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Dafiro HCT (amlodipine besylate / valsartan / hydrochlorothiazide) – Package leaflet - C09DX01

Updated on site: 06-Oct-2017

Medication nameDafiro HCT
ATC CodeC09DX01
Substanceamlodipine besylate / valsartan / hydrochlorothiazide
ManufacturerNovartis Europharm Limited

Package leaflet: Information for the user

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

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 them, 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 side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Dafiro HCT is and what it is used for

2.What you need to know before you take Dafiro HCT

3.How to take Dafiro HCT

4.Possible side effects

5.How to store Dafiro HCT

6.Contents of the pack and other information

1.What Dafiro HCT is and what it is used for

Dafiro HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help to control high blood pressure.

Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall, which stops the blood vessels from tightening.

Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.

Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II.

Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”.

Hydrochlorothiazide increases urine output, which also lowers blood pressure.

As a result of all three mechanisms, the blood vessels relax and blood pressure is lowered.

Dafiro HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.

2. What you need to know before you take Dafiro HCT

Do not take Dafiro HCT

if you are more than 3 months pregnant. (It is also recommended to avoid Dafiro HCT in early pregnancy – see Pregnancy section.)

if you are allergic to amlodipine or to any other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, do not take Dafiro HCT and talk to your doctor.

if you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the build up of bile in the liver (cholestasis).

if you have severe kidney problems or if you are having dialysis.

if you are unable to produce urine (anuria).

if the level of potassium or sodium in your blood is too low despite treatment to increase the potassium or sodium levels in your blood.

if the level of calcium in your blood is too high despite treatment to reduce the calcium levels in your blood.

if you have gout (uric acid crystals in the joints).

if you have severe low blood pressure (hypotension).

if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).

if you suffer from heart failure after a heart attack.

if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, do not take Dafiro HCT and talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dafiro HCT

if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).

if you have a low level of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions).

if you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).

if you have kidney problems, have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.

if you have liver problems.

if you have or have had heart failure or coronary artery disease, particularly if you are prescribed the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg).

if you have experienced a heart attack. Follow your doctor’s instructions for the starting dose carefully. Your doctor may also check your kidney function.

if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “obstructive hypertrophic cardiomyopathy”).

if you suffer from aldosteronism. This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Dafiro HCT is not recommended.

if you suffer from a disease called systemic lupus erythematosus (also called “lupus” or “SLE”).

if you have diabetes (high level of sugar in your blood).

if you have high levels of cholesterol or triglycerides in your blood.

if you experience skin reactions such as rash after sun exposure.

if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water tablets”), especially if you suffer from asthma and allergies

if you have been sick (vomiting or diarrhoea).

if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors). If you get these symptoms, stop taking Dafiro HCT and contact your doctor straight away. You should never take Dafiro HCT again.

if you experience dizziness and/or fainting during treatment with Dafiro HCT, tell your doctor as soon as possible.

if you experience a decrease in vision or eye pain. These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Dafiro HCT. This can lead to permanent vision impairment, if not treated.

if you are taking any of the following medicines used to treat high blood pressure:

an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Dafiro HCT”.

If any of these apply to you, talk to your doctor.

Children and adolescents

The use of Dafiro HCT in children and adolescents under 18 years of age is not recommended.

Elderly people (age 65 years and older)

Dafiro HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide. Elderly patients, particularly those taking the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.

Other medicines and Dafiro HCT

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change your dose and/or to take other precautions. In some cases you may have to stop using one of the medicines. This is especially important if you are using any of the medicines listed below:

Do not take together with:

lithium (a medicine used to treat some types of depression);

medicines or substances that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin;

ACE inhibitors or aliskiren –(see also information under the headings “Do not take Dafiro HCT” and “Warnings and precautions”) .

Caution should be used with:

alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures);

amantadine (anti-Parkinson therapy, also used to treat or prevent certain illnesses caused by viruses);

anticholinergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia);

anticonvulsant medicines and mood-stabilising medicines used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);

cholestyramine, colestipol or other resins (substances used mainly to treat high levels of lipids in the blood);

simvastatin (a medicine used to control high cholesterol levels);

ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis);

cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;

digoxin or other digitalis glycosides (medicines used to treat heart problems);

verapamil, diltiazem (heart medicines);

iodine contrast media (agents used for imaging examinations);

medicines for the treatment of diabetes (oral agents such as metformin or insulins);

medicines for the treatment of gout, such as allopurinol;

medicines that may increase blood sugar levels (beta blockers, diazoxide);

medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;

medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics;

medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, amphotericin or penicillin G;

medicines to increase blood pressure such as adrenaline or noradrenaline;

medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);

medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);

medicines used for oesophageal ulceration and inflammation (carbenoxolone);

medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors);

muscle relaxants (medicines to relax the muscles which are used during operations);

nitroglycerin and other nitrates, or other substances called “vasodilators”;

other medicines to treat high blood pressure, including methyldopa;

rifampicin (used, for example, to treat tuberculosis);

St. John’s wort;

dantrolene (infusion for severe body temperature abnormalities);

vitamin D and calcium salts.

Dafiro HCT with food, drink and alcohol

Grapefruit and grapefruit juice should not be consumed by people who are prescribed Dafiro HCT. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Dafiro HCT. Talk to your doctor before drinking alcohol. Alcohol may make your blood pressure fall too much and/or increase the possibility of dizziness or fainting.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Dafiro HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Dafiro HCT. Dafiro HCT is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Dafiro HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine may make you feel dizzy, drowsy, nauseous or have a headache. If you experience these symptoms, do not drive or use tools or machines.

3.How to take Dafiro HCT

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This will help you get the best results and lower the risk of side effects.

The usual dose of Dafiro HCT is one tablet per day.

It is best to take the tablet at the same time each day. Morning is the best time.

Swallow the tablet whole with a glass of water.

You can take Dafiro HCT with or without food. Do not take Dafiro HCT with grapefruit or grapefruit juice.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

If you take more Dafiro HCT than you should

If you have accidentally taken too many Dafiro HCT tablets, talk to a doctor immediately.You may require medical attention.

If you forget to take Dafiro HCT

If you forget to take a dose of this medicine, take it as soon as you remember and then take the next dose at its usual time. 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 (two tablets at once) to make up for a forgotten tablet.

If you stop taking Dafiro HCT

Stopping your treatment with Dafiro HCT may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.

Always take this medicine, even if you are feeling well

People who have high blood pressure often do not notice any signs of the problem. Many feel 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 appointments with the doctor even if you are feeling well.

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.

As for any combination containing three active substances, side effects associated with each individual component cannot be excluded. The side effects reported with Dafiro HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur with the use of Dafiro HCT.

Some side effects can be serious and need immediate medical attention.

Consult a doctor immediately if you experience any of the following serious side effects after taking this medicine:

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

dizziness

low blood pressure (feeling of faintness, light-headedness, sudden loss of consciousness)

Uncommon (may affect up to 1 in 100 people):

severely decreased urine output (decreased kidney function)

Rare (may affect up to 1 in 1,000 people):

spontaneous bleeding

irregular heart beat

liver disorder

Very rare (may affect up to 1 in 10,000 people):

sudden wheeziness, chest pain, shortness of breath or difficulty breathing

swelling of eyelids, face or lips

swelling of the tongue and throat which causes great difficulty breathing

severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions

heart attack

inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell

weakness, bruising, fever and frequent infections

stiffness

Other side effects may include:

Very common (may affect more than 1 in 10 people):

low level of potassium in the blood

increase of lipids in the blood

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

sleepiness

palpitations (awareness of your heart beat)

flushing

ankle swelling (oedema)

abdominal pain

stomach discomfort after meal

tiredness

headache

frequent urination

high level of uric acid in the blood

low level of magnesium in the blood

low level of sodium in the blood

dizziness, fainting on standing up

reduced appetite

nausea and vomiting

itchy rash and other types of rash

inability to achieve or maintain erection

Uncommon (may affect up to 1 in 100 people):

fast heart beat

spinning sensation

vision disorder

stomach discomfort

chest pain

increase of urea nitrogen, creatinine and uric acid in the blood

high level of calcium, fat or sodium in the blood

decrease of potassium in the blood

breath odour

diarrhoea

dry mouth

weight increase

loss of appetite

disturbed sense of taste

back pain

joint swelling

muscle cramps/weakness/pain

pain in extremity

inability to either stand or walk in a normal manner

weakness

abnormal coordination

dizziness on standing up or after exercising

lack of energy

sleep disturbances

tingling or numbness

neuropathy

sudden, temporary loss of consciousness

low blood pressure on standing up

cough

breathlessness

throat irritation

excessive sweating

itching

swelling, reddening and pain along a vein

skin reddening

trembling

mood changes

anxiety

depression

sleeplessness

taste abnormalities

fainting

loss of pain sensation

visual disturbances

visual impairment

ringing in the ears

sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis)

altered bowel habits

indigestion

hair loss

itchy skin

skin discolouration

disorder in passing urine

increased need to urinate at night

increased number of times of passing urine

discomfort or enlargement of the breasts in men

pain

feeling unwell

weight decrease

Rare (may affect up to 1 in 1,000 people):

low level of blood platelets (sometimes with bleeding or bruising underneath the skin)

sugar in the urine

high level of sugar in the blood

worsening of the diabetic metabolic state

abdominal discomfort

constipation

liver disorders which can occur together with yellow skin and eyes, or dark-coloured urine (haemolytic anaemia)

increased sensitivity of skin to sun

purple skin patches

kidney disorders

confusion

Very rare (may affect up to 1 in 10,000 people):

decreased number of white blood cells

decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage)

swelling of the gums

abdominal bloating (gastritis)

inflammation of the liver (hepatitis)

yellowing of the skin (jaundice)

liver enzyme increase which may have an effect on some medical tests

increased muscle tension

inflammation of blood vessels often with skin rash

sensitivity to light

disorders combining rigidity, tremor and/or movement disorders

fever, sore throat or mouth ulcers, more frequent infections (lack or low level of white blood cells)

pale skin, tiredness, breathlessness, dark-coloured urine (haemolytic anaemia, abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body)

confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)

severe upper stomach ache (inflammation of the pancreas)

difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress, pulmonary oedema, pneumonitis)

facial rash, joint pain, muscle disorder, fever (lupus erythematosus)

inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)

severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

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

changes in blood tests for kidney function, increase of potassium in your blood, low level of red blood cells

abnormal red blood cell test

low level of a certain type of white blood cell and blood platelet

increase of creatinine in the blood

abnormal liver function test

severely decreased urine output

inflammation of blood vessels

weakness, bruising and frequent infections (aplastic anaemia)

decrease in vision or pain in your eyes due to high pressure (possible signs of acute angle- closure glaucoma)

breathlessness

severely decreased urine output (possible signs of renal disorder or renal failure)

severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (erythema multiforme)

muscle spasm

fever (pyrexia)

blistering skin (sign of a condition called dermatitis bullous)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Dafiro HCT

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 after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

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

Do not use any Dafiro HCT pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dafiro HCT contains

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets

The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171).

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets

The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets

The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).

Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets

The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, yellow iron oxide (E172).

Dafiro 10 mg/320 mg/25 mg film-coated tablets

The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide.

The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, yellow iron oxide (E172).

What Dafiro HCT looks like and contents of the pack

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.

Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.

Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side.

Dafiro HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

Novartis Pharma N.V.

Тел.: +359 2 489 98 28

Tél/Tel: +32 2 246 16 11

Česká republika

Magyarország

Novartis s.r.o.

Novartis Hungária Kft. Pharma

Tel: +420 225 775 111

Tel.: +36 1 457 65 00

Danmark

Malta

Novartis Healthcare A/S

Novartis Pharma Services Inc.

Tlf: +45 39 16 84 00

Tel: +356 2122 2872

Deutschland

Nederland

UCB Innere Medizin GmbH & Co. KG

Novartis Pharma B.V.

Tel: +49 2173 48 4949

Tel: +31 26 37 82 111

Eesti

Norge

Novartis Pharma Services Inc.

Novartis Norge AS

Tel: +372 66 30 810

Tlf: +47 23 05 20 00

Ελλάδα

Österreich

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

Novartis Pharma GmbH

Τηλ: +30 210 281 17 12

Tel: +43 1 86 6570

España

Polska

Laboratorios Dr. Esteve, S.A.

Novartis Poland Sp. z o.o.

Tel: +34 93 446 60 00

Tel.: +48 22 375 4888

France

Portugal

Novartis Pharma S.A.S.

Novartis Farma - Produtos Farmacêuticos, S.A.

Tél: +33 1 55 47 66 00

Tel: +351 21 000 8600

Hrvatska

România

Novartis Hrvatska d.o.o.

Novartis Pharma Services Romania SRL

Tel. +385 1 6274 220

Tel: +40 21 31299 01

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

Κύπρος

Sverige

Novartis Pharma Services Inc.

Novartis Sverige AB

Τηλ: +357 22 690 690

Tel: +46 8 732 32 00

Latvija

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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