Leaflet: Information for the user

Dafiro HCT 5mg/160mg/12,5mg film-coated tablets

Dafiro HCT 10mg/160mg/12,5mg film-coated tablets

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

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

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

amlodipino/valsartán/hidroclorotiazida

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

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

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

3.How to take Dafiro HCT

4.Possible side effects

5.Storage of Dafiro HCT

6.Contents of the pack and additional information

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

• Amlodipine belongs to a group of substances called 'calcium channel blockers'. Amlodipine prevents calcium from entering the blood vessel wall, which prevents blood vessels from narrowing.
• Valsartan belongs to a group of substances called 'angiotensin II receptor antagonists'. Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartan acts by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances known as 'thiazide diuretics'. Hydrochlorothiazide increases urine production, which also reduces blood pressure.

As a result of the three mechanisms, blood vessels relax and blood pressure decreases.

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 a tablet that contains the three substances.

Do not take Dafiro HCT

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Dafiro HCT at the beginning of your pregnancy - see Pregnancy section).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medications (medications used to treat chest or urinary tract infections), or any of the other components of this medication (listed in section 6).

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

• if you have liver disease, destruction of the small bile ducts inside the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are undergoing dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels.
• if your blood calcium levels are too high despite treatment to reduce calcium levels.
• if you have gout (crystals of uric acid in the joints).
• if you have severe low blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation in which your heart cannot supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.

Do not take Dafiro HCT and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dafiro HCT

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle contractions, seizures).
• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle contractions, and muscle weakness).
• if you have kidney problems, have undergone a kidney transplant, or have been told that you have a narrowing of the kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, especially if you have been prescribed the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start treatment carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have a narrowing of the heart valves (called "aortic or mitral stenosis") or that your heart muscle has become abnormally thickened (called "hypertrophic obstructive cardiomyopathy").
• if you have aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Dafiro HCT is not recommended.
• if you have a disease called systemic lupus erythematosus (also known as "lupus" or "LES").
• if you have diabetes (high blood sugar levels).
• if you have high levels of cholesterol or triglycerides in your blood.
• if you experience skin reactions such as sunburn after exposure to the sun.
• if you have had an allergic reaction to other medications for high blood pressure or diuretics, especially if you have asthma and allergies.
• if you have been sick (with vomiting or diarrhea).
• if you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking Dafiro HCT and contact your doctor immediately. Never take Dafiro HCT again.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Dafiro HCT. Your doctor will decide whether to continue treatment. Do not stop taking Dafiro HCT on your own.
• if you experience dizziness and/or fainting during treatment with Dafiro HCT, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may appear within hours to a week of Dafiro HCT administration. If not treated, this can cause permanent vision loss.
• if you are taking any of the following medications used to treat high blood pressure:

• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Dafiro HCT.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Dafiro HCT, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood at regular intervals.

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

Inform your doctor if you are affected by any of the cases mentioned.

Children and adolescents

Dafiro HCT is not recommended for use in children or adolescents under 18 years old.

Older adults (65 years and older)

Dafiro HCT can be used in people aged 6 years and older at the same dose as used in other adults and in the same way as they have already taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. Your doctor should monitor your blood pressure regularly, particularly those taking the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg).

Other medications and Dafiro HCT

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medications. This is especially important if you are taking any of the medications listed below:

Do not take with:

• lithium (a medication used to treat certain types of depression);
• medications or substances that may increase the amount of potassium in your blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Dafiro HCT" and "Warnings and precautions").

Use with caution with:

• alcohol, sleeping pills, and anesthetics (medications for patients undergoing surgery and other procedures);
• amantadine (treatment for Parkinson's disease, also used to treat or prevent certain diseases caused by viruses);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• colestiramine, colestipol, or other resins (substances used mainly to treat high levels of lipids in the blood);
• simvastatin (a medication used to control high levels of cholesterol);
• ciclosporin (a medication used in transplants to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis);
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medications used to treat heart problems);
• verapamil, diltiazem (heart medications);
• contrast agents containing iodine (agents used in imaging tests);
• medications used to treat diabetes (oral medications such as metformin or insulin);
• medications used to treat gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);
• medications that may induce "torsades de pointes" (irregular heart rhythm), such as antiarrhythmics and some antipsychotics;
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptic medications;
• medications that may reduce the amount of potassium in the blood, such as diuretics, corticosteroids, laxatives, amphotericin B, or penicillin G;
• medications used to increase blood pressure, such as adrenaline or noradrenaline;
• medications used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medications used to treat esophageal inflammation and ulcers (carbenoxolone);
• medications used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors;
• muscle relaxants (medications used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• other medications used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's Wort;
• dantrolene (used in perfusion for severe temperature disorders);
• tacrolimus (used to control the body's immune response, allowing it to accept the transplanted organ);
• vitamin D and calcium salts.

Taking Dafiro HCT with food, drinks, and alcohol

People taking Dafiro HCT should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase the levels of the active ingredient amlodipine in the blood, which may cause unpredictable reductions in blood pressure.Consult your doctor before drinking alcohol. Alcohol may significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctorif you are pregnant,if you suspect you may be pregnant or if you plan to become pregnant. Your doctor will usually advise you to stop taking Dafiro HCT before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Dafiro HCT is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

You must inform your doctorif youare planning to start or are breastfeeding. It has been shown that amlodipine passes into breast milk in small amounts.Dafiro HCT is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

As with other medications used to treat high blood pressure, Dafiro HCT may cause dizziness, drowsiness, nausea, or headaches. If you experience these symptoms, do not drive or operate tools or machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again. This will help you obtain the best results and reduce the risk of adverse effects.

The normal dose of Dafiro HCT isone tabletper day.

• It is best to take the tablet at the same time every day. The best time is in the morning.
• 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 your response to 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 tablets of Dafiro HCT, consult your doctor immediately. You may need medical attention.Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop within 24-48hours after ingestion.

If you forget to take Dafiro HCT

If you forget to take a dose of this medication, take it as soon as you remember and then take the next dose at the usual time. If it is almost time for the next dose, only take the next tablet at the usual time.Do nottake a double dose (two tablets at once) to make up for the missed doses.

If you interrupt treatment with Dafiro HCT

Stopping your treatment with Dafiro HCT may cause your condition to worsen. Do not stop taking the medication unless your doctor tells you to.

Take this medication always, even if you feel well

People with hypertension often do not notice any symptoms of their problem. Many feel fine. It is very important that you take this medication exactly as your doctor has instructed to obtain the best results and reduce the risk of adverse effects. Keep your appointments with your doctor even if you feel well.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

As with any combination that contains three active principles, it cannot be ruled out that side effects associated with each individual component may occur. The side effects observed with Dafiro HCT or one of its three active principles (amlodipine, valsartan, and hydrochlorothiazide) appear below and may occur with the use of Dafiro HCT.

Some side effects may be severe and require immediate medical attention.

Consult your doctor immediately if, after taking this medicine, you experience any of the following severe side effects:

Frequent (may affect up to 1 in 10 patients):

• dizziness
• low blood pressure (sensation of fainting, dizziness, sudden loss of consciousness)

Infrequent (may affect up to 1 in 100 patients):

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• sudden onset of wheezing (sibilant breathing), chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes severe difficulty breathing
• intestinal angioedema: swelling in the intestine that is accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea
• severe skin reactions that include intense skin rash, hives, skin redness all over the body, severe itching, blistering, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• acute respiratory difficulty (signs include severe breathing difficulty, fever, weakness, and confusion)
• heart attack
• pancreatitis that can cause severe abdominal pain and back pain accompanied by a feeling of great discomfort
• weakness, bruises, fever, and frequent infections
• stiffness

Other side effects may include:

Very frequent (may affect more than 1 in 10 patients):

• low potassium levels in the blood
• increased levels of lipids in the blood

Frequent (may affect up to 1 in 10 patients):

• drowsiness
• palpitations (feeling the heartbeat)
• headaches
• swelling of the ankles (edema)
• abdominal pain
• postprandial discomfort
• fatigue
• headache
• increased frequency of urination
• high levels of uric acid in the blood
• low levels of magnesium in the blood
• low levels of sodium in the blood
• dizziness, dizziness when standing up
• decreased appetite
• nausea and vomiting
• pruritic rash and other types of rash
• inability to achieve or maintain an erection

Infrequent (may affect up to 1 in 100 patients):

• rapid heart rate
• sensation of everything spinning around
• visual disturbances
• gastric discomfort
• chest pain
• increased levels of nitrogen, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• low levels of potassium in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• muscle cramps/weakness/pain
• pain in the extremities
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercise
• lack of energy
• sleep disturbances

• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• irritation of the throat
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• shaking
• changes in mood
• anxiety
• depression
• drowsiness
• altered sense of taste
• syncope
• loss of pain sensation
• visual disturbances
• visual deterioration
• tinnitus in the ears
• runny nose and nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urinary tract disorder
• increased frequency of urination at night
• increased number of urinations
• discomfort or enlargement of the breasts in men
• pain
• discomfort
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• glucose in the urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders that may be accompanied by yellow skin and eyes, or dark-colored urine (hemolytic anemia)
• increased skin sensitivity to the sun
• purpuric skin lesions
• renal disorders
• confusion

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

• decreased white blood cell count
• decreased platelet count in the blood that may cause unusual bruising or bleeding (damage to red blood cells)
• gingivitis
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellow discoloration of the skin (jaundice)
• increased liver enzymes that may affect some medical tests
• muscle tension
• inflammation of blood vessels often accompanied by skin eruptions
• light sensitivity
• movement disorders combining stiffness, tremor, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia, abnormal decrease in red blood cells due to rupture in blood vessels and other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle alteration, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)

Frequency unknown (the frequency cannot be estimated from available data):

• alteration of kidney function test results in blood, increased potassium levels in the blood, low red blood cell count in the blood
• abnormal red blood cell count
• low count of a certain type of white blood cell and platelets in the blood
• increased creatinine levels in the blood
• abnormal liver function test
• important decrease in urine production
• inflammation of blood vessels
• weakness, bruises, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high intraocular pressure (possible signs offluid accumulation in the vascular layer of the eye (choroidal hemorrhage) oracute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of renal dysfunction or renal insufficiency)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasms
• fever (pyrexia)
• bullous skin disease (sign of a disease called dermatitis bullosa)
• skin cancer and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Annex V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister (after CAD/EXP). The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from humidity.

Do not use Dafiro HCT if you observe that the packaging is damaged or shows signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Dafiro HCT

Dafiro HCT 5mg/160mg/12,5mg film-coated tablets

The active ingredients of Dafiro HCT are amlodipine (as amlodipine besilate), valsartan, and hydrochlorothiazide. Each film-coated tablet contains 5mg of amlodipine (as amlodipine besilate), 160mg of valsartan, and 12,5mg of hydrochlorothiazide.

The other components are microcrystalline cellulose; crospovidone(type A); colloidal anhydrous silica; magnesium stearate; hypromellose(substitution type 2910 (3 mPa·s)), macrogol 4000, talc, titanium dioxide (E171).

Dafiro HCT 10mg/160mg/12,5mg film-coated tablets

The active ingredients of Dafiro HCT are amlodipine (as amlodipine besilate), valsartan, and hydrochlorothiazide. Each film-coated tablet contains 10mg of amlodipine (as amlodipine besilate),160mg of valsartan, and 12,5mg of hydrochlorothiazide.

The other components are microcrystalline cellulose; crospovidone(type A); colloidal anhydrous silica; magnesium stearate; hypromellose(substitution type 2910 (3 mPa·s)), macrogol 4000, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).

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

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

The other components are microcrystalline cellulose; crospovidone(type A); colloidal anhydrous silica, magnesium stearate, hypromellose(substitution type 2910 (3 mPa·s)), macrogol 4000, talc, titanium dioxide (E171), iron oxide yellow (E172).

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

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

The other components are microcrystalline cellulose; crospovidone(type A); colloidal anhydrous silica, magnesium stearate, hypromellose(substitution type 2910 (3 mPa·s)), macrogol 4000, talc, iron oxide yellow (E172).

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

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

The other components are microcrystalline cellulose; crospovidone(type A); colloidal anhydrous silica, magnesium stearate, hypromellose(substitution type 2910 (3 mPa·s)), macrogol 4000, talc, iron oxide yellow (E172).

Appearance of the product and contents of the pack

The film-coated tablets of Dafiro HCT 5mg/160mg/12,5mg film-coated tablets are oval-shaped, white in color, with «NVR» on one face and «VCL» on the other face.Approximate size: 15mm (length) x 5,9mm (width).

The film-coated tablets of Dafiro HCT 10mg/160mg/12,5mg film-coated tablets are oval-shaped, pale yellow in color, with «NVR» on one face and «VDL» on the other face.Approximate size: 15mm (length) x 5,9mm (width).

The film-coated tablets of Dafiro HCT 5mg/160mg/25mg film-coated tablets are oval-shaped, yellow in color, with «NVR» on one face and «VEL» on the other face.Approximate size: 15mm (length) x 5,9mm (width).

The film-coated tablets of Dafiro HCT 10mg/160mg/25mg film-coated tablets are oval-shaped, yellow-brown in color, with «NVR» on one face and «VHL» on the other face.Approximate size: 15mm (length) x 5,9mm (width).

The film-coated tablets of Dafiro HCT 10mg/320mg/25mg film-coated tablets are oval-shaped, yellow-brown in color, with «NVR» on one face and «VFL» on the other face.Approximate size: 19mm (length) x 7,5mm (width).

Dafiro HCT is available in packs containing 14, 28, 30, 56, 90, 98, or 280film-coated tablets, in multiple packs with 280film-coated tablets (with 4boxes, each containing 70film-coated tablets, or 20boxes, each containing 14film-coated tablets), and in clinical packs with 56, 98, or 280film-coated tablets in perforated dose blisters. Not all pack sizes may be marketed in your country.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Irlanda

Responsible for manufacturing

Novartis Farma S.p.A.

Via Provinciale Schito 131

80058 Torre Annunziata (NA)

Italia

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

España

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Alemania

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu