What is it and how is it used?

Renagel contains sevelamer as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.

Adult patients whose kidneys have failed and who are receiving haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood. The amount of phosphate then rises (your doctor will call this hyperphosphataemia). Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.

Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.

It may be necessary to use other medicines with Renagel, which could include calcium or vitamin D supplements, to control the development of renal bone disease.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Renagel if:

  • you have low levels of phosphate in your blood
  • you have bowel obstruction.
  • you are allergic (hypersensitive) to sevelamer or to any of the other ingredients of the product ( see Section 6: Further information).

Take special care with Renagel

If any of the following applies to you, please consult your doctor before taking Renagel :

  • you are not on dialysis
  • swallowing problems
  • problems with motility (movement) in your stomach and bowel
  • retention of stomach contents
  • active inflammation of the bowel
  • have undergone major surgery on your stomach or bowel.

The safety and efficacy in children (below the age of 18 years) has not been established. Therefore Renagel is not recommended for use in this population.

Additional treatments:
Due to either your kidney condition or your dialysis treatment you may:

  • develop a low or high level of calcium in your blood. Since Renagel does not contain calcium your doctor might prescribe additional calcium tablets.
  • have a low amount of vitamin D in your blood. Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary. If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.

Changing treatment:
When you switch from another phosphate binder to Renagel, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Renagel may decrease the levels of bicarbonate.

Special note for patients on peritoneal dialysis

You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis. This risk can be reduced by careful adherence to sterile techniques during bag changes. You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress,abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.
You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.

Taking other medicines
Please tell your doctor if you are taking or have recently taken other medicines, including medicines obtained without a prescription.

Renagel should not be taken at the same time as ciprofloxacin (an antibiotic).

If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Renagel.

The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Renagel. Your doctor will advise you if you are taking these medicines.

Increased levels of thyroid stimulating hormone (TSH, a substance in your blood which stimulates the thyroid gland to make thyroid hormone which helps control your body?s metabolism) may very rarely be observed in certain people taking levothyroxine (a thyroid hormone) and Renagel. Therefore your doctor may monitor the levels of TSH in your blood more closely.

Your doctor will check for interactions between Renagel and other medicines on a regular basis.

Taking Renagel with food and drink

You should take Renagel tablets with meals. However, you should adhere to your prescribed diet and liquid intake.
Do not chew. The tablets must be swallowed whole.

Pregnancy and breast-feeding

The safety of Renagel has not been established in pregnant or lactating women. Renagel should only be given to pregnant or lactating women if clearly needed.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. If you are affected, do not drive and do not use any tools or machines.

How is it used?

You should take Renagel as prescribed by your doctor. He/she will base the dose on your serum phosphate level. The recommended starting dose of Renagel for adults and the elderly (> 65 years) is one or two tablets with each meal 3 times a day.

Your doctor will check the levels of phosphate in your blood periodically and he/she may adjust the dose of Renagel when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.

In some cases where Renagel should be administered at the same time as another medicine. Your doctor may advise you to take this medicine 1 hour before or 3 hours after Renagel intake, or he/she may consider monitoring the blood levels of that medicine.

If you take more Renagel than you should
There are no reported overdoses in patients.
In the event of a possible overdose you should contact your doctor immediately.

If you forget to take Renagel

If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for a forgotten dose .

What are possible side effects?

Like all medicines, Renagelcan cause side effects, although not everybody gets them.

The following side effects have been reported in patients taking Renagel:
Very common (affects more than 1 user in 10): nausea, vomiting
Common (affects 1 to 10 users in 100): diarrhoea, indigestion, abdominal pain, constipation, flatulence.

In clinical use of Renagel, cases of itching, rash, abdominal pain, slow intestine motility (movement), blockages in the intestine, inflammation of abnormal small pouches (called diverticula) in the large intestine and perforation in the intestine wall have been reported.

Since constipation may be a preceding symptom in very rare cases of blockages in the intestine, please inform your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not store above 25 °C. Keep the bottle tightly closed in order to protect from moisture.

Do not use Renagel after the expiry date stated on the carton and/or bottle after the letters ?EXP?.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Renagel contains

  • The active substance is sevelamer.
  • The other ingredients are silica colloidal anhydrous and stearic acid. The tablet coating contains hypromellose and diacetylated monoglycerides. The printing ink contains iron oxide black (E172), hypromellose and propylene glycol.
What Renagel looks like and contents of the pack

Renagel tablets are film coated, off white, oval tablets with Renagel 800 imprinted on one side. The tablets are packed in high density polyethylene bottles with a child resistant polypropylene cap and an induction seal.

Pack sizes are:
6 bottles of 30 tablets
1 bottle of 100 tablets
1 bottle of 180 tablets
2 bottles of 180 tablets
3 bottles of 180 tablets

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:
Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
The Netherlands

Manufacturing authorisation holders responsible for batch release:
Genzyme Ltd.
37 Hollands Road
Haverhill, Suffolk
CB9 8PU
United Kingdom

Genzyme Ireland Ltd.
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.

Ísland Vistor hf. Tel 354 535 7000 BelgiëBelgiqueBelgien LuxembourgLuxemburg Genzyme Belgium nvsa BelgiqueBelgien, TélTel 32 2 714 17 11 Magyarország Genzyme Europe B.V. Képviselet, Tel 36 1 310 7440 Genzyme CEE GmbH . 359 2 971 1001 eská republikaSlovenská republika Genzyme Czech s.r.o. Tel 420 227 133 665 Nederland Genzyme Europe BV, Tel 31 35 6991200 DanmarkNorgeSverigeSuomiFinland Genzyme AS, DanmarkTanska, TlfPuh. 45 32712600 Österreich Genzyme Austria GmbH, Tel 43 1 774 65 38 Deutschland Genzyme GmbH, Tel 49 610236740 PolskaEestiLatvijaLietuva Genzyme Polska sp. z o.o. PoolaPolijaLenkija, Tel 48 22 516 24 32 Genzyme Hellas Ltd. , 30 210 99 49 270 Portugal Genzyme Portugal, Tel 351 21 422 0100 España Genzyme, S.L., Tel 34 91 6591670 România Genzyme CEE GmbH- Reprezentanta pentru Romania Tel 40 21 243 42 28 France Genzyme S.A.S, Tél 33 0 825 825 863 Slovenija Genzyme Europe B.V. Predstavnitvo za Hrvako in Slovenijo Hrvaka, Tel 385 1 6386 250 Italia Malta Genzyme Srl ItaliaItalja, Tel 39 059 349811 United KingdomIreland Genzyme Therapeutics United Kingdom, Tel 44 1865 405200

This leaflet was last approved in {MM/YYYY} .

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