SEVELAMER KERN PHARMA 2.4 g POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Sevelamer Kern Pharma 2.4 g oral powder for suspension

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 experience 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 Sevelamer Kern Pharma is and what it is 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 Sevelamer KernPharma is and what it is used for

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

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

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

Do not take Sevelamer KernPharma

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

• if you have intestinal obstruction
• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• swallowing problems

• stomach and intestine motility problems

• frequent vomiting

• active inflammation of the intestine

• you have undergone major stomach or intestine surgery.
• if you have severe inflammatory bowel disease.

Children and adolescents

The safety and efficacy of sevelamer have not been studied in children (under 18 years). Therefore, the use of sevelamer is not recommended in children.

Additional treatments:

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

• have low or high calcium levels in your blood. As sevelamer does not contain calcium, your doctor may prescribe calcium supplement tablets

• have low vitamin D levels in your blood. Therefore, your doctor may check 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.

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.

You should also expect closer monitoring if you have problems with low levels of vitamins A, D, E, K, and folic acid.

Using Sevelamer KernPharma with other medicines

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 using other medicines for heart rhythm problems or for 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 low thyroid hormone level 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.

• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or stomach ulcers, you should consult your doctor when taking sevelamer.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is not known if sevelamer has any effect on the fetus.

Tell your doctor if you want to breastfeed your baby. It is not known if sevelamer passes into breast milk and affects the baby.

Driving and using machines

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

3. How to take Sevelamer KernPharma

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

The dose of 2.4 g of oral powder for suspension should be dispersed in 60 ml of water. Drink within 30 minutes of preparation. It is important to drink all of the liquid and you may need to rinse the glass with water and drink it to ensure you take all of the powder.

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

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.

Patients taking sevelamer should follow the diets prescribed for them.

If you take more Sevelamer KernPharma than you should

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

If you forget to take Sevelamer KernPharma

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.

4. Possible side effects

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

As constipation could be an early symptom of intestinal obstruction, tell your doctor or pharmacist.

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

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

vomiting, constipation, upper abdominal pain, nausea

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

diarrhoea, abdominal pain, indigestion, flatulence

Very rare (may affect up to 1 in 10,000 people):

hypersensitivity

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

cases 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 tenderness), gastrointestinal bleeding, large intestine inflammation, and crystal deposits in the intestine.

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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) 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 KernPharma

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 is the last day of the month stated.

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

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

What Sevelamer KernPharma contains

• The active substance is sevelamer carbonate. Each sachet of Sevelamer Kern Pharma contains 2.4 g of sevelamer carbonate, as stated on the sachet
• The other ingredients are microcrystalline cellulose, sodium carmellose, sucralose (E955), lemon flavour, orange flavour, and yellow iron oxide (E172).

Appearance and packaging

Sevelamer Kern Pharma is a white to yellowish powder supplied in an aluminium foil sachet. The aluminium foil sachets are packaged in an outer carton.

Pack sizes:

90 sachets per carton

Marketing authorisation holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

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

Date of last revision of this leaflet: October 2019

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/