Leaflet: information for the user

Dafiro 5mg/80mg film-coated tablets

Dafiro 5mg/160mg film-coated tablets

Dafiro 10mg/160mg film-coated tablets

amlodipino/valsartán

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 doubts, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of disease 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 isDafiroand what it is used for

2.What you need to know before starting to takeDafiro

3.How to takeDafiro

4.Side effects

5.Storage ofDafiro

6.Contents of the pack and additional information

Dafirotablets contain two substances called amlodipine and valsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of substances called«calcium channel antagonists». Amlodipine prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction.
• Valsartan belongs to a group of substances called«angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to constrict, thereby increasing blood pressure. Valsartan acts by blocking the effect of angiotensin II.

This means that both substances help prevent blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.

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

Do not take Dafiro

• if you are allergic to amlodipine or any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing.
• if you are allergic to valsartan or any of the other components of this medication (listed in section 6). If you think you may be allergic, inform your doctor before taking Dafiro.
• if you have severe liver problems or bile duct problems such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant. (In any case, it is best to avoid taking this medication at the beginning of your pregnancy, see Pregnancy section).
• if you have a severe decrease in 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 failure and are being treated with a medication to lower blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor before starting to take Dafiro:

• if you have been sick (with vomiting or diarrhea).
• if you have liver or kidney problems.
• if you have had a kidney transplant or if you have been told that you have a narrowing of the kidney arteries.
• if you have a disease that affects the adrenal glands called "primary hyperaldosteronism".
• if you have had heart failure or have had a heart attack. Follow your doctor's instructions to start taking Dafiro 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 the thickness of your heart muscle has increased abnormally (called "hypertrophic obstructive cardiomyopathy").
• 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 and contact your doctor immediately. Never take Dafiro again.
• if you experience abdominal pain, nausea, vomiting, or diarrhea 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 medications used to treat high blood pressure:

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

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) regularly.

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

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

Children and adolescents

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

Other medications and Dafiro

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 applies especially to the medications listed below:

• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Dafiro” and “Warnings and precautions”);
• diuretics (a type of medication that increases urine production);
• lithium (a medication 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 medications called nonsteroidal anti-inflammatory drugs (NSAIDs) or selective COX-2 inhibitors. Your doctor may also check your kidney function;
• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• 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 bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medications);
• simvastatin (a medication used to control high cholesterol levels);
• dantrolene (for severe temperature abnormalities);
• medications used to prevent rejection in a transplant (ciclosporin).

Taking Dafiro with food and drinks

People taking Dafiro 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 by Dafiro.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.

Breastfeeding

Inform your doctor if you are planning to start or are breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts.

Dafiro is not recommended for use during this period. Your doctor may decide to give you a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication may make you feel dizzy, which may affect your ability to concentrate. Therefore, if you are unsure how this medication will affect you, do not drive, operate machinery, or perform other activities that require concentration.

Follow exactly the administration instructions for this medication as indicated 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 medication at the same time every day.
• Swallow the tablets with a glass of water.
• You can take Dafiro with or without food. Do not take Dafiro with grapefruit or grapefruit juice.

Your doctor may suggest a higher or lower dose depending on your response to treatment.

Do not exceed the prescribed dose.

Dafiro and Older Adults (65 years or older)

Your doctor should exercise caution when increasing the dose.

If you have any other questions about the use of this medication, 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. Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that may develop within 24-48 hours after ingestion.

If You Forget to Take Dafiro

If you forget to take this medication, 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 the missed doses.

If You Stop Taking Dafiro

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

Like all medications,Dafiromay cause side effects, although not everyone will experience them.

Some side effects can be severe and require immediate medical attention:

A few patients have experienced these severe side effects.Notify your doctor immediately if you notice any of the following:

Rare(may affect up to 1 in 1,000 patients):allergic reaction with symptoms such as skin rash, itching, facial swelling, lip or tongue swelling, difficulty breathing, low blood pressure (dizziness, fainting).

Very rare (may affect up to 1 in 10,000 patients):Intestinal angioedema: intestinal swelling accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Other possible side effects of Dafiro:

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

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

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

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

Side effects reported with amlodipine or valsartan alone and not observed with Dafiro or observed with a higher frequency than with Dafiro:

Amlodipine

Consult your doctor immediately if you experience any of the following severe side effects, which are very rare after taking this medication:

• Sudden hissing sounds while breathing (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.
• Severe skin reactions that include intense skin rash, blisters, redness of the skin, severe itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heartbeat.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a feeling of great discomfort.

The following side effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Frequent(may affect up to 1 in 10 patients):dizziness, somnolence; palpitations (feeling the heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, feeling unwell (nausea).

Occasional(may affect up to 1 in 100 patients):mood changes, anxiety, depression, somnolence, tremor, taste alterations, fainting, loss of pain sensation; visual disturbances, visual deterioration, tinnitus; decreased blood pressure; nasal congestion and secretion caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or breast enlargement in men, pain, feeling unwell, muscle pain, muscle cramps; weight gain or loss.

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

Very rare(may affect up to 1 in 10,000 patients):decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising (damage to red blood cells); high blood sugar (hyperglycemia); inflammation of the gums, abdominal swelling (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that may affect some medical tests; muscle tension; inflammation of blood vessels often with skin eruptions, light sensitivity; disorders combining stiffness, tremor, and/or movement disorders.

Valsartan

Unknown frequency (frequency cannot be estimated from available data):decreased red blood cell count, fever, sore throat or ulcers in the mouth due to infection; spontaneous bleeding or skin hematomas; increased potassium in the blood; abnormal liver function test results; decreased kidney function and severely decreased kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, red purpura spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called dermatitis bullosa).

Consult your doctor immediately if you experience any of the cases mentioned.

Report any side effects to your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAnexo V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and the blister pack.

Do not store above30°C.

Store in the original packaging to protect it from moisture.

Do not useDafiroif you observe that the packaging is damaged or shows signs of tampering.

Composition of Dafiro

Dafiro 5mg/80mg film-coated tablets

The active ingredients ofDafiroare amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5mg of amlodipine and 80mg of valsartan.

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

Dafiro 5mg/160mg film-coated tablets

The active ingredients ofDafiroare amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5mg of amlodipine and 160mg of valsartan.

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

Dafiro 10mg/160mg film-coated tablets

The active ingredients ofDafiroare amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 10mg of amlodipine and 160mg of valsartan.

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

Appearance of the product and contents of the pack

Dafiro5mg/80mg tablets are round and dark yellow in color with«NVR»on one face and«NV»on the other face.Approximate size: diameter 8.20mm.

Dafiro5mg/160mg tablets are oval and dark yellow in color with«NVR»on one face and«ECE»on the other face.Approximate size: 14.2mm (length) x 5.7mm (width).

Dafiro10mg/160mg tablets are oval and light yellow in color with«NVR»on one face and«UIC»on the other face.Approximate size: 14.2mm (length) x 5.7mm (width).

Dafirois available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280tabletsand in multiple packs containing 4boxes, each containing70tablets, or 20boxes, each containing 14tablets.All packs are available with standard blisters; the packs of56, 98 and 280tablets are also available with perforated unit 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

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 further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

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