Package Insert: Information for the User

Sevelamer Ratiopharm 2.4 g Powder for Oral Suspension

Sevelamer Carbonate

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Sevelamer ratiopharm 2,4 g 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 undergoing 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 undergoing dialysis and have a serum (in the blood) phosphate level of 1.78 mmol/l or higher;
• adult 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.

The increase in 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. The increase in serum phosphorus levels can also produce itching skin, red eyes, bone pain, and fractures.

Do not takeSevelámero ratiopharm:

• 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 or pharmacist before starting to take sevelámero if you are in any of the following situations:

• problems with stomach and intestine motility
• you frequently vomit
• active intestinal inflammation
• you have had major surgery on your stomach or intestine.
• if you have a severe inflammatory bowel disease.

Consult your doctor while taking sevelámero:

• if you experience intense abdominal pain, stomach or intestinal disorders, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to the deposition of sevelámero 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 sevelámero does not contain calcium, your doctor may prescribe calcium supplements for you
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your vitamin D levels in the blood 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 body tissues. Your doctor must monitor your bicarbonate levels in your blood.

Special note for patients undergoing 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, or rigidity, constipation, fever, chills, nausea, or vomiting.

Children

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

Other medications and Sevelámero ratiopharm

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

• Sevelámero 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 sevelámero.

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

• It may occasionally be observed that certain individuals taking levotiroxine (used to treat low thyroid hormone levels) and sevelámero have a deficiency of thyroid hormone. Therefore, your doctor may closely monitor your thyroid-stimulating hormone levels in the blood.

• Medications for treating 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 sevelámero. Your doctor must monitor your phosphate levels in your blood.

Your doctor will regularly check if there are any interactions between sevelámero and other medications.

In some cases, sevelámero 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 sevelámero. Your doctor must also consider the possibility of monitoring the levels of that medication in your blood.

Pregnancy and breastfeeding

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

The potential risk of sevelámero passing into breast milk and affecting the baby is unknown. Consult your doctor, who will decide whether you can breastfeed your baby or not and whether you need to interrupt treatment with sevelámero.

Driving and operating machines

It is unlikely that sevelámero will affect your ability to drive or operate machines.

Sevelámero ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free."

Sevelámero ratiopharm contains benzyl alcohol

This medication contains 0.0173 mg per tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Follow exactly the administration instructions for this medication as indicated by your doctor. Your doctor will establish the dosage based on your serum phosphorus levels.

To administer the 2.4 g powder for oral suspension, disperse it in 60 ml of water. Drink within 30 minutes of preparation. It is essential to drink all the liquid, and it may be necessary to rinse the glass with water and drink it as well to ensure you ingest all the powder.

Instead of water, the powder can be mixed with a small amount of cold beverage (approximately 120 ml or half a glass) or food (about 100 grams), and take it within the next 30 minutes. Do not heat the powder (e.g., 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. Your doctor will determine the exact initial dose and administration schedule. In case of doubt, consult your doctor, pharmacist, or nurse. Take sevelamer after a meal or with food. If a dose of 0.4 g is required, please use the 0.8 g powder with a dosing spoon.

Use in children and adolescents

The initial recommended dose of sevelamer 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 since the tablets are not suitable for this population. This medication should not be administered on an empty stomach and should be taken with meals or snacks. Your doctor will determine the exact initial dose and administration schedule.

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

Follow the diet prescribed by your doctor.

If you take more Sevelámero ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Sevelámero ratiopharm

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 the treatment withSevelámero ratiopharm

It is essential to continue your treatment with sevelamer to maintain an appropriate level of phosphate in your blood. Stopping sevelamer treatment would lead to significant consequences, such as vascular calcification. If you consider stopping your sevelamer 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 will 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 a painful or sensitive abdomen). The frequency is unknown.

- Intestinal bleeding, inflammatory bowel disease, and crystal deposition in the intestine have been reported. The frequency is unknown.

Other adverse effects have been reported in patients taking sevelamer:

Very frequent(it may affect more than 1 in 10 patients): vomiting, upper abdominal pain, nausea.

Frequent(it may affect up to 1 in 10 patients): diarrhea, stomach pain, indigestion, flatulence.

Unknown frequency(it cannot be estimated from available data): cases of itching, rash, slow intestinal motility (movement)..

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. 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 packaging or on the overwrap after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Sevelámero ratiopharm

The active ingredient is sevelamer carbonate. Each pack of Sevelámero ratiopharm contains 2.4 g of sevelamer carbonate, as indicated on the pack.

The other components are microcrystalline cellulose, sodium carmellose, sucralose (E955), lemon flavor, orange flavor (contains benzyl alcohol) and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Sevelámero ratiopharm 2.4 g oral powder for suspension is a white to yellowish powder supplied in a PET/Al/LDPE pack. The PET/Al/LDPE packs are packaged in an external box.

Packaging sizes: 90 packs per box.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)
Spain

Responsible for manufacturing

Synthon Hispania S.L.

C/Castelló, nº1, Pol. Las Salinas, Sant Boi de Llobregat

08830 Barcelona

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

Last review date of this leaflet:August 2022

Other sources of information

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).