Package Insert: Information for the Patient

Sevelamer Teva 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others who 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 package insert.See section 4.

Sevelamer Teva 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.

This medication 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.

This medication 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 take Sevelámero Teva:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you havelow levels of phosphate in your blood (your doctor will check this for you)
• if you haveintestinal obstruction

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sevelámero Teva, if you are in any of the following situations:

• if you have problems swallowing
• if you have problems with themotility (movement) of the stomach and intestines
• if you havefrequent vomiting
• if you have active intestinal inflammation
• if you have undergonemajor surgery of the stomach or intestines

Consult your doctor while taking Sevelámero Teva:

• if you experience intense abdominal pain, gastrointestinal or intestinal disorders, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to a severe intestinal inflammatory disease, caused by the deposition of sevelamer crystals in the intestine. Contact your doctor, who will decide whether to continue treatment or not.

Additional treatments:

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

• have low or high levels of calcium in your blood. Since this medication 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 the blood and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your doctor may also monitor your blood levels of vitamins A, E, K, and folic acid, and prescribe vitamin supplements as needed.
• have altered bicarbonate levels in your blood and elevated acidity in your blood and other body tissues. Your doctor should monitor your bicarbonate levels in your blood.

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. Inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal sensitivity, constipation, fever, chills, nausea, or vomiting.

Children

This medication has not been studied in children (under 6 years). Therefore, it is not recommended for use in children under 6 years.

Use of Sevelámero Teva with other medications

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

• Sevelámero Teva should not be administered at the same time asciprofloxacin (an antibiotic).

• If you usemedications for heart rhythm problems or epilepsy,consult your doctor when taking Sevelámero Teva.

• The effects of medications such as ciclosporin, micofenolato de mofetilo, and tacrolimus(medications used to suppress the immune system)may be reduced by Sevelámero Teva. Your doctor will advise you if you are taking these medications.

• You may occasionally experience a deficiency of thyroid hormone in people takinglevotiroxine (used to treat low levels of thyroid hormone) and Sevelámero Teva. Therefore, your doctor may closely monitor your thyroid-stimulating hormone levels in the blood.

• Medications to treat stomach acid and reflux in your stomach or esophagus, such as omeprazol, pantoprazol, or lansoprazol, known as "proton pump inhibitors," may reduce the effectiveness of Sevelámero Teva. Your doctor should monitor your phosphate levels in the blood.

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

In some cases, Sevelámero Teva 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 Teva. Your doctor should also consider monitoring your blood levels of this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The potential risk of Sevelámero Teva during human pregnancy is unknown. Consult your doctor, who will decide whether to continue treatment with Sevelámero Teva.

The potential risk of Sevelámero Teva passing into breast milk and affecting your baby is unknown. Consult your doctor, who will decide whether you can breastfeed your baby or not and whether you need to interrupt treatment with Sevelámero Teva.

Driving and operating machines

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

Sevelámero Teva contains lactose

If your doctor has told you that you have alactose intolerance,consult with him before taking this medication.

Sevelamer Teva should be taken as prescribed by a doctor. The doctor will determine the dosage based on serum phosphate levels.

The recommended starting dose of sevelamer tablets for adults and elderly patients is one to two 800 mg tablets with each meal three times a day. Consult with your doctor, pharmacist, or nurse if you are unsure.

Take sevelamer after a meal or with food.

The tablets should be swallowed whole. Do not crush, chew, or break.

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.

Follow the diet prescribed by your doctor.

If you take more Sevelamer Teva 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 take Sevelamer Teva

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.

If you interrupt treatment with Sevelamer Teva

Continuing your treatment with sevelamer is important to maintain an appropriate level of phosphate in your blood. Stopping sevelamer treatment would have significant consequences, such as calcification in blood vessels. If you consider stopping your sevelamer treatment, contact your doctor or pharmacist first.

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

Like all medications, this medication may cause 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 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 wall rupture has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or a painful or sensitive abdomen). The frequency is unknown.
• Severe inflammation of the large intestine and deposition of crystals in the intestine have been reported (symptoms include: severe abdominal pain, digestive or intestinal disorders, blood in the stool [intestinal bleeding]). The frequency is unknown.

Other adverse effects have been reported in patients taking Sevelamer Teva:

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, stomach pain, indigestion, flatulence

Unknown frequency(cannot be estimated from available data):

itching, rash, slow intestinal motility (movement) have been reported

Reporting Adverse Effects

If you experience any 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 of Pharmacovigilance for 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 container and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition of Sevelamer Teva

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

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

HDPE bottles with polypropylene screw caps.

Each bottle contains 30, 50, or 180 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Responsible for manufacturing

Synthon Hispania SL

Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat

Spain

Or

Merckle GmbH

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

Or

Pliva Hrvatska d.o.o.

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Sevelamercarbonat-ratiopharm 800 mg Filmtabletten

Austria:Sevelamer ratiopharm 800 mg - Filmtabletten

Spain:Sevelámero Teva 800 mg film-coated tablets

France:SEVELAMER TEVA 800mg, coated tablet

Netherlands:Sevelameercarbonaat 800 mg Teva, filmomhulde tabletten

Sweden:Sevelamer Teva

Last review date of this leaflet: September 2021

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

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78865/P_78865.html

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