BINDREN Film-coated tablet Ref.[50321] Active ingredients: Colestilan

Posology

The recommended starting dose is 6-9 g per day (2-3 g three times daily).

Patients previously on other phosphate binders who are switched to BindRen should start taking 6-9 g per day (2-3 g three times daily).

Dose titration

Serum phosphorus concentrations should be monitored. If an acceptable serum phosphorus concentration is not achieved, the dose may be increased by 3 g per day (1 g three times daily) in 2-3 weekly intervals. The maximum daily dose of BindRen tested in clinical trials was 15 g per day (5 g three times daily).

Special populations

Elderly population

Experience from clinical studies in patients above the age of 75 years is very limited.

Renal impairment

BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis. No data on the use of BindRen in pre-dialysis patients are available.

Severe hepatic impairment

Patients with severe hepatic impairment were excluded from clinical studies. Therefore, the use of BindRen is not recommended in patients with severe hepatic impairment (see also section 4.4). No data are available.

Paediatric population

The safety and efficacy of BindRen in children and adolescents aged under 18 years has not yet been established. No data are available.

Method of administration

BindRen is for oral use. Tablets should be taken whole.

The daily dose of BindRen tablets should be taken in three equally divided doses with or immediately after meals with a sufficient amount of water to aid swallowing.

The division of the daily dose may be adjusted on a physician’s advice taking into account the dietary intake of phosphate. Patients should be encouraged to adhere to their prescribed low phosphate diets.

Treatment of high blood phosphorus levels usually requires long-term treatment.

BindRen has been given to dialysis patients in doses up to 15 g/day for up to one year continuously with no cases of overdose. The potential risk of overdosing could include adverse reactions or a worsening of adverse reactions mentioned in section 4.8.

There are no known antidotes to BindRen.

4 years.

This medicinal product does not require any special temperature storage conditions.

Keep the bottle tightly closed in order to protect from moisture.

High density polyethylene (HDPE) bottles, with a polypropylene cap and an induction seal.

Aluminium/polychlorotrifluoroethylene/PVC blister.

Pack sizes of 45, 99, 198, 270 or 297 tablets per carton.

Not all pack sizes may be marketed.

No special requirements.