Amlodipine / Valsartan Mylan - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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.

What is in this leaflet

• 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. 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 of these substances help to control high blood pressure.

• – Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine

stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.

• – Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.

Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.

Amlodipine/Val­sartan Mylan is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.

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 blockers. This may involve

itching, reddening of the skin or difficulty in 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, talk to your doctor before taking Amlodipine/Val­sartan Mylan.

• – if you have severe liver problems or bile problems such as biliary cirrhosis or cholestasis.

• – if you are more than 3 months pregnant (It is also better to avoid Amlodipine/Val­sartan Mylan

in early pregnancy, see Pregnancy section).

• – if you have severe low blood pressure (hypotension).

• – if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition

where your heart is unable to supply enough blood to the body).

• – if you suffer from heart failure after a heart attack.

• – if you have diabetes or impaired kidney function and you are treated with a blood pressure

lowering medicine containing aliskiren.

If any of the above applies to you, do not take Amlodipine/Val­sartan Mylan and talk to your doctor.

Warnings and precautions

Talk to your doctor before taking Amlodipine/Val­sartan Mylan:

• – if you have been sick (vomiting or diarrhoea).

• – if you have liver or kidney problems.

• – if you have had a kidney transplant or if you had been told that you have a narrowing of your

kidney arteries.

• – if you have a condition affecting the renal glands called “primary hyperaldostero­nism”.

• – if you have had heart failure or have experienced a heart attack. Follow your doctor’s

instructions for the starting dose carefully. Your doctor may also check your kidney function.

• – if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic

or mitral stenosis”) or that the thickness of your heart muscle is 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 get these symptoms, stop taking Amlodipine/Val­sartan Mylan and contact your doctor straight away. You should never take Amlodipine/Val­sartan Mylan again.

• – if you have kidney problems where the blood supply to your kidneys is reduced (renal artery

stenosis)

• – if you are taking any of the following medicines used to treat high blood pressure:

• – an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril,

ramipril), in particular if you have diabetes-related kidney problems.

• – aliskiren.

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

If any of these apply to you, tell your doctor before taking Amlodipine/Val­sartan Mylan.

Children and adolescents

Do not give this medicine to children and adolescents below 18 years old.

Other medicines and Amlodipine/Val­sartan Mylan

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

• – ACE inhibitors or aliskiren (see also information under the headings “Do not take

Amlodipine/Val­sartan Mylan” and “Warnings and precautions”);

• – diuretics (a type of medicine also called “water tablets” which increases the amount of urine you

produce);

• – lithium (a medicine used to treat some types of depression);

• – potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and

other substances that may increase potassium levels;

• – certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or

selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also check 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,

talithromycin);

• – verapamil, diltiazem (heart medicines);

• – simvastatin (a medicine used to control high cholesterol levels);

• – dantrolene (infusion for severe body temperature abnormalities);

• – medicines used to protect against transplant rejection (ciclosporin).

Amlodipine/Val­sartan Mylan with food and drink

Grapefruit and grapefruit juice should not be consumed by people who are taking Amlodipine/Val­sartan Mylan. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine/Val­sartan Mylan.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Amlodipine/Val­sartan Mylan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Amlodipine/Val­sartan Mylan. Amlodipine/Val­sartan Mylan is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding.

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

Amlodipine/Val­sartan Mylan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

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

Driving and using machines

This medicine may make you feel dizzy. This can affect how well you can concentrate. So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.

3. How to take Amlodipine/Valsartan Mylan

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. This will help you get the best results and lower the risk of side effects.

The usual dose of Amlodipine/Val­sartan Mylan is one tablet per day.

• – It is preferable to take your 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 how you respond to the treatment, your doctor may suggest a higher or lower strength.

Do not exceed the prescribed dose.

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

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 tablets of Amlodipine/Val­sartan Mylan, consult a doctor immediately.

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 its usual time. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Amlodipine/Val­sartan Mylan

Stopping your treatment with Amlodipine/Val­sartan Mylan may cause your disease to get worse. 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). If any of the following happen, tell your doctor straight away:

Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).

Other possible side effects of Amlodipine/Valsartan Mylan:

Common (may affect up to 1 in 10 people)

Influenza (flu); blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; asthenia (weakness); redness and warm feeling of the face and/or neck; low level of potassium in blood.

Uncommon (may affect up to 1 in 100 people)

Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints; anorexia; high level of calcium in the blood; high level of plasma lipids; high level of uric acid in the blood; low level of sodium in the blood; abnormal coordination; visual impairment; sore throat.

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

Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light-headedness; excessive sweating; skin rash all over your body; itching; muscle spasm; visual disturbance.

If any of these affect you severely, tell your doctor.

Side effects reported with amlodipine or valsartan alone and either not observed with Amlodipine/Val­sartan Mylan or observed with a higher frequency than with Amlodipine/Val­sartan Mylan:

Amlodipine

Consult a doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine:

• – Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing.

• – Swelling of eyelids, face or lips.

• – Swelling of the tongue and throat which causes great difficulty breathing.

• – Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole

body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions.

• – Heart attack, abnormal heart beat.

• – Inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling

5. How to store 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 after EXP. The expiry date refers to the last day of that month.

For bottle packs: After first opening use within 100 days.

This medicine does not require any special storage conditions.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Amlodipine/Val­sartan Mylan contains

The active substances of Amlodipine/Val­sartan Mylan are amlodipine (as amlodipine besilate) and valsartan.

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

Each tablet contains 5 mg amlodipine and 80 mg valsartan.

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

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

Each tablet contains 5 mg amlodipine and 160 mg valsartan.

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

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

Each tablet contains 10 mg amlodipine and 160 mg valsartan.

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

What Amlodipine/Valsartan Mylan looks like and contents of the pack

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

Amlodipine/Val­sartan Mylan 5 mg/80 mg tablets are light yellow, round, biconvex film-coated tablet marked 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 tablets are yellow, oval, biconvex film-coated tablet marked with “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 tablets are light brown, oval, biconvex film-coated tablet marked with “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 packs are available in perforated unit dose 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.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allée des parcs

69800 Saint Priest

France

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories

Unit 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

Ireland

Mylan Hungary Kft.

Mylan utca 1,

Komarom – 2900

Hungary

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe

Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352

Germany

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

België/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00 Efcarapua MaňaaH EOOfl Tea: +359 2 44 55 400 Česká republika Mylan Healthcare CZ.s.r.o. Tel: + 420 222 004 400 Danmark Mylan Denmark ApS Tlf: +45 28 11 69 32 Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800 Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052

Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288 Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Nederland Mylan BV Tel: +31 (0)20 426 3300 Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00

Tql: + 30 210 993 6410	Tel: +43 1 416 2418
España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712	Polska Mylan Healthcare Sp. z.o.o. Tel: + 48 22 546 64 00
France Mylan S.A.S Tel: + 33 4 37 25 75 00	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BGP Products SRL Tel: + 40 372 579 000
Ireland Mylan Ireland Limited Tel: +353 (0) 87 1694982	Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
Ísland Icepharma hf Tel: +354 540 8000	Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100
Italia Mylan Italia S.r.l. Tel: + 39 02 612 46921	Suomi/Finland Mylan Finland OY Puh/Tel: + 358 20 720 9555
Kúnpog Varnavas Hadjipanayis Ltd Tql: +357 2220 7700	Sverige Mylan AB Tel: + 46 855 522 750
Latvija Mylan Healthcare SIA Tel: +371 676 055 80	United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

53