Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - amlodipine

Document Subject

Generated Narrative: MedicinalProductDefinition mp613075564472c8742b180667f231d172

identifier: http://ema.europa.eu/identifier/EU/1/16/1092/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

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

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-613075564472c8742b180667f231d172

identifier: http://ema.europa.eu/identifier/EU/1/16/1092/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - amlodipine

Attesters

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

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.

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.

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. Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.

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.

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 of being very unwell.

The following side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

Common (may affect up to 1 in 10 people) Dizziness); tiredness; sleepiness; palpitations (awareness of your heart beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).

Uncommon (may affect up to 1 in 100 people) Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss; increased sweating; itchy skin; rash; skin discolouration; disorder in passing urine; increased need to urinate at night; increased number of times of passing urine; inability to obtain an erection; discomfort or enlargement of the breasts in men; pain; feeling unwell; feeling weak; muscle pain; muscle cramps; muscle spasm; back pain; joint pain; weight increase or decrease; change of bowel habit; diarrhoea; dry mouth; chest pain.

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

Very rare (may affect up to 1 in 10,000 people) Decreased number of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining rigidity, tremor and/or movement disorders, nerve damage; cough.

Valsartan

Uncommon (may affect up to 1 in 100 people) Vertigo, tiredness

Not known (frequency cannot be estimated from the available data) Decrease in red blood cells and white blood cells, decrease in blood platlets, fever, sore throat or mouth sores due to infections; spontaneous bleeding or bruising; high level of potassium in the blood; high level of creatinine in the blood, abnormal liver test results; decreased renal functions and severely decreased renal functions; swelling mainly of the face and the throat; muscle pain; rash, purplish-red spots; fever; itching; allergic reaction; blistering skin (sign of a condition called dermatitis bullous).

If you experience any of these, tell your doctor straight away.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin Ireland

Mylan Hungary Kft. Mylan utca 1, Kom rom - 2Hungary

Mylan Germany GmbH Zweigniederlassung Bad Homburg v. d. Hoehe Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61Germany

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

Belgi /Belgique/Belgien Viatris
T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Viatris
Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o.
Tel: + 420 222 004 Magyarorsz g Mylan EPD Kft Tel: + 36 1 465 2Danmark
Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH
Tel: +49 800 0700 Nederland Mylan BV
Tel: +31 (0)20 426 3Eesti Norge

BGP Products Switzerland GmbH Eesti filiaal
Tel: + 372 6363 Viatris AS Tlf: + 47 66 75 33
Viatris Hellas Ltd
: + 30 2100 100 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U
Tel: + 34 900 102 Polska Mylan Healthcare Sp. z.o.o.
Tel: + 48 22 546 64 France Viatris Sant
T l: + 33 4 37 25 75 Portugal Mylan, Lda.
Tel: + 351 214 127 Hrvatska Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 Ireland Mylan Ireland Limited Tel: +353 1 8711Rom nia BGP Products SRL
Tel: + 40 372 579 Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o.
Tel: +421 2 32 199 Italia
Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris OyPuh/Tel: + 358 20 720 9
Varnavas Hadjipanayis Ltd
: +357 2220 7Sverige Viatris AB
Tel: + 46 (0)8 630 19 Latvija Mylan Healthcare SIA
Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited
Tel: +353 18711This leaflet was last revised in

Other sources of information

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