Sevelamer Stada 2.4 g powder for oral suspension

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Sevelámero STADA 2.4 g oral suspension powder

Sevelamer carbonate

Read the entire 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 you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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
6. 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 on dialysis (a blood-cleaning procedure). It can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which 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 of 1.78 mmol/l or higher.

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 lead to hard deposits in the body called calcifications. These deposits can harden in 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 Stada

• 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 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 stomach or intestinal motility (movement)
• you frequently vomit
• active inflammation of the intestine
• you have undergone major surgery of the stomach or intestine
• if you have severe inflammatory bowel disease.

Contact your doctor while taking sevelamer:

• if you experience severe abdominal pain, stomach or intestinal disturbances, 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.

Children and adolescents

The safety and efficacy 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 may be reduced by careful use of sterile techniques during bag exchanges.

You must inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting.

You should also expect more careful 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 need to take any other medicines.

• Sevelamer should not be administered at the same time as ciprofloxacin (an antibiotic).
• If you are taking other medicines for heart rhythm disorders or epilepsy, you must 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 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.
• 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 must be taken together with another medicine. Your doctor may instruct you to take this medicine 1 hour before or 3 hours after taking sevelamer, or may 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. 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.

Sevelamer Stada contains sodium

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

3. How to take Sevelamer Stada

Sevelamer must be taken according to the doctor's prescription. Your doctor will determine the dose based on your serum phosphorus levels.

The 2.4 g dose of oral suspension powder per sachet should be dispersed in 60 ml of water. It should be consumed within 30 minutes after 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 the entire powder has been ingested.

The recommended initial dose of sevelamer is 2.4–4.8 g per day, divided equally with three meals. 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.

Patients taking sevelamer should follow the diet prescribed for them.

If you take more Sevelamer Stada than you should

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

In the event of overdose or accidental ingestion, contact the Toxicology Information Service at phone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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.

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 may be an early sign of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.

Some side effects may be serious. If you have 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 bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).

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

• gastrointestinal bleeding, inflammation of the large intestine, and deposition of crystals in the intestine have been reported. Frequency is unknown.

Other side 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 side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side 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 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 stated on the sachet and carton after the letters “EXP”. The expiry date refers to the last day of the month indicated. The reconstituted suspension must be administered within 30 minutes of reconstitution.

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 in your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevelamer Stada

• The active substance is sevelamer carbonate. Each sachet of Sevelamer Stada contains 2.4 g of sevelamer carbonate.
• The other components are microcrystalline cellulose (E460), sodium carboxymethylcellulose, sucralose (E955), lemon flavour, orange flavour, and yellow iron oxide (E172).

What Sevelamer Stada looks like and contents of the pack

Sevelamer Stada powder for oral suspension is a pale yellow powder supplied in aluminium sachets. The aluminium sachets are packed in an outer carton.

Pack sizes:

20 sachets per carton
60 sachets per carton
90 sachets per carton

Only some 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.
C/ Castelló no 1, Pol. Las Salinas,
08830 Sant Boi de Llobregat (Barcelona)
Spain

or

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

or

STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany

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

Date of the last review of this leaflet: October 2021

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