SEVELAMER 2.4 G Oral suspension

Зміст інструкції

1. Sevelamer Sandoz GmbH 2.4 g powder for oral suspension
   1. What is Sevelamer Sandoz GmbH and what is it 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. Package contents and other information

Sevelamer Sandoz GmbH 2.4 g powder for oral suspension

Generic medicine
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Sevelamer Sandoz GmbH and what is it used for

Sevelamer Sandoz GmbH contains the active ingredient sevelamer carbonate which works by preventing
the absorption by the digestive system of phosphate present in food and in this way reduces levels
of phosphorus in the blood.
Sevelamer Sandoz GmbH is used to control hyperphosphataemia (high levels of phosphate in the blood)
in:

• adult patients undergoing dialysis (a blood purification technique). The medicine 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 an internal membrane of the body filters the blood);
• adult patients with chronic kidney disease (long-term) who are not undergoing dialysis and have a level of phosphorus in the blood equal to or greater than 1.78 mmol/l
• paediatric patients with chronic kidney disease (long-term) over 6 years of age and above a certain height and weight (used to calculate the body surface area by your doctor) Sevelamer Sandoz GmbH must be used with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone diseases. Increased levels of phosphorus in the blood can cause the formation of solid deposits in the body, called calcifications. These deposits can harden blood vessels and make it more difficult to distribute blood throughout the body. In addition, increased phosphorus in the blood can 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 phosphatein your blood (your doctor will check this)
• if you suffer from intestinal obstruction
• if you are allergic to the active substance or to any of the other ingredientsof 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 conditions apply to you:

• problems with swallowing
• problems with motility (movement) of the stomach and intestines
• feeling unwell frequently
• active inflammationof the intestines
• you have undergone major surgeryto the stomach or intestines.
• you have a severe inflammatory bowel disease.

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

• experience low or high levels of calcium in your blood. Because Sevelamer Sandoz GmbH does not contain calcium, your doctor may prescribe calcium supplements.
• have a low level of vitamin D in your blood. As a result, your doctor may check the levels of vitamin D in your blood 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 your blood, and therefore your doctor may check 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 adopting strict techniques for maintaining sterility when replacing the bag. Immediately inform your doctor 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 subject to closer monitoring if problems related to low levels of vitamin A, D, E, K and folic acid occur.

Children
Safety and efficacy in children (under 6 years of age) have not been studied. Therefore Sevelamer Sandoz GmbH is not recommended for use in children under 6 years of age.

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

• Sevelamer Sandoz GmbH should not be taken at the same time as ciprofloxacin (anantibiotic).
• If you are taking medicines for heart rhythm problems or for epilepsy, consult your doctor when 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 what to do if you are taking these medicines.
• In some patients, the simultaneous use of levothyroxine (a medicine used for thetreatment of low thyroid hormone levels)and Sevelamer Sandoz GmbH has, uncommonly, caused a deficiency of thyroid hormone. Consequently, your doctor may check your blood levels of thyroid-stimulating hormone more carefully.
• If you are taking medicines for the treatment of heartburn, gastroesophageal reflux disease or gastric ulcer, such as omeprazole, pantoprazole or lansoprazole, consult your doctor when taking Sevelamer Sandoz GmbH. Your doctor will check at regular intervals for any interactions between Sevelamer Sandoz GmbH and other medicines.

In some cases, i.e. when Sevelamer Sandoz GmbH must be taken at the same time as another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking Sevelamer Sandoz GmbH, or consider the possibility of checking the levels of that medicine in your blood.
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Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. It is not known whether Sevelamer Sandoz GmbH has effects on the fetus.
Tell your doctor if you wish to breastfeed your baby. It is not known whether Sevelamer Sandoz GmbH can pass into breast milk and cause effects on your baby.

Driving and using machines
It is unlikely that Sevelamer Sandoz GmbH will impair your ability to drive or operate machinery.

3. How to take Sevelamer Sandoz GmbH

You must take Sevelamer Sandoz GmbH exactly as your doctor has instructed. The doctor will decide
the dosage based on your blood phosphate level.
For a dose of 2.4 g, the Sevelamer Sandoz GmbH oral suspension powder must 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 again, so as to be certain that all of the
powder is taken.
The recommended initial dose of Sevelamer Sandoz GmbH for adults is 2.4 - 4.8 g per day, evenly
divided into three 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
their weight (used by the doctor to calculate the body surface area). For children, Sevelamer Sandoz
GmbH powder is preferred, as the Sevelamer Sandoz GmbH tablets are not indicated for
this population. Sevelamer Sandoz GmbH should not be given on an empty stomach and must be taken with
meals or with a snack.
The exact initial dose and therapeutic regimen will be determined by your doctor.
For doses less than 2.4 g, the Sevelamer Sandoz GmbH powder in the sachet can 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 cup:
For a dose of 0.4 g

• open the sachet with scissors along the dotted line
• insert the measuring cup into the sachet
• Fill the measuring cup above the upper limit
• Remove the measuring cup from the sachet using the upper edge of the open sachet to level the powder with the top of the measuring cup. 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 cup 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 again to make sure you ingest all of the powder
• close the sachet by folding it twice
• The remaining Sevelamer Sandoz GmbH powder can be used within 24 hours for the next dose
• Discard 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 cup 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 cup 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 cup four times for a total of 4.0 ml of Sevelamer Sandoz GmbH

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 to fill the spoon up 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 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 again to make sure you ingest all of the powder
• Close the sachet by folding it twice
• The remaining Sevelamer Sandoz GmbH powder can be used within 24 hours for the next dose
• Discard 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.

Initially, the doctor will check the phosphorus levels in your blood every 2 - 4 weeks and may adjust, if
necessary, the dose of Sevelamer Sandoz GmbH, to reach an adequate 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 have forgotten a dose, do not consider 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 everybody gets them.
Because constipation can be an early symptom of a bowel 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):
Hypersensitivity.

Not known(frequency cannot be estimated from the available data):
cases of itching, rash, reduced intestinal (bowel) motility, bowel obstruction (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation),
perforation of the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting, or
abdominal pain), intestinal bleeding, inflammation of the colon and crystal deposits
in the intestine.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at 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 which is stated on the sachet and on the package after “Exp”.
The reconstituted suspension must be administered within 30 minutes of reconstitution.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is sevelamer carbonate. Each sachet of Sevelamer Sandoz GmbH contains 2.4 g of sevelamer carbonate.
• The other ingredients are microcrystalline cellulose (E460), sodium carboxymethylcellulose, sucralose (E955), lemon flavour, orange flavour and yellow iron oxide (E172).

Description of the appearance of Sevelamer Sandoz GmbH and package contents
Sevelamer Sandoz GmbH oral suspension powder is a powder ranging in colour from whitish to yellow,
contained in an aluminium sachet. The aluminium sachets are contained in a cardboard box.
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Pack sizes:

• 60 sachets per box
• 90 sachets per box

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz GmbH, Biochemiestraβe, 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, 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 with the following
names:
Belgium Sevelamer Sandoz 2.4 g powder for oral suspension
Croatia
Denmark
Sevelamercarbonate Hexal
SEVELAMER CARBONATE SANDOZ 2.4 g, powder for oral
suspension
France
Germany
Sevelamercarbonate HEXAL 2.4 g Powder for the preparation of a
Suspension for ingestion
Italy Sevelamer Sandoz GmbH
Luxembourg Sevelamer Sandoz 2.4 g powder for oral suspension
Netherlands Sevelameercarbonaat Sandoz 2.4 g, powder for oral suspension
Spain Sevelámero Sandoz 2.4 g powder for oral suspension
Sweden Sevelamer Sandoz 2.4 g powder for oral suspension
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