Amlodipine and valsartan Mylan

Italy
Brand name Amlodipine and valsartan Mylan
Form tablets, film-coated
Active substance / Dosage
VALSARTAN
AMLODIPINE
Prescription type Prescription only
ATC code
C09DB01
Registration number 044833
Manufacturer MYLAN PHARMACEUTICALS LIMITED

Table of Contents

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
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet
    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 of these substances help control high blood pressure.

  • Amlodipine belongs to a group of substances known as “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels, thereby preventing the narrowing of blood vessels.
  • 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, thereby 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 sufficiently controlled with 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 antagonist. This may cause 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, consult your doctor or pharmacist before taking Amlodipine/Valsartan Mylan.
  • if you have severe liver problems or bile-related disorders such as biliary cirrhosis or cholestasis.
  • if you are more than 3 months pregnant. (It is also advisable to avoid taking Amlodipine/Valsartan Mylan during early pregnancy; see section "Pregnancy".)
  • if you have very low blood pressure (hypotension).
  • if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to supply sufficient blood to the body).
  • if you have heart failure following a heart attack.
  • if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren. If any of these situations apply to you, do not take Amlodipine/Valsartan Mylan and consult your doctor.

Warnings and precautions
Talk to your doctor before taking Amlodipine/Valsartan Mylan:

  • if you have felt unwell (vomiting or diarrhoea).
  • if you have liver or kidney problems.
  • if you have had a kidney transplant or have been told you have narrowing of the renal arteries.
  • if you suffer from a disorder of the adrenal glands called “primary hyperaldosteronism”.
  • if you have had heart failure or a heart attack. Follow your doctor’s instructions carefully regarding the initial dosage. Your doctor may also monitor your kidney function.
  • if your doctor has told 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 (a condition called “obstructive hypertrophic cardiomyopathy”).
  • if you have previously experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you experience these symptoms, stop taking Amlodipine/Valsartan Mylan immediately and contact your doctor. You must never take Amlodipine/Valsartan Mylan again.
  • if you have kidney problems in which blood flow to the kidneys is reduced (renal artery stenosis).
  • if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Amlodipine/Valsartan Mylan. Your doctor will decide whether treatment should continue. 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 (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.
If any of these conditions apply to you, inform your doctor before taking Amlodipine/Valsartan Mylan.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age.

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 adjust the dose and/or take additional precautions. In some cases, it may be necessary to stop taking one of the medicines. This is particularly important for the following medicines:

  • ACE inhibitors or aliskiren (see also the sections "Do not take Amlodipine/Valsartan Mylan" and "Warnings and precautions");
  • diuretics (a type of medicine that increases the amount of urine produced);
  • lithium (a medicine used to treat certain types of depression);
  • potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other substances that may increase potassium levels;
  • certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. Your doctor may also monitor kidney function;
  • anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
  • St. John’s wort (Hypericum perforatum);
  • 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 (infusion for severe body temperature abnormalities);
  • tacrolimus (used to control the immune response to allow the body to accept a transplanted organ);
  • medicines used to prevent transplant rejection (cyclosporine).

Amlodipine/Valsartan Mylan with food and drink
Grapefruit and grapefruit juice must not be consumed by people taking Amlodipine/Valsartan Mylan. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of Amlodipine/Valsartan Mylan.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Amlodipine/Valsartan Mylan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Amlodipine/Valsartan Mylan is not recommended during early pregnancy (first 3 months) and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts. Amlodipine/Valsartan Mylan is not recommended for breastfeeding women, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine may cause dizziness. This may affect your ability to concentrate. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any other activities requiring concentration.

3. How to take Amlodipine/Valsartan Mylan

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor. This will help you achieve better results and reduce the risk of unwanted side effects.
The usual dose of Amlodipine/Valsartan Mylan is one tablet daily.

  • It is preferable to take the medicine at the same time every day.
  • Swallow the tablets with a glass of water.
  • Amlodipine/Valsartan Mylan can be taken with or without food. Do not take Amlodipine/Valsartan Mylan with grapefruit or grapefruit juice. Depending on your response to treatment, your doctor may recommend a lower or higher dose. Do not take more than the prescribed dose.
    Amlodipine/Valsartan Mylan and elderly patients (65 years and over) 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 shortness of breath, which may develop within 24–48 hours after ingestion.
    If you forget to take Amlodipine/Valsartan Mylan If you forget to take your 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, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.
    If you stop taking Amlodipine/Valsartan Mylan Stopping 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 questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical attention:
A small number of patients have experienced these serious side effects. If you notice any of the
following side effects, contact your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
Allergic reactions with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling of weakness, slight confusion).
Very rare (may affect up to 1 in 10,000 people)
Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Other possible side effects of Amlodipine/Valsartan Mylan:
Common (may affect up to 1 in 10 people)
Influenza-like illness; stuffy nose, sore throat and difficulty swallowing, headache; swelling of the arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); flushing and/or feeling of warmth in the face and/or neck; low levels of potassium in the blood.
Uncommon (may affect up to 1 in 100 people)
Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness in the hands or feet; vertigo; rapid heartbeat, including palpitations; dizziness when standing up; cough; diarrhoea; constipation; skin rashes, redness of the skin; joint swelling, back pain; joint pain; anorexia; high levels of calcium in the blood; high levels of plasma lipids; high levels of uric acid in the blood; low levels of sodium in the blood; abnormal coordination; visual disturbance; inflamed throat.
Rare (may affect up to 1 in 1,000 people)
Feeling of anxiety; ringing in the ears (tinnitus); fainting; passing larger amounts of urine than usual or increased urgency to urinate, inability to achieve or maintain an erection, feeling of heaviness; low blood pressure with symptoms such as dizziness, feeling of emptiness in the head; excessive sweating; rashes all over the body; itching; muscle spasm; visual disturbance.
If any of these side effects become severe, inform your doctor.

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

Amlodipine
If you notice any of the following very rare and serious side effects, consult your doctor immediately:

  • Sudden onset of breathlessness, chest pain, shortness of breath or difficulty breathing.
  • Swelling of the eyelids, face or lips.
  • Swelling of the tongue and throat which may cause difficulty breathing.
  • Severe skin reactions including severe rash, hives, widespread redness of the skin, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
  • Myocardial infarction, arrhythmia.
  • Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of illness.

The following side effects have been reported. If any of these occur, or if they persist for more than one week, contact your doctor.
Common (may affect up to 1 in 10 people)
Dizziness; fatigue; drowsiness; palpitations (awareness of your heartbeat); flushing, swelling of the ankles (oedema); abdominal pain, nausea.
Uncommon (may affect up to 1 in 100 people)
Mood changes, anxiety, depression, insomnia, tremor, altered taste, fainting, loss of sensitivity to pain; visual disturbances, impaired vision, ringing in the ears; low blood pressure; sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting; hair loss; increased sweating; itchy skin; skin rash; change in skin colour; urinary disorders, need to urinate at night; frequent need to urinate; inability to achieve an erection; discomfort or enlargement of the breasts in men; pain; malaise; feeling of weakness; muscle pain; muscle cramps; muscle spasm; back pain; joint pain; weight gain or loss; changes in bowel habits; 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)
Low levels of white blood cells and platelets in the blood which may lead to unusual bruising or tendency to bleed (damage to red blood cells); high blood sugar levels (hyperglycaemia); gum swelling, abdominal swelling (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to abnormalities in certain clinical tests; increased muscle tension; inflammation of blood vessels, often with rash, photosensitivity; disorders related to stiffness, tremor and/or movement disorders, nerve damage, cough.

Valsartan
Uncommon (may affect up to 1 in 100 people)
Dizziness, fatigue
Not known (frequency cannot be estimated from the available data)
Decrease in red and white blood cells, decrease in platelets in the blood, fever, sore throat or mouth pain due to infections; spontaneous bleeding or bruising; high levels of potassium in the blood; high levels of creatinine in the blood, abnormal liver function tests; reduced kidney function and severe reduction in kidney function; swelling, especially of the face and throat; muscle pain; skin rash, red-purple spots; fever; itching; allergic reaction; blistering of the skin (a sign of a condition called bullous dermatitis).
If any of these side effects affect you, inform your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
For bottles: 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 packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amlodipine/Valsartan Mylan contains
The active substances 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 components are microcrystalline cellulose; crospovidone; magnesium stearate; anhydrous colloidal 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; anhydrous colloidal 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; anhydrous colloidal silica; hypromellose; macrogol 8000; talc; titanium dioxide (E171); yellow iron oxide (E172); red iron oxide (E172); black iron oxide (E172); vanillin.

Description of the appearance of Amlodipine/Valsartan Mylan and contents of the pack
Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets
The film-coated tablets (tablets) of Amlodipine/Valsartan Mylan 5 mg/80 mg are light yellow, biconvex, round, with "AV1" engraved on one side and "M" on the other.
Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets
The film-coated tablets (tablets) of Amlodipine/Valsartan Mylan 5 mg/160 mg are yellow, biconvex, oval, with "AV2" engraved on one side and "M" on the other.
Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets
The film-coated tablets (tablets) of Amlodipine/Valsartan Mylan 10 mg/160 mg are light brown, biconvex, oval, with "AV3" engraved on one side and "M" on the other.
Amlodipine/Valsartan Mylan is available in blisters containing 14, 28, 30, 56, 90 and 98 tablets.
All packs are available in divisible unit-dose blisters; packs containing 14, 28, 30, 56, 90 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 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 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Mylan bvba/sprl Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Mylan bvba/sprl
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf.: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OU Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Generics Pharma Hellas ΕΠΕ Viatris Austria GmbH
Τηλ: + 30 210 993 6410 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 21 412 72 56

Hrvatska România
Mylan Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Mylan Healthcare d.o.o
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd. Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.