in the bone, lungs and nerve tissue.

Aluminium accumulation in the CNS may be the cause of dialysis dementia which sometimes occurs in chronic renal failure patients receiving long term aluminium therapy for hyperphosphataemia.

Effect on drug absorption: Aluminium hydroxide reduces absorption of tetracyclines and vitamins and may delay the absorption of quinidine (see interactions). Aluminium hydroxide and such drugs should be administered 2 hours apart.

4.5 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 should be administered 2 hours apart.

4.6 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 postnatal development (see section 5.3). The potential risk for humans is unknown.

Alu-Cap capsules should not be used during pregnancy unless clearly necessary.

4.7 Effects on ability to drive and use machines

None

4.8    Undesirable effects

Aluminium hydroxide is astringent and may cause constipation. 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 of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9    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, followed by a mild aperient if required.

Excessive long-term dosage may cause phosphate depletion, manifested in muscle weakness, anorexia and malaise. If left unchecked this condition may give rise to osteomalacia, osteoporosis and urinary calculi.

5.1 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. It is used to provide symptomatic relief in gastric hyperacidity. In addition, the antipeptic and demulcent activity of aluminium hydroxide helps to protect inflamed gastric mucosa against further irritation by gastric secretions.

5.2 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 in the urine. Some unabsorbed aluminium hydroxide combines with phosphates and some form carbonates and salts of fatty acids, all these salts are excreted in the faeces.

5.3 Preclinical safety data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Polyethylene Glycol 6000 Purified Talc

‘Solka Floc’ BW 100, Special Capsule shell: E104, E110, E127, E131

Incompatibilities

None known

6.3    Shelf life

5 years

6.4    Special precautions for storage

Store the capsules below 30°C.

6.5    Nature and contents of container

Amber glass bottles with screw cap containing 120 capsules.

6.6    Special precautions for disposal

None

7. MARKETING AUTHORISATION HOLDER

Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley

Bishop’s Stortford CM22 6PU

8 MARKETING AUTHORISATION NUMBER(S)

PL 15142/0033

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/11/2005

10    DATE OF REVISION OF THE TEXT

26/02/2014