SEVELAMER TEVA-RATIOPHARM 2.4 g ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Sevelamer Teva-ratiopharm 2.4 g Oral Powder for Suspension

sevelamer carbonate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sevelamer Teva-ratiopharm and what is it used for
2. What you need to know before you take Sevelamer Teva-ratiopharm
3. How to take Sevelamer Teva-ratiopharm
4. Possible side effects
5. Storage of Sevelamer Teva-ratiopharm

1. Contents of the pack and further information

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

Sevelamer Teva-ratiopharm 2.4 g contains sevelamer carbonate as the active substance. It binds to phosphate from food in the digestive tract and thereby reduces serum phosphate levels in the blood.

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

• adult patients on dialysis (a blood cleaning 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 a body membrane filters the blood);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level of 1.78 mmol/l or higher.
• paediatric patients aged 6 years and older with chronic kidney disease (long-term) and with a certain height and weight (which your doctor will use to calculate your body surface area).

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

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

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

Do not takeSevelamer Teva-ratiopharm:

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

Warnings and precautions

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

• you have stomach or intestine motility problems
• you frequently vomit
• you have active intestine inflammation
• you have had major stomach or intestine surgery.
• if you have severe inflammatory bowel disease.

Talk to your doctor while taking sevelamer:

• if you experience severe abdominal pain, stomach or intestine disorders, or blood in your stools (gastrointestinal bleeding). These symptoms can be due to sevelamer crystal deposits 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 calcium levels in your blood. As sevelamer does not contain calcium, your doctor may prescribe calcium supplement tablets
• have low vitamin D levels in your blood. Therefore, your doctor may check your vitamin D levels in your blood and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your 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 bicarbonate levels in your blood and increased acidity in your blood and other body tissues. Your doctor should monitor your bicarbonate levels 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 can be reduced with careful use of sterile techniques during bag changes. You should immediately inform your doctor if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, or stiffness, 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 of sevelamer have not been studied in children (under 6 years). Therefore, sevelamer is not recommended for use in children under 6 years.

Other medicines and Sevelamer Teva-ratiopharm

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

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

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

• The effects of medicines such as cyclosporin, 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 rare deficiency of thyroid hormone has been reported in some people taking levothyroxine (used to treat low thyroid hormone levels) and sevelamer. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in your blood more closely.

• Medicines for treating stomach acid and reflux in your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", may reduce the effectiveness of sevelamer. Your doctor should monitor your phosphate levels in your blood.

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

In some cases, Sevelamer Teva-ratiopharm should be taken at the same time as another medicine, your doctor may advise you to take this medicine 1 hour before or 3 hours after taking sevelamer. Your doctor should also consider monitoring the levels of that medicine in your blood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 can pass into breast milk and affect the baby. Consult your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with sevelamer.

Driving and using machines

Sevelamer is unlikely to 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 dose; this is essentially "sodium-free".

Sevelamer Teva-ratiopharm contains benzyl alcohol

This medicine contains 0.0173 mg per dose. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

3. How to take Sevelamer Teva-ratiopharm

Follow the instructions for administration of this medicine exactly as told by your doctor. This will establish the dose based on your serum phosphate levels.

For the 2.4 g dose of oral powder for suspension, the powder should be dispersed 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 it as well to ensure that 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 taken within 30 minutes. Do not heat sevelamer (e.g. in the microwave) or add it to hot liquids or foods.

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

Take sevelamer after a meal or with food.

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

Use in children and adolescents

The recommended initial dose of sevelamer for children is based on their height and weight (which your doctor will use to calculate their body surface area). For children, the powder formulation is preferred as tablets are not suitable for this population. This medicine 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 phosphate levels every 2-4 weeks and may adjust the dose of sevelamer as needed to achieve an adequate phosphate 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sevelamer Teva-ratiopharm

In the event that you forget to take a dose, it should be omitted, so the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for forgotten doses.

If you stop taking Sevelamer Teva-ratiopharm

Taking your treatment with sevelamer is important to maintain an appropriate phosphate level in your blood. Stopping sevelamer treatment would have significant consequences, such as calcification in the blood vessels. If you consider stopping your treatment with sevelamer, contact your doctor or pharmacist first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Constipation is a very common side effect (affects more than 1 in 10 patients). It can be an early symptom of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.

Some side effects can be serious. If you get any of the following side effects, seek medical attention immediately:

• Allergic reaction (signs include rash, hives, swelling, difficulty breathing). This is a very rare side effect (affects 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 (cannot be estimated from the 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.

• Intestinal bleeding, large intestine inflammation, and crystal deposits in the intestine have been reported. The frequency is unknown.

Other side effects have been reported in patients taking sevelamer:

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

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

Frequency unknown (cannot be estimated from the available data): cases of itching, rash, slow intestinal motility.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side 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 carton or on the label after EXP. The expiry date refers to the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further 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 ingredients are microcrystalline cellulose, sodium carmellose, sucralose (E955), lemon flavour, orange flavour (contains benzyl alcohol) and yellow iron oxide (E172).

Appearance and packaging

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

Package sizes: 90 sachets per carton.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª planta

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

Netherlands

Date of last revision of this leaflet:May 2022

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).