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Riprazo (aliskiren) – Package leaflet - C09XA02

Updated on site: 09-Oct-2017

Medication nameRiprazo
ATC CodeC09XA02
Substancealiskiren
ManufacturerNovartis Europharm Ltd.

Package leaflet: information for the user

Riprazo 150 mg film-coated tablets

Aliskiren

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

 

 

-

Keep this leaflet. You may need to read it again.

 

 

-

If you have any further questions, ask your doctor or pharmacist.

 

-

This medicine has been prescribed for you only. Do not pass it on to others. It may harm th m,

 

even if their signs of illness are the same as yours.

 

-

If you get any side effects, talk to your doctor or pharmacist. This includes any possible de

 

effects not listed in this leaflet.

 

authorised

What is in this leaflet

 

1.

What Riprazo is and what it is used for

 

2.

What you need to know before you take Riprazo

 

3.

How to take Riprazo

longer

4.

Possible side effects

5.

How to store Riprazo

 

6.

Contents of the pack and other information

 

1.

What Riprazo is and what it is used for

 

 

 

 

Riprazo tablets contain an active substance called aliskiren. Aliskiren belongs to a class of medicines

called renin inhibitors. Riprazo helps to lower high blood pressure in adult patients. Renin inhibitors

reduce the amount of angiotensin II the body cannoproduce. Angiotensin II causes blood vessels to

tighten, which increases the blood pressure. Reducing the amount of angiotensin II allows the blood

vessels to relax, which lowers blood pressure.

 

 

High blood pressure increases the workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels f the brain, heart and kidneys, and may result in a stroke, heart

failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk

of developing these disorders.

 

product

2.

What you eed to know before you take Riprazo

Do not take Riprazo

-f you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

-if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue):

-angioedema when taking aliskiren.

-hereditary angioedema.

-angioedema without any known cause.

-during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and breastfeeding.

-if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or

for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).Medicinal

-if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure:

-an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

or

-an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

Warnings and precautions

Talk to your doctor before taking Riprazo:

-

if you are taking a diuretic (a type of medicine also known as “water” tablets which increases

-

if you have serious congestive heart failure (a type of heart disease whereauthorisedthe heart cannot

 

the amount of urine you produce).

-

if you are taking either of the following classes of medicines used to treat high blood pressur :

 

-

an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

 

or

 

 

-

an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

-

if you have impaired kidney function, your doctor will carefully consider whether Riprazo is

 

suitable for you and may wish to monitor you carefully.

-

if you have already experienced angioedema (difficulties in breathing or swallowing, or

 

swelling of the face, hands and feet, eyes, lips and/or tongue). If this happens, stop taking

 

Riprazo and contact your doctor.

-

if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys).

Children and adolescents

The use of Riprazo in children and adolescents up to 18 years f age is not recommended.

Elderly

In the majority of patients aged 65 years or older, the 300 mg dose of Riprazo shows no additional

pump enough blood around the body).longer

benefit in reducing blood pressure compared to the 150 mg dose.

product

no

Other medicines and Riprazo

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

Do not take Riprazo if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditi ns, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).

Your doctor may need to change your dose and/or to take other precautions if you are taking one of the following medicines:

-medici es th t increase the amount of potassium in your blood. These include potassium-

spar g diuretics, potassium supplements.

-furosemide, a medicine belonging to the type known as diuretics, or “water” tablets, which is used to increase the amount of urine you produce.

-one of the following classes of medicines used to treat high blood pressure:

-an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

or

-an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

-ketoconazole, a medicine used to treat fungal infections.

-verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat angina pectoris.

-certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).Medicinal

Riprazo with food and drink

You should take this medicine with a light meal once a day, preferably at the same time each day. You should not take this medicine together with grapefruit juice.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or breast-feeding (see section Do not take Riprazo). If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor.

Driving and using machines

This medicine may make you feel dizzy and this can affect your ability to concentrate. Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of this medicine.

authorised

3.How to take Riprazo

Always take this medicine exactly as your doctor has told you. Check with yo r doctor or pharmacist if you are not sure.

within two weeks after beginning treatment.

longer

People who have high blood pressure often do not notice any signs of the problem. Many may feel

quite normal. It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep your appoi tments with the doctor even if you are feeling well.

The usual starting dose is one 150 mg tablet once dai y. The blood pressure lowering effect is present

Depending on how you respond to the treatme not your doctor may prescribe a higher dose of one 300 mg tablet once daily.productYour doctor may prescribe Riprazo together with other medicines used to treat high blood pressure.

Method of administration

It is recommended that you take the tablets with some water. You should take this medicine with a light meal once a day, p efe ably at the same time each day. You should not take this medicine together with grapefruit juice.

MedicinalIf you take more Riprazo than you should

If you have accident lly taken too many Riprazo tablets, consult a doctor immediately. You may require medic l ttention.

If you forget to take Riprazo

If you forget to take a dose of Riprazo, take it as soon as you remember and then take the next dose at its usual time. However, if it is almost time for your next dose you should simply take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Some side effects can be serious:

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). If any of the following occur, tell your doctor straight away:

Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, dizziness.

Possible side effects:

Common (may affect up to 1 in 10 people): Diarrhoea, joint pain (arthralgia), high level of pota ium in the blood, dizziness.

Uncommon (may affect up to 1 in 100 people): Skin rash (this may also be a sign of allergic eactions or angioedema – see “Rare” side effects below), kidney problems including acute renal failure (severely decreased urine output), swelling of hands, ankles or feet (peripheral oedema), severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blis ering of the lips,

If any of these affect you severely, tell your doctor. Y u may eed to stop Riprazo.

eyes or mouth, skin peeling, fever), low blood pressure, palpitations, cough, itching, itchy rash

(urticaria), increased liver enzymes.

 

Rare (may affect up to 1 in 1,000 people): Severe allergic reaction (anaphyl ctic reaction), allergic

reactions (hypersensitivity) and angioedema (the symptoms of which can includeauthoriseddifficulties in

breathing or swallowing, rash, itching, hives or swelling of the fac , hands and feet, eyes, lips and/or

tongue, dizziness), increased level of creatinine in the blood, red skin ( rythema).

not listed in this leaflet.

longer

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

product

no

5. How to store Riprazo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day f that month.

Do not store above 30°C.

Store in the original ackage in order to protect from moisture.

Medicinal

6.

Contents of the pack and other information

What R prazo contains

-

The a tive substance is aliskiren (as hemifumarate) 150 mg.

-

The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,

 

microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),

 

black iron oxide (E 172), red iron oxide (E 172).

What Riprazo looks like and contents of the pack

Riprazo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.

Riprazo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. Packs containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets are multi-packs. Not all pack sizes may be available in your country.

Italy

 

authorised

Marketing Authorisation Holder

 

Novartis Europharm Limited

 

Wimblehurst Road

 

 

Horsham

 

 

West Sussex, RH12 5AB

 

United Kingdom

 

 

Manufacturer

 

 

Novartis Farma S.p.A.

 

 

Via Provinciale Schito 131

 

I-80058 Torre Annunziata/NA

Tél/Tel:longer+49 911 273 0

Tél/Tel: +32 2 246 16 11

For any information about this medicine, please contact the local r pr s ntative of the Marketing

Authorisation Holder:

 

 

België/Belgique/Belgien

Luxemb urg/Luxemburg

Novartis Pharma N.V.

 

Novartis Pharma GmbH

България

product

Magyarország

 

noNovartis Hungária Kft. Pharma

Novartis Pharma Services Inc.

Тел.: +359 2 489 98 28

Tel.: +36 1 457 65 00

Česká republika

 

Malta

Novartis s.r.o.

 

Novartis Pharma Services Inc.

Tel: +420 225 775 111

 

Tel: +356 2122 2872

Danmark

 

Nederland

Medicinal

 

 

Novartis Healthcare A/S

Novartis Pharma B.V.

Tlf: +45 39 16 84 00

 

Tel: +31 26 37 82 111

Deutschla d

 

Norge

Novart s Pharma GmbH

Novartis Norge AS

Tel: +49 911 273 0

 

Tlf: +47 23 05 20 00

E sti

 

Österreich

Novartis Pharma Services Inc.

Novartis Pharma GmbH

Tel: +372 66 30 810

 

Tel: +43 1 86 6570

Ελλάδα

 

Polska

Novartis (Hellas) A.E.B.E.

Novartis Poland Sp. z o.o.

Τηλ: +30 210 281 17 12

Tel.: +48 22 375 4888

España

 

Portugal

 

Laboratorios Dr. Esteve, S.A.

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +34 93 446 60 00

 

Tel: +351 21 000 8600

 

France

 

România

 

Novartis Pharma S.A.S.

Novartis Pharma Services Romania SRL

Tél: +33 1 55 47 66 00

 

Tel: +40 21 31299 01

authorised

Ireland

 

Slovenija

 

 

Novartis Ireland Limited

Novartis Pharma Services Inc.

Tel: +353 1 260 12 55

 

Tel: +386 1 300 75 50

 

Ísland

 

Slovenská republika

 

Vistor hf.

 

Novartis Slovakia s.r.o.

 

Sími: +354 535 7000

 

Tel: +421 2 5542 5439

 

Italia

 

Suomi/Finland

 

Novartis Farma S.p.A.

 

Novartis Finland Oy

 

Tel: +39 02 96 54 1

 

Puh/Tel: +358 (0)10 6133 200

Tel: +371 67 887 070

 

Tel:longer+44 1276 698370

 

Κύπρος

 

Sverige

 

Novartis Pharma Services Inc.

Novartis Sveri AB

 

Τηλ: +357 22 690 690

 

Tel: +46 8 732 32 00

 

Latvija

 

United Kingdom

 

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Lietuva

product

no

 

 

 

Novartis Pharma Services Inc.

 

Tel: +370 5 269 16 50

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: Medicinalhttp://www.ema.europa.eu

Package leaflet: information for the user

Riprazo 300 mg film-coated tablets

Aliskiren

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

 

 

-

Keep this leaflet. You may need to read it again.

 

 

-

If you have any further questions, ask your doctor or pharmacist.

 

-

This medicine has been prescribed for you only. Do not pass it on to others. It may harm th m,

 

even if their signs of illness are the same as yours.

 

-

If you get any side effects, talk to your doctor or pharmacist. This includes any possible de

 

effects not listed in this leaflet.

 

authorised

What is in this leaflet

 

1.

What Riprazo is and what it is used for

 

2.

What you need to know before you take Riprazo

 

3.

How to take Riprazo

longer

4.

Possible side effects

5.

How to store Riprazo

 

6.

Contents of the pack and other information

 

1.

What Riprazo is and what it is used for

 

 

 

 

Riprazo tablets contain an active substance called aliskiren. Aliskiren belongs to a class of medicines

called renin inhibitors. Riprazo helps to lower high blood pressure in adult patients. Renin inhibitors

reduce the amount of angiotensin II the body cannoproduce. Angiotensin II causes blood vessels to

tighten, which increases the blood pressure. Reducing the amount of angiotensin II allows the blood

vessels to relax, which lowers blood pressure.

 

 

High blood pressure increases the workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels f the brain, heart and kidneys, and may result in a stroke, heart

failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk

of developing these disorders.

 

product

2.

What you eed to know before you take Riprazo

Do not take Riprazo

-f you are allergic to aliskiren or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

-if you have experienced the following forms of angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue):

-angioedema when taking aliskiren.

-hereditary angioedema.

-angioedema without any known cause.

-during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and breastfeeding.

-if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or

for other conditions, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).Medicinal

-if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure:

-an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

or

-an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

Warnings and precautions

Talk to your doctor before taking Riprazo:

-

if you are taking a diuretic (a type of medicine also known as “water” tablets which increases

-

if you have serious congestive heart failure (a type of heart disease whereauthorisedthe heart cannot

 

the amount of urine you produce).

-

if you are taking either of the following classes of medicines used to treat high blood pressur :

 

-

an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

 

or

 

 

-

an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

-

if you have impaired kidney function, your doctor will carefully consider whether Riprazo is

 

suitable for you and may wish to monitor you carefully.

-

if you have already experienced angioedema (difficulties in breathing or swallowing, or

 

swelling of the face, hands and feet, eyes, lips and/or tongue). If this happens, stop taking

 

Riprazo and contact your doctor.

-

if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys).

Children and adolescents

The use of Riprazo in children and adolescents up to 18 years f age is not recommended.

Elderly

In the majority of patients aged 65 years or older, the 300 mg dose of Riprazo shows no additional

pump enough blood around the body).longer

benefit in reducing blood pressure compared to the 150 mg dose.

product

no

Other medicines and Riprazo

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

Do not take Riprazo if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditi ns, e.g. rheumathoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).

Your doctor may need to change your dose and/or to take other precautions if you are taking one of the following medicines:

-medici es th t increase the amount of potassium in your blood. These include potassium-

spar g diuretics, potassium supplements.

-furosemide, a medicine belonging to the type known as diuretics, or “water” tablets, which is used to increase the amount of urine you produce.

-one of the following classes of medicines used to treat high blood pressure:

-an “angiotensin converting enzyme inhibitor” such as enalapril, lisinopril, ramipril etc.

or

-an “angiotensin II receptor blocker” such as valsartan, telmisartan, irbesartan etc.

-ketoconazole, a medicine used to treat fungal infections.

-verapamil, a medicine used to lower high blood pressure, to correct heart rhythm or to treat angina pectoris.

-certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).Medicinal

Riprazo with food and drink

You should take this medicine with a light meal once a day, preferably at the same time each day. You should not take this medicine together with grapefruit juice.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or breast-feeding (see section Do not take Riprazo). If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor.

Driving and using machines

This medicine may make you feel dizzy and this can affect your ability to concentrate. Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of this medicine.

authorised

3.How to take Riprazo

Always take this medicine exactly as your doctor has told you. Check with yo r doctor or pharmacist if you are not sure.

within two weeks after beginning treatment.

longer

People who have high blood pressure often do not notice any signs of the problem. Many may feel

quite normal. It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep your appoi tments with the doctor even if you are feeling well.

The usual starting dose is one 150 mg tablet once dai y. The blood pressure lowering effect is present

Depending on how you respond to the treatme not your doctor may prescribe a higher dose of one 300 mg tablet once daily.productYour doctor may prescribe Riprazo together with other medicines used to treat high blood pressure.

Method of administration

It is recommended that you take the tablets with some water. You should take this medicine with a light meal once a day, p efe ably at the same time each day. You should not take this medicine together with grapefruit juice.

MedicinalIf you take more Riprazo than you should

If you have accident lly taken too many Riprazo tablets, consult a doctor immediately. You may require medic l ttention.

If you forget to take Riprazo

If you forget to take a dose of Riprazo, take it as soon as you remember and then take the next dose at its usual time. However, if it is almost time for your next dose you should simply take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Some side effects can be serious:

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). If any of the following occur, tell your doctor straight away:

Severe allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, dizziness.

Possible side effects:

Common (may affect up to 1 in 10 people): Diarrhoea, joint pain (arthralgia), high level of pota ium in the blood, dizziness.

Uncommon (may affect up to 1 in 100 people): Skin rash (this may also be a sign of allergic eactions or angioedema – see “Rare” side effects below), kidney problems including acute renal failure (severely decreased urine output), swelling of hands, ankles or feet (peripheral oedema), severe skin reactions (toxic epidermal necrolysis and/or oral mucosal reactions - red skin, blis ering of the lips,

If any of these affect you severely, tell your doctor. Y u may eed to stop Riprazo.

eyes or mouth, skin peeling, fever), low blood pressure, palpitations, cough, itching, itchy rash

(urticaria), increased liver enzymes.

 

Rare (may affect up to 1 in 1,000 people): Severe allergic reaction (anaphyl ctic reaction), allergic

reactions (hypersensitivity) and angioedema (the symptoms of which can includeauthoriseddifficulties in

breathing or swallowing, rash, itching, hives or swelling of the fac , hands and feet, eyes, lips and/or

tongue, dizziness), increased level of creatinine in the blood, red skin ( rythema).

not listed in this leaflet.

longer

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

product

no

5. How to store Riprazo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day f that month.

Do not store above 30°C.

Store in the original ackage in order to protect from moisture.

Medicinal

6.

Contents of the pack and other information

What R prazo contains

-

The a tive substance is aliskiren (as hemifumarate) 300 mg.

-

The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,

 

microcrystalline cellulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),

 

black iron oxide (E 172), red iron oxide (E 172).

What Riprazo looks like and contents of the pack

Riprazo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.

Riprazo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs. Not all pack sizes may be available in your country.

Italy

 

authorised

Marketing Authorisation Holder

 

Novartis Europharm Limited

 

Wimblehurst Road

 

 

Horsham

 

 

West Sussex, RH12 5AB

 

United Kingdom

 

 

Manufacturer

 

 

Novartis Farma S.p.A.

 

 

Via Provinciale Schito 131

 

I-80058 Torre Annunziata/NA

Tél/Tel:longer+49 911 273 0

Tél/Tel: +32 2 246 16 11

For any information about this medicine, please contact the local r pr s ntative of the Marketing

Authorisation Holder:

 

 

België/Belgique/Belgien

Luxemb urg/Luxemburg

Novartis Pharma N.V.

 

Novartis Pharma GmbH

България

product

Magyarország

 

noNovartis Hungária Kft. Pharma

Novartis Pharma Services Inc.

Тел.: +359 2 489 98 28

Tel.: +36 1 457 65 00

Česká republika

 

Malta

Novartis s.r.o.

 

Novartis Pharma Services Inc.

Tel: +420 225 775 111

 

Tel: +356 2122 2872

Danmark

 

Nederland

Medicinal

 

 

Novartis Healthcare A/S

Novartis Pharma B.V.

Tlf: +45 39 16 84 00

 

Tel: +31 26 37 82 111

Deutschla d

 

Norge

Novart s Pharma GmbH

Novartis Norge AS

Tel: +49 911 273 0

 

Tlf: +47 23 05 20 00

E sti

 

Österreich

Novartis Pharma Services Inc.

Novartis Pharma GmbH

Tel: +372 66 30 810

 

Tel: +43 1 86 6570

Ελλάδα

 

Polska

Novartis (Hellas) A.E.B.E.

Novartis Poland Sp. z o.o.

Τηλ: +30 210 281 17 12

Tel.: +48 22 375 4888

España

 

Portugal

 

Laboratorios Dr. Esteve, S.A.

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +34 93 446 60 00

 

Tel: +351 21 000 8600

 

France

 

România

 

Novartis Pharma S.A.S.

Novartis Pharma Services Romania SRL

Tél: +33 1 55 47 66 00

 

Tel: +40 21 31299 01

authorised

Ireland

 

Slovenija

 

 

Novartis Ireland Limited

Novartis Pharma Services Inc.

Tel: +353 1 260 12 55

 

Tel: +386 1 300 75 50

 

Ísland

 

Slovenská republika

 

Vistor hf.

 

Novartis Slovakia s.r.o.

 

Sími: +354 535 7000

 

Tel: +421 2 5542 5439

 

Italia

 

Suomi/Finland

 

Novartis Farma S.p.A.

 

Novartis Finland Oy

 

Tel: +39 02 96 54 1

 

Puh/Tel: +358 (0)10 6133 200

Tel: +371 67 887 070

 

Tel:longer+44 1276 698370

 

Κύπρος

 

Sverige

 

Novartis Pharma Services Inc.

Novartis Sveri AB

 

Τηλ: +357 22 690 690

 

Tel: +46 8 732 32 00

 

Latvija

 

United Kingdom

 

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Lietuva

product

no

 

 

 

Novartis Pharma Services Inc.

 

Tel: +370 5 269 16 50

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: Medicinalhttp://www.ema.europa.eu

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