SEVELAMERO 800 mg Film-Coated Tablets

Contents of the leaflet

1. Introduction
2. What is Sevelamer Viatris and what is it used for
3. What you need to know before you take Sevelamer Viatris
4. How to take Sevelamer Viatris
5. Possible side effects
6. Storage of Sevelamer Viatris
7. Contents of the pack and further information

Introduction

Package Leaflet: Information for the User

Sevelamer Viatris 800 mg Film-Coated Tablets

Sevelamer Carbonate

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sevelamer Viatris and what is it used for
2. What you need to know before you take Sevelamer Viatris
3. How to take Sevelamer Viatris
4. Possible side effects
5. Storage of Sevelamer Viatris

1. Contents of the pack and further information

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

Sevelamer Viatris contains sevelamer carbonate as the active substance. It binds to phosphate from food in the digestive tract and thereby reduces serum phosphate levels in the blood.

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

• Adult patients on dialysis (a blood cleaning 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 a body membrane filters the blood).
• Patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level of 1.78 mmol/l or higher.

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

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

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

Do not take Sevelamer Viatris:

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

Warnings and precautions

Talk to your doctor before taking Sevelamer Viatris if you are in any of the following situations:

• Difficulty swallowing. Your doctor may prefer to prescribe Fosquel powder for oral suspension for you.
• Problems with stomach and intestinal motility.
• You vomitfrequently.
• Inflammationof the intestine.
• You have had major stomach or intestinal surgery.
• If you have a severe inflammatory bowel disease.

Talk to your doctor while taking Sevelamer Viatris:

• If you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stools (gastrointestinal bleeding). 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 condition or dialysis treatment, you may:

• Have low or high calcium levels in your blood. As this medicine does not contain calcium, your doctor may prescribe calcium supplement tablets for you.
• Have low vitamin D levels in your blood. Therefore, your doctor may monitor your vitamin D levels in your blood and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your blood levels of vitamins A, E, K, and folic acid may also decrease, so your doctor may monitor these levels and prescribe vitamin supplements as necessary.
• Have altered bicarbonate levels in your blood and increased 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. You should inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or stiffness, constipation, fever, chills, nausea, or vomiting.

Children

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

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

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

Your doctor will check for interactions between sevelamer and other medicines on a regular basis.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

It is unknown whether Sevelamer Viatris passes into breast milk and affects your baby. Talk to your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with Sevelamer Viatris.

Driving and using machines

Sevelamer is unlikely to affect your ability to drive or use machines.

Sevelamer Viatriscontains lactose

This medicine contains . If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Sevelamer Viatris

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

The recommended initial dose of Sevelamer Viatris film-coated tablets for adults and the elderly (> 65 years) is one to two 800 mg tablets with each meal, 3 times a day.Ask your doctor, pharmacist, or nurse if you are unsure.

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

Initially, your doctor will check your blood phosphate levels every 2-4 weeks and may adjust the dose of sevelamer 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sevelamer Viatris

If you miss a dose, it should be omitted, so the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for forgotten doses.

If you stop taking Sevelamer Viatris

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist 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 the available data):

• Reports of itching, rash, slow intestinal motility, intestinal obstruction (signs include severe distension, abdominal pain, swelling, or cramps, severe constipation), intestinal wall rupture (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain or tenderness), gastrointestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine.

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

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

• Vomiting.
• Pain in the upper abdomen.
• Nausea.

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

• Diarrhoea.
• Abdominal pain.
• Indigestion.
• Flatulence.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Sevelamer Viatris

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

Appearance and packaging of the product

Sevelamer Viatris film-coated tablets are white to off-white, oval, and engraved with “SVL” 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. Packs containing 1, 2, or 3 bottles are available.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area 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

UK 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 last revision of this leaflet:December 2019

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