Package Insert: Information for the Patient

Sevelamer Stada 800 mg Film-Coated Tablets

Sevelamer Carbonate

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, 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. Do not give it to others, even if they have the same symptoms of illness 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 package insert.See section 4.

Contents of the package 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 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 calcification. 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 takessevelamer

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

Warnings and precautions

Consult your doctor before takingssevelamer, if you are in any of the following situations:

• difficulty swallowing.Your doctor may prefer to prescribe you other medications
• problems withgastrointestinal motility
• you have frequent vomiting
• you have active intestinal inflammation
• you have hadmajor surgeryof the stomach or intestines
• you have a severe inflammatory bowel disease.

Consult your doctor while taking sevelamer:

• if you experience severe abdominal pain, gastrointestinal disturbances, or blood in your stool (gastrointestinal hemorrhage). 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

Sevelamer 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. Sincessevelamerdoes not contain calcium, your doctor may prescribe calcium supplements
• have low levels of vitamin D in your blood. 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 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 mustinform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, constipation, fever, chills, nausea, or vomiting.

You should also have your levels of vitamins A, D, E, K, and folic acid monitored more closely.

Other medications andsevelamerStada

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

• The effects of medications such as ciclosporin, micofenolato mofetil, and tacrolimus (medications used to suppress the immune system) may be reduced by sevelamer. Your doctor will advise you if you are taking these medications.
• You may occasionally experience a deficiency of thyroid hormone in people taking levotiroxine (used to treat low levels of thyroid hormone) and sevelamer. Your doctor may therefore monitor your thyroid-stimulating hormone levels in blood more closely.

• If you are taking medications such as omeprazol, pantoprazol, or lansoprazol to treat heartburn, gastroesophageal reflux disease (GERD), or stomach ulcers, you should consult your doctor when taking sevelamer.

Your doctor will regularly check for any interactions betweensevelamerand other medications.

In some casessevelamershould be taken at the same time as another medication. Your doctor may advise you to take this medication 1 hour before or 3 hours after takingsevelamer, or may consider monitoring your blood levels of that medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication. The effects ofsevelameron the fetus are unknown.

Inform your doctor if you want to breastfeed your baby. The effects ofsevelameron the baby are unknown.

Driving and operating machinery

It is unlikely thatsevelamerwill affect your ability to drive or operate machinery.

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medicationshould be taken as prescribed by a doctor. The doctor will determine the dosage based on serum phosphate levels.

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

The tablets must be taken whole. Do not crush, chew, or break.

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

Patients taking sevelamer should follow the diets prescribed to them.

If you take moreSevelamerStada than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to takeSevelamer Stada

If you forget to take a dose, omit it, and take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people 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 that 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). The 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). The frequency is unknown.
• intestinal bleeding, inflammatory bowel disease, and crystal deposition in the intestine have been reported. The frequency is unknown.

Other adverse effects have been reported in patients takingsevelamer:

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

vomiting, upper abdominal pain, nausea

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

diarrhea, abdominal 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 experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 thecontainerafter the letters «CAD». The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist where to dispose of the medications you no longer use. By doing so, you will help protect the environment.

Composition of Sevelámero Stada

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

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

Appearance of the product and contents of the package

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

HDPE bottles with a polypropylene cap.

Each bottle contains30,50,180, 200 or 210 tablets.

Bottlesthatcontain30tabletsavailable in a pack of 1 bottle.

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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 authorized in the Member States of the European Economic Area with the following names:

Denmark:Sevelamercarbonate Stada

Austria:Sevelamercarbonat STADA 800 mg Filmtabletten
Germany:Sevelamercarbonat STADA 800 mg Filmtabletten

Spain:Sevelámero STADA 800 mg comprimido recubierto con película

Italy:SEVELAMER EG

Iceland:Sevelamercarbonat Stada 800 mg film-coated tablets

Date of the last revision of this leaflet:December 2019

The 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/