Leaflet: information for the patient

Sevelamer STADA 2.4 g powder for oral suspension

Sevelamer carbonate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isSevelamer Stadaand what it is used for

2. What you need to know before you start takingSevelamer Stada

3. How to takeSevelamer Stada

4. Possible side effects

5. Storage ofSevelamer Stada

6. Contents of the pack and additional information

Sevelamer Stada contains sevelamer carbonate as the active ingredient. It binds to the phosphorus in food in the digestive tract and thereby reduces serum phosphorus levels in the blood.

Sevelamer is used to control hyperphosphatemia (high levels of phosphate in the blood) in:

• adult patients undergoing dialysis (a blood cleansing technique). It can be used in patients undergoing hemodialysis (using a machine to filter the blood) or peritoneal dialysis (where fluid is pumped into the abdomen and a membrane filters the blood);
• patients with chronic kidney disease (long-term) who are not undergoing dialysis and have a serum (in the blood) phosphate level of 1.78 mmol/l or higher.

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

An increase in serum phosphorus levels can produce hard deposits in the body called calcifications. These deposits can harden in blood vessels and make it more difficult for blood to be pumped throughout the body. An increase in serum phosphorus levels can also produce itching skin, red eyes, bone pain, and fractures.

Do not take Sevelámero Stada

• if you havelow levels of phosphatein your blood (your doctor will check this for you)
• if you haveintestinal obstruction
• if you areallergic to the active ingredient or any of the other componentsof this medication (listed in section 6)

Warnings and precautions

Consult your doctor before taking sevelámero if you are in any of the following situations:

• problems with stomach and intestine motility
• you have frequent vomiting
• you have active intestinal inflammation
• you have had major surgery on your stomach or intestine
• you have a severe inflammatory bowel disease

Consult your doctor while taking sevelámero:

•ifyou experience intense abdominal pain, stomach or intestinal disorders, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to the deposition of sevelámero crystals in the intestine. Contact your doctor, who will decide whether to continue or discontinue treatment.

Children and adolescents

Sevelámero has not been studied in children (under 18 years). Therefore, it is not recommended for use in children.

Additional treatments:

Due to your kidney disease or dialysis treatment, you may:

• have low or high levels of calcium in your blood. Since sevelámero does not contain calcium, your doctor may prescribe calcium supplements
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your vitamin D levels in blood and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your doctor may also monitor your levels of vitamins A, E, K, and folic acid, 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 decrease with the careful use of sterile techniques during bag changes.

You must immediately inform your doctor 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 have your vitamin levels (A, D, E, K, and folic acid) closely monitored if you experience problems.

Other medications and Sevelámero Stada

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

• Sevelámero should not be administered at the same time as ciprofloxacin (an antibiotic).
• If you are taking other medications for heart rhythm problems or epilepsy, consult your doctor when taking sevelámero.
• The effects of medications such as ciclosporin, micofenolato mofetilo, and tacrolimus (medications used to suppress the immune system) may be reduced by sevelámero. Your doctor will advise you if you are taking these medications.
• It may occasionally be observed that certain individuals taking levotiroxine (used to treat low thyroid hormone levels) and sevelámero have a deficiency of thyroid hormone. Therefore, your doctor may closely monitor your thyroid-stimulating hormone levels in the blood.
• If you are taking medications such as omeprazol, pantoprazol, or lansoprazol to treat heartburn, gastroesophageal reflux disease (GERD), or stomach ulcers, consult your doctor when taking sevelámero.

Your doctor will regularly check for interactions between sevelámero and other medications.

In some cases, sevelámero should be taken at the same time as another medication. Your doctor may instruct you to take this medication 1 hour before or 3 hours after taking sevelámero, or may consider controlling the blood levels of that medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. The effects of sevelámero on the fetus are unknown.

Inform your doctor if you want to breastfeed. The effects of sevelámero on the baby are unknown.

Driving and operating machines

It is unlikely that sevelámero will affect your ability to drive or operate machines.

Sevelámero Stada contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

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

The dose of 2.4 g of oral powder suspension should be dispersed in 60 ml of water. Drink within 30 minutes of preparation. It is essential to drink the entire liquid and may be necessary to rinse the glass with water and drink it as well to ensure all the powder is ingested.

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

Initially, your doctor will check your blood phosphate concentrations every 2-4 weeks and may adjust the sevelamer dose as needed to achieve an adequate phosphate level.

Patients taking sevelamer must follow the diets prescribed to them.

If you take more Sevelamer Stada than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Sevelamer Stada

If you forget to take a dose, it should be omitted, and the next dose should be taken at the usual time with a meal. Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Constipation is a very frequent adverse effect (it 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 adverse effects may be severe. If you have 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 (it 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 (it cannot be estimated from available data).

• Intestinal perforation has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain or tenderness). Frequency is unknown.

• Intestinal bleeding, inflammatory bowel disease, and crystal deposition in the intestine have been reported. Frequency is unknown.

Other adverse effects have been reported in patients taking sevelamer:

Very frequent(it may affect more than 1 in 10 patients):

nausea, upper abdominal pain, vomiting

Frequent(it may affect up to 1 in 10 patients):

diarrhea, stomach pain, indigestion, flatulence

Unknown frequency(it cannot be estimated from available data):

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

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the package and carton after the letters “CAD”. The expiration date is the last day of the month indicated. The reconstituted suspension must be administered within 30 minutes of reconstitution.

The medication does not require special storage conditions.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Sevelamer Stada

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

Appearance of the product and contents of the package

Sevelamer Stada oral suspension powder is a pale yellow powder supplied in an aluminum sachet. The aluminum sachets are packaged in an outer carton.

Package sizes:

20 sachets per carton

60 sachets per carton

90 sachets per carton

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible 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 CMNijmegen

Netherlands

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:October 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/