Sevelamer KERN Pharma 800 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sevelamer Kern Pharma 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, 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 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 or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

This medicine is used to control hyperphosphataemia (high blood phosphate levels) 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 (in which 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 (in blood) phosphate level equal to or above 1.78 mmol/l.

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

Elevated serum phosphate levels may cause hard deposits in the body known as calcifications. These deposits may 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 taking Sevelamer Kern Pharma

Do not take Sevelamer Kern Pharma

• 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 your blood (your doctor will check this for you)
• if you have intestinal obstruction.

Warnings and precautions

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

• difficulty swallowing. Your doctor may prefer to prescribe you sevelamer carbonate oral suspension powder,
• problems with stomach or intestinal motility (movement),
• you frequently experience vomiting,
• active inflammation of the intestine,
• you have undergone major stomach or intestinal surgery.

Talk to your doctor while you are taking sevelamer:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stool (gastrointestinal bleeding). These symptoms may be due to a serious inflammatory bowel disease caused by deposition of sevelamer crystals in the intestine. Contact your doctor, 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. Since this medicine does not contain calcium, your doctor may prescribe additional calcium supplements,
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your blood 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 careful use of 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 established 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 Kern Pharma

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 epilepsy, you should consult your doctor when taking this medicine.

• The effects of medicines such as cyclosporine, 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 in 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) blood levels more closely.

• Medicines used 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 sevelamer. Your doctor should monitor your blood phosphate levels.

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

In some cases, when sevelamer must be taken at the same time as another medicine, your doctor may instruct you to take this medicine either 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 may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The potential risk of sevelamer during human pregnancy is unknown. Discuss with your doctor, who will decide whether you can continue treatment with sevelamer.

It is unknown whether sevelamer passes into breast milk and could affect your baby. Consult your doctor, who will decide whether you can breastfeed or not, and whether it is necessary to discontinue treatment with sevelamer.

Driving and using machines

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

Sevelamer Kern Pharma 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 Kern Pharma

Take sevelamer exactly as prescribed by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.

The recommended initial dose of sevelamer tablets for adults and elderly patients (aged > 65 years) is one to two 800 mg tablets with each meal, three times daily. Consult your doctor, pharmacist, or nurse if you are unsure.

Take sevelamer after a meal or with food.

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

Initially, your doctor will monitor your blood phosphorus levels every 2 to 4 weeks and may adjust the dose of sevelamer as necessary to achieve an appropriate phosphorus level.

Follow the diet prescribed by your doctor.

If you take more Sevelamer Kern Pharma than you should

In case of possible overdose, contact your doctor immediately.

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 Kern Pharma

If you miss a dose, skip that dose 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 Kern Pharma

Taking your sevelamer treatment is important to maintain an appropriate level of phosphate in your blood. Discontinuing sevelamer treatment may lead to serious consequences, such as calcification of blood vessels. If you are considering stopping your sevelamer treatment, contact your doctor or pharmacist first.

If you have any further questions about 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 everyone will experience them.

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

Some side effects may be serious. If you experience 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 bloating; abdominal pain, bloating or cramps; severe constipation). Frequency is unknown (frequency cannot be estimated from available data).
• Cases of intestinal wall rupture have been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness). Frequency is unknown.
• Severe inflammation of the large intestine (includes symptoms such as: severe abdominal pain, stomach or intestinal problems, or blood in the stool [intestinal bleeding]) and crystal deposits in the intestine. Frequency is unknown.

Other side effects have been reported in patients taking sevelamer.

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, stomach pain, indigestion, flatulence.

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the letters “EXP”. The expiry date refers to 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 medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist where to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sevelamer Kern Pharma

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

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

Appearance of the product and contents of the pack

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

Pack sizes:

HDPE bottles with a polypropylene cap.

Each bottle contains 180, 200 or 210 tablets.

Packs containing 1, 2 or 3 bottles are 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:

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 medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: April 2022

Other sources of information

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