Package Leaflet: Information for the UserRenvela 0.8 g powder for oral suspension

Sevelamer carbonate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What Renvela is and what it is used for

2. What you need to know before you start taking Renvela

3. How to take Renvela

4. Possible side effects

5. Storage of Renvela

6. Contents of the pack and additional information

Renvela contains sevelamer carbonate as the active ingredient. It binds to the phosphorus in food in the digestive tract and thereby reduces serum phosphorus levels in the blood.

This medication is used to control hyperphosphatemia (high levels of phosphate in the blood) in:

• adult patients on dialysis (a blood-cleansing technique).It can be used in patients undergoing hemodialysis (using a machine to filter the blood) or peritoneal dialysis (where fluid is pumped into the abdomen and a membrane filters the blood);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum (in the blood) phosphate level of 1.78 mmol/l or higher.
• pediatric patients aged 6 years or older with chronic kidney disease (long-term) and a certain height and weight (with which their doctor will calculate their body surface area).

This medication should be used with other treatments such as calcium supplements and vitamin D

to prevent the development of bone disease.

Increased serum phosphorus levels can produce hard deposits in the body called calcifications. These deposits can harden in blood vessels and make it more difficult for blood to be pumped throughout the body. Increased phosphorus levels can also produce itching skin, red eyes, bone pain, and fractures.

Do not take Renvela

• if you are allergic to the active ingredient or to any of the other components of this medication (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 precautions

• Consult your doctor before taking Renvela if you are in any of the following situations:problems with stomach and intestine motility
• you frequently vomit
• you have active intestinal inflammation
• you have had major surgery on your stomach or intestine.

Consult your doctor while taking Renvela:

• if you experience intense abdominal pain, stomach or intestinal disorders, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to a severe intestinal inflammatory disease, caused by the deposition of sevelamer crystals in the intestine. Contact your doctor, who will decide whether to continue treatment or not.

Additional treatments

Due to your kidney disease or dialysis treatment, you may:

• have low or high levels of calcium in your blood. Since this medication does not contain calcium, your doctor may prescribe calcium supplements.
• have low levels of vitamin D in your blood.Therefore, your doctor may monitor your vitamin D blood levels and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your doctor may also monitor your blood levels of vitamins A, E, K, and folic acid, and prescribe vitamin supplements as needed.

• have altered bicarbonate levels in your blood and elevated acidity in your blood and other tissues. Your doctor must monitor your bicarbonate blood levels.

Special note for patients on peritoneal dialysis

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk may decrease with the careful use of sterile techniques during bag changes. Inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, constipation, fever, chills, nausea, or vomiting.

Children

This medication has not been studied in children (under 6 years). Therefore, it is not recommended for use in children under 6 years.under 6 years.

Other medications and Renvela

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

• Renvela should not be administered at the same time as ciprofloxacin (an antibiotic).

• If you use other medications for heart rhythm problems or epilepsy, consult your doctor when taking Renvela.

• The effects of medications such as ciclosporin, micofenolato mofetilo, and tacrolimus (medications used to suppress the immune system) may be reduced by Renvela.Your doctor will advise you if you are taking these medications.

• A deficiency of thyroid hormone may be observed in certain individuals who take levotiroxine (used to treat low thyroid hormone levels) and Renvela.Therefore, your doctor may closely monitor your thyroid hormone levels in the blood.

• Medications to treat stomach acid and reflux in your stomach or esophagus, such as omeprazol, pantoprazol, or lansoprazol, known as "proton pump inhibitors," may reduce the effectiveness of Renvela. Your doctor must monitor your phosphate blood levels.

Your doctor will regularly check for interactions between Renvela and other medications.

In some cases, when Renvela must be taken at the same time as another medication, your doctor may instruct you to take this medication 1 hour before or 3 hours after taking Renvela. Your doctor must also consider monitoring the levels of that medication in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.. The potential risk of Renvela during human pregnancy is unknown. Consult your doctor, who will decide whether to continue treatment with Renvela.

The safety of Renvela for use during breastfeeding is unknown. Consult your doctor, who will decide whether you can breastfeed your baby or not and whether you need to stop treatment with Renvela.

Driving and operating machinery

It is unlikely that Renvela will affect your ability to drive or operate machinery.

Excipients

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially“sodium-free”.

This medication contains 8.42 mg of propylene glycol in each 0.8 g sachet.

Renvela should be taken as directed by your doctor. The doctor will determine the dose based on your serum phosphorus levels.

For a dose of 0.8 g the powder for oral suspension should be dispersed in 30 ml of water. Drink within 30 minutes of preparation. It is essential to drink the entire liquid and may be necessary to clear the glass with water and drink it as well to ensure all the powder is ingested.

Instead of water, the powder can be mixed with a small amount of cold drink (approximately 120 ml or half a glass) or food (about 100 grams), and take it within the next 30 minutes. Do not heat Renvela powder (for example, in the microwave) or add it to hot liquids or foods.

The recommended initial dose of this medication for adults and elderly patients is 2.4-4.8 g per day, divided equally into three meals. Consult with your doctor, pharmacist, or nurse if you are unsure. Your doctor will determine the exact initial dose and administration schedule.

Take Renvela after a meal or with food.

(Instructions for the presentation with a dosing spoon)

For doses of 0.4 g, the powder from the packet can be divided. In this case, the 0.4 g dose of Renvela powder should be measured with the dosing spoon included in the packaging.

Always use the dosing spoon included in the packaging.

(Instructions for the presentation WITHOUT a dosing spoon)

If a dose of 0.4 g is to be administered, please use the 0.8 g powder presentation with a dosing spoon.

Use in children and adolescents

The initial recommended dose of Renvela for children is based on their height and weight (with which your doctor will calculate their body surface area). For children, it is preferred to use the powder presentation as tablets are not suitable for this population. This medication should not be taken on an empty stomach and should be taken with meals or snacks. Your doctor will determine the exact initial dose and administration schedule.

For doses less than 0.8 g, the powder from the packet can be divided. The 0.4 g dose of Renvela powder should be measured with the dosing spoon included in the packaging.

Preparation using a dosing spoon:

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

For a dose of 0.4 g:

• Before opening the packet, shake it by the top corner, to move the powder to the bottom of the packet.
• Open the packet with a tear along the marked line.
• Ensure the dosing spoon is dry.
• Hold the dosing spoon horizontally and pour the powder from the packet into the spoon.

dosing spoon

• Fill the powder to the level of the dosing spoon.
• 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 within 30 minutes of preparation. It is essential to drink the entire liquid to ensure all the powder is ingested.
• Close the packet by folding it twice.
• The remaining powder can be used for the next dose within 24 hours.
• Discard the remaining powder from the packet if it has been open for more than 24 hours.

Initially, your doctor will check your blood phosphorus levels every 2-4 weeks and may adjust the Renvela dose as needed to achieve an adequate phosphorus level.

Follow the diet prescribed by your doctor.

If you take more Renvela than you should

In case of a possible overdose, you must contact your doctor immediately.

If you forget to take Renvela

If you forget to take a dose, omit it, and take the next dose at the usual time with a meal. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Renvela

Continuing your treatment with Renvela is essential to maintain an appropriate level of phosphate in your blood. Stopping Renvela treatment would lead to significant consequences, such as calcification in blood vessels. If you consider stopping your Renvela treatment, contact your doctor or pharmacist first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Constipation is a very frequent adverse effect (it may affect more than 1 in 10 patients). It may be an early sign of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.

Some adverse effects may be severe. If you have any of the following adverse effects, seek medical attention immediately:

- Allergic reaction (signs that include rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (it may affect up to 1 in 10,000 patients).

- Intestinal obstruction has been reported (signs include: severe distension, abdominal pain, swelling or cramps, severe constipation). The frequency is unknown (it cannot be estimated from available data).

- Intestinal wall rupture has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain or tenderness). The frequency is unknown.

- Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, digestive or intestinal disorders, blood in the stool [intestinal bleeding]) and crystal deposition in the intestine.The frequency is unknown.

Other adverse effects have been reported in patients taking Renvela:

Very frequent::

vomiting, upper abdominal pain, nausea

Frequent (may affect up to 1 in 10 patients):

diarrhea, stomach pain, indigestion, flatulence

Unknown frequency:

cases of itching, rash, slow intestinal motility (movement).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in the

Appendix Vvia the link.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the package after the letters "CAD". The expiration date is the last day of the month indicated.

The reconstituted suspension must be administered within 30minutes of reconstitution.

The medication does not require special storage conditions.

Instructions for presentation with dosing spoon)

Dispose of the package 24 hours after opening.

Do not throw the medications down the drain or in the trash.Ask your pharmacist where to dispose of unused medications. This will help protect the environment.

Composition of Renvela

• The active ingredient is sevelamer carbonate. Each sachet contains 0.8 g of sevelamer carbonate.
• The other components are propylene glycol alginate (E405), citrus cream flavor, sodium chloride, sucralose, and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Renvela oral suspension powder is a pale yellow powder supplied in an aluminium foil sachet. The sachets are packed in an outer carton.

(Instructions for presentation with dosing spoon)

A dosing spoon of 0.4 g is included in the carton.

Package size:

90 sachets per carton.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Responsible for manufacture:

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140, Alcalá de Henares,

Madrid, 28805

Spain

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder.

Last update of this leaflet

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.