Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - renvela

Document Subject

Generated Narrative: MedicinalProductDefinition mp5d41e6d3881ce675625375af18a0589a

identifier: http://ema.europa.eu/identifier/EU/1/09/521/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Renvela 800 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5d41e6d3881ce675625375af18a0589a

identifier: http://ema.europa.eu/identifier/EU/1/09/521/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - renvela

Attesters

What is in this leaflet

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

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.

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 .

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.

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

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.

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.

What Renvela looks like and contents of the pack

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

Sanofi B.V. Paasheuvelweg 1105 BP Amsterdam The Netherlands

Manufacturer

Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford Ireland

Sanofi Winthrop Industrie 1 rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc cedex France

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

Belgi /Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium T l/Tel: + 32 2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Magyarorsz g SANOFI-AVENTIS Zrt Tel: +36 1 505 0 esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Malta Sanofi S.r.l. Tel: +39 02 39394Danmark
Sanofi A/S Tlf: +45 45 16 70 Nederland Sanofi B.V. Tel: +31 20 245 4Deutschland Sanofi-Aventis Deutschland GmbH Tel: +49 (0)180 2 222Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 Eesti Swixx Biopharma O
Tel: +372 640 10 sterreich sanofi-aventis GmbH Tel: + 43 1 80 185 - 0

Sanofi-Aventis AEBE : +30 210 900 1Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Portugal Sanofi Produtos Farmac uticos, Lda.. Tel: +351 21 35 89 France Sanofi Winthrop Industrie T l : 0 800 222 Appel depuis l tranger : +33 1 57 63 23 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 Ireland sanofi-aventis Ireland Ltd T/A SANOFI Tel: +353 (0) 1 4035 Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 sland Vistor hf. S mi: +354 535 7Suomi/Finland Sanofi Oy Puh/Tel: + 358 201 200 Italia Sanofi S.r.l. Tel: 800 536 Sverige Sanofi AB Tel: +46 (0)8 634 50
C.A. Papaellinas Ltd. : +357 22 741Latvija Swixx Biopharma SIA
Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in

Other sources of information

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