SEVELAMER 0.8 Оральный порошок для суспензии

Содержание инструкции

1. Sevelamer carbonato Winthrop 800 mg film-coated tablets
   1. What is Sevelamer carbonato Winthrop and what it is used for
   2. What you need to know before taking Sevelamer carbonato Winthrop
   3. How to take Sevelamer carbonato Winthrop
   4. Possible side effects
   5. How to store Sevelamer carbonato Winthrop
   6. Contents of the pack and other information
2. Sevelamer carbonato Winthrop 0.8 g powder for oral suspension
   1. What is Sevelamer carbonato Winthrop and what it is used for
   2. What you need to know before taking Sevelamer carbonato Winthrop
   3. How to take Sevelamer carbonato Winthrop
   4. Possible side effects
   5. How to store Sevelamer carbonato Winthrop
   6. Package contents and other information
3. Sevelamer carbonato Winthrop 2.4 g powder for oral suspension
   1. What is Sevelamer carbonato Winthrop and what it is used for
   2. What you need to know before taking Sevelamer carbonato Winthrop
   3. How to take Sevelamer carbonato Winthrop
   4. Possible side effects
   5. How to store Sevelamer carbonato Winthrop
   6. Package contents and other information

Sevelamer carbonato Winthrop 800 mg film-coated tablets

sevelamer carbonato

Read this leaflet carefully before you start taking this medicinebecause 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 carbonato Winthrop is and what it is used for
• 2. What you need to know before you take Sevelamer carbonato Winthrop
• 3. How to take Sevelamer carbonato Winthrop
• 4. Possible side effects
• 5. How to store Sevelamer carbonato Winthrop
• 6. Contents of the pack and other information

1. What is Sevelamer carbonato Winthrop and what it is used for

Sevelamer carbonato Winthrop contains the active substance sevelamer carbonate which acts at the level
of the digestive system preventing the absorption of phosphate present in food, and in this way reduces
phosphate levels in the blood.
This medicine 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 for blood filtration) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal membrane of the body filters the blood);
• patients with chronic kidney disease (long-term) who are not on dialysis and have a phosphate level in the blood equal to or greater than 1.78 mmol/l.

This medicine 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 for blood to circulate
throughout the body. In addition, increased phosphate in the blood can cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before taking Sevelamer carbonato Winthrop

Do not take Sevelamer carbonato Winthrop

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

Warnings and precautions
Talk to your doctor before taking Sevelamer carbonato Winthrop:

• if you have difficulty swallowing. Your doctor may alternatively prescribe Sevelamer carbonato Winthrop powder for oral suspension
• if you have problems with the motility (movement) of your stomach and intestines
• if you have active inflammation of the intestine
• if you have undergone major surgery to your stomach or intestines.

Talk to your doctor during therapy with Sevelamer carbonato Winthrop:

• if you experience severe abdominal pain, stomach or intestinal discomfort, or if you find blood in your stool (gastrointestinal bleeding). These symptoms may be due to the deposition of sevelamer crystals in your intestine. Consult your doctor, who will decide whether to continue or discontinue treatment.

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

• experience low or high levels of calcium in your blood. Because this medicine does not contain calcium, your doctor may prescribe calcium supplements,
• have a low level of vitamin D in your blood. Consequently, your doctor may check the levels of vitamin D in your blood and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also experience 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,
• have an altered level of bicarbonate in your blood and increased acidity in your blood and other tissues of the body. Your doctor will monitor the level of bicarbonate in your blood.

Special note for patients undergoing peritoneal dialysis:
You may suffer from peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis.
This risk can be reduced by adopting strict techniques to maintain sterility when
replacing the bags. Immediately inform your doctor if you experience new signs or symptoms of suffering
abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or abdominal rigidity,
constipation, fever, chills, nausea or vomiting.

Children
Do not give this medicine to children under 6 years of age because the safety and efficacy in children (under
6 years) have not been studied.

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

• Sevelamer carbonato Winthrop must not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for problems related to heart rhythm or for epilepsy, consult your doctor when taking Sevelamer carbonato Winthrop.
• Sevelamer carbonato Winthrop may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some patients, the simultaneous use of levothyroxine (a medicine used to treat low levels of thyroid hormones) and Sevelamer carbonato Winthrop has caused, infrequently, a deficiency of thyroid hormones. Consequently, your doctor may check your thyroid-stimulating hormone levels in your blood more carefully.
• Medicines such as omeprazole, pantoprazole or lansoprazole, known as “proton pump inhibitors”, used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Sevelamer carbonato Winthrop. Your doctor may consider monitoring phosphate levels in your blood.

The doctor will check at regular intervals for any interactions between Sevelamer carbonato Winthrop and other
medicines.
In some cases where Sevelamer carbonato Winthrop 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 carbonato Winthrop. Your doctor may also consider monitoring the levels
of that medicine in your blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
The potential risk of Sevelamer carbonato Winthrop during human pregnancy is unknown. Talk to your
doctor, who will decide if you can continue treatment with Sevelamer carbonato Winthrop.
It is not known whether Sevelamer carbonato Winthrop is excreted in breast milk and whether it can affect the baby.
Inform your doctor, who will decide whether you can breastfeed the baby and whether it is necessary to discontinue treatment
with Sevelamer carbonato Winthrop.

Driving and using machines
It is unlikely that Sevelamer carbonato Winthrop will affect your ability to drive vehicles or operate machinery.

Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per tablet i.e. essentially “sodium-free”.

3. How to take Sevelamer carbonato Winthrop

You must take this medicine following the instructions of your doctor exactly. The doctor will base the
dose on your blood phosphate level.
The recommended initial dose of this medicine tablets, for adults and the elderly, is one or two
800 mg tablets, 3 times a day, to be taken with main meals. If you are not sure, check with your doctor, pharmacist or
nurse.
Take Sevelamer carbonato Winthrop after a meal or with food.
The tablets must be swallowed whole. Do not crush, chew or break the tablets.
Initially, the doctor will check your blood phosphate levels every 2-4 weeks and may adjust the dose
of Sevelamer carbonato Winthrop, if necessary, to reach the appropriate phosphate level.
Follow the diet prescribed by your doctor.

If you take more Sevelamer carbonato Winthrop than you should
In the event of a possible overdose, contact your doctor immediately.

If you forget to take Sevelamer carbonato Winthrop
If you have forgotten a dose, take the next dose at the usual time, with a meal. Do not take a
double dose to make up for a missed dose.

If you stop taking Sevelamer carbonato Winthrop
Continuing treatment with Sevelamer carbonato Winthrop is important to maintain an appropriate
level of phosphate in your blood. Stopping Sevelamer carbonato Winthrop would lead to important consequences, such as
calcification in the blood vessels. If you are considering stopping treatment with Sevelamer carbonato
Winthrop, contact your doctor or pharmacist first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Constipation is a very common side effect. It can be an early symptom of a bowel obstruction. If you experience constipation, inform your doctor or pharmacist.
Some side effects may be serious. If you experience any of the following side effects, consult your doctor immediately:

• Allergic reaction (signs include rash, hives, swelling, breathing problems). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Bowel obstruction (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency not known.
• Perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency not known.
• Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disorders, or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency not known.

Other side effects have been observed in patients taking Sevelamer carbonato Winthrop:
Very common (may affect more than 1 in 10 people):

• vomiting,
• pain in the upper part of the abdomen,
• nausea.

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

• diarrhoea,
• stomach pain,
• indigestion,
• flatulence.

Not known (frequency cannot be estimated from available data):

• cases of itching,
• rash,
• reduction of intestinal (bowel) motility.

Reporting of side effects
If you get any side effects, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sevelamer carbonato Winthrop

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 bottle and the packaging after “Exp”.
The expiry date refers to the last day of that month.
Keep the container tightly closed to protect the medicine from moisture.
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 the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sevelamer carbonate Winthrop contains

• The active ingredient is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
• The excipients are microcrystalline cellulose, sodium chloride, zinc stearate.

Description of the appearance of Sevelamer carbonate Winthrop and contents of the pack
Sevelamer carbonate Winthrop film-coated tablets are presented as white or almost white oval tablets with RV800 engraved on one side.
The tablets are packaged in high-density polyethylene bottles, equipped with a child-resistant polypropylene cap and an induction seal.
Pack sizes
Each bottle contains 30 or 180 tablets
Packs of 1 bottle of 30 or 180 tablets without outer carton
Not all pack sizes may be marketed

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer:
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
Sanofi Winthrop Industrie
1 rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc cedex
France
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

België/Belgique/Belgien/
Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: + 32 2 710 54 00

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Norge
sanofi-aventis Norge AS
Tlf: + 47 67 10 71 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: + 43 1 80 185 - 0

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Portugal
Sanofi – Produtos Farmacêuticos, Lda..
Tel: +351 21 35 89 400

France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
Call from abroad: +33 1 57 63 23 23

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ireland
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Sanofi Oy
Puh/Tel: + 358 201 200 300

ItaliaSverige
Sanofi S.r.l.
Tel: 800 536 389
Sanofi AB
Tel: +46 (0)8 634 50 00

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Sevelamer carbonato Winthrop 0.8 g powder for oral suspension

sevelamer carbonato

Read this leaflet carefully before you start 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 carbonato Winthrop is and what it is used for
• 2. What you need to know before you take Sevelamer carbonato Winthrop
• 3. How to take Sevelamer carbonato Winthrop
• 4. Possible side effects
• 5. How to store Sevelamer carbonato Winthrop
• 6. Contents of the pack and other information

1. What is Sevelamer carbonato Winthrop and what it is used for

Sevelamer carbonato Winthrop contains the active ingredient sevelamer carbonate which acts at the level
of the digestive system, preventing the absorption of phosphate present in food, and in this way reduces
phosphate levels in the blood.
This medicine 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 (in which fluid is pumped into the abdomen and an internal membrane of the body filters the blood);
• adult patients with chronic kidney disease who are not undergoing dialysis and have a phosphate level 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 by the doctor to calculate the body surface area).

This medicine must be used with other treatments, such as calcium and vitamin D supplements, to
prevent the development of bone diseases. Increased levels of phosphate 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 for blood to circulate throughout the body. In addition, increased phosphate in
the blood can cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before taking Sevelamer carbonato Winthrop

Do not take Sevelamer carbonato Winthrop

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

Warnings and precautions
Talk to your doctor before taking Sevelamer carbonato Winthrop:

• If you have problems with the motility (movement) of your stomach and intestines
• if you have active inflammation of the intestine
• if you have undergone major surgery on your stomach or intestines

Talk to your doctor during therapy with Sevelamer carbonato Winthrop:

• if you experience severe abdominal pain, stomach or intestinal discomfort, or if you find blood in your stool (gastrointestinal bleeding). These symptoms may be due to the deposition of sevelamer crystals in your intestine. Consult your doctor, who will decide whether to continue or discontinue treatment.

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

• experience low or high levels of calcium in your blood. Since this medicine does not contain calcium, your doctor may prescribe calcium supplements,
• have a low level of vitamin D in your blood. Consequently, your doctor may check the levels of vitamin D in your blood and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also experience 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,
• have an altered level of bicarbonate in your blood and increased acidity in your blood and other tissues of the body. Your doctor should monitor the level of bicarbonate in your blood.

Special note for patients undergoing peritoneal dialysis:
You may suffer from peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This
risk can be reduced by adopting strict techniques to maintain sterility when replacing the
bags. Immediately inform your doctor if you experience new signs or symptoms of abdominal discomfort,
abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever,
chills, nausea or vomiting.

Children
Do not give this medicine to children under 6 years of age because the safety and efficacy in children (under
6 years of age) have not been studied.

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

• Sevelamer carbonato Winthrop should not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm problems or for epilepsy, consult your doctor when taking Sevelamer carbonato Winthrop.
• Sevelamer carbonato Winthrop may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some patients, the concomitant use of levothyroxine (medicine used for the treatment of low thyroid hormone levels) and Sevelamer carbonato Winthrop has caused, uncommonly, a deficiency of thyroid hormones. Consequently, your doctor may check your thyroid-stimulating hormone levels in your blood more carefully.
• Medicines such as omeprazole, pantoprazole or lansoprazole, known as “proton pump inhibitors”, used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Sevelamer carbonato Winthrop. Your doctor may consider monitoring phosphate levels in your blood.
• .

The doctor will check at regular intervals for any interactions between Sevelamer carbonato Winthrop and other
medicines.
In some cases where Sevelamer carbonato Winthrop has to 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 carbonato Winthrop.
Your doctor may also consider monitoring the levels of that medicine in your blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
The potential risk of Sevelamer carbonato Winthrop during human pregnancy is unknown. Talk to your
doctor, who will decide whether you can continue treatment with Sevelamer carbonato Winthrop.
It is not known whether Sevelamer carbonato Winthrop is excreted in breast milk and whether it can affect the baby.
Inform your doctor, who will decide whether you can breastfeed your baby and whether it is necessary to stop
treatment with Sevelamer carbonato Winthrop.

Driving and operating machinery
It is unlikely that Sevelamer carbonato Winthrop will impair the ability to drive vehicles or operate machinery.

Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. essentially “sodium-free”.
This medicine contains 8.42 mg of propylene glycol per 0.8 g sachet.

3. How to take Sevelamer carbonato Winthrop

You must take this medicine following your doctor’s instructions exactly. Your doctor will base the
dose on your blood phosphate level.
For a dosage of 0.8 g, the oral suspension powder must be dissolved in 30 ml of water for each
sachet. Drink within 30 minutes of preparation. It is important that you drink all of the liquid, and you may
need to rinse the glass with water and drink again, to make sure you swallow all of the powder.
Instead of water, the powder can be mixed with a small amount of cold drinks (about 120 ml or
half a glass) or food (about 100 g) and consumed within 30 minutes. Do not heat the Sevelamer
carbonato Winthrop powder (e.g. in the microwave) and do not add it to hot foods or liquids.
The recommended initial dose of Sevelamer carbonato Winthrop for adults and the elderly is 2.4-4.8 g/day
divided equally among three meals. Check with your doctor, pharmacist or nurse if you are not sure.
The correct initial dose and regimen will be decided by your doctor.
Take Sevelamer carbonato Winthrop after a meal or with food.

(Instructions for packaging with a measuring spoon)
For doses of 0.4 g, the powder in the sachet can be divided. In this case, the 0.4 g dose of Sevelamer
Carbonato Winthrop powder must be measured using the measuring spoon provided in the box.
Always use the measuring spoon provided in the box.

(Instructions for packaging WITHOUT a measuring spoon)
If you need to administer a 0.4 g dose, use the specific 0.8 g powder pack with a measuring
spoon.

Use in children and adolescents
The recommended initial dose of Sevelamer carbonato Winthrop tablets for children is based on their
height and weight (used by the doctor to calculate the body surface area). For children, it is preferable to use
the powder, as the tablets are not suitable in this population. This medicine should not be
taken on an empty stomach and must be taken with meals or snacks. The correct initial dose and regimen
will be decided by your doctor.
For doses less than 0.8 g, the powder in the sachet can be divided. The 0.4 g dose of Sevelamer carbonato
Winthrop powder must be measured using the measuring spoon provided in the box.

Preparation using a measuring spoon
Use the measuring spoon provided for each 0.4 g dose of Sevelamer carbonato Winthrop powder.
For a 0.4 g dose:
o Shake the sachet holding the top corner before opening, to move the powder to the bottom of the
sachet.
o Open the sachet by cutting along the marked line.
o Make sure the measuring spoon is dry.
o Hold the measuring spoon horizontally and pour the powder from the sachet into the measuring spoon.
o Fill the powder up to the level of the spoon.
o Do not tap the measuring spoon to compact the powder.
o Pour the powder contained in the measuring spoon into 30 ml of water. Shake the suspension and drink within
30 minutes of preparation. It is important that you drink all of the liquid to make sure you swallow all of the
powder.
o Close the sachet by folding it twice.
o The remaining powder can be used within 24 hours for the next dose.
o Discard sachets that have been open for more than 24 hours.
Initially, the doctor will check your blood phosphate levels every 2-4 weeks and may adjust the
dose of Sevelamer carbonato Winthrop, if necessary, to reach the appropriate phosphate level.
Follow the diet prescribed by your doctor.

If you take more Sevelamer carbonato Winthrop than you should
In the event of a possible overdose, contact your doctor immediately.

If you forget to take Sevelamer carbonato Winthrop
If you have forgotten a dose, take the next dose at the usual time, with a meal. Do not take a
double dose to make up for a missed dose.

If you stop taking Sevelamer carbonato Winthrop
Continuing treatment with Sevelamer carbonato Winthrop is important to maintain an appropriate
level of phosphate in the blood. Stopping Sevelamer carbonato Winthrop would lead to important consequences such as
calcification in blood vessels. If you are considering stopping treatment with Sevelamer carbonato
Winthrop, contact your doctor or pharmacist first.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Constipation is a very common side effect. It may be an early symptom of a bowel obstruction. If you experience constipation, inform your doctor or pharmacist.
Some side effects may be serious. If you experience any of the following side effects, consult your doctor immediately:

• Allergic reaction (signs include rash, hives, swelling, breathing problems). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Bowel obstruction (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency not known.
• Perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency not known.
• Severe inflammation of the colon (symptoms include: severe abdominal pain, stomach or intestinal disorders, or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency not known.

Other side effects have been observed in patients taking Sevelamer carbonato Winthrop:
Very common (may affect more than 1 in 10 people):

• vomiting,
• pain in the upper abdomen,
• nausea.

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

• diarrhea,
• stomach pain,
• indigestion,
• flatulence.

Not known (frequency cannot be estimated from available data):

• cases of itching,
• rash,
• reduction of intestinal (bowel) motility.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sevelamer carbonato Winthrop

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 the package after “Exp”.
The expiry date refers to the last day of that month.
The reconstituted suspension must be administered within 30 minutes of reconstitution.
This medicine does not require any special storage conditions.

(Instructions for the pack with a dosing spoon)
Discard the sachet after 24 hours of opening.
Do not dispose of any medicine in the drain 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 carbonato Winthrop contains

• The active ingredient is sevelamer carbonate. Each sachet of Sevelamer carbonato Winthrop contains 0.8 g of sevelamer carbonate.
• The excipients are propylene glycol alginate (E405), cream of citrus flavour, sodium chloride, sucralose and Yellow iron oxide (E172).

Description of the appearance of Sevelamer carbonato Winthrop and contents of the pack
Sevelamer carbonato Winthrop powder for oral suspension is a pale yellow coloured powder, supplied in
an aluminium foil sachet with heat sealing. The sachets are packaged in an outer carton.

(Instructions for the pack with measuring spoon)
A 0.4 g measuring spoon is provided in the carton.
Package sizes
90 sachets per pack

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
ROVI Pharma Industrial Services, S.A.
Vía Complutense, 140, Alcalá de Henares,
Madrid, 28805, Spain
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

België/Belgique/Belgien/
Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: + 32 2 710 54 00

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Norge
sanofi-aventis Norge AS
Tlf: + 47 67 10 71 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: + 43 1 80 185 - 0

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Portugal
Sanofi – Produtos Farmacêuticos, Lda..
Tel: +351 21 35 89 400

France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
Call from abroad: +33 1 57 63 23 23

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ireland
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Sanofi Oy
Puh/Tel: + 358 201 200 300

Italia
Sanofi S.r.l.
Tel: 800 536 389

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency:
http://www.ema.europa.eu.

Sevelamer carbonato Winthrop 2.4 g powder for oral suspension

sevelamer carbonato

Read this leaflet carefully before you start 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 may 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 carbonato Winthrop is and what it is used for
• 2. What you need to know before you take Sevelamer carbonato Winthrop
• 3. How to take Sevelamer carbonato Winthrop
• 4. Possible side effects
• 5. How to store Sevelamer carbonato Winthrop
• 6. Contents of the pack and other information

1. What is Sevelamer carbonato Winthrop and what it is used for

Sevelamer carbonato Winthrop contains the active ingredient sevelamer carbonate which acts at the level
of the digestive system, preventing the absorption of phosphate present in food, and in this way reduces
levels of phosphate in the blood.
This medicine is used to control hyperphosphatemia (high levels of phosphate in the blood) in:

• adult patients undergoing dialysis (a blood purification technique). The medicine can be used in patients undergoing hemodialysis (using a machine for blood filtration) 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 who are not undergoing dialysis and have a phosphate level in the blood equal to or greater than 1.78 mmol/l;
• pediatric patients with chronic kidney disease (long-term) over 6 years of age and above a certain height and weight (used by the doctor to calculate the body surface area).

This medicine must be used with other treatments, such as calcium and vitamin D supplements, to
prevent the development of bone diseases. Increased levels of phosphate 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 phosphate in
the blood can cause skin itching, red eyes, bone pain and fractures.

2. What you need to know before taking Sevelamer carbonato Winthrop

Do not take Sevelamer carbonato Winthrop

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

Warnings and precautions
Talk to your doctor before taking Sevelamer carbonato Winthrop:

• problems with motility (movement) of the stomach and intestines
• active inflammation of the intestine
• you have undergone major surgery on the stomach or intestines.

Talk to your doctor during therapy with Sevelamer carbonato Winthrop:

• if you experience severe abdominal pain, stomach or intestinal discomfort, or if you find blood in your stool (gastrointestinal bleeding). These symptoms may be due to the deposition of sevelamer crystals in your intestine. Contact your doctor who will decide whether to continue or discontinue treatment.

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

• experience low or high levels of calcium in your blood. Because this medicine does not contain calcium, your doctor may prescribe calcium supplements,
• have a low level of vitamin D in your blood. Consequently, your doctor may check the levels of vitamin D in your blood and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also experience 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,
• have an altered level of bicarbonate in your blood and increased acidity in your blood and other tissues of the body. Your doctor should monitor the level of bicarbonate in your blood.

Special note for patients undergoing peritoneal dialysis:
You may suffer from peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This
risk can be reduced by adopting strict techniques to maintain sterility when replacing the
bags. Immediately inform your doctor if you experience new signs or symptoms of abdominal discomfort,
abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever,
chills, nausea or vomiting.

Children
Do not give this medicine to children under 6 years of age because the safety and efficacy in children (under
6 years of age) have not been studied.

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

• Sevelamer carbonato Winthrop should not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm problems or for epilepsy, consult your doctor when taking Sevelamer carbonato Winthrop.
• Sevelamer carbonato Winthrop may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil and tacrolimus (medicines used to suppress the activity of the immune system). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some patients, the concomitant use of levothyroxine (medicine used for the treatment of low thyroid hormone levels) and Sevelamer carbonato Winthrop has caused, uncommonly, a deficiency of thyroid hormones. Consequently, your doctor may more closely monitor the levels of thyroid stimulating hormone in your blood.
• Medicines such as omeprazole, pantoprazole or lansoprazole, known as “proton pump inhibitors”, used to treat heartburn and gastroesophageal reflux, may reduce the effectiveness of Sevelamer carbonato Winthrop. Your doctor may consider monitoring phosphate levels in your blood.

The doctor will check at regular intervals for any interactions between Sevelamer carbonato Winthrop and other
medicines.
In some cases where Sevelamer carbonato Winthrop 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 carbonato Winthrop.
Your doctor may also consider monitoring the levels of that medicine in your blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
The potential risk of Sevelamer carbonato Winthrop during human pregnancy is unknown. Talk to your
doctor who will decide if you can continue treatment with Sevelamer carbonato Winthrop.
It is not known whether Sevelamer carbonato Winthrop is excreted in breast milk and whether it can affect the baby.
Inform your doctor who will decide whether you can breastfeed the baby and whether it is necessary to stop
treatment with Sevelamer carbonato Winthrop.

Driving and using machines
It is unlikely that Sevelamer carbonato Winthrop will impair the ability to drive vehicles or operate machinery.

Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. essentially “sodium-free”.
This medicine contains 25.27 mg of propylene glycol per 2.4 g sachet.

3. How to take Sevelamer carbonato Winthrop

You must take this medicine following your doctor's instructions exactly at all times. Your doctor will base the
dose on your blood phosphate level.
For a dosage of 2.4 g, the oral suspension powder must be dissolved in 60 ml of water for each
sachet. Drink within 30 minutes of preparation. It is important that you drink all of the liquid, and you may
need to rinse the glass with water and drink again, to ensure you ingest all of the powder.
Instead of water, the powder can be mixed with a small amount of cold drinks (about 120 ml or
half a glass) or food (about 100 g) and consumed within 30 minutes. Do not heat the Sevelamer
carbonato Winthrop powder (e.g. in the microwave) and do not add it to hot foods or liquids.
The recommended initial dose of Sevelamer carbonato Winthrop for adults and the elderly is 2.4-4.8 g/day
divided equally among three meals. Check with your doctor, pharmacist or nurse if you are not sure.
The correct initial dose and regimen will be decided by your doctor.
Take Sevelamer carbonato Winthrop after a meal or with food.
If you need to administer a dose of 0.4 g, use the specific 0.8 g powder pack with measuring spoon.

Use in children and adolescents
The recommended initial dose of Sevelamer carbonato Winthrop tablets, for children, is based on their
height and weight (used by the doctor to calculate the body surface area). For children, it is preferable to use
the powder, as the tablets are not suitable in this population. This medicine should not be
taken on an empty stomach and must be taken with meals or snacks. The correct initial dose and regimen
will be decided by your doctor.
Initially, the doctor will check your blood phosphate levels every 2-4 weeks and may adjust the
dose of Sevelamer carbonato Winthrop, if necessary, to reach the appropriate phosphate level.
Follow the diet prescribed by your doctor.

If you take more Sevelamer carbonato Winthrop than you should
In the event of a possible overdose, contact your doctor immediately.

If you forget to take Sevelamer carbonato Winthrop
If you have forgotten a dose, take the next dose at the usual time, with a meal. Do not take a
double dose to make up for a missed dose.

If you stop taking Sevelamer carbonato Winthrop
Continuing treatment with Sevelamer carbonato Winthrop is important to maintain an appropriate
level of phosphate in the blood. Stopping Sevelamer carbonato Winthrop would lead to important consequences such as
calcification in blood vessels. If you are considering stopping treatment with Sevelamer carbonato
Winthrop, contact your doctor or pharmacist first.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Constipation is a very common side effect. It may be an early symptom of a bowel obstruction. If you experience constipation, inform your doctor or pharmacist.
Some side effects could be serious. If you experience any of the following side effects, consult your doctor immediately:

• Allergic reaction (signs include skin rash, hives, swelling, breathing problems). This is a very rare side effect (may affect up to 1 in 10,000 people).
• Bowel obstruction (signs include severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency not known.
• Perforation of the intestinal wall (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain). Frequency not known.
• Severe inflammation of the large intestine (symptoms include: severe abdominal pain, stomach or bowel disorders or blood in the stool [gastrointestinal bleeding]) and deposition of crystals in the intestine. Frequency not known.

Other side effects have been observed in patients taking Sevelamer carbonato Winthrop:
Very common (may affect more than 1 in 10 people):

• vomiting,
• pain in the upper abdomen,
• nausea.

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

• diarrhoea,
• stomach pain,
• indigestion,
• flatulence.

Not known (frequency cannot be estimated from available data):

• cases of itching,
• skin rash,
• reduction of intestinal (bowel) motility.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sevelamer carbonato Winthrop

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 the carton after “Exp”.
The expiry date refers to the last day of that month.
The reconstituted suspension must be administered within 30 minutes of reconstitution.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sevelamer carbonate Winthrop contains

• The active ingredient is sevelamer carbonate. Each sachet of Sevelamer carbonate Winthrop contains 2.4 g of sevelamer carbonate.
• The excipients are propylene glycol alginate (E405), citrus cream flavour, sodium chloride, sucralose and Yellow iron oxide (E172).

Description of the appearance of Sevelamer carbonate Winthrop and contents of the pack
Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow coloured powder, supplied in
a heat-sealed aluminium foil sachet. The sachets are packaged in an outer carton.
Pack sizes
60 sachets per pack
90 sachets per pack
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
ROVI Pharma Industrial Services, S.A.
Vía Complutense, 140, Alcalá de Henares,
Madrid, 28805, Spain
For further information on this medicinal product, contact the local representative of the marketing authorisation
holder:

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

België/Belgique/Belgien/
Luxembourg/Luxemburg
Sanofi Belgium
Tel/Tél: + 32 2 710 54 00

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Magyarország
SANOFI-AVENTIS Zrt
Tel: +36 1 505 0050

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. from abroad: +49 69 305 21 131

Norge
sanofi-aventis Norge AS
Tlf: + 47 67 10 71 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: + 43 1 80 185 - 0

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 1600

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Portugal
Sanofi – Produtos Farmacêuticos, Lda..
Tel: +351 21 35 89 400

France
Sanofi Winthrop Industrie
Tél : 0 800 222 555
Call from abroad: +33 1 57 63 23 23

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ireland
sanofi-aventis Ireland Ltd T/A SANOFI
Tel: +353 (0) 1 4035 600

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Sanofi Oy
Puh/Tel: + 358 201 200 300

ItaliaSverige
Sanofi S.r.l.
Tel: 800 536 389
Sanofi AB
Tel: +46 (0)8 634 50 00

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.