SEVELAMER STADA 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

SevelamerStada 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 experience 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 Stada and what is it used for
2. What you need to know before you take Sevelamer Stada
3. How to take Sevelamer Stada
4. Possible side effects
5. Storage of Sevelamer Stada

Contents of the pack and further information

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

Sevelamer Stada 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.

Sevelamer 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);
• 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.

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

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

Do not takeSevelamer

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

Warnings and precautions

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

• problems swallowing. Your doctor may prefer to prescribe you other medicines
• problems with stomach and intestinal motility (movement)
• you have frequent vomiting
• active intestinal inflammation
• you have undergone major stomach or intestinal surgery
• if you have a severe inflammatory bowel disease.

Talk to your doctor while taking sevelamer:

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

Children and adolescents

The safety and efficacy of sevelamer have not been studied in children (under 18 years). Therefore, the use of sevelamer is not recommended in children.

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 you calcium supplement tablets
• have low vitamin D levels 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 necessary.

Special note for patients onperitoneal dialysis:

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk may decrease with careful observation 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 abdominal 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.

Other medicines and Sevelamer Stada

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 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 deficit of the thyroid hormone has been reported in certain individuals 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.

• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat stomach ulcers, gastroesophageal reflux disease (GERD), or heartburn, you should consult your doctor when taking sevelamer.

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

In some cases, sevelamer 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, or may consider monitoring the blood levels of that medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not known if sevelamer has any effect on the fetus.

Tell your doctor if you want to breastfeed your baby. It is not known if sevelamer can pass into breast milk and affect your baby.

Driving and using machines

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

This medicine contains lactose

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

3. How to take Sevelamer Stada

This medicine should be taken as prescribed by your doctor. The doctor will determine the dose based on your serum phosphate levels.

The recommended initial dose of sevelamer tablets for adults and the elderly (> 65 years) is one to two 800 mg tablets with each meal, three times a day.

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

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.

Patients taking sevelamer should follow the diets prescribed for them.

If you take more Sevelamer Stada than you should

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

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

If you forget to take Sevelamer Stada

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 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 (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 experience any of the following side effects, seek medical attention immediately:

• allergic reaction (symptoms 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 (symptoms include severe distension, abdominal pain, swelling, or cramps, severe constipation). The frequency is not known (cannot be estimated from the available data).
• intestinal wall rupture has been reported (symptoms include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain or tenderness). The frequency is not known.
• gastrointestinal bleeding, colitis, and crystal deposition in the intestine have been reported. The frequency is not known.

Other side effects have been 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, abdominal pain, indigestion, flatulence

Frequency not known (cannot be estimated from the available data):

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

Reporting of side effects

If you experience 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 Stada

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 after the letters "EXP". The expiry date is the last day of the month shown.

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 Stada

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

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

Appearance and packaging

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

HDPE bottles with a polypropylene cap.

Each bottle contains 30, 50, 180, 200, or 210 tablets.

Bottles containing 30 tablets are available in packs of 1 bottle.

Bottles containing 50, 180, 200, or 210 tablets are available in packs of 1, 2, or 3 bottles.

The HDPE bottles contain a desiccant. Do not remove the desiccant from the bottle.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Synthon Hispania S.L

Castelló 1, Polígono Las Salinas.

08830 Sant Boi de Llobregat

Spain

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Vienna

Austria

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

Denmark: Sevelamercarbonate Stada

Austria: Sevelamercarbonat STADA 800 mg Filmtabletten

Germany: Sevelamercarbonat STADA 800 mg Filmtabletten

Spain: Sevelámero STADA 800 mg film-coated tablets

Italy: SEVELAMER EG

Iceland: Sevelamercarbonat Stada 800 mg filmuhúðaðar töflur

Date of last revision of this leaflet:December 2019

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