Sevelamer Viatris 800 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sevelámero Viatris 800 mg film-coated tablets

Sevelamer carbonate

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Sevelámero Viatris is and what it is used for

2. What you need to know before taking Sevelámero Viatris

3. How to take Sevelámero Viatris

4. Possible adverse effects

5. How to store Sevelámero Viatris

6. Contents of the container and other information

1. What Sevelamer Viatris is and what it is used for

Sevelamer Viatris contains sevelamer carbonate as the active substance. It binds to dietary phosphate in the gastrointestinal tract, thereby reducing serum phosphate levels in the blood.

Sevelamer Viatris is used to control hyperphosphataemia (high blood phosphate levels) in:

• Adult patients on dialysis (a blood-cleansing technique). 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 an internal body membrane filters the blood).
• Patients with chronic kidney disease (long-term) who are not on dialysis and who have a serum (blood) phosphate level equal to or above 1.78 mmol/l.

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

Elevated serum phosphate levels may lead to hard deposits in the body known as calcification. These deposits can harden blood vessels and make it more difficult for blood to be pumped through the body. Increased serum phosphate may also cause skin itching, red eyes, bone pain, and fractures.

2. What you need to know before starting to take Sevelamer Viatris

Do not take Sevelamer Viatris:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you have low levels of phosphate in the blood (your doctor will check this for you).
• If you have intestinal obstruction.

Warnings and precautions

Talk to your doctor before starting to take Sevelamer Viatris if any of the following apply to you:

• Problems with swallowing. Your doctor may prefer to prescribe you Fosrenol powder for oral suspension.
• Problems with gastrointestinal motility (movement of the stomach and intestines).
• You have frequent vomiting.
• Active inflammation of the intestine.
• You have undergone major surgery of the stomach or intestine.
• You have severe inflammatory bowel disease.

Talk to your doctor while taking Sevelamer Viatris:

• If you experience severe abdominal pain, stomach or intestinal disturbances, or blood in the stool (gastrointestinal bleeding). These symptoms may be due to deposition of sevelamer crystals in the intestine. Contact your doctor immediately, who will decide whether or not to continue treatment.

Additional treatments:

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

• Have low or high levels of calcium in your blood. As this medicine does not contain calcium, your doctor may prescribe additional calcium tablets.
• Have low levels of Vitamin D in your blood. Therefore, your doctor may monitor your vitamin D levels and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, blood levels of vitamins A, E, K, and folic acid may also decrease; your doctor may monitor these levels and prescribe vitamin supplements as needed.
• Have altered bicarbonate levels in your blood and increased acidity in your blood and other body tissues. Your doctor should monitor your blood bicarbonate levels.

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 by carefully following sterile techniques during bag exchanges. You must inform your doctor immediately 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

The safety and efficacy have not been studied in children (under 6 years of age). Therefore, the use of this medicine is not recommended in children under 6 years of age.

Other medicines and Sevelamer Viatris
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

• Sevelamer should not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm disorders or for epilepsy, you should consult your doctor when taking sevelamer.
• The effects of medicines such as cyclosporine, 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 deficiency of thyroid hormone may rarely occur in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and sevelamer. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) levels in blood more closely.
• Medicines used to treat stomach acid and reflux in the stomach or esophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors,” may reduce the effectiveness of Sevelamer Viatris. Your doctor should monitor your blood phosphate levels.

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

In some cases where sevelamer must be taken at the same time as another medicine, your doctor may instruct you to take that medicine 1 hour before or 3 hours after taking sevelamer. Your doctor may also consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

It is unknown whether Sevelamer Viatris passes into breast milk and could affect your baby. Consult your doctor, who will decide whether you can breastfeed or not, and whether treatment with Sevelamer Viatris needs to be stopped.

Driving and using machines

It is unlikely that sevelamer will affect your ability to drive or use machines.

Sevelamer Viatris contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Sevelamer Viatris

Sevelamer should be taken exactly as prescribed by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.

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

The tablets must be swallowed whole. Do not crush, chew, or divide them.

Initially, your doctor will monitor your blood phosphorus levels every 2–4 weeks and may adjust the dose of sevelamer as needed to achieve an appropriate phosphorus 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Sevelamer Viatris

If you miss a dose, skip it and take the next dose at the usual time with food. Do not take a double dose to make up for a missed dose.

If you stop taking Sevelamer Viatris

Taking this medication as prescribed is important to maintain appropriate phosphate levels in your blood. Stopping treatment may lead to serious consequences, such as calcification of blood vessels. If you are considering stopping treatment with this medicine, speak to your doctor or pharmacist first.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell 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 symptom 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.

Frequency not known (cannot be estimated from available data):

• Cases of itching, rash, slow intestinal motility (movement), intestinal obstruction (signs include: severe distension, abdominal pain, bloating or cramps, severe constipation), perforation of the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or painful or tender abdomen), intestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine.

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

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

• Vomiting.
• Abdominal pain in the upper part of the stomach.
• Nausea.

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

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sevelamer Viatris

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevelamer Viatris

• The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
• The other components are lactose monohydrate, silica (anhydrous colloidal), and zinc stearate. The tablet coating contains hypromellose (E-464) and diacetylated monoglycerides.

Appearance of the medicine and contents of the pack

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

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

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

Only certain pack 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

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Germany Sevelamer carbonat Mylan 800 mg Filmtabletten
Denmark Sevelamer carbonat Mylan
Slovakia Sevelamer Carbonate Mylan 800 mg, filmom obalené tablety
Spain Sevelámero Viatris 800 mg comprimidos recubiertos con película
France Sevelamer Mylan Pharma 800 mg, comprimés pelliculés
Greece Sevelamer/Mylan
Ireland Sevelamer Carbonate 800 mg Film-coated tablets
Italy Sevelamer Mylan Pharma
Norway Sevelamer Mylan 800 mg filmdrasjerte tabletter
Netherlands Sevelameercarbonaat Mylan 800 mg, filmomhulde tabletten
Portugal Sevelâmero Mylan
United Kingdom Sevelamer carbonate 800 mg Film-coated Tablets
Czech Republic Sevelamer Carbonate Mylan 800 mg, potahované tablety
Sweden Sevelamer Mylan 800 mg filmdragerade tabletter

Date of the most recent revision of this leaflet: December 2019

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