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

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 who are already taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.

Do not take Dafiro HCT

• if you are more than 3 months pregnant (It is also better to avoid Dafiro HCT in early pregnancy ? see Pregnancy section).
• if you are allergic (hypersensitive) to amlodipine, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of Dafiro HCT (see section 6, ?What Dafiro HCT contains?. If you think you may be allergic, do not take Dafiro HCT and talk to your doctor.
• if you have liver problems, such as liver disorders and jaundice (cholestasis).
• if you have severe kidney problems or if you are having dialysis.
• if you are suffering from an inability to produce urine.
• if the level of potassium or sodium in your blood is too low despite treatment.
• if the level of calcium in your blood is too high despite treatment.
• if you have gout (uric acid crystals in the joints). If any of the above applies to you, do not take Dafiro HCT and talk to your doctor.

Take special care with Dafiro HCT

• if you have a low level of potassium, sodium or magnesium in your blood.
• if you have a high level of calcium in your blood.
• if you are taking 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. It may be necessary to check the amount of potassium in your blood at regular intervals.
• 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 arterydisease, particularly if you are taking the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg)
• 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 blood sugar).
• 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 experience dizziness and/or fainting during treatment with Dafiro HCT, tell your doctor as soon as possible. If any of these apply to you, talk to your doctor.

You must tell your doctor if you think that you are ( or might become) pregnant. Dafiro HCT is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section ?Pregnancy and breast-feeding?).

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

Dafiro HCT and older 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.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicine, including medicines obtained without a prescription. Your doctor may need to change the dose or 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.

Caution should be used with:

• alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures);
• allopurinol (anti-gout treatment);
• amantadine (anti-Parkinson therapy, also used for influenza treatment);
• 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 and colestipol (substances used mainly to treat high levels of lipids in the blood);
• ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis);
• cortisone-like medicines, steroids;
• curare derivatives (a medicine to relax the muscles which is used during operations);
• cytotoxic medicines (used to treat cancer);
• digoxin (a heart medicine);
• medicines for the treatment of diabetes (oral agents such as metformin or insulins);
• medicines to increase blood pressure (adrenaline, noradrenaline);
• medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole);
• medicines used for oesophageal ulceration and inflammation (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents;
• nitroglycerin and other nitrates, or other substances called ?vasodilators?;
• other medicines to treat high blood pressure (beta blockers, diazoxides, methyldopa);
• rifampicin (used, for example, to treat tuberculosis);
• some medicines used to treat infections such as amphotericin, penicillin G, tetracycline;
• St. John?s wort;
• vitamin D and calcium salts. 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.

Taking Dafiro HCT with food and drink

You can take Dafiro HCT with or without food.

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 if you are more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.

Breast-feedingTell 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

As with many other medicines used to treat high blood pressure, this medicine may make you feel dizzy. If you experience this symptom, do not drive or use tools or machines.

Always take this medicine exactly as your doctor has told you. You should 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.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower 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 medecine 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 product ask your doctor or pharmacist.

Like all medicines, Dafiro HCT can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data

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

You should see your doctor immediately if you experience any of the following symptoms: Common

• dizziness
• low blood pressure (feeling of faintness, light-headedness, sudden loss of consciousness) Uncommon
• severely decreased urine output (decreased kidney function)

Rare

• spontaneous bleeding
• irregular heart beat
• liver disorder Very rare
• allergic reaction with symptoms such as rash, itching
• angioedema: swelling of face or lips or tongue, difficulty of breathing
• crushing/tight chest pain that gets worse or that does not go away
• weakness, bruising, fever and frequent infections
• stiffness

Other possible side effects of Dafiro HCT:

Common: Stomach discomfort after meal; tiredness; swelling; low level of potassium in the blood; headache; frequent urination.
Uncommon: 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; nausea; vomiting; abdominal pain; 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; sleepiness; sudden, temporary loss of consciousness; low blood pressure on standing up; impotence; cough; breathlessness; throat irritation; excessive sweating; itching; swelling, reddening and pain along a vein; skin reddening; trembling. Not known: Changes in blood tests for kidney function, increase of potassium in your blood, low level of red blood cells.

Side effects reported with amlodipine or valsartan or hydrochlorothiazide alone, but not observed with Dafiro HCT or observed in a higher frequency:

AmlodipineCommon: Palpitations; abdominal pain; nausea; sleepiness; hot flushes.
Uncommon: Ringing noise in ears; change of bowel habit; pain; weight decrease; joint pain; trembling; mood swings; urination disorders; urination at night; breast enlargement in men; runny nose; hair loss; skin eruption; purple skin patches; rash; skin discoloration.
Very rare: Low level of white blood cells and blood platelets; irregular heart beat; heart attack; inflammation of the stomach lining or of the pancreas, gingival overgrowth, abnormal liver function test; liver disorder which can occur together with yellow skin and eyes, or dark-coloured urine; allergic reaction including swelling deeper in the skin and difficulty breathing; high level of sugar in the blood; increased muscle stiffness; skin reaction with skin reddening and peeling, blistering of lips, eyes or mouth; itchy rash; inflammation of blood vessels.
Not known: Stiff limbs and trembling hands.

ValsartanNot known: Abnormal red blood cell test; low level of a certain type of white blood cell and blood platelet; increase of potassium in the blood; increase of creatinine in the blood; abnormal liver function test; allergic reaction including swelling deeper in the skin and difficulty breathing; muscle pain; severely decreased urine output; itching; rash; inflammation of blood vessels.

HydrochlorothiazideCommon: Increase of lipids in the blood.
Uncommon: Low level of magnesium in the blood; rash; itchy rash.
Rare: Low level of blood platelets, sugar in the urine; high level of sugar in the blood; depression; irregular heart beat; abdominal discomfort; constipation; liver disorder which can occur together with yellow skin and eyes, or dark-coloured urine; increased sensitivity of skin to sun; purple skin patches.

Very rare: Lack or low level of white blood cells; haemolytic anaemia (abnormal breakdown of red blood cells either in the blood vessels or elsewhere in the body); inflammation of the pancreas; allergic reaction; difficulty breathing, breathlessness; inflammation of the lungs, lupus erythematosus; inflammation of blood vessels; severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use Dafiro HCT 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.

What Dafiro HCT contains

• The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
• Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets: 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).

What Dafiro HCT looks like and contents of the pack

• 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 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 unit blisters. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
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:

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11

Novartis Pharma Services Inc. . 359 2 976 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Laboratorios Dr. Esteve, S.A. Tel 34 93 446 60 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 9 61 33 22 11

357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva

Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

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