Sevelamer STADA 800 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sevelámero Stada 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 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 may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sevelámero Stada is and what it is used for
2. What you need to know before taking Sevelámero Stada
3. How to take Sevelámero Stada
4. Possible side effects
5. How to store Sevelámero Stada

Contents of the pack and other information

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

Sevelámero Stada contains sevelamer carbonate as the active substance. It binds to dietary phosphate in the gastrointestinal tract and thereby reduces serum phosphate levels in the blood.

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

• adult patients undergoing dialysis (a blood-cleansing technique). It can be used in patients receiving 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);
• patients with chronic kidney disease (long-term) who are not undergoing dialysis and who have a serum (in blood) phosphate level equal to or above 1.78 mmol/l.

Sevelamer 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 cause hard deposits in the body known as calcification. 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 Stada

DO NOT take sevelamer

• if you have low levels of phosphate in the 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 ingredients of 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 with swallowing. Your doctor may prefer to prescribe another medicine
• problems with gastrointestinal motility (movement of the stomach and intestines)
• you have frequent vomiting
• active intestinal inflammation
• you have undergone major surgery of the stomach or intestines
• you have severe inflammatory bowel disease.

Talk to your doctor while taking sevelamer:

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

Children and adolescents

The safety and efficacy of sevelamer have not been studied in children (under 18 years of age). 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 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 a vitamin D supplement 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.

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 following sterile techniques during bag exchanges. You must 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 to be monitored more closely 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 need to take any other medicines.

• Sevelamer must 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 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 occasionally be observed in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and sevelamer. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) blood levels more closely.

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

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

In some cases, sevelamer should be taken at the same time as another medicine. Your doctor may instruct 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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. It is unknown whether sevelamer has any effect on the fetus.

Inform your doctor if you intend to breastfeed. It is unknown whether sevelamer passes into breast milk and could affect the baby.

Driving and using machines

It is unlikely that sevelamer will affect your ability to drive or operate machinery.

This medicine contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Sevelamer Stada

This medicine should be taken according to the physician's instructions. Your doctor will determine the dose based on your serum phosphorus levels.

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

The tablets must be swallowed whole. Do not crush, chew, or divide them.

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

Patients taking sevelamer should follow the diet prescribed for them.

If you take more Sevelamer Stada than you should

In case of potential overdose, you must contact your doctor immediately.

In the event of an 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 ingested.

If you forget to take Sevelamer Stada

If you forget to take a dose, skip that dose. 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 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 produce adverse effects, although not everyone experiences them.

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

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

• allergic reaction (signs 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 (signs include: severe distension, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).
• intestinal wall perforation has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or tender/ painful abdomen). Frequency is unknown.
• intestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine have been reported. Frequency is unknown.

Other adverse 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):

diarrhea, abdominal 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, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish System of Pharmacovigilance of 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 Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the letters «EXP». The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevelamero Stada

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

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

Appearance of the product and contents of the pack

Sevelamero Stada are film-coated tablets, white to off-white in colour, oval-shaped, with "SVL" printed on one side.

HDPE bottles with a polypropylene cap.

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

Bottles containing 30 tablets available in pack size of 1 bottle.

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

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

Only certain 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 medicinal product 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: Sevelamero STADA 800 mg film-coated tablet

Italy: SEVELAMER EG

Iceland: Sevelamercarbonat Stada 800 mg filmuhúðaðar töflur

Date of the most recent revision of this leaflet: December 2019

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