Renvela 800 mg film coated tablets

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• 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 you doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Renvela is and what it is used for
2. What you need to know before you take Renvela
3. How to take Renvela
4. Possible side effects
5. How to store Renvela
6. Contents of the pack and other information

• 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

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.

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.

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.

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.

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

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

In the event of a possible overdose you should contact your doctor immediately.

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.

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.

• 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.

Very common (may affect more than 1 in 10 people):

vomiting, upper abdominal pain, nausea

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

diarrhoea, stomach ache, indigestion, flatulence

Not known (frequency cannot be estimated from available data):

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

If you get any side effects, talk to your doctor pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• 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.

Renvela film-coated tablets are white oval tablets with RV800 engraved 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

Manufacturer

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.