800 mg film-coated tablets
sevelamer carbonate
What Renvela is and what it is used for
Renvela contains sevelamer carbonate as the active substance. It binds phosphate from the food in the digestive tract and thus lowers the serum levels of phosphorus in the blood.
This medicine is used to control hyperphosphatemia (high levels of phosphate in the blood) in women
- adult patients undergoing dialysis (a blood purification technique). It can be used to treat patients who receive hemodialysis (through a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdominal cavity and an internal membrane in the body filters the blood);
- patients with chronic (long-term) kidney disease with serum phosphorus levels (in the blood) greater than or equal to 1.78 mmol / l, who do not receive dialysis.
This medicine should be used together with other treatment methods such as calcium supplements and vitamin D to prevent the development of skeletal disease.
Elevated levels of serum phosphorus can lead to hard deposits in the body which are called calcifications. These deposits can make the blood vessels stiff so that it becomes more difficult to pump the blood into the body. Elevated levels of serum phosphorus can also lead to itchy skin, red eyes, skeletal pain, and fractures.
What you need to know before you take Renvela
Do not take Renvela
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
- if you have low levels of phosphate in your blood (your doctor will check this for you)
- if you have intestinal obstruction
Warnings and cautions
If any of the following apply to you, talk to your doctor before taking Renvela:
- if you have swallowing problems. Your doctor may instead prescribe Renvela powder for oral suspension.
- if you have problems with motility (mobility) in the stomach and intestines
- if you vomit often
- if you have an active intestinal inflammation
- if you have had major surgery on your stomach or intestines
Talk to a doctor during treatment with Renvela:
- if you experience severe abdominal pain, gastrointestinal upset, or blood in the stool ( gastrointestinal bleeding). These symptoms may be due to severe inflammatory bowel disease caused by sevelamer crystals in the intestine. Contact your doctor who will decide whether to continue treatment or not.
Additional treatments :
Due to either your kidney condition or your dialysis treatment, you can:
- develop low or high calcium levels in the blood. Because this medicine does not contain calcium, your doctor may prescribe extra calcium tablets.
- have a low amount of vitamin D in the blood. Therefore, your doctor may check the levels of vitamin D in your blood and prescribe more vitamin D if needed. If you do not take any multivitamin supplements, you may also have low levels of vitamins A, E, K, and folic acid in your blood therefore your doctor may check these levels and prescribe vitamin supplements if needed.
- get abnormal levels of bicarbonate in the blood and increased acidity in the blood and other body tissues. Your doctor should check the bicarbonate levels in your blood.
Important to consider for patients receiving peritoneal dialysis:
You may develop peritonitis (peritonitis) associated with peritoneal dialysis. This risk can be reduced if you carefully follow the sterile methods during bag changes. You should tell your doctor immediately if you get new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal pain or hard/stiff abdomen, constipation, fever, chills, nausea, or vomiting.
Children
Safety and efficacy in children (under 6 years of age) have not been studied. Therefore, this medicine is not recommended for children under 6 years of age.
Other medicines and Renvela
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- You should not take Renvela at the same time as ciprofloxacin (an antibiotic ).
- If you are taking medicines for heart rhythm problems or epilepsy, you should consult your doctor when taking Renvela.
- Renvela may reduce the effects of medicines such as ciclosporin, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system). Your doctor will advise you if you are taking these medicines.
- Thyroid hormone deficiency can be observed in less common cases in some people taking levothyroxine (used to treat low levels of thyroid hormone) and Renvela. Therefore, your doctor may check the levels of thyroid-stimulating hormone in your blood more closely.
- Drugs to treat heartburn and acid reflux from your stomach or esophagus, such as omeprazole, pantoprazole, or lansoprazole, so-called “proton pump inhibitors”, may reduce the effect of Renvela. Your doctor may want to check the phosphate levels in your blood.
Your doctor will regularly check the risk of Renvela being affected or affected by other medicines.
In some cases when Renvela is to be taken while you are taking another medicine, your doctor may ask you to take the other medicine 1 hour before or 3 hours after taking Renvela. Your doctor may also want to check the levels of the other medicine in your blood.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 treatment or not.
It is unknown if Renvela can pass into breast milk and affect your baby. Talk to your doctor who will decide if you can breastfeed or not and if it is necessary to stop taking Renvela.
Driving and using machines
Renvela is unlikely to affect your ability to drive or use machines.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take Renvela
Always take Renvela exactly as your doctor has told you. Your doctor will base dose one on your serum phosphorus level.
The recommended starting dose of Renvela tablets for adults and the elderly is one to two tablets of 800 mg at each meal, ie 3 times a day. If you are not sure, talk to your doctor, pharmacist, or nurse.
Take Renvela after a meal or with food.
The tablets must be swallowed whole. They must not be crushed, chewed, or split.
In the beginning, the doctor will check the phosphorus levels in your blood at 2-4 week intervals and may adjust Renvelados one if necessary to achieve a suitable phosphate level.
Follow the diet prescribed by your doctor.
If you take more Renvela than you should
In the event of an overdose, contact your doctor immediately.
If you forget to take Renvela
If you have missed a dose, skip this dose and take the next dose at regular meal times. Do not take a double dose to make up for a forgotten dose.
If you stop taking Renvela
Taking Renvela treatment is important to maintain an appropriate level of phosphate in your blood. Quitting Renvela would lead to significant consequences such as calcification of the blood vessels. If you are considering stopping treatment with Renvela, contact your doctor or pharmacist first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 intestinal blockage. In case of constipation, you should contact a doctor or pharmacist.
Some side effects can be serious. If you get any of the following side effects, seek immediate medical attention:
- Allergic reaction (symptoms include rash, hives, swelling, and difficulty breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).
- Intestinal blockage (symptoms include severe bloating (abdominal pain, swelling, or cramps), and severe constipation) have been reported. No known frequency (frequency can not be calculated from available data).
- Holes in the intestinal wall (symptoms include severe abdominal pain, chills, fever, nausea, vomiting, or sore abdomen). No known frequency.
- Severe inflammation of the colon (symptoms include severe abdominal pain, gastrointestinal upset or blood in the stool ( gastrointestinal bleeding)), and deposition of sevelamer crystals in the intestinal mucosa have been reported. No known frequency.
Other side effects have been reported in patients taking Renvela:
Very common:
vomiting, pain in the upper abdomen, nausea
Common (may affect up to 1 in 10 people):
diarrhea, stomach pain, indigestion, flatulence
No known frequency:
cases of pruritus, rash, slow bowel motility (mobility)
How to store Renvela
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the can and carton after “EXP”. The expiration date is the last day of the specified month.
Close the jar tightly. Moisture sensitive.
No special storage instructions.
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.
Contents of the pack and other information
Content declaration
- The active substance is sevelamer carbonate. One 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 label ink contains black iron oxide (E172), isopropyl alcohol, and propylene glycol.
What the medicine looks like and the contents of the pack
Renvela film-coated tablets are white tablets with “Renvela 800” embossed on one side. The tablets are packaged in high-density polyethylene cans with a polypropylene cap and induction seal.
Pack sizes :
Each jar contains 30 tablets or 180 tablets.
Packs of 1 can with 30 or 180 tablets (without outer carton) and aultiple packs containing 180 (6 cans of 30) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genzyme Europe BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Manufacturer
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine.
Sanofi AB
Tel: +46 (0) 8 634 50 00