Sevelamero viatris 800 mg comprimidos recubiertos con pelicula

Package Insert: Information for the User

Sevelamer Viatris 800 mg Film-Coated Tablets

Sevelamer Carbonate

Read this package insert carefully before starting to take this medication, 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 medication has been prescribed to you alone and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

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

The 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. The increase in serum phosphorus levels can also produce itching skin, red eyes, bone pain, and fractures.

Do not take Sevelámero Viatris:

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

Warnings and precautions

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

• Difficulty swallowing. Your doctor may prefer to prescribe Fosquel in powder for oral suspension.
• Problems with themotility (movement) of the stomach and intestine.
• Frequent vomiting
• Active intestinal inflammation.
• You have hadmajor surgeryof the stomach or intestine.
• You have a severe inflammatory intestinal disease.

Consult your doctor while taking Sevelámero Viatris:

• If you experience intense abdominal pain, gastrointestinal or intestinal disorders, 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.

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 blood levels 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 blood levels.

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 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.

Children

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

Other medications and Sevelámero ViatrisInform 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 asciprofloxacin(an antibiotic).
• If you takemedications for heart rhythm problems or epilepsy, you should consult your doctor when taking sevelamer.
• The effects of medications such as ciclosporin, micophenolate 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 takinglevotiroxine(used to treat low levels of thyroid hormone) and sevelamer. Therefore, your doctor may closely monitor your thyroid-stimulating hormone blood levels.
• Medications to treat stomach acid and reflux in your stomach or esophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors," may reduce the effectiveness of Sevelámero Viatris. Your doctor should monitor your phosphate blood levels.

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

In some cases where sevelamer 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 sevelamer. Your doctor should also consider monitoring your blood levels of that medication.

Pregnancy and breastfeeding

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

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

The safety of Sevelámero Viatris for breastfeeding women 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 Viatris.

Driving and operating machinery

It is unlikely that sevelamer will affect your ability to drive or operate machinery.

Sevelámero Viatris contains lactose

This medication containslactose. If your doctor has told you that you have anintolerance to certain sugars, consult with him before taking this medication.

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

The recommended initial dose of Sevelamer Viatris tablets for adults and elderly people (> 65 years) isone to two 800 mg tablets with each meal, three times a day.Consult with your doctor, pharmacist, or nurse if you are unsure.

The tablets must 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.

Patients taking sevelamer should follow the diet prescribed by their doctor.

If you take more Sevelamer Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone91 562 04 20indicating the medication and the amount ingested.

If you forget to take Sevelamer Viatris

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 compensate for the missed dose.

If you interrupt treatment withSevelamer Viatris

It is essential to continue taking your sevelamer treatment to maintain an appropriate phosphate level in your blood. Stopping treatment with this medication may lead to serious consequences, such as vascular calcification. If you consider stopping your treatment with this medication, 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 produce adverse effects, although not all people will experience them.

Inform your doctor or pharmacist as soon as possible if you experience the following:

Very Common(may affect more than 1 in 10 people):

• Constipation, which could be an early sign of intestinal obstruction.

Very Rare(may affect up to 1 in 10,000 people):

• Severe allergic reactions, including swelling of the face, lips, tongue, or throat, causing difficulty breathing or swallowing.

Unknown Frequency(cannot be estimated from available data):

• Cases of pruritus, rash, slow intestinal motility (movement), intestinal obstruction (signs include: severe distension, abdominal pain, swelling, or cramps, severe constipation), intestinal perforation (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain or tenderness), intestinal bleeding, inflammatory bowel disease, and crystal deposition in the intestine.

Other adverse effects have been described in patients taking sevelamer carbonate:

Very Common(may affect more than 1 in 10 people):

• Vomiting.
• Upper abdominal pain.
• Nausea.

Common(may affect up to 1 in 10 people):

• Diarrhea.
• Abdominal pain.
• Indigestion.
• Flatulence.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, 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 packaging after 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sevelamer Viatris

• 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 film coating of the tablet contains hypromellose (E-464) and diacetyl monoglycerides.

Appearance of the product and contents of the package

Sevelamer Viatris film-coated tablets are white to off-white, oval-shaped, and have "SVL" printed on one side. The tablets are approximately 20 mm long and 7 mm wide.

The tablets are packaged in high-density polyethylene (HDPE) bottles with a polypropylene cap. Each bottle contains 180, 200, or 210 tablets. Packages containing 1, 2, or 3 bottles are available.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Synthon Hispania, S.L.

Castelló 1, Polígono Las Salinas

08830 - Sant Boi de Llobregat

Spain

or

Mylan Hungary Kft

H-2900 Komárom

Mylan utca, 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanySevelamer carbonat Mylan 800 mg Filmtabletten

DenmarkSevelamer carbonat Mylan

SlovakiaSevelamerCarbonateMylan 800 mg, filmom obalené tablety

SpainSevelámero Viatris 800 mg comprimidos recubiertos con película

FranceSevelamer Mylan Pharma 800 mg, comprimés pelliculés

GreeceSevelamer/Mylan

IrelandSevelamer Carbonate 800 mg Film-coated tablets

ItalySevelamer Mylan Pharma

NorwaySevelamer Mylan 800 mg filmdrasjerte tabletter

NetherlandsSevelameercarbonaatMylan 800 mg, filmomhulde tabletten

PortugalSevelâmero Mylan

United KingdomSevelamer carbonate 800 mg Film-coated Tablets

Czech RepublicSevelamer Carbonate Mylan 800 mg, potahované tablety

SwedenSevelamer Mylan 800 mg filmdragerade tabletter

Last review date of this leaflet:December 2019

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): https://www.aemps.gob.es/