A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstr. 12

37081 Göttingen

Germany

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

• D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE

USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

• At the request of the European Medicines Agency;
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTERS – FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

BindRen 1 g film-coated tablets colestilan

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House

69, Old Broad Street

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 2 G GRANULES IN SACHETS

• 1. NAME OF THE MEDICINAL PRODUCT

BindRen 2 g granules colestilan

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 2 g colestilan.

• 3. LIST OF EXCIPIENTS

• 4. PHARMACEUTICAL FORM AND CONTENTS

Granules

30 sachets

60 sachets

90 sachets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House

69, Old Broad Street

London

EC2M 1QS

United Kingdom

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON – 3 G GRANULES IN SACHETS

• 1. NAME OF THE MEDICINAL PRODUCT

BindRen 3 g granules colestilan

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 3 g colestilan.

• 3. LIST OF EXCIPIENTS

• 4. PHARMACEUTICAL FORM AND CONTENTS

Granules

30 sachets

60 sachets

90 sachets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.

Read the package leaflet before use.

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House

69, Old Broad Street

London

EC2M 1QS

United Kingdom

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET FOR 2 G GRANULES

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

BindRen 2 g granules colestilan

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET FOR 3 G GRANULES

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

BindRen 3 g granules colestilan

Oral use

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BOTTLES – FILM-COATED TABLETS

1. NAME OF THE MEDICINAL PRODUCT

BindRen 1 g film-coated tablets colestilan

Read the package leaflet before use. Oral use

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7 OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

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

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

  Medicinal product subject to medical prescription.

  
  

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

BindRen 1 g tablets

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE LABEL – FILM-COATED TABLETS

• 1. NAME OF THE MEDICINAL PRODUCT

BindRen 1 g film-coated tablets colestilan

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 1 g colestilan.

• 4. PHARMACEUTICAL FORM AND CONTENTS 45 film-coated tablets

99 film-coated tablets

198 film-coated tablets

270 film-coated tablets

297 film-coated tablets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

  Read the package leaflet before use. Oral use

  
  

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

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

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House

69, Old Broad Street

16. INFORMATION IN BRAILLE

Package leaflet: Information for the patient

BindRen 1 g film-coated tablets colestilan

' ' This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What BindRen is and what it is used for

• 2. What you need to know before you take BindRen

• 3. How to take BindRen

• 4. Possible side effects

• 5. How to store BindRen

• 6. Contents of the pack and other information

1. What BindRen is and what it is used for

BindRen contains the active substance colestilan. It is used to lower high blood phosphorus levels in adult patients undergoing dialysis due to poor kidney function.

About high blood phosphorus levels (hyperphospha­taemia)

If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys. You have also been advised to follow a special diet to reduce the amount of phosphorus that your body takes from food. Sometimes, the dialysis and diet are not enough to stop the phosphorus in your blood rising to high levels, a condition referred to by your doctor as hyperphosphataemia. Keeping the phosphorus level in your blood low is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures.

How BindRen works

Colestilan binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood. The colestilan-bound phosphorus is then excreted from your body in faeces. However, even though you are taking BindRen, you must also follow the special diet recommended by your doctor.

2. What you need to know before you take BindRen

Do not take BindRen

• – if you are allergic to colestilan or any of the other ingredients of this medicine (listed in section 6)

• – if you have bowel obstruction (a blockage of your intestines)

Warning and precautions

Talk to your doctor or pharmacist before taking BindRen if you are suffering from any of the following problems, since this medicine may not be right for you: – swallowing problems

• – severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines

• – recent major stomach or bowel surgery

• – gall bladder obstruction

• – severe liver problems

• – seizures

• – recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity (peritonitis)

• – low levels of albumin (a protein) in your blood

Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you:

• – you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4).

• – you have been told that you have a disorder that decreases the intestines ability to absorb nutrients (malabsorption syndrome) or if you are treated with so called coumarin anticoagulants (e.g. warfarin), since your doctor may want to monitor your blood and possibly ask you to start taking vitamin supplements.

• – you have abnormally low levels of calcium in your blood. BindRen does not contain calcium and your doctor may prescribe additional calcium tablets.

• – you have abnormally high levels of calcium in your blood due to overactivity of the parathyroid glands. BindRen alone cannot treat this condition and other medicines should be prescribed for you.

Children and adolescents

No data are available on the safety and effectiveness of BindRen in children and adolescents (below the age of 18 years). BindRen should not be used in children and adolescents.

Other medicines and BindRen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines for irregular heart rhythm (such as digoxin), for treating high blood pressure (such as enalapril maleate), anti-seizure medicines (such as valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide and levetiracetam), levothyroxine (used to treat thyroid hormone deficiency), oral birth control medicines (oestrogen, progestogen or combination pills), immune system suppressing medicines (such as cyclosporine, mycophenolate mofetil, tacrolimus). This is because your doctor may want to monitor your health, change the dose of BindRen or the other medicine you are taking or tell you to not take BindRen and the other medicine at the same time.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do become pregnant or you are breast-feeding, and your doctor decides that you should continue your treatment with BindRen, your doctor may ask you to also take vitamin supplements.

Driving and using machines

BindRen has no or negligible influence on the ability to drive or use machines.

3. How to take BindRen

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is 6–9 g per day taken as 2 g or 3 g three times per day with meals. Your doctor may decide to increase this up to a total dose of 15 g per day depending on the level of phosphorus in your blood. If you do not regularly eat three meals per day then please tell your doctor.

Take BindRen by mouth.

It is recommended that you take the tablets whole with meals and with a small amount of water.

Your doctor may advise you to take calcium, vitamin D supplements and other vitamins or other medicines in addition to BindRen.

If you have to take other medicines your doctor will tell you if you can take the other medicines at the same time as BindRen or if you need to take the other medicines 1 hour before or 3 hours after taking BindRen. Your doctor may consider measuring blood levels of the other medicines you are taking.

If you take more BindRen than you should

If you take too much BindRen, tell your doctor or pharmacist.

If you forget to take BindRen

Do not take a double dose to make up for forgotten doses. Just carry on with the next dose at the normal time.

If you stop taking BindRen

Treatment of high blood phosphorus levels is usually required for a long period of time. It is important that you continue taking BindRen for as long as your doctor prescribes the medicine and to keep to your diet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects are bleeding from the stomach or lower bowel (uncommon). This may show as either fresh or altered blood in your vomit, or when from the lower bowel, as a black stool or with blood mixed in your stool.

Constipation is common and if you suffer from persistent or worsening constipation please tell your doctor or pharmacist as this may be the first sign of blockage of your intestines.

The following side effects have also been seen in patients taking BindRen:

Common (may affect up to 1 in 10 people) side effects: feeling sick (nausea), vomiting, a burning sensation in your stomach, diarrhoea, bloating, stomach ache and bowel pain, gas, a decreased appetite and low blood calcium.

Uncommon (may affect up to 1 in 100 people) side effects: low blood pressure, weakness, thirst, headache, dizziness, shaking, dry mouth, swallowing difficulties, change in taste sensation, heartburn, hardening of the stool, inflammation or pain of the stomach or bowel, change in bowel habit, sleeplessness, itching, dry skin, rash, hives, itching red spots, collection of blood (haematoma) e.g. under the skin, joint pain, back pain, pain in limbs, muscle pain or spasms, increased blood levels of parathyroid hormone (a protein), certain blood fats and liver enzymes and a low level of folate (a vitamin).

Rare (may affect up to 1 in 1000 people) side effects: blockage of intestines, a low level of vitamin K, obstruction of the blood vessels that supply the heart muscle and swelling of the ankles or extremities.

Reporting of side effects

If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BindRen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the box, the bottle label or the blister after the abbreviation “EXP”. The expiry date refers to the last day of that month.

Blisters

This medicine does not require any special storage conditions.

Bottles

This medicine does not require any special temperature storage conditions.

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

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment and to prevent accidental access by children.

6. Contents of the pack and other information

What BindRen contains

The active substance is colestilan.

Each film-coated tablet contains 1 g of colestilan.

The other ingredients are purified water, hydroxypropyl­cellulose, colloidal, anhydrous silica, hydrogenated castor oil, hypromellose, acetic acid esters of mono- and diglycerides of fatty acids, polysorbate 80, shellac, indigo carmine aluminium lake (E132) and carnauba wax.

What BindRen looks like and contents of the pack

BindRen tablets are white oval shaped film-coated tablets printed with “BINDREN” in blue ink on one side. They are supplied in blisters or bottles in cartons of 45, 99, 198, 270 or 297 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House

69, Old Broad Street

London

EC2M 1QS

United Kingdom

Manufacturer

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstr. 12

37081 Göttingen

Germany

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Deutschland, Österreich

Mitsubishi Tanabe Pharma GmbH

Willstätterstr. 30

40549 Düsseldorf

Germany

Tel: +49 211 – 520 544 33

Fax: +49 211 – 520 544 99

UK, BE, BG, CY, CZ, DK, EE, EL, ES, FI, FR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK

Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House 69, Old Broad Street London EC2M 1QS United Kingdom

Tel/Tel./ TeWTlf/Tel/Simi/Tnk +44 (0) 20 7382 9000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

BindRen 2 g granules

BindRen 3 g granules colestilan

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What BindRen is and what it is used for

• 2. What you need to know before you take BindRen

• 3. How to take BindRen

• 4. Possible side effects

• 5. How to store BindRen

• 6. Contents of the pack and other information

1. What BindRen is and what it is used for

BindRen contains the active substance colestilan. It is used to lower high blood phosphorus levels in adult patients undergoing dialysis due to poor kidney function.

About high blood phosphorus levels (hyperphospha­taemia)

If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys. You have also been advised to follow a special diet to reduce the amount of phosphorus that your body takes from food. Sometimes, the dialysis and diet are not enough to stop the phosphorus in your blood rising to high levels, a condition referred to by your doctor as hyperphosphataemia. Keeping the phosphorus level in your blood low is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures.

How BindRen works

Colestilan binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood. The colestilan-bound phosphorus is then excreted from your body in faeces. However, even though you are taking BindRen, you must also follow the special diet recommended by your doctor.

2. What you need to know before you take BindRen

Do not take BindRen

• – if you are allergic to colestilan or any of the other ingredients of this medicine (listed in section 6)

• – if you have bowel obstruction (a blockage of your intestines)

Warning and precautions

Talk to your doctor or pharmacist before taking BindRen if you are suffering from any of the following problems:

• – swallowing problems

• – severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines

• – recent major stomach or bowel surgery

• – gall bladder obstruction

• – severe liver problems

• – seizures

• – recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity (peritonitis)

• – low levels of albumin (a protein) in your blood

Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you:

• – you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4).

• – you have been told that you have a disorder that decreases the intestines ability to absorb nutrients (malabsorption syndrome) or if you are treated with so called coumarin anticoagulants (e.g. warfarin), since your doctor may want to monitor your blood and possibly ask you to start taking vitamin supplements.

• – you have abnormally low levels of calcium in your blood. BindRen does not contain calcium and your doctor may prescribe additional calcium tablets.

• – you have abnormally high levels of calcium in your blood due to overactivity of the parathyroid glands. BindRen alone cannot treat this condition and other medicines should be prescribed for you.

Children and adolescents

No data are available on the safety and effectiveness of BindRen in children and adolescents (below the age of 18 years). BindRen should not be used in children and adolescents.

Other medicines and BindRen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines for irregular heart rhythm (such as digoxin), for treating high blood pressure (such as enalapril maleate), anti-seizure medicines (such as valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide and levetiracetam), levothyroxine (used to treat thyroid hormone deficiency), oral birth control medicines (oestrogen, progestogen or combination pills), immune system suppressing medicines (such as cyclosporine, mycophenolate mofetil, tacrolimus). This is because your doctor may want to monitor your health, change the dose of BindRen or the other medicine you are taking or tell you to not take BindRen and the other medicine at the same time.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do become pregnant or you are breast-feeding, and your doctor decides that you should continue your treatment with BindRen, your doctor may ask you to also take vitamin supplements.

Driving and using machines

BindRen has no or negligible influence on the ability to drive or use machines.

3. How to take BindRen

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is 6–9 g per day taken as 2 g or 3 g three times per day with meals. Your doctor may decide to increase this up to a total dose of 15 g per day depending on the level of phosphorus in your blood. If you do not regularly eat three meals per day then please tell your doctor.

Take BindRen by mouth.

It is recommended that you take BindRen granules as one dose from the sachet with a small amount of water, at the time of a meal or directly after. However, if you cannot swallow the contents of a whole sachet at once you can divide the contents of the sachet dose into smaller portions.

Your doctor may advise you to take calcium, vitamin D supplements and other vitamins or other medicines in addition to BindRen.

If you have to take other medicines your doctor will tell you if you can take the other medicines at the same time as BindRen or if you need to take the other medicines 1 hour before or 3 hours after taking BindRen. Your doctor may consider measuring blood levels of the other medicines you are taking.

If you take more BindRen than you should

If you take too much BindRen, tell your doctor or pharmacist.

If you forget to take BindRen

Do not take a double dose to make up for forgotten doses. Just carry on with the next dose at the normal time.

If you stop taking BindRen

Treatment of high blood phosphorus levels is usually required for a long period of time. It is important that you continue taking BindRen for as long as your doctor prescribes the medicine and to keep to your diet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects are bleeding from the stomach or lower bowel (uncommon). This may show as either fresh or altered blood in your vomit, or when from the lower bowel, as a black stool or with blood mixed in your stool.

Constipation is common and if you suffer from persistent or worsening constipation please tell your doctor or pharmacist as this may be the first sign of blockage of your intestines.

The following side effects have also been seen in patients taking BindRen:

Common (may affect up to 1 in 10 people) side effects: feeling sick (nausea), vomiting, a burning sensation in your stomach, diarrhoea, bloating, stomach ache and bowel pain, gas, a decreased appetite and low blood calcium.

Uncommon (may affect up to 1 in 100 people) side effects: low blood pressure, weakness, thirst, headache, dizziness, shaking, dry mouth, swallowing difficulties, change in taste sensation, heartburn, hardening of the stool, inflammation or pain of the stomach or bowel, change in bowel habit, sleeplessness, itching, dry skin, rash, hives, itching red spots, collection of blood (haematoma) e.g. under the skin, joint pain, back pain, pain in limbs, muscle pain or spasms, increased blood levels of parathyroid hormone (a protein), certain blood fats and liver enzymes and a low level of folate (a vitamin).

Rare (may affect up to 1 in 1000 people) side effects: blockage of intestines, a low level of vitamin K, obstruction of the blood vessels that supply the heart muscle and swelling of the ankles or extremities.

Reporting of side effects

If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BindRen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the box or the sachet after the abbreviation “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment and to prevent accidental access by children.

6. Contents of the pack and other information

What BindRen contains

The active substance is colestilan.

• – BindRen 2 g granules: each sachet contains 2 g of colestilan.

• – BindRen 3 g granules: each sachet contains 3 g of colestilan.

What BindRen looks like and contents of the pack

BindRen tablets are white oval shaped film-coated tablets printed with “BINDREN” in blue ink on one side. They are supplied in blisters or bottles in cartons of 45, 99, 198, 270 or 297 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mitsubishi Tanabe Pharma Europe Ltd.

Dashwood House

69, Old Broad Street

London

EC2M 1QS

United Kingdom

Manufacturer

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstr. 12

37081 Göttingen

Germany

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Deutschland, Österreich

Mitsubishi Tanabe Pharma GmbH

Willstätterstr. 30

40549 Düsseldorf

Germany

Tel: +49 211 – 520 544 33

Fax: +49 211 – 520 544 99

UK, BE, BG, CY, CZ, DK, EE, EL, ES, FI, FR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK

Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House 69, Old Broad Street London EC2M 1QS United Kingdom

Tel/Tel./ TeWTlf/Tel/Simi/Tnk +44 (0) 20 7382 9000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

BindRen 2 g granules

BindRen 3 g granules colestilan

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What BindRen is and what it is used for

• 2. What you need to know before you take BindRen

• 3. How to take BindRen

• 4. Possible side effects

• 5. How to store BindRen

• 6. Contents of the pack and other information

1. What BindRen is and what it is used for

BindRen contains the active substance colestilan. It is used to lower high blood phosphorus levels in adult patients undergoing dialysis due to poor kidney function.

About high blood phosphorus levels (hyperphospha­taemia)

If your kidneys no longer function properly you may undergo dialysis, which replaces many of the functions of your kidneys. You have also been advised to follow a special diet to reduce the amount of phosphorus that your body takes from food. Sometimes, the dialysis and diet are not enough to stop the phosphorus in your blood rising to high levels, a condition referred to by your doctor as hyperphosphataemia. Keeping the phosphorus level in your blood low is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures.

How BindRen works

Colestilan binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood. The colestilan-bound phosphorus is then excreted from your body in faeces. However, even though you are taking BindRen, you must also follow the special diet recommended by your doctor.

2. What you need to know before you take BindRen

Do not take BindRen

• – if you are allergic to colestilan or any of the other ingredients of this medicine (listed in section 6)

• – if you have bowel obstruction (a blockage of your intestines)

Warning and precautions

Talk to your doctor or pharmacist before taking BindRen if you are suffering from any of the following problems:

• – swallowing problems

• – severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines

• – recent major stomach or bowel surgery

• – gall bladder obstruction

• – severe liver problems

• – seizures

• – recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity (peritonitis)

• – low levels of albumin (a protein) in your blood

Talk to your doctor or pharmacist if during your treatment with BindRen, any of the following applies to you:

• – you experience constipation, since your doctor may wish to monitor your bowel function to detect potential side effects (see section 4).

• – you have been told that you have a disorder that decreases the intestines ability to absorb nutrients (malabsorption syndrome) or if you are treated with so called coumarin anticoagulants (e.g. warfarin), since your doctor may want to monitor your blood and possibly ask you to start taking vitamin supplements.

• – you have abnormally low levels of calcium in your blood. BindRen does not contain calcium and your doctor may prescribe additional calcium tablets.

• – you have abnormally high levels of calcium in your blood due to overactivity of the parathyroid glands. BindRen alone cannot treat this condition and other medicines should be prescribed for you.

Children and adolescents

No data are available on the safety and effectiveness of BindRen in children and adolescents (below the age of 18 years). BindRen should not be used in children and adolescents.

Other medicines and BindRen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines for irregular heart rhythm (such as digoxin), for treating high blood pressure (such as enalapril maleate), anti-seizure medicines (such as valproic acid, phenytoin, carbamazepine, lamotrigine, oxcarbazepine, topiramate, gabapentin, vigabatrin, zonisamide and levetiracetam), levothyroxine (used to treat thyroid hormone deficiency), oral birth control medicines (oestrogen, progestogen or combination pills), immune system suppressing medicines (such as cyclosporine, mycophenolate mofetil, tacrolimus). This is because your doctor may want to monitor your health, change the dose of BindRen or the other medicine you are taking or tell you to not take BindRen and the other medicine at the same time.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do become pregnant or you are breast-feeding, and your doctor decides that you should continue your treatment with BindRen, your doctor may ask you to also take vitamin supplements.

Driving and using machines

BindRen has no or negligible influence on the ability to drive or use machines.

3. How to take BindRen

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is 6–9 g per day taken as 2 g or 3 g three times per day with meals. Your doctor may decide to increase this up to a total dose of 15 g per day depending on the level of phosphorus in your blood. If you do not regularly eat three meals per day then please tell your doctor.

Take BindRen by mouth.

It is recommended that you take BindRen granules as one dose from the sachet with a small amount of water, at the time of a meal or directly after. However, if you cannot swallow the contents of a whole sachet at once you can divide the contents of the sachet dose into smaller portions.

Your doctor may advise you to take calcium, vitamin D supplements and other vitamins or other medicines in addition to BindRen.

If you have to take other medicines your doctor will tell you if you can take the other medicines at the same time as BindRen or if you need to take the other medicines 1 hour before or 3 hours after taking BindRen. Your doctor may consider measuring blood levels of the other medicines you are taking.

If you take more BindRen than you should

If you take too much BindRen, tell your doctor or pharmacist.

If you forget to take BindRen

Do not take a double dose to make up for forgotten doses. Just carry on with the next dose at the normal time.

If you stop taking BindRen

Treatment of high blood phosphorus levels is usually required for a long period of time. It is important that you continue taking BindRen for as long as your doctor prescribes the medicine and to keep to your diet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects are bleeding from the stomach or lower bowel (uncommon). This may show as either fresh or altered blood in your vomit, or when from the lower bowel, as a black stool or with blood mixed in your stool.

Constipation is common and if you suffer from persistent or worsening constipation please tell your doctor or pharmacist as this may be the first sign of blockage of your intestines.

The following side effects have also been seen in patients taking BindRen:

Common (may affect up to 1 in 10 people) side effects: feeling sick (nausea), vomiting, a burning sensation in your stomach, diarrhoea, bloating, stomach ache and bowel pain, gas, a decreased appetite and low blood calcium.

Uncommon (may affect up to 1 in 100 people) side effects: low blood pressure, weakness, thirst, headache, dizziness, shaking, dry mouth, swallowing difficulties, change in taste sensation, heartburn, hardening of the stool, inflammation or pain of the stomach or bowel, change in bowel habit, sleeplessness, itching, dry skin, rash, hives, itching red spots, collection of blood (haematoma) e.g. under the skin, joint pain, back pain, pain in limbs, muscle pain or spasms, increased blood levels of parathyroid hormone (a protein), certain blood fats and liver enzymes and a low level of folate (a vitamin).

Rare (may affect up to 1 in 1000 people) side effects: blockage of intestines, a low level of vitamin K, obstruction of the blood vessels that supply the heart muscle and swelling of the ankles or extremities.

Reporting of side effects

If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BindRen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the box or the sachet after the abbreviation “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment and to prevent accidental access by children.

6. Contents of the pack and other information

What BindRen contains

The active substance is colestilan.

• – BindRen 2 g granules: each sachet contains 2 g of colestilan.

• – BindRen 3 g granules: each sachet contains 3 g of colestilan.