Package Insert: Information for the User

Sevelamer Kern Pharma 2.4 g Powder for Oral Suspension

Sevelamer Carbonate

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Sevelamer Kern Pharma contains 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.

Sevelamer 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.

Sevelamer 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 itching skin, red eyes, bone pain, and fractures.

Do not take Sevelámero Kern Pharma

• if you have low levels of phosphate in your blood (your doctor will check this for you)

• if you have intestinal obstruction
• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor before taking sevelámero if you are in any of the following situations:

• swallowing difficulties

• problems with stomach and intestine motility

• you frequently vomit

• you have active intestinal inflammation

• you have had major surgery on your stomach or intestine.
• if you have a severe inflammatory bowel disease.

Children and adolescents

Sevelámero has not been studied in children (under 18 years). Therefore, it is not recommended for use in children.

Additional treatments:

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

• have low or high levels of calcium in your blood. Since sevelámero does 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.

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. Inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, constipation, fever, chills, nausea, or vomiting.

You should also be closely monitored if you have low levels of vitamins A, D, E, K, and folic acid.

Use of Sevelámero Kern Pharma with other medications

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

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

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

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

• It may occasionally be observed a deficiency of thyroid hormone in certain people who take levotiroxine (used to treat low levels of thyroid hormone) and sevelámero. Therefore, your doctor may closely monitor your thyroid-stimulating hormone levels in the blood.

• If you are taking medications such as omeprazol, pantoprazol, or lansoprazol to treat stomach acid, heartburn, gastroesophageal reflux disease (GERD), or stomach ulcers, consult your doctor when taking sevelámero.

Your doctor will regularly check for interactions between sevelámero and other medications.

In some cases, sevelámero should 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 sevelámero, or may consider controlling the blood levels of that medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication. It is unknown if sevelámero has any effect on the fetus.

Inform your doctor if you want to breastfeed your baby. It is unknown if sevelámero can pass into breast milk and affect the baby.

Driving and operating machines

It is unlikely that sevelámero will affect your ability to drive or operate machines.

Sevelamer must be taken as prescribed by your doctor. The doctor will determine the dosage based on your serum phosphorus levels.

The 2.4 g oral powder suspension dose should be dispersed in 60 ml of water. Drink within 30 minutes of preparation. It is essential to drink the entire liquid, and it may be necessary to rinse the glass with water and drink it as well to ensure you ingest the entire powder.

The recommended initial dose of sevelamer is 2.4-4.8 g per day, divided equally among three meals. Your doctor will determine the exact initial dose and regimen.

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

Patients taking sevelamer must follow the diets prescribed to them.

If you take more Sevelamer KernPharma than you should

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

If you forgot to take Sevelamer KernPharma

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Since constipation could be an early sign of intestinal obstruction, inform your doctor or pharmacist.

The following adverse effects have been reported in patients taking sevelamer:

Very Common(may affect more than 1 in 10 patients):

nausea, constipation, upper abdominal pain, vomiting

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

diarrhea, abdominal pain, indigestion, flatulence

Very Rare(may affect up to 1 in 10,000 patients):

hypersensitivity

Unknown Frequency(cannot be estimated from available data):

cases of pruritus, rash, slow intestinal motility (movement), 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), intestinal bleeding, colonic inflammation, and crystal deposition in the intestine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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 the packaging after CAD. The expiration date is the last day of the month indicated.

The reconstituted suspension must be administered within 30 minutes of reconstitution.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Sevelamer KernPharma

- The active ingredient is sevelamer carbonate. Each pack of Sevelamer KernPharma contains 2.4 g of sevelamer carbonate, as indicated on the pack

- The other components are microcrystalline cellulose, sodium carmellose, sucralose (E955), lemon aroma, orange aroma, and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Sevelamer KernPharma is a white to yellowish powder supplied in an aluminum thermosealed pack. The aluminum packs are packaged in an external box.

Packaging sizes:

90 packs per box

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

Synthon Hispania S.L.

C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat,

08830 Barcelona

Spain

or

Synthon s.r.o.

Microweg 22

6545 CM Nijmegen

The Netherlands

Last review date of this leaflet: October 2019

Further detailed and updated information on this medication is available on the website of the Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/