Package Insert: Patient Information

Amlodipino/Valsartán Mylan 5 mg/80 mg Film-Coated Tablets

Amlodipino/Valsartán Mylan 5 mg/160 mg Film-Coated Tablets

Amlodipino/Valsartán Mylan 10 mg/160 mg Film-Coated Tablets

amlodipino/valsartán

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Amlodipino/Valsartán Mylan tablets contain two active ingredients called amlodipino and valsartán. Both substances help control high blood pressure.

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

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

Amlodipino/Valsartán Mylan is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipino or valsartán alone.

Do not take Amlodipino/Valsartán Mylan:

• if you are allergic to amlodipine or to any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing.
• if you are allergic to valsartan or to any of the other components of this medication (including those listed in section 6). If you think you may be allergic, inform your doctor before taking Amlodipino/Valsartán Mylan.
• 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 Amlodipino/Valsartán Mylan also 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 blood pressure medication that contains aliskiren.

Do not take Amlodipino/Valsartán Mylan and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor before starting to take Amlodipino/Valsartán Mylan:

• 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 the medication carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have a narrowing of the heart valves (which is called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (which is 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 Amlodipino/Valsartán Mylan and contact your doctor immediately. Never take Amlodipino/Valsartán Mylan again.
• 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) in your blood at regular intervals.

See also the information under the heading "Do not take Amlodipino/Valsartán Mylan".

Inform your doctor before taking Amlodipino/Valsartán Mylan if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipino/Valsartán Mylan is not recommended for use in children or adolescents (under 18 years old).

Taking Amlodipino/Valsartán Mylan with other medications

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 Amlodipino/Valsartán Mylan" 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;
• a certain type of medication used to treat pain 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, telithromycin);
• clarithromycin (for bacterial infections)
• verapamil, diltiazem (heart medications);
• simvastatin (a medication used to control high cholesterol levels);
• tacrolimus (used to control the body's immune response to allow it to accept the transplanted organ)
• dantrolene (for severe muscle disorders);
• medications used to prevent rejection in a transplant (cyclosporin).

Taking Amlodipino/Valsartán Mylan with food and drinks

People taking Amlodipino/Valsartán Mylan should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipine, which may lead to unpredictable reductions in blood pressure.

Pregnancy and breastfeeding

Pregnancy

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

Do not take Amlodipino/Valsartán Mylan and inform your doctor if you are affected by any of the cases mentioned.

Do not take Amlodipino/Valsartán Mylan at the beginning of your pregnancy (first 3 months) and do not administer it after the third month of pregnancy as it may cause serious harm to your baby when administered from that time onwards.

Lactation

Inform your doctor ifyou are planning to start or are breastfeeding.

Amlodipine has been shown to pass into breast milk in small amounts.

Do not administer Amlodipino/Valsartán Mylan to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially to 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 Amlodipino/Valsartán Mylan 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 Amlodipino/Valsartán Mylan with or without food. Do not take Amlodipino/Valsartán Mylan with grapefruit or grapefruit juice.

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

Do not exceed the prescribed dose.

Amlodipino/Valsartán Mylan and Older Adults (65 years or older)

Your doctor should exercise caution when increasing the dose.

If You Take More Amlodipino/Valsartán Mylan Than You Should

If you have taken too many tablets of Amlodipino/Valsartán Mylan, or if someone else has taken your tablets, consult a doctor immediately.

If You Forget to Take Amlodipino/Valsartán Mylan

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 dose.

If You Stop Taking Amlodipino/Valsartán Mylan

Stopping your treatment with Amlodipino/Valsartán Mylan may cause your condition to worsen. Do not stop taking your medication unless your doctor tells you to.

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

Like all medicines, Amlodipino/Valsartán Mylan can cause side effects, although not everyone will experience them.

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

A few patients have experienced these serious side effects(which can affect up to 1 in 1,000 patients).Notify your doctor immediately if you experience any of the following:

Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling faint, dizziness).

Other possible side effects of Amlodipino/Valsartán Mylan:

Frequent (can affect up to 1 in 10 patients):Common cold; 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.

Infrequent (can 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 when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint inflammation, back pain; joint pain.

Rare (can affect up to 1 in 1,000 patients):Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased urine production or feeling the need to urinate urgently; 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 any of the mentioned cases severely affect you.

Side effects reported with amlodipine or valsartan alone and not observed with Amlodipino/Valsartán Mylan or observed with a higher frequency than with Amlodipino/Valsartán Mylan:

Amlodipine

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

• Sudden hissing sounds while breathing (sudden onset of bronchospasm), chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes great difficulty breathing.
• Severe skin reactions that include intense skin rash, blisters, 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.
• Heart attack, abnormal heartbeat.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by 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 (can 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).

Infrequent (can affect up to 1 in 100 patients):Mood changes, anxiety, depression, somnolence, tremor, altered taste, fainting; visual disturbances, visual deterioration, ringing in the ears; 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, breast tenderness or discomfort in men, muscle pain, muscle cramps, muscle spasms; weight gain or loss.

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

Very rare (can affect up to 1 in 10,000 patients):Decreased white blood cell count, decreased platelet count that can 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 can affect some medical tests; muscle tension; inflammation of blood vessels often with skin eruptions, light sensitivity; movement disorders combining rigidity, tremor, and/or movement disorders.

Frequency unknown (the frequency cannot be estimated from the available data):Tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait dragging the feet.

Valsartan

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

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

If you experience any side effects, consult 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 the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on 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 after CAD. The expiration date is the last day of the month indicated.

For bottles: use the medication within 100 days after the first opening of the container.

This medication does not require special conditions for conservation.

Do not use this medication if you observe that the container is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Amlodipino/Valsartán Mylan

The active ingredients of Amlodipino/Valsartán Mylan are amlodipine (as amlodipine besylate) and valsartan.

Amlodipino/Valsartán Mylan 5 mg/80 mg film-coated tablets EFG

Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone; magnesium stearate; anhydrous colloidal silica; hypromellose; macrogol 8000; talc, titanium dioxide (E171); iron oxide yellow (E172).

Amlodipino/Valsartán Mylan 5 mg/160 mg film-coated tablets EFG

Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone; magnesium stearate; anhydrous colloidal silica; hypromellose; macrogol 8000; talc, titanium dioxide (E171); iron oxide yellow (E172).

Amlodipino/Valsartán Mylan 10 mg/160 mg film-coated tablets EFG

Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.

The other components are microcrystalline cellulose; crospovidone; magnesium stearate; anhydrous colloidal silica; hypromellose; macrogol 8000; talc, titanium dioxide (E171); iron oxide yellow (E172); iron oxide red (E172); iron oxide black (E172).

Appearance of Amlodipino/Valsartán Mylan and contents of the package

Amlodipino/Valsartán Mylan 5 mg/80 mg film-coated tablets EFG

Amlodipino/Valsartán Mylan 5 mg/80 mg film-coated tablets are biconvex, round, and yellowish in color with "AV1" on one face and "M" on the other face.

Amlodipino/Valsartán Mylan 5 mg/160 mg film-coated tablets EFG

Amlodipino/Valsartán Mylan 5 mg/160 mg film-coated tablets are yellow, oval, biconvex with the impression "AV2" on one face and "M" on the other face.

Amlodipino/Valsartán Mylan 10 mg/160 mg film-coated tablets EFG

Amlodipino/Valsartán Mylan 10 mg/160 mg film-coated tablets are light brown, oval, biconvex with the impression "AV3" on one face and "M" on the other face.

Amlodipino/Valsartán Mylan is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets. All packages are available in perforated single-dose blisters; packages of 14, 28, 56 and 98 tablets are also available in standard blisters.

Amlodipino/Valsartán Mylan is also available in bottles containing 28, 56 or 98 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Mylan S.A.S.

117 Allée des parcs

69800 Saint Priest

France

Responsible Person

McDermott Laboratories Limited under the commercial name of Gerard Laboratories

Unit 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

Ireland

Mylan Hungary Kft.

Mylan utca 1,

Komárom - 2900

Hungary

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: <{MM/AAAA}><{month YYYY}>.

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.