SEVELAMER TEVA 800 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet: Information for the Patient

Sevelamer Teva 800 mg Film-Coated Tablets

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 pack

1. What is Sevelamer Teva and what is it used for
2. What you need to know before you take Sevelamer Teva
3. How to take Sevelamer Teva
4. Possible side effects
5. Storage of Sevelamer Teva
6. Contents of the pack and further information

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

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

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

• adult patients on dialysis (a technique for cleaning the blood). 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);
• 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.

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

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

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

Do not take Sevelamer Teva:

• 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 intestinal obstruction

Warnings and precautions

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

• if you have problems swallowing
• if you have problems with stomach and intestinal motility (movement)
• if you vomit frequently
• if you have active inflammation of the intestine
• if you have had major stomach or intestinal surgery

Talk to your doctor while taking Sevelamer Teva:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stools (gastrointestinal bleeding). These symptoms can be due to a serious inflammatory bowel 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 condition or dialysis treatment, you may:

• have low or high calcium levels in your blood. As this medicine does not contain calcium, your doctor may prescribe calcium supplement tablets
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor 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 by carefully observing sterile techniques during bag changes. You should inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal stiffness, constipation, fever, chills, nausea, or vomiting.

Children

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

Using Sevelamer Teva with other medicines

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

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

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

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

• A deficiency of the thyroid hormone may be observed rarely in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and Sevelamer Teva. 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 Teva. Your doctor should monitor your phosphate levels in your blood.

Your doctor will check for interactions between Sevelamer Teva and other medicines on a regular basis.

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

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 Teva during human pregnancy is unknown. Talk to your doctor, who will decide whether you can continue treatment with Sevelamer Teva.

It is unknown whether Sevelamer Teva can pass into breast milk and affect your baby. Talk to your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with Sevelamer Teva.

Driving and using machines

Sevelamer Teva is unlikely to affect your ability to drive or use machines.

Sevelamer Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Sevelamer Teva

Sevelamer Teva should be taken as prescribed by your doctor. The doctor will determine the dose based on your phosphate levels in the blood.

The recommended starting dose of sevelamer tablets for adults and elderly patients is 1 to 2 tablets of 800 mg with each meal 3 times a day. Talk to your doctor, pharmacist, or nurse if you are not sure.

Take sevelamer after a meal or with food.

The tablets should be swallowed whole.Do not crush, chew, or break them.

Initially, your doctor will check your phosphate levels in the blood 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 than you should

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

In case of overdose or accidental ingestion, contact 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

If 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

Taking your treatment with sevelamer is important to maintain an appropriate level of phosphate in your blood. Stopping sevelamer treatment could have serious 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 product, 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 (may affect 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 (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 (cannot be estimated from the available data).
• Rupture of the intestinal wall has been reported (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness). The frequency is unknown.
• Severe inflammation of the large intestine has been reported (symptoms include severe abdominal pain, stomach or intestinal disorders, blood in the stools [intestinal bleeding]) and crystal deposition in the intestine. The frequency is unknown.

Other side effects have been reported in patients taking Sevelamer Teva:

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 the available data):

Itching, rash, slow intestinal motility (movement) have been reported

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: 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

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 and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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

The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.

The other ingredients are lactose monohydrate, silica (colloidal anhydrous), zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.

Appearance and packaging

Sevelamer Teva are white to off-white, oval, film-coated tablets with "SVL" engraved on one side.

HDPE bottles with a screw cap made of polypropylene.

Each bottle contains 30, 50, or 180 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid

Manufacturer

Synthon Hispania SL

Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat

Spain

Or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

Or

Pliva Hrvatska d.o.o.

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Sevelamercarbonat-ratiopharm 800 mg Filmtabletten

Austria: Sevelamer ratiopharm 800 mg - Filmtabletten

Spain: Sevelámero Teva 800 mg film-coated tablets

France: SEVELAMER TEVA 800mg, film-coated tablet

Netherlands: Sevelameercarbonaat 800 mg Teva, film-coated tablets

Sweden: Sevelamer Teva

Date of last revision of this leaflet: September 2021

"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/ "

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78865/P_78865.html

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