RENACET Film-coated tablet Ref.[49790] Active ingredients: Calcium acetate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2010  Publisher: RenaCare NephroMed GmbH, Werrastr. 1 a, 35625 Hรผttenberg, Germany Phone: +49 (0) 64 03 9 21 60 Fax: +49 (0) 64 03 9 21 63 E-mail: mail@renacare.com

4.1. Therapeutic indications

Hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis.

4.2. Posology and method of administration

Dosage should be effected individually. Unless a different dose has been prescribed, adults should take no more than 14 Renacet 475 mg film-coated tablets daily.

To achieve optimal efficacy, Renacet 475 mg should be taken during or immediately after meals

The usual dose is:

with breakfast: 1 to 2 film-coated tablets Renacet 475 mg,

with a snack: 1 to 2 film-coated tablets Renacet 475 mg,

with a main meal: 2 to 6 film-coated tablets Renacet 475 mg,

with supper: 2 to 4 film-coated tablets Renacet 475 mg.

Renacet 475 mg film-coated tablets should be taken with some liquid during or immediately after meals and must not be chewed.

Experience with children is not available.

4.9. Overdose

Overdose would not be expected to cause gross hypercalcaemia except in patients taking excessive doses of vitamin D.

Measures in case of overdose: Discontinuation of the medicinal product and symptomatic treatment including lowering calcium levels e.g. administration of oral phosphates and non-saline laxatives such as lactulose.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Pack sizes:

100 film-coated tablets
200 film-coated tablets

PVDC-coated PVC/aluminium foil blisters

6.6. Special precautions for disposal and other handling

No special requirements.

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