Renvela - patient leaflet, side effects, dosage

1. What Renvela is and what it is used for

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

This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:

• adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
• patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.

This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.

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.

2. What you need to know before you take Renvela

Do not take Renvela if:

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

Warnings and precautions

Talk to your doctor before taking Renvela if any of the following applies to you:

• swallowing problems. Your doctor can rather prescribe Renvela powder for oral suspension
• 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

Talk to your doctor while taking Renvela:

• if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding). These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystals deposit in your bowel. Contact your doctor who will decide on continuing the treatment or not.

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 this medicine 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.
• have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue. Your doctor should monitor the level of bicarbonate in your blood.

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.

Children

The safety and efficacy in children (below the age of 6 years) have not been studied. Therefore this medicine is not recommended for use in children below the age of 6 years.

Other medicines and Renvela

Tell your doctor if you are taking, have recently taken or might take any other medicines.

• 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 treat low thyroid hormone levels) and Renvela. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
• Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Renvela. Your doctor may monitor the phosphate level in your blood.

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

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. Your doctor may also consider monitoring the levels of that medicine in your blood.

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.

The potential risk of Renvela during human pregnancy is unknown. Talk to your doctor who will decide if you can continue the treatment with Renvela.

It is unknown whether Renvela is excreted in breast milk and may affect your baby. Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Renvela treatment.

Driving and using machines

Renvela is unlikely to affect your ability to drive or to use machines.

Excipients

This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.

3. How to take Renvela

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 elderly is one to two tablets of 800 mg with each meal, 3 times a day. Check with your doctor, pharmacist or nurse if you are not sure.

Take Renvela after your meal or with food.

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

Initially, your doctor will check the levels of phosphorus in your blood every 2–4 weeks and may adjust the dose of Renvela when necessary to reach an adequate phosphate level.

Follow the diet prescribed by your doctor.

If you take more Renvela than you should

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.

If you stop taking Renvela

Taking your Renvela treatment is important to maintain an appropriate phosphate level in your blood. Stopping Renvela would lead to important consequences such as calcification in the blood vessels. If you consider stopping your Renvela treatment, contact your doctor or pharmacist first.

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.

Constipation is a very common side effect (may affect more than 1 in 10 people). It can be an early symptom of a blockage in your intestine. In case of constipation, please inform your doctor or pharmacist.

Some side effects could be serious. If you get any of the following side effects, seek immediate medical attention:

• – Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).

• – Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation) has been reported. Frequency is not known (frequency cannot be estimated from the available data).

• – Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a tender abdomen) has been reported. Frequency is not known.

• – Serious inflammation of the large bowel (symptoms include: severe abdominal pain, stomach or intestine disorders, or blood in the stool [gastrointestinal bleeding]) and crystal deposit in the intestine have been reported. Frequency is not known.

Other side effects have been reported in patients taking Renvela:

Very common :

vomiting, upper abdominal pain, nausea

Common (may affect up to 1 in 10 people):

diarrhoea, stomach ache, indigestion, flatulence

Not known :

cases of itching, rash, slow intestine motility (movement)

Reporting of side effects

If you get any side effects, talk to your doctor. 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 Renvela

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

Do not use this medicine after the expiry date stated on the bottle and carton after the letters “EXP”. The expiry date refers to the last day of that month.

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

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Renvela contains

• – The active substance is sevelamer carbonate. Each 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 and propylene glycol.

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:

Each bottle contains 30 tablets or 180 tablets.

Packs of 1 bottle of 30 or 180 tablets (no outer carton) and a multipack containing 180 (6 bottles of 30) tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genzyme Europe B.V.

Paasheuvelweg 25

1105 BP Amsterdam

The Netherlands

Manufacturer

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

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

België/Belgiqu­e/Belgien/ Luxembourg/Lu­xemburg Sanofi Belgium

Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40

Tél/Tel: + 32 2 710 54 00

Efc^rapufl Swixx Biopharma EOOD Ten.: +359 (0)2 4942 480	Magyarország SANOFI-AVENTIS Zrt Tel: +36 1 505 0050
Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111	Malta Sanofi S.r.l. Tel: +39 02 39394275
Danmark Sanofi A/S Tlf: +45 45 16 70 00	Nederland Genzyme Europe B.V. Tel: +31 20 245 4000
Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222010	Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 00
Eesti Swixx Biopharma OÜ Tel: +372 640 10 30	Österreich sanofi-aventis GmbH Tel: + 43 1 80 185 – 0
EXÀàôa sanofi-aventis AEBE Tql: +30 210 900 1600	Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
España sanofi-aventis, S.A. Tel: +34 93 485 94 00	Portugal Sanofi – Produtos Farmacéuticos, Lda.. Tel: +351 21 35 89 400
France sanofi-aventis France Tél : 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Ireland sanofi-aventis Ireland Ltd T/A SANOFI Tel: +353 (0) 1 4035 600	Slovenská republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Ísland Vistor hf. Sími: +354 535 7000	Suomi/Finland Sanofi Oy Puh/Tel: + 358 201 200 300
Italia Sanofi S.r.l. Tel: 800 536 389	Sverige Sanofi AB Tel: +46 (0)8 634 50 00 72

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

Latvija

Swixx Biopharma SIA

Tel: +371 6 616 47 50

This leaflet was last revised in

Other sources of information

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