SEVELAMER KERN PHARMA 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sevelamer Kern Pharma 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, 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 pack

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

1. What is Sevelamer Kern Pharma and what is it used for

This medicine contains sevelamer carbonate as the active substance. It binds to phosphate in the digestive tract and reduces phosphate levels in the blood.

This medicine 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.

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

High phosphate levels in the blood can cause hard deposits in the body called calcifications. These deposits can harden in blood vessels and make it harder for blood to be pumped through the body. High phosphate levels in the blood can also cause itching of the skin, red eyes, bone pain, and fractures.

2. What you need to know before you take Sevelamer Kern Pharma

Do not takeSevelamerKern Pharma

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

Warnings and precautions

Tell your doctor before taking sevelamer, if you are in any of the following situations:

• have problems swallowing. Your doctor may prefer to prescribe sevelamer carbonate powder for oral suspension,
• have problems with stomach and intestinal motility (movement),
• have frequent vomiting,
• have active intestinal inflammation,
• have had major stomach or intestinal surgery,

Tell your doctor while you are taking sevelamer:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stools (gastrointestinal bleeding). These symptoms can be due to a serious intestinal inflammatory disease caused by the deposit 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
• 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 needed.
• 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 on peritoneal dialysis:

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced with careful use 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 abdominal stiffness, constipation, fever, chills, nausea, or vomiting.

Children

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

Other medicines and Sevelamer Kern Pharma

Tell 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 are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking this medicine.

• The effects of medicines such as cyclosporin, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by this medicine. Your doctor will advise you if you are taking these medicines.

• A deficiency of the thyroid hormone may be observed rarely 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 effectiveness of sevelamer. 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, when sevelamer needs to be taken with another medicine. Your doctor may tell you to take this medicine 1 hour before or 3 hours after taking sevelamer. Your doctor should consider monitoring the levels of that medicine in your blood.

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 during human pregnancy is unknown. Consult your doctor, who will decide whether you can continue treatment with sevelamer.

It is unknown whether sevelamer can pass into breast milk and affect your baby. Consult your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with sevelamer.

Driving and using machines

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

Sevelamer Kern Pharma contains lactose

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

3. How to take Sevelamer Kern Pharma

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

The recommended initial dose of sevelamer tablets for adults and elderly patients (> 65 years) is one to two 800 mg tablets with each meal, three times a day. Consult 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 them.

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

Follow the diet prescribed by your doctor.

If you take more Sevelamer Kern Pharma than you should

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

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 Kern Pharma

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 Kern Pharma

Taking your treatment with sevelamer is important to maintain an appropriate phosphate level in your blood. Stopping treatment with sevelamer would have significant consequences, such as calcification in blood vessels. If you consider stopping your treatment with sevelamer, 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.

Constipation is a very common side effect (may affect more than 1 in 10 people). It can be an early symptom of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.

Some side effects can be serious. If you get any of the following side effects, seek medical attention immediately:

• Allergic reaction (signs include rash, hives, swelling, difficulty breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Intestinal obstruction (signs include: severe swelling; abdominal pain, swelling, or cramps; severe constipation). The frequency is unknown (cannot be estimated from the available data).
• Intestinal wall rupture has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness). The frequency is unknown.
• Severe inflammation of the large intestine (includes symptoms such as: severe abdominal pain, stomach or intestinal disorders, or blood in the stools [intestinal bleeding]) and crystal deposits in the intestine. The frequency is unknown.

Other side effects have been reported in patients taking sevelamer.

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, stomach pain, indigestion, flatulence.

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

Cases of itching, rash, slow intestinal motility (movement).

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet.

You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sevelamer Kern Pharma

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 the letters "CAD". The expiry date is 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 other information

Composition of

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

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

Appearance and packaging

Sevelamer Kern Pharma are white to off-white, oval, film-coated tablets with "SVL" engraved on one side.

Packet sizes:

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:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Tarrasa – Barcelona

Spain

Manufacturer:

Synthon Hispania SL

Castelló 1, Polígono Las Salinas.

08830 Sant Boi de Llobregat

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: April 2022

Other sources of information

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