Sevelamer Teva-Ratiopharm 2.4 g powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sevelamer Teva-ratiopharm 2.4 g oral suspension powder

sevelamer carbonate

Read all of 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sevelamer Teva-ratiopharm is and what it is used for

2. What you need to know before taking Sevelamer Teva-ratiopharm

3. How to take Sevelamer Teva-ratiopharm

4. Possible side effects

5. How to store Sevelamer Teva-ratiopharm

6. Contents of the pack and other information

1. What Sevelamer Teva-ratiopharm is and what it is used for

Sevelamer Teva-ratiopharm 2.4 g contains sevelamer carbonate as the active substance. It binds to dietary phosphate in the gastrointestinal tract, thereby reducing serum phosphate levels in the blood.

This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:

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

This medicine should be used together with other treatments such as calcium and vitamin D supplements to prevent the development of bone disease.

Elevated serum phosphate levels may lead to hard deposits in the body known as calcifications. These deposits may harden blood vessels and make it more difficult for blood to be pumped through the body. Increased serum phosphate may also cause skin itching, red eyes, bone pain, and fractures.

2. What you need to know before taking Sevelamer Teva-ratiopharm

Do not take Sevelamer Teva-ratiopharm:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have low levels of phosphate in the blood (your doctor will check this for you)
• if you have intestinal obstruction

Warnings and precautions

Talk to your doctor or pharmacist before taking sevelamer if you are in any of the following situations:

• problems with stomach or intestinal motility (movement)
• you frequently have vomiting
• active inflammation of the intestine
• you have undergone major surgery of the stomach or intestine
• you have severe inflammatory bowel disease

Talk to your doctor while taking sevelamer:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in the stool (gastrointestinal bleeding). These symptoms may be due to 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 condition or dialysis treatment, you may:

• have low or high levels of calcium in your blood. Since sevelamer does not contain calcium, your doctor may prescribe additional calcium tablets.
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your blood vitamin D levels and prescribe vitamin D supplements if necessary. If you do not take multivitamin supplements, blood levels of vitamins A, E, K, and folic acid may also decrease, so your doctor may monitor these levels and prescribe vitamin supplements as needed.
• have altered blood bicarbonate levels and increased acidity in the blood and other body tissues. Your doctor should monitor the bicarbonate level in your blood.

Special note for patients on peritoneal dialysis:

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk may be reduced by careful use of sterile techniques during bag exchanges. You should inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal bloating, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.

You should also expect closer monitoring if you have problems with low levels of vitamins A, D, E, K, and folic acid.

Children and adolescents

The safety and efficacy have not been studied in children (under 6 years of age). Therefore, the use of sevelamer is not recommended in children under 6 years of age.

Other medicines and Sevelamer Teva-ratiopharm

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

• Sevelamer must not be taken at the same time as ciprofloxacin (an antibiotic).

• If you are taking other medicines for heart rhythm problems or epilepsy, you should consult your doctor while taking sevelamer.

• The effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by sevelamer. Your doctor will advise you if you are taking these medicines.

• A deficiency of thyroid hormone may rarely occur in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and sevelamer. Therefore, your doctor may monitor your blood levels of thyroid-stimulating hormone more closely.

• Medicines used to treat stomach acidity and gastroesophageal reflux, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors," may reduce the effectiveness of sevelamer. Your doctor should monitor the phosphate level in your blood.

Your doctor will regularly check for possible interactions between sevelamer and other medicines.

In some cases, Sevelamer Teva-ratiopharm should be taken together with another medicine. Your doctor may instruct you to take that medicine 1 hour before or 3 hours after taking sevelamer. Your doctor should also consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding

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

It is unknown whether sevelamer passes into breast milk and could affect the baby. Consult your doctor, who will decide whether you can breastfeed or not, and whether it is necessary to discontinue treatment with sevelamer.

Driving and using machines

It is unlikely that sevelamer will affect your ability to drive or use machines.

Sevelamer Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; this is essentially “sodium-free”.

Sevelamer Teva-ratiopharm contains benzyl alcohol

This medicine contains 0.0173 mg per sachet. 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 the body and cause adverse effects (metabolic acidosis).

3. How to take Sevelamer Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.

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

Instead of water, the powder may be mixed with a small amount of cold drink (approximately 120 ml or half a glass) or food (about 100 grams) and taken within the following 30 minutes. Do not heat sevelamer (e.g., in a microwave) or add it to hot liquids or food.

The recommended initial dose of this medicine for adults and elderly patients is 2.4–4.8 g per day, divided equally into three doses with meals. Your doctor will determine the exact initial dose and dosing regimen. If in doubt, consult your doctor, pharmacist, or nurse.

Take sevelamer after a meal or with food.

If a 0.4 g dose is required, please use the 0.8 g powder presentation with the provided dosing spoon.

Use in children and adolescents

The recommended initial dose of sevelamer for children is based on their height and weight (from which your doctor will calculate body surface area). For children, the powder formulation is preferred, as tablets are not suitable for this population. This medicine must not be administered on an empty stomach and should be taken with meals or snacks.

Your doctor will determine the exact initial dose and dosing regimen.

Initially, your doctor will monitor your blood phosphorus levels every 2–4 weeks and may adjust the dose of sevelamer as necessary to achieve an appropriate phosphorus level.

Follow the diet prescribed by your doctor.

If you take more Sevelamer Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sevelamer Teva-ratiopharm

If you forget to take a dose, skip it and take the next dose at the usual time with food. Do not take a double dose to make up for a missed dose.

If you stop taking Sevelamer Teva-ratiopharm

Taking your sevelamer treatment regularly is important to maintain appropriate phosphate levels in your blood. Stopping sevelamer treatment may lead to serious consequences, such as vascular calcification. If you are considering stopping your sevelamer treatment, contact your doctor or pharmacist first.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Constipation is a very common adverse effect (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 serious. If you experience any of the following adverse effects, seek medical attention immediately:

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

• Intestinal obstruction has been reported (symptoms include: severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).

• Rupture of the intestinal wall has been reported (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or tender or painful abdomen). Frequency is unknown.

• Cases of intestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine have been reported. Frequency is unknown.

Other adverse effects reported in patients taking sevelamer:

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

Common (may affect up to 1 in 10 patients): diarrhoea, stomach pain, indigestion, flatulence.

Frequency not known (cannot be estimated from available data): cases of itching, rash, slow intestinal motility (movement).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sevelamer Teva-ratiopharm

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

Do not use this medicine after the expiry date which is stated on the container or sachet after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevelamer Teva-ratiopharm

The active substance is sevelamer carbonate. Each sachet of Sevelamer Teva-ratiopharm contains 2.4 g of sevelamer carbonate, as indicated on the sachet.

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

Appearance of the medicinal product and contents of the pack

Sevelamer Teva-ratiopharm 2.4 g oral suspension powder is a white to yellowish powder supplied in PET/Al/LDPE sachets. The PET/Al/LDPE sachets are packed in an outer carton.

Pack sizes: 90 sachets per box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid), Spain

Manufacturer

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

The Netherlands

Date of the most recent revision of this leaflet: May 2022

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82399/P_82399.html