Sevelamer Sandoz GmbH

Patient Information Leaflet

Sevelamer Sandoz GmbH 2.4 g oral suspension powder

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

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

1. What Sevelamer Sandoz GmbH is and what it is used for

Sevelamer Sandoz GmbH contains the active substance sevelamer carbonate, which works by preventing the gastrointestinal tract from absorbing phosphate from food, thereby reducing phosphate levels in the blood.
Sevelamer Sandoz GmbH is used to control hyperphosphataemia (high levels of phosphate in the blood) in:

• adult patients on dialysis (a blood purification technique). The medicine 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);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level equal to or greater than 1.78 mmol/l;
• paediatric patients with chronic kidney disease (long-term) above 6 years of age and above a certain height and weight (used by the physician to calculate body surface area).

Sevelamer Sandoz GmbH should be used together with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease. Elevated phosphate levels in the blood may lead to the formation of solid deposits in the body, known as calcifications. These deposits can harden blood vessels and make it more difficult for blood to circulate throughout the body. In addition, high phosphate levels in the blood may cause itchy skin, red eyes, bone pain and fractures.

2. What you need to know before taking Sevelamer Sandoz GmbH

Do not take Sevelamer Sandoz GmbH

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

Warnings and precautions
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Talk to your doctor before taking Sevelamer Sandoz GmbH if any of the following apply to you:

• problems with swallowing
• problems with motility (movement) of the stomach and intestines
• frequent nausea or vomiting
• active inflammation of the intestine
• you have undergone major surgery on the stomach or intestines
• you have severe inflammatory bowel disease.

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

• develop low or high levels of calcium in the blood. Since Sevelamer Sandoz GmbH does not contain calcium, your doctor may prescribe calcium supplements.
• have low levels of vitamin D in the blood. Therefore, your doctor may check your vitamin D levels and prescribe vitamin D supplementation as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood; consequently, your doctor may monitor these levels and prescribe vitamin supplements as needed.
  Special note for patients undergoing peritoneal dialysis: You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by strictly maintaining sterile techniques when changing the dialysis bag. Inform your doctor immediately if you experience new signs or symptoms of abdominal discomfort, abdominal bloating, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting. You will be monitored more closely if problems related to low levels of vitamin A, D, E, K, or folic acid occur.

Children
The safety and efficacy in children (under 6 years of age) has not been established. Therefore, Sevelamer Sandoz GmbH is not recommended for use in children under 6 years of age.

Other medicines and Sevelamer Sandoz GmbH
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Sevelamer Sandoz GmbH must not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm disorders or epilepsy, consult your doctor before taking Sevelamer Sandoz GmbH.
• Sevelamer Sandoz GmbH may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the activity of the immune system). Your doctor will advise you on how to proceed if you are taking these medicines.
• In some patients, taking levothyroxine (a medicine used to treat low thyroid hormone levels) together with Sevelamer Sandoz GmbH has uncommonly caused thyroid hormone deficiency. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) levels more closely.
• If you are taking medicines for heartburn, gastroesophageal reflux disease, or gastric ulcer, such as omeprazole, pantoprazole, or lansoprazole, consult your doctor before taking Sevelamer Sandoz GmbH. Your doctor will monitor regularly for possible interactions between Sevelamer Sandoz GmbH and other medicines.

In some cases, when Sevelamer Sandoz GmbH must be taken together with another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Sevelamer Sandoz GmbH, or may consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. It is not known whether Sevelamer Sandoz GmbH has effects on the fetus.
Inform your doctor if you intend to breastfeed. It is not known whether Sevelamer Sandoz GmbH passes into breast milk and may affect your baby.

Driving and using machines
It is unlikely that Sevelamer Sandoz GmbH affects the ability to drive vehicles or operate machinery.

3. How to take Sevelamer Sandoz GmbH

You must take Sevelamer Sandoz GmbH exactly as instructed by your doctor. Your doctor will decide the dosage based on your blood phosphate level.
For the 2.4 g dose, the oral suspension powder of Sevelamer Sandoz GmbH must be dispersed in 60 ml of water. Drink within 30 minutes after preparation. It is important to drink all the liquid, and you may need to rinse the glass with water and drink it again to ensure that all the powder is consumed.
The recommended initial dose of Sevelamer Sandoz GmbH for adults is 2.4 – 4.8 g per day, divided equally among the three main meals. The correct initial dose and regimen will be decided by your doctor.
Use in children and adolescents
The recommended initial dose of Sevelamer Sandoz GmbH for children is based on their height and weight (used by the doctor to calculate body surface area). For children, Sevelamer Sandoz GmbH powder is preferred, as Sevelamer Sandoz GmbH tablets are not indicated for this population. Sevelamer Sandoz GmbH must not be given on an empty stomach and should be taken with meals or snacks.
The exact initial dose and treatment regimen will be determined by your doctor.
For doses lower than 2.4 g, the powder in the sachet of Sevelamer Sandoz GmbH may be divided. Sevelamer Sandoz GmbH powder can be measured by volume (mL) using a dosing spoon or a measuring cup.
Sevelamer carbonate dose (g) Volume (ml)

Preparation using a 1 mL measuring spoon:
For a 0.4 g dose

• Open the sachet with scissors along the dotted line
• Insert the measuring spoon into the sachet
• Fill the measuring spoon above the upper mark
• Remove the measuring spoon from the sachet, using the top edge of the opened sachet to level off the powder with the top of the spoon. This allows excess Sevelamer Sandoz GmbH powder to fall back into the sachet.

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• Disperse 1.0 mL of Sevelamer Sandoz GmbH powder from the measuring spoon into 60 mL of water. Drink within 30 minutes of preparation. It is important to drink all the liquid, and it may be necessary to rinse the glass with water and drink again to ensure that all the powder is ingested.
• Close the sachet by folding it over twice
• The remaining Sevelamer Sandoz GmbH powder may be used within 24 hours for the next dose
• Discard any Sevelamer Sandoz GmbH sachets that have been open for more than 24 hours. For the 0.8 g dose:
• Follow the instructions above, filling the measuring spoon twice for a total of 2.0 mL of Sevelamer Sandoz GmbH powder
• For the 1.2 g dose: Follow the instructions above, filling the measuring spoon three times for a total of 3.0 mL of Sevelamer Sandoz GmbH powder
• For the 1.6 g dose: Follow the instructions above, filling the measuring spoon four times for a total of 4.0 mL of Sevelamer Sandoz GmbH powder

Preparation using a dosing spoon
For the 0.4 g dose:

• Open the sachet with scissors along the dotted line
• Hold the dosing spoon vertically
• Pour the contents of the sachet into the dosing spoon until it is filled to 1.0 mL
• Do not tap the dosing spoon to compact the powder
• Disperse 1.0 mL of Sevelamer Sandoz GmbH powder from the dosing spoon into 60 mL of water. Drink within 30 minutes of preparation. It is important to drink all the liquid, and it may be necessary to rinse the glass with water and drink again to ensure that all the powder is ingested
• Close the sachet by folding it over twice
• The remaining Sevelamer Sandoz GmbH powder may be used within 24 hours for the next dose
• Discard any Sevelamer Sandoz GmbH sachets that have been open for more than 24 hours. For the 0.8 g dose:
• Follow the instructions above, filling the dosing spoon twice for a total of 2.0 mL of Sevelamer Sandoz GmbH powder
• For the 1.2 g dose: Follow the instructions above, filling the dosing spoon three times for a total of 3.0 mL of Sevelamer Sandoz GmbH powder
• For the 1.6 g dose: Follow the instructions above, filling the dosing spoon four times for a total of 4.0 mL of Sevelamer Sandoz GmbH powder

Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust, if necessary, the dose of Sevelamer Sandoz GmbH to achieve an appropriate phosphate level.
Patients taking Sevelamer Sandoz GmbH must follow the prescribed diet.
If you take more Sevelamer Sandoz GmbH than you should
If you take too high a dose, contact your doctor immediately.
If you forget to take Sevelamer Sandoz GmbH
If you forget a dose, skip that dose and take the next dose at the usual time, with a meal. Do not take a double dose to make up for the missed dose.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Since constipation may be the initial symptom of intestinal obstruction, inform your doctor or pharmacist.
The following side effects have been observed in patients taking Sevelamer Sandoz GmbH:
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.
Not known (frequency cannot be estimated from the available data):
cases of itching, rash, reduced intestinal motility (movement), intestinal obstruction (symptoms include: severe bloating; abdominal pain, swelling or cramps; severe constipation), intestinal wall rupture (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain), gastrointestinal bleeding, inflammation of the large intestine, and deposition of crystals in the intestine have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sevelamer Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the carton after "Exp".
The reconstituted suspension must be administered within 30 minutes of reconstitution.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sevelamer Sandoz GmbH contains

• The active substance is sevelamer carbonate. Each sachet of Sevelamer Sandoz GmbH contains 2.4 g of sevelamer carbonate.
• The other ingredients are microcrystalline cellulose (E460), sodium carmellose, sucralose (E955), lemon flavour, orange flavour and yellow iron oxide (E172).

Description of the appearance of Sevelamer Sandoz GmbH and the contents of the pack
Sevelamer Sandoz GmbH oral suspension powder is a white to yellowish powder, contained in an aluminium sachet. The aluminium sachets are packed in a cardboard box.
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Pack sizes:

• 60 sachets per box
• 90 sachets per box

It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz GmbH, Biochemiestraße, 10 – 6250 Kundl, Austria.
Manufacturers:

• Synthon Hispania SL - C/ Castelló n. 1, Pol. Las Salinas, Sant Boi de Llobregat - 08830 Barcelona - Spain
• Synthon BV, Microweg, 22 - Nijmegen, 6545 CM, The Netherlands
• Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium Sevelamer Sandoz 2.4 g powder for oral suspension
Croatia Sevelamer Sandoz 2.4 g powder for oral suspension
Denmark Sevelamercarbonat Hexal
France SEVELAMER CARBONATE SANDOZ 2.4 g, poudre pour suspension orale
Germany Sevelamercarbonat HEXAL 2.4 g, powder for the preparation of an oral suspension
Italy Sevelamer Sandoz GmbH
Luxembourg Sevelamer Sandoz 2.4 g poudre pour suspension buvable
The Netherlands Sevelameercarbonaat Sandoz 2.4 g, poeder voor orale suspensie
Spain Sevelámero Sandoz 2.4 g polvo para suspensión oral
Sweden Sevelamer Sandoz 2.4 g pulver till oral suspension
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