What is it and how is it used?

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

Patients who have kidneys that do not work properly are not able to control the level of serum phosphorus 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 is 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.

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 Renvela if:

you have low levels of phosphate in your blood (your doctor will check this for you) you have bowel obstruction
you are allergic (hypersensitive) to the active substance or to any of the other ingredients of the product (see section 6).

Take special care with Renvela

If any of the following applies to you, please consult your doctor before taking Renvela swallowing problems problems with motility movement in your stomach and bowel being sick frequently 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 Renvela is not recommended for use in children.

Additional treatments:
Due to either your kidney condition or your dialysis treatment you may:
develop low or high levels of calcium in your blood. Since Renvela 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.

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 any other medicines including medicines obtained without a prescription.

Renvela 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 Renvela.

The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Renvela. Your doctor will advise you if you are taking these medicines.

Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treatment low thyroid hormone levels) and Renvela. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.

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

Taking Renvela with food and drink

You must take Renvela tablets with meals.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or intend to become pregnant. It is unknown whether Renvela has any affect on unborn babies.

Tell your doctor if you wish to breast-feed your baby. It is unknown whether Renvela may pass through breast milk and affect your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

How is it used?

You must take Renvela as prescribed by your doctor. They will base the dose on your serum phosphorus level.

The recommended starting dose of Renvela tablets for adults and the elderly (> 65 years) is one to two tablets of 800 mg with each meal, 3 times a day.

The tablets must be swallowed whole. Do not crush, chew or break into pieces.

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

Your doctor will check the levels of phosphorus in your blood periodically and they may adjust the dose of Renvela when necessary to reach an adequate phosphate level.

If you take more Renvela 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 Renvela

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, Renvelacan cause side effects, although not everybody gets them.

The following side effects have been reported in patients taking Renvela:
Very common (affects more than 1 user in 10):
vomiting, constipation, upper abdominal pain, nausea

Common (affects 1 to 10 users in 100):
diarrhoea, abdominal pain, indigestion, flatulence

In clinical use, cases of itching, rash, slow intestine motility (movement)/blockages in the intestine, and perforation in the intestine wall have been reported.

Since constipation may be an early symptom of a blockage in your 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 use Renvela after the expiry date stated on the bottle and carton after the letters ?EXP?.

Keep the bottle container tightly closed in order to protect from moisture.
This medicinal product does not require any special storage conditions.

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 Renvela contains

  • The active substance is sevelamer carbonate. Each Renvela film-coated tablet contains 800 mg of sevelamer carbonate
  • The other ingredients are microcrystalline cellulose, sodium chloride and zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides. The printing ink contains iron oxide black (E172), isopropyl alcohol, propylene glycol and hypromellose (E464).
What Renvela looks like and contents of the pack

Renvela film-coated tablets are white tablets with RENVELA 800 imprinted on one side. The tablets are packed in high density polyethylene bottles with a polypropylene cap and an induction seal. Pack sizes:
1 x 30 tablets per bottle
1 x 180 tablets per bottle
180 tablets (6 bottles of 30 tablets)

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturer:

Genzyme Ltd.
37 Hollands Road
Haverhill, Suffolk
CB9 8PB

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 420 221 722 511 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 S.A., Tel 351 21 422 0100 España Genzyme, S.L.U., 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

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