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What Renvela is and what it is used for
Renvela contains sevelamer
carbonate as the active ingredient.
It binds phosphate from food in the
digestive tract and so reduces serum
phosphorus levels in the blood.
Renvela 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);
• adult patients with chronic (longterm) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.
• paediatric patients with chronic (long-term) kidney disease above the age of 6 and above a certain height and weight (used to calculate body surface area by your physician). Renvela 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.
How to take Renvela
You must take Renvela as prescribed by your doctor. They will base the dose on your serum phosphorus level. For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 mL of water per sachet. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed. Instead of water, the powder may be pre-mixed with a small amount of cold beverage (about 120 ml or half a glass) or food (about 100 grams) and consumed within 30 minutes. Do not heat Renvela powder (e.g. microwave) or add to hot foods or liquids. The recommended starting dose of Renvela for adults is 2.4-4.8 g per day equally divided over three meals. The exact starting dose and regimen will be determined by your doctor. Use in children and adolescents The recommended starting dose of Renvela for children is based on their height and weight (used to calculate body surface area by your physician). For children, Renvela powder is preferred, as Renvela tablets are not appropriate in this population. Renvela should not be given on an empty stomach and should be taken with meals or snacks. The exact starting dose and regimen will be determined by your doctor. For doses of less than 2.4 g, the Renvela powder in the sachet may be divided. The Renvela powder may be measured by volume (mL) using a measuring scoop or measuring spoon. Sevelamer carbonate dose (g) Volume (mL) 0.4 g (400 mg) 1.0 mL 0.8 g (800 mg) 2.0 mL 1.2 g (1200 mg) 3.0 mL 1.6 g (1600 mg) 4.0 mL Preparation using a 1 mL measuring scoop: For a 0.4 g dose: · Open the sachet with scissors along the marked line. · Insert the scoop into the sachet. · Fill the scoop above the top edge. · Withdraw the scoop from the sachet using the top edge of the open sachet to level the powder with the top of the scoop. This allows excess Renvela powder to fall back into the sachet. · Disperse the 1.0 mL of the Renvela powder from the measuring scoop in 60 mL of water. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed. · Close the sachet by folding over twice. · The remaining Renvela powder may be used within 24 hours for the next dose. · Discard sachets of Renvela powder that have been opened for more than 24 hours. For a 0.8 g dose: · Follow the instructions above, filling the scoop twice for a total of 2.0 mL Renvela powder. For a 1.2 g dose: · Follow the instructions above, filling the scoop three times for a total of 3.0 mL Renvela powder. For a 1.6 g dose: · Follow the instructions above, filling the scoop four times for a total of 4.0 mL Renvela powder. Preparation using a measuring spoon: For a 0.4 g dose: · Open the sachet with scissors along the marked line. · Hold the measuring spoon vertically. · Pour the contents of the sachet into the measuring spoon to fill the spoon to 1.0 mL. · Do not tap the dosing spoon to compact the powder. · Disperse the 1.0 mL of the Renvela powder from the measuring spoon in 60 mL of water. Drink within 30 minutes of being prepared. It is important to drink all of the liquid and it may be necessary to rinse the glass with water and drink this as well to ensure that all of the powder is swallowed. · Close the sachet by folding over twice. · The remaining Renvela powder may be used within 24 hours for the next dose. · Discard sachets of Renvela powder that have been opened for more than 24 hours. For a 0.8 g dose: · Follow the instructions above, filling the spoon twice for a total of 2.0 mL Renvela powder. For a 1.2 g dose: · Follow the instructions above, filling the spoon three times for a total of 3.0 mL Renvela powder. For a 1.6 g dose: · Follow the instructions above, filling the spoon four times for a total of 4.0 mL Renvela powder. Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and they may adjust the dose of Renvela when necessary to reach an adequate phosphate level. Patients taking Renvela should adhere to their prescribed diets. 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.
Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
Since constipation may be an early
symptom of a blockage in your intestine,
please inform your doctor or pharmacist.
The following side effects have been reported in patients taking Renvela:
Very common (may affect more than 1 in 10 people): vomiting, constipation, upper abdominal pain, nausea
Common (may affect up to 1 in 10 people): diarrhoea, abdominal pain, indigestion, flatulence
Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Not known (frequency cannot be estimated from the available data): cases of itching, rash, slow intestine motility (movement)/blockages in the intestine, and perforation in the intestine wall have been reported
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. United Kingdom 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. Ireland You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected] Malta You can also report side effects directly via ADR Reporting www. medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine
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 sachet and carton after the letters “EXP”. The reconstituted suspension must be administered within 30 minutes of reconstitution. The medicinal product 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.
2 to 3 weeks on average
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