SEVELAMER STADA 2.4 g POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Sevelamer STADA 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 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
6. 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 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.

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 calcifications. 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 take Sevelamer Stada

• if you have low phosphate levelsin the blood (your doctor will check this for you)
• if you have intestinal obstruction
• if you are allergic to the active substance or 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 with stomach and intestinal motility (movement)
• you frequently vomit
• active inflammation of the intestine
• you have had major stomach or intestinal surgery
• if you have 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 stool (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 calcium supplement tablets
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your vitamin D levels in the 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.

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

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

In some cases, sevelamer should be taken with 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 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. It is not known if sevelamer has any effect on the fetus.

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

Driving and using machines

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

Sevelamer Stada contains sodium

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

3. How to take Sevelamer Stada

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

The dose of 2.4 g of oral powder for suspension per dose should be dispersed in 60 ml of water. Drink within 30 minutes of preparation. It is important to drink all the liquid and you may need to rinse the glass with water and drink it to ensure you take all the powder.

The recommended initial dose of sevelamer is 2.4-4.8 g per day, divided into three meals. Your doctor will determine the exact initial dose and regimen.

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, contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. You should take the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Sevelamer Stada

If you miss 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.

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, tell 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 bloating, 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 (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a painful or tender abdomen). The frequency is not known.

• intestinal bleeding, inflammation of the large intestine, 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, stomach 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 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 Agency's 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 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 and blister after the letters “EXP”. The expiry date refers to the last day of the month shown. The reconstituted suspension should be administered within 30 minutes of reconstitution.

The 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 sachet of Sevelamer Stada contains 2.4 g of sevelamer carbonate.
• The other ingredients are microcrystalline cellulose (E460), sodium carmellose, sucralose (E955), lemon flavour, orange flavour, and yellow iron oxide (E172).

Appearance of the product and pack contents

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

Pack sizes:

20 sachets per carton

60 sachets per carton

90 sachets per carton

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.

C/ Castelló no 1, Pol. Las Salinas,

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

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

Date of last revision of this leaflet:October 2021

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