Amlodipine/valsartan Mylan 5 mg/160 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets

Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets

Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets

amlodipine/valsartan

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Amlodipine/Valsartan Mylan is and what it is used for

Amlodipine/Valsartan Mylan tablets contain two active 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.

Amlodipine/Valsartan Mylan is used to treat high blood pressure in adults whose blood pressure is not adequately controlled by amlodipine or valsartan alone.

2. What you need to know before taking Amlodipine/Valsartan Mylan

Do not take Amlodipine/Valsartan Mylan:

• If you are allergic to amlodipine or to any other calcium channel blocker. This may include itching, skin redness, or difficulty breathing.

• If you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking Amlodipine/Valsartan Mylan.

• 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 Amlodipine/Valsartan Mylan 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 Amlodipine/Valsartan Mylan and inform your doctor if any of the above conditions apply to you.

Warnings and precautions

Talk to your doctor before starting Amlodipine/Valsartan Mylan:

• If you have been ill (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 experienced heart failure or had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.
• If your doctor has informed you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has abnormally increased (called "obstructive hypertrophic cardiomyopathy").
• If you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you develop these symptoms, stop taking Amlodipine/Valsartan Mylan and contact your doctor immediately. You must never take Amlodipine/Valsartan Mylan again.
• If you have kidney problems that reduce blood flow to your kidneys (renal artery stenosis).
• If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Amlodipine/Valsartan Mylan. Your doctor will decide whether to continue treatment. Do not stop taking Amlodipine/Valsartan Mylan on your own.
• If you are taking any of the following medicines used to treat high blood pressure:
• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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

Inform your doctor before taking Amlodipine/Valsartan Mylan if any of the above conditions apply to you.

Children and adolescents

Do not administer to children or adolescents (under 18 years of age).

Other medicines and Amlodipine/Valsartan Mylan

Tell your doctor or pharmacist if you are using, have recently used, or might need to use 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 especially applies to the following medicines:

• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan Mylan” 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, potassium-containing salt substitutes, 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;
• anticonvulsants (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);
• tacrolimus (used to control the body's immune response to allow acceptance of a transplanted organ);
• medicines used to prevent transplant rejection (cyclosporine).

Taking Amlodipine/Valsartan Mylan with food and drink

People taking Amlodipine/Valsartan Mylan should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effects of Amlodipine/Valsartan Mylan.

Pregnancy and breastfeeding

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 Amlodipine/Valsartan Mylan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Amlodipine/Valsartan Mylan is not recommended during the first three months of pregnancy and must not be used from the fourth month of pregnancy onwards, as it may cause serious harm to the unborn baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding.

It has been shown that amlodipine passes into breast milk in small amounts.

Amlodipine/Valsartan Mylan is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine may make you feel dizzy, 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 activities requiring concentration.

3. How to take Amlodipine/Valsartan Mylan

Follow exactly the instructions given by your doctor for taking this medicine. 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 Amlodipine/Valsartan Mylan is one tablet daily.

• It is preferable to take the medicine at the same time each day.

• Swallow the tablets with a glass of water.

• You may take Amlodipine/Valsartan Mylan with or without food. Do not take Amlodipine/Valsartan Mylan with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a higher or lower strength.

Do not exceed the prescribed dose.

Amlodipine/Valsartan Mylan and elderly people (65 years of age or older)

Your doctor should exercise caution when increasing your dose.

If you take more Amlodipine/Valsartan Mylan than you should

If you have taken too many Amlodipine/Valsartan Mylan tablets, consult a doctor immediately. Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 24–48 hours after ingestion.

If you forget to take Amlodipine/Valsartan Mylan

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

If you stop taking Amlodipine/Valsartan Mylan

Stopping your treatment with Amlodipine/Valsartan Mylan may cause your condition to worsen. Do not stop taking your medicine unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, Amlodipine/Valsartan Mylan may produce 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, contact 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)

Swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea (intestinal angioedema).

Other possible adverse effects of Amlodipine/Valsartan Mylan:

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); flushing and warmth of the face and/or neck; decreased potassium levels in blood.

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, redness of the skin; joint inflammation, back pain; joint pain; anorexia; high calcium levels in blood; high lipid levels in plasma; high uric acid levels in blood; low sodium levels in blood; abnormal coordination; vision disorders; sore throat.

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; skin rash all over the body, itching, muscle spasms; visual disturbances.

Tell your doctor if any of the above affect you severely.

Adverse effects reported with amlodipine or valsartan alone, not observed with Amlodipine/Valsartan Mylan or observed with a higher frequency than with Amlodipine/Valsartan Mylan:

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.
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense 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.
• 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, fatigue; drowsiness; palpitations (awareness of heartbeat); 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 (nausea); hair loss, increased sweating, skin itching, erythema; skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, feeling weak; muscle pain, muscle cramps, muscle spasms; back pain; joint pain; weight gain or weight loss; change in bowel habits; diarrhoea; dry mouth; chest pain.

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, inflammation of the liver (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, photosensitivity; disorders combining stiffness, tremor and/or movement disorders, nerve damage; cough.

Valsartan

Uncommon (may affect up to 1 in 100 patients)

Dizziness, fatigue.

Frequency not known (frequency cannot be estimated from available data)

Decrease in red and white blood cells, decrease in blood platelets, fever, sore throat or mouth ulcers due to infection; spontaneous bleeding or skin bruising; increased potassium levels in blood; increased creatinine 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.

Reporting of adverse effects

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

5. Storage of Amlodipine/Valsartan Mylan

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 pack after EXP. The expiry date refers to the last day of the month indicated.

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan Mylan

The active substances in Amlodipine/Valsartan Mylan are amlodipine (as amlodipine besylate) and valsartan.

Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets

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

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

Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets

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

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

Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets

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

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

Appearance of Amlodipine/Valsartan Mylan and contents of the pack

Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets

Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets are biconvex, round, light yellow tablets with "AV1" on one side and "M" on the other.

Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets

Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets are yellow, oval, biconvex tablets with the imprint "AV2" on one side and "M" on the other.

Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets

Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets are light brown, oval, biconvex tablets with the imprint "AV3" on one side and "M" on the other.

Amlodipine/Valsartan Mylan is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets. All pack sizes are available in single-dose perforated blisters; the 14, 28, 56 and 98 tablet packs are also available in standard blisters.

Amlodipine/Valsartan Mylan is also available in bottles containing 28, 56 or 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories
Unit 35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

Mylan Hungary Kft.
Mylan utca 1
Komárom - 2900
Hungary

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe
Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352
Germany

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

Date of the most recent review of this leaflet: 05/2025.

Other sources of information

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