Renvela® Sevelamer carbonate Consumer Medicine Information What is in this leaflet Your doctor, however, may have Do not take Renvela if you have: prescribed Renvela for another This leaflet answers some common purpose. • hypophosphatemia, a condition where you do not have enough questions about Renvela. Ask your doctor if you have any phosphorus in your body It does not contain all the available questions about why it has been information. It does not take the prescribed for you. • a bowel obstruction. place of talking to your doctor or This medicine is only available with pharmacist. a doctor's prescription. Renvela should not be used after the expiry date (exp) printed on the All medicines have risks and pack. If you take this medicine after benefits. Your doctor has weighed the expiry date it may have no effect the risks of you taking Renvela at all, or worse, an unexpected effect. against the benefits this medicine is Before you take expected to have for you. Renvela Renvela should not be used if the packaging is torn or shows signs of If you have any concerns about tampering. taking this medicine, ask your When you must not take doctor or pharmacist. Renvela Do not give Renvela to children. The safety and efficacy of Renvela in Keep this leaflet. You may need to Do not take Renvela if you have an children under the age of 18 years as read it again. allergy to: not been established. • any medicine containing If you are not sure whether you sevelamer carbonate (the active should start taking this medicine, ingredient) What Renvela is used talk to your doctor. for • any of the ingredients listed at the end of this leaflet Before you start to take it Renvela contains the active substance • any other similar medicine, such Tell your doctor or pharmacist if sevelamer carbonate and is used to as sevelamer hydrochloride. you have: treat hyperphosphatemia, a condition allergies to any other medicines caused by too much dietary • Symptoms that may indicate an or substances such as foods, phosphorus being retained in your allergic reaction include preservatives or dyes. body due to a diseased kidney. swallowing problems Increased levels of serum phosphorus • shortness of breath • can lead to hard deposits in your • wheezing or difficulty breathing • severe constipation body called calcification. These deposits can stiffen your blood • swelling of the face, lips, tongue • problems with movement in your stomach and bowel vessels and make it harder for blood or other parts of the body to be pumped around the body. • rash, itching or hives on the skin. • active inflammation of the bowel Renvela helps to remove excess Tell your doctor if you are • undergone major surgery on phosphorus that has built up in your experiencing these symptoms. your stomach or bowel body by binding the phosphorus that is in the food that you eat. • you have or have had any other medical conditions, including a bowel obstruction or hypophosphatemia RENVELA® 1 • thyroid problems. Some medicines may be affected by How to take it Renvela or may affect how well If you are pregnant or breast- Renvela works. You may need Tablets feeding, think you may be different amounts of your medicine, Swallow Renvela tablets whole with pregnant or are planning to have a or you may need to take different a glass of water. Do not crush, chew baby. medicines. Your doctor will advise or break into pieces. Tell your doctor about any of the you. If you are having difficulty above before you take Renvela. The effects of medicines such as swallowing Renvela tablets, speak to Renvela powder contains ciclosporin, mycophenolate mofetil you doctor. You may be prescribed and tacrolimus (medicines used to sucralose. Renvela powder as an alternative. suppress the immune system) may be reduced by Renvela. Your doctor will Additional Information advise you if you are taking these Powder Due to either your kidney medicines. The 1.6 g powder for oral suspension condition or your dialysis should be dispersed in 40 ml of water Renvela should not be taken at the treatment you may: per sachet. same time as ciprofloxacin (an • Develop low or high levels of antibiotic). The 2.4 g powder for oral suspension calcium in your blood. Since should be dispersed in 60 ml of water Renvela does not contain Thyroid hormone deficiency may per sachet. calcium your doctor might uncommonly be observed in certain prescribe additional calcium people taking levothyroxine (used to The powder isn’t expected to fully tablets treat low thyroid hormone levels) and dissolve in water. When dispersed it Renvela. Therefore your doctor may creates a cloudy white suspension in • Have a low amount of vitamin D monitor the levels of thyroid which small particles are visible. in your blood. Therefore your stimulating hormone in your blood Drink within 30 minutes of being doctor may monitor the levels of more closely. prepared. It is important to drink all vitamin D in your blood and of the dose and it may be necessary prescribe additional vitamin D as If you are taking medicines for heart to rinse the glass with water and necessary. If you do not take rhythm problems, stomach problems, drink this as well to ensure that all of multivitamin supplements you or for epilepsy, you should consult the powder is swallowed. may also develop low levels of your doctor before taking Renvela. vitamins A, E, K and folic acid in your blood and therefore your How long to take it doctor may monitor these levels Renvela helps lower your dietary and prescribe supplemental vitamins as necessary. How to take Renvela phosphate. It does not cure your condition. Therefore, you must • Develop peritonitis (infection of continue to take it as directed by your your abdominal fluid) associated How much to take doctor. with your peritoneal dialysis. The recommended starting dose of This risk can be reduced by You may have to take phosphate- Renvela is 2.4 g to 4.8 g per day to careful adherence to sterile lowering medicines for the rest of be divided over 3 meals. techniques during bag changes. your life. If you stop taking Renvela, You should tell your doctor For tablets, this means one to two your phosphate levels may rise again. immediately if you experience 800 mg tablets with each meal three It is important to keep taking your any new signs or symptoms of times a day. For powder this means medicines even if you feel well. abdominal distress, abdominal up to one full sachet (1.6 g) with swelling, abdominal tenderness, Do not stop taking Renvela. Your each meal, three times a day. constipation, fever, chills, doctor may need to change the dose nausea or vomiting. The dose will depend on your serum of your other medicines if you stop phosphorus level. taking Renvela, so you should only Taking other medicines stop when your treating doctor tells Tell your doctor or pharmacist if you Follow all directions given to you you to. are taking, have recently taken, or by your doctor or pharmacist might take any other medicines carefully. If you forget to take it (including vaccinations), medicines that you buy without a prescription These directions may differ from the If you miss a dose, do not take an from your pharmacy, supermarket or information contained in this leaflet. extra dose to make up for the one you health food shop. missed. Take the next dose at the usual time with your meal. RENVELA® 2 It is important to take Renvela as Do not stop taking your medicine or • wheezing or difficulty in prescribed by your doctor. lower the dosage without checking breathing with your doctor. If you take too much • swelling of the face, lips, tongue (overdose) or other parts of the body Immediately telephone your Side Effects • severe abdominal pain, stomach or intestine disorders, or blood in treating doctor or Poisons Tell your doctor, pharmacist or the stool (gastrointestinal Information Centre telephone 0800 bleeding). These symptoms can nurse as soon as possible if you do POISON or 0800 764 766, or go to be due to serious inflammatory accident and emergency at your not feel well while you are taking bowel disease caused by nearest hospital, if you think that Renvela. sevelamer crystal deposit in your you or anyone else may have taken All medicines can have side effects. bowel. too much Renvela. Do this even if Sometimes they are serious, most of Other side effects not listed above there are no signs of discomfort or the time they are not. You may need may occur in some patients. Tell poisoning. You may need urgent medical treatment if you get some of your doctor if you notice anything medical attention. Keep telephone the side effects. making you feel unwell when you numbers of these places handy. are taking, or soon after you have Tell your doctor or pharmacist if finished taking Renvela. you notice any of the following and they worry you: While you are taking • allergic reaction After using Renvela Renvela • vomiting Storage Things you must do • nausea Keep Renvela in a cool dry place If you become pregnant while you • constipation where the temperature stays below are taking Renvela, tell your • diarrhoea 25°C. Do not put Renvela in the doctor. • flatulence refrigerator. Do not put it in the Tell your doctor or pharmacist if bathroom or near the sink. Do not you are taking any other • indigestion leave it in the car or on window sills. medicines, including any that you Heat and dampness can destroy some • abdominal pain get without a prescription from medicines.