Package Leaflet: Information for the user

Sevelamer Kern Pharma 800 mg film-coated tablets

Sevelamer carbonate

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

This medicationcontains 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.

This medication 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.

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

An increase in serum phosphorus levels can produce hard deposits in the body called calcifications. These deposits can harden in blood vessels and make it more difficult for blood to be pumped throughout the body. An increase in serum phosphorus levels can also produce skin itching, red eyes, bone pain, and fractures.

Do not takeSSevelamer Kern Pharma

• if you are allergic to the active ingredient or any of the other components of this medication (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

Consult 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 powder for oral suspension,
• problems with stomach and intestinal motility,
• frequent vomiting,
• active intestinal inflammation,
• you have had major surgery on your stomach or intestines,

Consult your doctor while taking sevelamer:

• if you experience intense abdominal pain, stomach or intestinal disorders, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to a severe intestinal inflammatory disease caused by 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. Sincethis medicationdoes 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 levels in blood 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 must 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 may decrease with the careful use 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 tendernessor rigidity, constipation, fever, chills, nausea, or vomiting.

Children

Sevelamer Kern Pharma has not been studied in children (under 6 years). Therefore, it is not recommended for use in children under 6 years.

Other medications andSSevelamer Kern Pharma

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

• Sevelamer should not be administered at the same time as ciprofloxacin (an antibiotic).

• If you are taking medications for heart rhythm problems or epilepsy, consult your doctor when taking this medication.

• The effects of medications such as ciclosporin, micofenolato mofetilo, and tacrolimus (medications used to suppress the immune system) may be reduced by this medication. Your doctor will advise you if you are taking these medications.

• A deficiency of thyroid hormone may be observed in some people who take levotiroxine (used to treat low levels of thyroid hormone) and sevelamer. Therefore, your doctor may closely monitor your thyroid-stimulating hormone levels in your blood.

• Medications to treat stomach acid and reflux in your stomach or esophagus, such as omeprazol, pantoprazol, or lansoprazol, known as "proton pump inhibitors," may reduce the effectiveness of sevelamer. Your doctor must monitor your phosphate levels in your blood.

Your doctor will regularly check for interactions betweensSevelamerand other medications.

In some cases, when sevelamer must 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 must consider even monitoring the levels of that medication in your blood.

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

The passage of sevelamer into breast milk and its effect on your baby is unknown.Consult with your doctor, who will decide whether you can breastfeed your baby or not and if it is necessary to interrupt treatment with sevelamer.

Driving and operating machinery

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

Sevelamer Kern Pharma contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Sevelamer should be taken as directed by your doctor. Your doctor will establish the dosage based on your serum phosphorus 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 with your doctor, pharmacist, or nurse if you are unsure.

Takesevelamerafter a meal or with food.

The tablets should be swallowed whole. Do notcrush, chew, or break.

Initially, your doctor will check your blood phosphorus concentrations every 2-4 weeks and may adjust the sevelamer dosage as needed to achieve an appropriate phosphorus level.

Follow the diet prescribed by your doctor.

If you take moreSevelamerKern Pharmathan you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to takeSevelamerKern Pharma

If you forget to take a dose, it should be omitted, and the next dose should be taken at the usual time with a meal. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withSevelamer Kern Pharma

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

Constipation is a very frequent adverse 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 adverse effects may be severe. If you have any of the following adverse effects, seek medical attention immediately:

Other adverse effects have been reported in patients taking sevelamer.

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

Vomiting, upper abdominal pain, nausea.

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

Diarrhea, stomach pain, indigestion, flatulence.

Unknown frequency(cannot be estimated from available data):

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

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 Medicines for Human Use, Website: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 thecontainerafter the letters “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist where to dispose of the medicines you no longer use. By doing so, you will help protect the environment.

Composition ofSevelámero Kern Pharma

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

The other components are lactose monohydrate, silica (colloidal anhydrous)and zinc stearate. The tablet coatingcontainshypromellose (E464) and diacetyl monoglycerides.

Appearance of the product and contents of the pack

Sevelámero Kern Pharma arefilm-coated tabletsof white to off-white color, ovaland carry the imprint “SVL” 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.

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Tarrasa – Barcelona

Spain

Manufacturer responsible:

Synthon Hispania SL

Castelló 1, Polígono Las Salinas.

08830 Sant Boi de Llobregat

Spain

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

Last review date of this leaflet: April 2022

Other sources of information

The detailed and updated 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/