Patient leaflet - Dafiro
1. What Dafiro is and what it is used for
Dafiro tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure.
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– 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.
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– 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.
This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.
Dafiro is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
2. What you need to know before you take Dafiro
Do not take Dafiro
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– if you are allergic to amlodipine or to any other calcium channel blockers. This may involve
itching, reddening of the skin or difficulty in breathing.
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– if you are allergic to valsartan or any of the other ingredients of Dafiro this medicine (listed in
section 6). If you think you may be allergic, talk to your doctor before taking Dafiro.
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– if you have severe liver problems or bile problems such as biliary cirrhosis or cholestasis.
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– if you are more than 3 months pregnant. (It is also better to avoid Dafiro in early pregnancy, see
Pregnancy section).
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– if you have severe low blood pressure (hypotension).
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– 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).
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– if you suffer from heart failure after a heart attack.
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– 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 and talk to your doctor.
Warnings and precautions
Talk to your doctor before taking Dafiro:
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– if you have been sick (vomiting or diarrhoea).
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– if you have liver or kidney problems.
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– if you have had a kidney transplant or if you had been told that you have a narrowing of your
kidney arteries.
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– if you have a condition affecting the renal glands called “primary hyperaldosteronism”.
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– if you have had heart failure or have experienced a heart attack. Follow your doctor’s
instructions for the starting dose carefully. Your doctor may also check your kidney function.
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– 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”).
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– 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 and contact your doctor straight away. You should never take Dafiro again.
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– if you are taking any of the following medicines used to treat high blood pressure:
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– an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have
diabetes-related kidney problems.
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– 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”.
If any of these apply to you, tell your doctor before taking Dafiro.
Children and adolescents
The use of Dafiro in children and adolescents is not recommended (aged below 18 years old).
Other medicines and Dafiro
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 taking one of the medicines. This applies especially to the medicines listed below:
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– ACE inhibitors or aliskiren (see also information under the headings “Do not take Dafiro” and
“Warnings and precautions”);
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– diuretics (a type of medicine also called “water tablets” which increases the amount of urine you
produce);
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– lithium (a medicine used to treat some types of depression);
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– potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and
other substances that may increase potassium levels;
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– certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or
selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also check your kidney function;
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– anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
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– St. John’s wort;
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– nitroglycerin and other nitrates, or other substances called “vasodilators”;
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– medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
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– medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
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– medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin,
telithromycin);
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– verapamil, diltiazem (heart medicines);
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– simvastatin (a medicine used to control high cholesterol levels);
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– dantrolene (infusion for severe body temperature abnormalities);
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– medicines used to protect against transplant rejection (ciclosporin).
Dafiro with food and drink
Grapefruit and grapefruit juice should not be consumed by people who are taking Dafiro. 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.
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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Dafiro. Dafiro is not recommended in early pregnancy (first 3 months), 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. Amlodipine has been shown to pass into breast milk in small amounts. Dafiro is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is 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. This can affect how well you can concentrate. So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.
3. How to take Dafiro
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 is one tablet per day.
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– It is preferable to take your medicine at the same time each day.
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– Swallow the tablets with a glass of water.
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– You can take Dafiro with or without food. Do not take Dafiro 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.
Dafiro and older people (age 65 years or over)
Your doctor should exercise caution when increasing your dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you take more Dafiro than you should
If you have taken too many tablets of Dafiro, or if someone else has taken your tablets, consult a doctor immediately.
If you forget to take Dafiro
If you forget to take this medicine, take it as soon as you remember. Then take your next dose at its usual time. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Dafiro
Stopping your treatment with Dafiro may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). If any of the following happen, tell your doctor straight away:
Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).
Other possible side effects of Dafiro:
Common (may affect up to 1 in 10 people): Influenza (flu); blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; asthenia (weakness); redness and warm feeling of the face and/or neck.
Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
If any of these affect you severely, tell your doctor.
Side effects reported with amlodipine or valsartan alone and either not observed with Dafiro or observed with a higher frequency than with Dafiro:
Amlodipine
Consult a doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine:
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– Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing.
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– Swelling of eyelids, face or lips.
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– Swelling of the tongue and throat which causes great difficulty breathing.
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– 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, toxic epidermal necrolysis) or other allergic reactions.
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– Heart attack, abnormal heart beat.
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– Inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling
5. How to store Dafiro
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.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use any Dafiro pack that is damaged or shows signs of tampering.
6. Contents of the pack and other information
What Dafiro contains
Dafiro 5 mg/80 mg film-coated tablets
The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg amlodipine and 80 mg valsartan.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Dafiro 5 mg/160 mg film-coated tablets
The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg amlodipine and 160 mg valsartan.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Dafiro 10 mg/160 mg film-coated tablets
The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 10 mg amlodipine and 160 mg valsartan.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
What Dafiro looks like and contents of the pack
Dafiro 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side. Approximate size: diameter 8.20 mm.
Dafiro 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Approximate size: 14.2 mm (length) x 5.7 mm (width).
Dafiro 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side. Approximate size: 14.2 mm (length) x 5.7 mm (width).
Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets. All packs are available with standard blisters; the 56, 98 and 280 tablet packs are additionally available with perforated unit dose blisters. Not all pack sizes may be available in your country.
Marketing Authorisation 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
Roonstraße 25
D-90429 Nuremberg
Germany
For any information about this medicine, please
Authorisation Holder:
België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Efcnrapua
Novartis Bulgaria EOOD
Ten.: +359 2 976 98 28
Česká republika
Novartis s.r.o.
Tel: +420 225 775 111
Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0
Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810
EXÀàôa
Novartis (Hellas) A.E.B.E.
Tql: +30 210 281 17 12
contact the local representative of the Marketing
Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50
Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Magyarorszag
Novartis Hungâria Kft.
Tel.: +36 1 457 65 00
Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111
Norge
Novartis Norge AS
Tlf: +47 23 05 20 00
Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570
| España Esteve Pharmaceuticals, S.A. Tel: +34 93 446 60 00 | Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888 |
| France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00 | Portugal Novartis Farma – Produtos Farmacêuticos, S.A Tel: +351 21 000 8600 |
| Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220 | România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 |
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| 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 | Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 |
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| Latvija SIA Novartis Baltics Tel: +371 67 887 070 | United Kingdom (Northern Ireland) Novartis Ireland Limited 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:
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