AMLODIPINE/VALSARTAN MYLAN 10 mg/160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Amlodipine/Valsartan Mylan is and what it is used for
2. What you need to know before you take Amlodipine/Valsartan Mylan
3. How to take Amlodipine/Valsartan Mylan
4. Possible side effects
5. Storage of 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 to control high blood pressure.

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

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

Amlodipine/Valsartan Mylan 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 you take Amlodipine/Valsartan Mylan

Do not take Amlodipine/Valsartan Mylan:

• If you are allergic to amlodipine or to any other calcium channel blocker. This can include itching, skin rash, 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 problems such as 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 at the start of your pregnancy, see section Pregnancy).
• If you have severe low blood pressure (hypotension).
• If you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation where your heart is unable to supply enough blood to your body).
• If you have heart failure after a heart attack.
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine containing aliskiren.

Do not take Amlodipine/Valsartan Mylan and inform your doctor if any of the above applies to you.

Warnings and precautions

Consult your doctor before starting to take Amlodipine/Valsartan Mylan:

• If you have been ill (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 arteries to your kidneys.
• 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 carefully to start the dosing. Your doctor may also check your kidney function.
• If your doctor has informed you that you have a narrowing of the heart valves (so-called «aortic or mitral stenosis») or that the thickness of your heart muscle has increased abnormally (so-called «hypertrophic obstructive cardiomyopathy»).
• If you have experienced swelling, particularly in the face and throat, while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking Amlodipine/Valsartan Mylan and contact your doctor immediately. 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 diarrhea 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), especially if you have kidney problems related to diabetes.
• Aliskiren.

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

Tell your doctor before taking Amlodipine/Valsartan Mylan if any of the above applies to you.

Children and adolescents

Do not give to children or adolescents (under 18 years).

Other medicines and Amlodipine/Valsartan Mylan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to modify your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially applicable to the medicines listed below:

• An ACE inhibitor or aliskiren (see also the information under the headings «Do not take Amlodipine/Valsartan Mylan» and «Warnings and precautions»);
• diuretics (a type of medicine that increases the amount of urine);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes that contain potassium, and other substances that may increase potassium levels;
• a certain type of pain medicine called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. Your doctor may also check your kidney function;
• antiepileptic agents (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• nitroglycerin and other nitrates, or other substances called «vasodilators»;
• medicines used to treat 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 (in infusion for severe body temperature abnormalities);
• tacrolimus (used to control the body's immune response to allow it to accept a transplanted organ)
• medicines used to protect against rejection in a transplant (cyclosporine).

Taking Amlodipine/Valsartan Mylan with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Amlodipine/Valsartan Mylan before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another blood pressure medicine instead. It is not recommended to use Amlodipine/Valsartan Mylan at the start of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding.

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

Amlodipine/Valsartan Mylan is not recommended for use in women during breastfeeding. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine may make you feel dizzy. This may affect your ability to concentrate. If you are unsure how this medicine will affect you, do not drive, use machines, or perform other activities that require concentration.

3. How to take Amlodipine/Valsartan Mylan

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. This will help you to get the best results and reduce the risk of side effects.

The usual dose of Amlodipine/Valsartan Mylan 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 can take Amlodipine/Valsartan Mylan with or without food. Do not take Amlodipine/Valsartan Mylan with grapefruit or grapefruit juice.

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

Do not exceed the prescribed dose.

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

Your doctor should exercise caution when increasing the dose.

If you take more Amlodipine/Valsartan Mylan than you should

If you have taken too many Amlodipine/Valsartan Mylan tablets, contact a doctor immediately. Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 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 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 missed 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Amlodipine/Valsartan Mylan can cause adverse effects, although not all people will experience them.

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

A few 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 skin rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling of fainting, dizziness).

Very Rare (may affect up to 1 in 10,000 patients)

Swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea (intestinal angioedema).

Other Possible Adverse Effects of Amlodipine/Valsartan Mylan:

Frequent(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); reddening and warming of the face and/or neck; decrease in potassium levels in the blood.

Infrequent(may affect up to 1 in 100 patients)

Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling, or numbness of the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, skin reddening; joint inflammation, back pain; joint pain; anorexia; high calcium levels in the blood; high lipid levels in plasma; high uric acid levels in the blood; low sodium levels in the blood; abnormal coordination; vision disorders; sore throat.

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

Anxiety; ringing in the ears (tinnitus); fainting; increased urine output 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 disturbance.

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

Adverse Effects Reported with Amlodipine or Valsartan Alone and Not Observed with Amlodipine/Valsartan Mylan or Observed with a Higher Frequency than with Amlodipine/Valsartan Mylan:

Amlodipine

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

• Sudden wheezing when breathing (sudden wheezing), 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, hives, skin reddening all over the body, significant itching, blistering, peeling, and skin inflammation, 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 great feeling of discomfort.

The following adverse 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, fatigue; drowsiness; palpitations (feeling the heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, feeling of discomfort (nausea).

Infrequent(may affect up to 1 in 100 patients)

Mood changes, anxiety, depression, drowsiness, tremors, taste disturbances, fainting, loss of pain sensation; vision disturbances, visual impairment, ringing in the ears; low blood pressure; nasal congestion/nasal secretion caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching of the skin, erythema; skin discoloration; urination disorder, increased need to urinate at night, increased number of times urinating; inability to achieve an erection, discomfort or breast enlargement in men, pain, feeling of discomfort, feeling weak; muscle pain, muscle cramps, muscle spasms; back pain; joint pain; weight gain or loss; change in bowel habits; diarrhea; 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 the number of white blood cells in the blood, decrease in blood platelets that can cause easy bleeding or unusual bruising (red blood cell damage); high blood sugar (hyperglycemia); gum inflammation, abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests; increased muscle tension; inflammation of blood vessels often with skin eruptions, sensitivity to light; disorders combining stiffness, tremors, and/or movement disorders, nerve damage; cough.

Valsartan

Infrequent(may affect up to 1 in 100 patients)

Dizziness, fatigue.

Frequency Not Known(frequency cannot be estimated from available data)

Decrease in the number of red and white blood cells, decrease in blood platelets, fever, sore throat or mouth ulcers due to infection; spontaneous bleeding or bruising; high potassium levels in the blood; high creatinine levels 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, purplish red spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis).

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

Reporting of Adverse Effects

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

5. Storage of Amlodipine/Valsartan Mylan

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

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

This medication does not require special storage conditions.

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

Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Amlodipine/Valsartan Mylan

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

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

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

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

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

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

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

Appearance of Amlodipine/Valsartan Mylan and Package Contents

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

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

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

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

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

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

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

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

Not all package sizes may be marketed.

Marketing Authorization Holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Manufacturer

McDermott Laboratories Limited under the trade name 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus: 05/2025.

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.