Renvela^® 0.8 g powder for oral suspension

sevelamer carbonate

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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)
• adult 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
• 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).

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.

You must take Renvela as prescribed by your doctor. They will base the dose on your serum phosphorus level.

For a 0.8 g dose, the powder for oral suspension should be dispersed in 30 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 g) 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 this medicine for adults and elderly is 2.4-4.8g per day equally divided over three meals. Check with your doctor, pharmacist or nurse if you are not sure. The exact starting dose and regimen will be determined by your doctor.

Take Renvela after your meal or with food.

For 0.4 g doses, the powder in the sachet may be divided. In this case the 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.

Always use the dosing spoon provided in the carton.

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, the powder is preferred, as tablets are not appropriate in this population. This medicine 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 0.8 g, the powder in the sachet may be divided. The 0.4 g dose of Renvela powder must be measured using the dosing spoon provided in the carton.

Preparation using a dosing spoon

Use the provided dosing spoon for each 0.4g dose of Renvela powder.

For a 0.4 g dose:

• Shake the sachet holding the top corner before opening, to move the powder to the bottom of the sachet.
• Open the sachet by tearing along the marked line.
• Ensure the dosing spoon is dry.
• Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing spoon.
• Fill the powder to the spoon level.
• Do not tap the dosing spoon to compact the powder.
• Mix the powder from the dosing spoon in 30 ml of water. Stir the suspension and drink it within 30 minutes of being prepared.
  It is important to drink all of the liquid to ensure that all of the powder is swallowed.
• Close the sachet by folding over twice.
• The remaining powder may be used within 24 hours for the next dose.
• Discard sachets of powder that have been opened for more than 24 hours.

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 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 (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)

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 expiry date refers to the last day of that month.

The reconstituted suspension must be administered within 30 minutes of reconstitution. This medicine does not require any special storage conditions.

Discard the sachet after 24 hours of opening.

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.