RENAGEL 403 mg Hard Capsules

Зміст інструкції

1. Renagel 400 mg film-coated tablets
   1. What is Renagel and what is it used for
   2. What you need to know before you take Renagel
   3. How to take Renagel
   4. Possible side effects
   5. How to store Renagel
   6. Package contents and other information
2. Renagel 800 mg film-coated tablets
   1. What is Renagel and what is it used for
   2. What you need to know before taking Renagel
   3. How to take Renagel
   4. Possible side effects
   5. HOW TO STORE RENAGEL
   6. Contents of the pack and other information

Renagel 400 mg film-coated tablets

sevelamer hydrochloride

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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Renagel and what is it used for

Renagel contains the active substance sevelamer, which, within the digestive system, binds phosphate
present in food and thereby reduces phosphate levels in the blood.
Renagel is used to control phosphate levels in the blood of adult patients with renal
insufficiency undergoing hemodialysis or peritoneal dialysis.
Adult patients with renal insufficiency undergoing hemodialysis or peritoneal dialysis are unable to control
the level of phosphate in the blood. Subsequently, the amount of phosphate increases (the
doctor will use the term hyperphosphatemia). Increased levels of phosphate in the blood can cause
solid deposits in the body, called calcifications. These deposits can stiffen blood vessels
and make it more difficult to distribute blood throughout the body. Furthermore, increased phosphate in
the blood can cause skin itching, red eyes, bone pain and fractures.
Renagel may be used with other medicines, such as calcium or vitamin D supplements, to
control the development of renal bone disease.

2. What you need to know before you take Renagel

Do not take Renagel:

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

Warnings and precautions
Talk to your doctor before taking Renagel if any of the following situations apply to you:

• if you are not undergoing dialysis
• if you have problems swallowing
• if you have problems with motility (movement) of the stomach and intestines
• if you have symptoms of delayed stomach emptying such as a feeling of fullness, nausea and/or vomiting
• if you have prolonged diarrhoea or suffer from abdominal pain (symptoms of an inflammatory bowel disease)
• if you have undergone major surgery to the stomach and intestines.

Talk to your doctor during therapy with Renagel:

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

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

• experience low or high levels of calcium in your blood. Since Renagel does not contain calcium, your doctor may prescribe calcium supplements.
• experience low levels of vitamin D in your blood. For this reason, your doctor may monitor your vitamin D levels and prescribe additional vitamin D if necessary. If you do not take multivitamin supplements, you may also experience low blood levels of vitamin A, E, K and folic acid, and consequently your doctor may check these levels and prescribe vitamin supplements as needed.

Change of treatment:
When switching from another phosphate binder to Renagel, your doctor may decide to check your bicarbonate levels more
frequently, as Renagel may reduce bicarbonate levels.

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 strictly adhering to aseptic techniques when
replacing the bags. Immediately inform your doctor if you notice new signs or symptoms related to
abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity
of the abdomen, fever, chills, nausea or vomiting. In addition, you will undergo more careful monitoring to
determine the possible occurrence of problems related to low levels of vitamin A, D, E, K and folic acid.

Children and adolescents
Safety and efficacy in children (under 18 years of age) have not been established. Therefore, the use of
Renagel is not recommended in this population.

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

• Renagel 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 Renagel.
• Renagel may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil and tacrolimus (medicines used for transplant patients). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some people taking levothyroxine (a thyroid hormone) and Renagel, a very rare increase in thyroid-stimulating hormone (TSH, a substance in your blood that helps control your body's chemical functions) may be observed. Therefore, your doctor may check your TSH levels in the blood more carefully.
• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease or gastric ulcer, consult your doctor when taking Renagel.

At regular intervals, your doctor will perform checks on possible interactions between Renagel and other
medicines.
In some cases, when Renagel needs 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
Renagel, or consider checking the levels of that medicine in
your blood.

Pregnancy and breastfeeding
The safety of Renagel during pregnancy or breastfeeding has not yet been established. Renagel should not
be administered during pregnancy or breastfeeding unless absolutely necessary.
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.

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

3. How to take Renagel

Take this medicine following the instructions of your doctor exactly. The doctor will establish the
dose based on phosphate levels in the blood. The recommended initial dose of Renagel for adults and
the elderly (over 65 years) is two – four tablets, 3 times a day with main meals.
Initially, the doctor will check phosphate levels in the blood every 2-3 weeks and may adjust the
dose of Renagel as needed (between 1 and 10 tablets of 400 mg with each meal), in order to
achieve the appropriate level of phosphate in the blood.
The tablets must be swallowed whole. Do not crush, chew, or break them into pieces before
swallowing.
Patients taking Renagel must follow the prescribed diet and drink fluids.

If you take more Renagel than you should
In case of possible overdose, contact your doctor immediately.

If you forget to take Renagel
If you have missed 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.

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, it is important to inform your
doctor or pharmacist of these symptoms before or during the use of Renagel.
The following side effects have been reported by patients taking Renagel:
Very common (may affect more than 1 in 10 people):
nausea, vomiting.
Common (may affect up to 1 in 10 people):
diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Uncommon (may affect up to 1 in 100 people):
increase in blood acidity
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, abdominal pain, reduced intestinal (bowel) motility, inflammation of small abnormal pouches (called diverticula) present
in the large intestine, bowel obstruction (signs include severe bloating, abdominal pain,
swelling or cramping, severe constipation), perforation of the intestinal wall (signs include severe pain
in the stomach, chills, fever, nausea, vomiting, or abdominal pain), severe inflammation of the large
intestine (symptoms include: severe abdominal pain, stomach or bowel discomfort, or blood
in the stool (gastrointestinal bleeding) and deposition of crystals in the intestine).

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 Renagel

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 outer packaging after
“Exp”. The expiry date refers to the last day of that month.
Do not store this medicine at a temperature above 25°C. Keep the bottle tightly closed to
protect the medicine from moisture.
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 Renagel contains

• The active ingredient is sevelamer hydrochloride. Each tablet contains 400mg of sevelamer hydrochloride.
• The excipients are anhydrous colloidal silica and stearic acid, hypromellose (E464), acetylated monoglycerides, black iron oxide (E172), and propylene glycol.

Description of the appearance of Renagel and package contents
Renagel tablets are whitish, oval-shaped and film-coated, with the writing Renagel 400
printed on one side.
The tablets are packaged in high-density polyethylene bottles, equipped with a child-resistant
closure in polypropylene and a tamper-evident seal.
The following pack sizes are available:
1 bottle containing 360 tablets
multipack containing 720 tablets (2 bottles of 360 tablets)
multipack containing 1080 tablets (3 bottles of 360 tablets)
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France
Manufacturer:
Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

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

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

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+49 (0)180 2 222010
Tel. aus dem Ausland: +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
Appel depuis l’étranger : +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 medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu

Renagel 800 mg film-coated tablets

sevelamer hydrochloride

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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Renagel and what is it used for

Renagel contains the active substance sevelamer, which, within the digestive system, binds phosphate
present in food and thereby reduces phosphate levels in the blood.
Renagel is used to control phosphate levels in the blood of adult patients with renal
insufficiency undergoing hemodialysis or peritoneal dialysis.
Adult patients with renal insufficiency undergoing hemodialysis or peritoneal dialysis are unable to control
the level of phosphate in the blood. Subsequently, the amount of phosphate increases (the
doctor will use the term hyperphosphatemia). Elevated levels of phosphate in the blood can cause
solid deposits in the body, called calcifications. These deposits can stiffen 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.
Renagel may be used with other medicines, such as calcium or vitamin D supplements, to
control the development of renal osteodystrophy.

2. What you need to know before taking Renagel

Do not take Renagel:

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

Warnings and precautions
Talk to your doctor before taking Renagel if any of the following situations apply to you:

• if you are not undergoing dialysis
• if you have problems with swallowing
• if you have problems with motility (movement) of the stomach and intestines
• if you have symptoms of delayed stomach emptying such as a feeling of fullness, nausea and/or vomiting
• if you have prolonged diarrhoea or suffer from abdominal pain (symptoms of inflammatory bowel disease)
• if you have undergone major surgery on the stomach and intestines.
• .

Talk to your doctor during therapy with Renagel:

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

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

• experience low or high levels of calcium in your blood. Since Renagel does not contain calcium, your doctor may prescribe calcium supplements.
• experience low levels of vitamin D in your blood. For this reason, your doctor may monitor your vitamin D levels and prescribe additional vitamin D if necessary. If you do not take multivitamin supplements, you may also experience low blood levels of vitamin A, E, K and folic acid and, as a result, your doctor may check these levels and prescribe vitamin supplements as needed.

Change of treatment:
When switching from another phosphate binder to Renagel, your doctor may decide to check your blood bicarbonate levels more
frequently, as Renagel may reduce bicarbonate levels.

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 strictly adhering to aseptic techniques when
replacing the bags. Immediately inform your doctor if you notice new signs or symptoms related to
abdominal disorders, abdominal swelling, abdominal pain, abdominal tenderness or rigidity
of the abdomen, fever, chills, nausea or vomiting. In addition, you will undergo more careful monitoring to
determine the possible occurrence of problems related to low levels of vitamin A, D, E, K and folic acid.

Children and adolescents
Safety and efficacy in children (under 18 years of age) have not been established. Therefore, the use of
Renagel is not recommended in this population.

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

• Renagel 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 Renagel.
• Renagel may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil and tacrolimus (medicines used for transplant patients). If you are taking these medicines, your doctor will advise you on how to proceed.
• In some people taking levothyroxine (a thyroid hormone) and Renagel, a very rare increase in thyroid stimulating hormone (TSH, a substance in your blood that helps control your body's chemical functions) may be observed. Therefore, your doctor may check your TSH levels in the blood more carefully.
• If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease or gastric ulcer, consult your doctor when taking Renagel.

At regular intervals, your doctor will check for possible interactions between Renagel and other
medicines.
In some cases, when Renagel needs 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
Renagel, or consider checking the levels of that medicine in
your blood.

Pregnancy and breastfeeding
The safety of Renagel during pregnancy or breastfeeding has not yet been established. Renagel should not
be administered during pregnancy or breastfeeding unless absolutely necessary.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.

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

3. How to take Renagel

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor. The doctor will establish the dose based on phosphate levels in the blood. The initial dose of Renagel
recommended for adults and the elderly (over 65 years of age) is one or two tablets, 3 times a
day with main meals.
Initially the doctor will check phosphate levels in the blood every 2-3 weeks and may adjust the
dose of Renagel as needed (between 1 and 5 tablets of 800 mg with each meal), in order to
achieve the adequate level of phosphate in the blood.
The tablets must be swallowed whole. Do not crush, chew or break into pieces before
swallowing.
Patients taking Renagel must follow the prescribed diet and take fluids.

If you take more Renagel than you should
In case of possible overdose, contact your doctor immediately.

If you forget to take Renagel
If you have missed 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since in very rare cases constipation can be a precursor symptom of intestinal obstruction, it is
important to inform your doctor or pharmacist of this symptom before or during the use of Renagel.
The following side effects have been reported by patients taking Renagel:
Very common (may affect more than 1 in 10 people):
nausea, vomiting.
Common (may affect up to 1 in 10 people):
diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Uncommon (may affect up to 1 in 100 people):
increase in blood acidity.
Very rare (may affect up to 1 in 10,000 people):
Hypersensitivity
Not known (frequency cannot be estimated from available data):
cases of itching, rash, abdominal pain, reduced intestinal (bowel) motility, inflammation of small abnormal pouches (called diverticula) present
in the colon, intestinal blockage (signs include severe bloating, abdominal pain,
swelling or cramps, severe constipation), rupture of the intestinal wall (signs include severe pain
in the stomach, chills, fever, nausea, vomiting, or abdominal pain), severe inflammation of the colon
(symptoms include: severe abdominal pain, stomach or bowel discomfort, or blood
in the stool (gastrointestinal bleeding) and crystal deposits in the intestine).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system reported in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE RENAGEL

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 outer packaging after
“Exp”. The expiry date refers to the last day of that month.
Do not store this medicine at a temperature above 25°C. Keep the bottle tightly closed to
protect the medicine from humidity.
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. Contents of the pack and other information

What Renagel contains

• The active ingredient is sevelamer hydrochloride. Each tablet contains 800 mg of sevelamer hydrochloride
• The excipients are colloidal anhydrous silica and stearic acid, hypromellose (E464), acetylated monoglycerides.

Description of the appearance of Renagel and contents of the pack
Renagel tablets are whitish, oval and film-coated, with the inscription RG800 imprinted on
one side.
The tablets are packaged in high-density polyethylene bottles, equipped with a
child-resistant closure in polypropylene and a tamper-evident seal.
The following packs are available:
1 bottle of 100 tablets
1 bottle of 180 tablets
multipack containing 180 tablets (6 bottles of 30 tablets)
multipack containing 360 tablets (2 bottles of 180 tablets)
multipack containing 540 tablets (3 bottles of 180 tablets)
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
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.

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

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

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+49 (0)180 2 222010
Tel. aus dem Ausland: +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

ΕλλάδαPolska
Sanofi-Aventis Μονοπρόσωπη AEBE
ηλ: +30 210 900 1600
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
Appel depuis l’étranger : +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 medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu