Dafiro 10 mg/160 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dafiro 5mg/80mg film-coated tablets
Dafiro 5mg/160mg film-coated tablets
Dafiro 10mg/160mg film-coated tablets

amlodipine/valsartan

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Dafiro is and what it is used for
2. What you need to know before taking Dafiro
3. How to take Dafiro
4. Possible side effects
5. How to store Dafiro
6. Contents of the pack and other information

1. What Dafiro is and what it is used for

Dafiro tablets contain two substances called amlodipine and valsartan. Both 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, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both substances help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Dafiro is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

2. What you need to know before taking Dafiro

Do not take Dafiro

• if you are allergic to amlodipine or any other calcium channel blocker. This may include itching, skin redness, or difficulty breathing.
• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking Dafiro.
• if you have severe liver problems or biliary disorders such as primary biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy; see Pregnancy section).
• if you have severely 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 and inform your doctor if any of the above apply to you.

Warnings and precautions

Talk to your doctor before starting Dafiro:

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

• if you have liver or kidney problems.

• if you have had a kidney transplant or if you have been told you have narrowing of the kidney arteries.

• if you have a disease affecting the adrenal glands called "primary hyperaldosteronism".

• if you have had heart failure or a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.

• if your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or abnormal thickening of your heart muscle (called "obstructive hypertrophic cardiomyopathy").

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

• if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking Dafiro. Your doctor will decide whether to continue treatment. Do not stop taking Dafiro on your own.

• if you are taking any of the following medicines for high blood pressure:

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

• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.

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

Tell your doctor before taking Dafiro if any of the above conditions apply to you.

Children and adolescents

Dafiro is not recommended for use in children and adolescents (under 18 years of age).

Other medicines and Dafiro

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 for the following medicines:

• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Dafiro” and “Warnings and precautions”);
• diuretics (medicines that increase urine production);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;
• certain types of pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also monitor your kidney function;
• anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St John’s wort;
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (intravenous infusion for serious body temperature abnormalities);
• medicines used to prevent transplant rejection (cyclosporine).

Taking Dafiro with food and drink

People taking Dafiro must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in Dafiro’s blood pressure-lowering effects.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Dafiro before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Dafiro is not recommended during early pregnancy (first 3 months), and must not be used after the third month of pregnancy, as it may cause serious harm to your unborn baby when used from that stage onward.

Breast-feeding

Inform your doctor if you are planning to breast-feed or are currently breast-feeding. Amlodipine has been shown to pass into breast milk in small amounts. Dafiro is not recommended for use in women who are breast-feeding. Your doctor may choose a treatment that is more suitable if you wish to breast-feed, especially if the baby is newborn or premature.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine may cause dizziness, which could affect your ability to concentrate. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activity requiring concentration.

3. How to take Dafiro

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 is one tablet per day.

• It is preferable to take the medicine at the same time each day.
• Swallow the tablets with a glass of water.
• You may take Dafiro with or without food. Do not take Dafiro 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.

Dafiro and elderly people (65 years or older)

Your doctor should exercise caution when increasing your dose.

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

If you take more Dafiro than you should

If you have taken too many Dafiro tablets, or if someone else has taken your tablets, consult a doctor immediately. 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

If you forget to take this medicine, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Dafiro

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

4. Possible adverse effects

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

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

A small number of patients have experienced these serious adverse effects. If you notice any of the following, inform your doctor immediately:

Rare (may affect up to 1 in 1,000 patients): Allergic reaction with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling faint, dizziness).

Very rare (may affect up to 1 in 10,000 patients): Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Other possible adverse effects of Dafiro:

Common (may affect up to 1 in 10 patients): Flu; stuffy nose, sore throat and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); redness and warmth of the face and/or neck.

Uncommon (may affect up to 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness in the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhoea; constipation; skin rash, skin redness; joint swelling, back pain; joint pain.

Rare (may affect up to 1 in 1,000 patients): Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased amount of urine or urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; rash all over the body, itching, muscle spasms.

Tell your doctor if any of the mentioned effects affect you severely.

Adverse effects reported with amlodipine or valsartan alone, not observed with Dafiro or observed with a higher frequency than with Dafiro:

Amlodipine

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

• Sudden wheezing, 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.
• Serious skin reactions including severe rash, hives, widespread skin redness, intense itching, blistering, peeling and skin inflammation, mucosal membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a general feeling of being unwell.

The following adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.

Common (may affect up to 1 in 10 patients): Dizziness, drowsiness; palpitations (awareness of heartbeats); hot flushes, swelling of the ankles (oedema); abdominal pain, feeling unwell (nausea).

Uncommon (may affect up to 1 in 100 patients): Mood changes, anxiety, depression, drowsiness, tremor, taste disturbances, fainting, loss of pain sensation; visual disturbances, impaired vision, ringing in the ears; low blood pressure; sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (feeling unwell); hair loss, increased sweating, itchy skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or enlargement of breasts in men, pain, discomfort, muscle pain, muscle cramps; weight gain or weight loss.

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

Very rare (may affect up to 1 in 10,000 patients): Decrease in white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycaemia); inflammation of the gums, abdominal swelling (gastritis); abnormal liver function, liver inflammation (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, sensitivity to light; disorders combining stiffness, tremor and/or movement disorders.

Valsartan

Frequency not known (frequency cannot be estimated from available data): Decrease in red blood cells, fever, sore throat or mouth ulcers due to infection; spontaneous skin bleeding or bruising; increased potassium levels in blood; abnormal liver function tests; reduced kidney function and severely reduced kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, purplish red spots; fever; itching; allergic reaction, blistering skin disease (sign of a condition called bullous dermatitis).

If you experience any of the above, consult your doctor immediately.

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

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

5. Storage of Dafiro

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

Do not use this medicine after the expiry date stated on the carton and blister.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Dafiro

Dafiro 5 mg/80 mg film-coated tablets

The active substances in Dafiro are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica; 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 in Dafiro are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone (type A); anhydrous colloidal silica; 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 in Dafiro are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.

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

Appearance of the product and contents of the pack

Dafiro 5 mg/80 mg tablets are round, dark yellow in colour, marked with "NVR" on one side and "NV" on the other. Approximate size: diameter 8.20 mm.

Dafiro 5 mg/160 mg tablets are oval, dark yellow in colour, marked with "NVR" on one side and "ECE" on the other. Approximate size: 14.2 mm (length) x 5.7 mm (width).

Dafiro 10 mg/160 mg tablets are oval, light yellow in colour, marked with "NVR" on one side and "UIC" on the other. 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 multiple packs containing 4 blisters of 70 tablets each, or 20 blisters of 14 tablets each. All packs are available with standard blisters; packs containing 56, 98 and 280 tablets are also available with single-dose perforated blisters.

Not all pack sizes may be marketed 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
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

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

Date of the most recent 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