Table of Contents

1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
 

1. Name of the medicinal product
 BindRen 1 g film-coated tablets
 
2. Qualitative and quantitative composition
 Each film-coated tablet contains 1 g colestilan.

For the full list of excipients, see section 6.1.
 
3. Pharmaceutical form
 Film-coated tablet.

White, oval shaped, film-coated tablet approximately 20.2 mm in length and 10.7 mm wide printed with “BINDREN” (in blue ink) on one side.

4. Clinical particulars
 
4.1 Therapeutic indications
 BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.

4.2 Posology and method of administration
 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.

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