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

Package leaflet: Information for the user

Introduction

Package 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

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 symptoms 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.

Contents of this leaflet

1. What Dafiro HCT is and what it is used for
2. What you need to know before taking 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 control high blood pressure.

• Amlodipine belongs to a group of substances known as «calcium channel blockers». Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing.
• Valsartan belongs to a group of substances known as «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works 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 these 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 single tablet containing all three substances.

2. What you need to know before taking Dafiro HCT

Do not take Dafiro HCT

• if you are more than 3 months pregnant. (In any case, Dafiro HCT is recommended to be avoided also during early pregnancy – see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medicines (medicines used to treat chest or urinary infections), or to any of the other components of this medicine (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 within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney problems or 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 in the blood.
• if your blood calcium levels are too high despite treatment to reduce blood calcium levels.
• 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 in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Dafiro HCT and inform your doctor if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dafiro HCT

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).

• if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle twitching, seizures).

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

• if you have kidney problems, have had a kidney transplant, or have been told you have 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 carefully when starting treatment. Your doctor may also check your kidney function.

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

• if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, Dafiro HCT is not recommended.

• if you have a disease called systemic lupus erythematosus (also known as “lupus” or “SLE”).

• if you have diabetes (high blood sugar levels).

• if you have high cholesterol or triglyceride levels in your blood.

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

• if you have had an allergic reaction to other high blood pressure medicines or diuretics, especially if you have asthma and allergies.

• if you have been ill (with vomiting or diarrhoea).

• if you develop swelling, particularly in the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking Dafiro HCT and contact your doctor immediately. You must never take Dafiro HCT again.

• if you have abdominal pain, nausea, vomiting, or diarrhoea 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 eye pressure and may occur within hours to a week after taking Dafiro HCT. If left untreated, this may lead to permanent vision loss.

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

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

• aliskiren.

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking Dafiro HCT.

• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop 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 (e.g. potassium) in your blood at regular intervals.

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

Inform your doctor if any of the above conditions apply to you.

Children and adolescents

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

Elderly people (65 years and older)

Dafiro HCT can be used in people aged 65 years and older at the same dose as in other adults and in the same way as they would have taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be monitored periodically in elderly patients, especially those taking the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg).

Other medicines and Dafiro HCT

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 medicines. This is especially important if you are taking any of the following medicines:

Do not take together with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Dafiro HCT” and “Warnings and precautions”).

Should be used with caution with:

• alcohol, sleeping pills, and anaesthetics (medicines for patients undergoing surgery or other procedures);
• amantadine (treatment for Parkinson’s disease, also used to treat or prevent certain viral diseases);
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances mainly used to treat high blood lipid levels);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in organ transplants 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);
• iodinated contrast agents (agents used in imaging scans);
• medicines for diabetes (oral medicines such as metformin or insulin);
• medicines for gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may cause «torsades de pointes» (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce blood potassium levels, such as diuretics (medicines to increase urination), 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 inflammation and ulceration of the oesophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors);
• muscle relaxants (medicines used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (by infusion for serious body temperature abnormalities);
• tacrolimus (used to control the body’s immune response to allow acceptance of a transplanted organ);
• vitamin D and calcium salts.

Taking Dafiro HCT with food, drinks, and alcohol

People prescribed Dafiro HCT should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effects of Dafiro HCT. Consult your doctor before drinking alcohol. Alcohol may greatly lower your blood pressure and/or increase the likelihood of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Dafiro HCT before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Dafiro HCT is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your unborn baby when used from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Amlodipine has been shown to pass into breast milk in small amounts. Dafiro HCT is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if you are nursing a newborn or premature infant.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

As with other medicines used to treat high blood pressure, this medicine may make you feel dizzy, drowsy, nauseous, or give you a headache. If you experience these symptoms, do not drive or operate tools or machinery.

3. How to take Dafiro HCT

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse 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. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You may 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 Dafiro HCT tablets, consult your doctor immediately. You may require medical attention. Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

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 the usual time. If it is almost time for your next dose, you should only take the next tablet at the usual time. Do not take a double dose (two tablets at the same time) to make up for a missed dose.

If you stop taking Dafiro HCT

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

Keep taking this medicine, even if you feel well

People with high blood pressure often do not notice any symptoms of their condition. Many feel perfectly well. It is very important that you take this medicine exactly as your doctor has instructed to achieve the best results and reduce the risk of adverse effects. Keep your doctor appointments even if you feel well.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

As with any combination containing three active ingredients, adverse effects associated with each individual component cannot be excluded. The adverse effects observed with Dafiro HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur during treatment with Dafiro HCT.

Some adverse effects may be serious and require immediate medical attention.

Contact your doctor immediately if, after taking this medicine, you experience any of the following serious adverse effects:

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

• dizziness
• low blood pressure (feeling faint, dizziness, sudden loss of consciousness)

Uncommon (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 wheezing (sudden whistling breath sounds), chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat causing severe difficulty breathing
• intestinal angioedema: swelling in the intestine associated with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
• severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion)
• heart attack
• inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of illness
• weakness, bruising, fever and frequent infections
• stiffness

Other adverse effects may include:

Very common (may affect more than 1 in 10 patients)

• low blood potassium levels
• increased blood lipids

Common (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (awareness of heartbeat)
• hot flushes
• swelling of the ankles (oedema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high blood uric acid levels
• low blood magnesium levels
• low blood sodium levels
• dizziness, dizziness upon standing
• decreased appetite
• nausea and vomiting
• itchy rash and other types of skin rash
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 patients)

• rapid heartbeat

• sensation that everything is spinning

• vision disorders

• stomach discomfort

• chest pain

• increased blood urea nitrogen, creatinine and uric acid

• high blood calcium, lipid or sodium levels

• decreased blood potassium

• bad breath

• diarrhoea

• dry mouth

• weight gain

• loss of appetite

• altered taste sensation

• back pain

• joint swelling

• muscle cramps / weakness / muscle pain

• pain in the limbs

• inability to stand or walk normally

• weakness

• abnormal coordination

• dizziness upon standing or after exercise

• lack of energy

• sleep disturbances

• tingling or numbness

• neuropathy

• sudden and transient loss of consciousness

• low blood pressure upon standing

• cough

• shortness of breath

• throat irritation

• excessive sweating

• itching

• swelling, redness and pain along a vein

• skin redness

• tremor

• mood changes

• anxiety

• depression

• drowsiness

• taste disturbances

• fainting

• loss of pain sensation

• visual disturbances

• visual deterioration

• ringing in the ears

• sneezing / nasal discharge due to inflammation of the nasal mucosa (rhinitis)

• changes in bowel habits

• indigestion

• hair loss

• skin itching

• skin discoloration

• urinary disorders

• increased need to urinate at night

• increased frequency of urination

• discomfort or enlargement of the breasts in men

• pain

• feeling unwell

• weight loss

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

• low blood platelet count (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders which may present with yellowing of the skin and eyes, or dark-coloured urine (haemolytic anaemia)
• increased sensitivity of the skin to sunlight
• purplish spots on the skin
• kidney disorders
• confusion

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

• decreased number of white blood cells in the blood
• decreased blood platelets which may cause unusual bruising or easy bleeding (damage to red blood cells)
• gum inflammation
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• increased liver enzymes which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rashes
• light sensitivity
• 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 urine (haemolytic anaemia, abnormal decrease due to destruction of red blood cells in blood vessels and other body parts)
• confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloraemic alkalosis)
• severe upper abdominal pain (inflammation of the pancreas)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary oedema, pneumonitis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease causing skin rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)

Frequency not known (frequency cannot be estimated from available data)

• changes in blood test results for kidney function, increased blood potassium, low red blood cell count
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in the blood
• increased blood creatinine
• abnormal liver function test
• marked decrease in urine production
• inflammation of blood vessels
• weakness, bruising and frequent infections (aplastic anaemia)
• decreased vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney disorder or kidney failure)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a condition called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dafiro HCT

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

Do not use this medicine after the expiry date stated on the packaging and blister (after EXP/CAD). The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Pack contents and other information

Composition of Dafiro HCT

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

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

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

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

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

The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica; magnesium stearate; hypromellose (type 2910 substitution (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 substances in Dafiro HCT are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 25 mg of hydrochlorothiazide.

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

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

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

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

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

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

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

Appearance of the product and contents of the pack

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets are oval-shaped, white tablets, marked with "NVR" on one side and "VCL" on the other. Approximate size: 15 mm (length) x 5.9 mm (width).

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets are oval-shaped, pale yellow tablets, marked with "NVR" on one side and "VDL" on the other. Approximate size: 15 mm (length) x 5.9 mm (width).

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets are oval-shaped, yellow tablets, marked with "NVR" on one side and "VEL" on the other. Approximate size: 15 mm (length) x 5.9 mm (width).

Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets are oval-shaped, brown-yellow tablets, marked with "NVR" on one side and "VHL" on the other. Approximate size: 15 mm (length) x 5.9 mm (width).

Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets are oval-shaped, brown-yellow tablets, marked with "NVR" on one side and "VFL" on the other. Approximate size: 19 mm (length) x 7.5 mm (width).

Dafiro HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multiple packs containing 280 tablets (with 4 boxes, each containing 70 tablets, or 20 boxes, each containing 14 tablets), and in clinical packs containing 56, 98 or 280 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
Ireland

Manufacturer

Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata (NA)
Italy

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet:

Other sources of information

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