Amlodipine/valsartan/hydrochlorothiazide Mylan Pharma: detailed information

PACKAGE LEAFLET

Package leaflet: Information for the user

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 5 mg/160 mg/12.5 mg film-coated tablets
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 5 mg/160 mg/25 mg film-coated tablets
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/160 mg/12.5 mg film-coated tablets
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/160 mg/25 mg film-coated tablets
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/320 mg/25 mg film-coated tablets
Equivalent medicine
Please read all of this 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma is and what it is used for
What you need to know before taking Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma
How to take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma
Possible side effects
How to store Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma
Contents of the pack and other information

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

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma tablets contain three substances called
amlodipine, valsartan and hydrochlorothiazide.
All 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, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
‐ Hydrochlorothiazide belongs to a group of substances known as “thiazide diuretics”.
Hydrochlorothiazide increases the elimination of urine, thereby reducing blood pressure.
As a result of these three mechanisms, blood vessels relax and blood pressure decreases.
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma is used to treat high blood pressure in adult patients whose blood pressure is already controlled with amlodipine, valsartan and hydrochlorothiazide, and who may benefit from taking a single tablet containing all three substances.

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

Do not take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma
‐ if you are more than 3 months pregnant. (It is recommended to avoid taking this medicine
even in the early stages of pregnancy – see the Pregnancy section.)
‐ if you are allergic to amlodipine or any other calcium antagonist, valsartan, hydrochlorothiazide, sulfonamide derivatives (medicines used to treat chest and urinary tract infections), or any of the other components of this medicine (see section 6).
‐ If you think you may be allergic, do not take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma and consult your doctor.
‐ if you have liver problems, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to bile retention in the liver (cholestasis).
‐ if you have severe kidney problems or are on dialysis.
‐ if you are unable to urinate (anuria).
‐ if your blood potassium or sodium levels are too low despite treatment to increase them.
‐ if your blood calcium level is too high despite treatment to reduce it.
‐ if you have gout (uric acid crystals in the joints).
‐ 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 cannot supply enough blood to the body).
‐ if you suffer from 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 conditions apply to you, do not take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma if:
‐ you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).
‐ you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle cramps, seizures).
‐ you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and cramps).
‐ you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the renal arteries.
‐ you have liver (hepatic) problems.
‐ you have or have had heart failure or coronary artery disease, especially if you have been prescribed the maximum dose of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma (10 mg/320 mg/25 mg).
‐ you have had a heart attack. Follow your doctor’s instructions carefully regarding initial dosing. Your doctor may also monitor your kidney function.
‐ your doctor has told you that you have narrowing of the heart valves (called “aortic or mitral stenosis”) or that the heart muscle has abnormally thickened (a condition called “obstructive hypertrophic cardiomyopathy”).
‐ you suffer from aldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma is not recommended.
‐ you suffer from systemic lupus erythematosus (also known as “lupus” or “SLE”).
‐ you have diabetes (high blood sugar levels).
‐ you have high cholesterol or triglyceride levels in your blood.
‐ you have skin reactions after sun exposure (e.g., a rash).
‐ you have had an allergic reaction to other blood pressure medicines or diuretics (a type of medicine also known as “water pills”), especially if you suffer from asthma or allergies.
‐ you have felt unwell (vomiting or diarrhea).
‐ 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 / Hydrochlorothiazide Mylan Pharma immediately and contact your doctor right away. You must never take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma again.
‐ you experience dizziness and/or fainting during treatment with Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma; inform your doctor as soon as possible.
‐ you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur hours to weeks after taking Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma. If untreated, they may lead to permanent vision damage.
‐ you are taking any of the following medicines used to treat high blood pressure:
‐ an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
‐ aliskiren.
‐ you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma.

Your doctor may regularly check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).
See also the section “Do not take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma.”
If any of these conditions apply to you, inform your doctor.

For athletes: using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma is not recommended for use in children and adolescents under 18 years of age.

Elderly (65 years and over)
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma can be used by individuals aged 65 years and older at the same dosage and in the same manner as adults, consistent with the use of the individual components amlodipine, valsartan, and hydrochlorothiazide. Elderly patients, especially those taking the maximum dose of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma (10 mg/320 mg/25 mg), should regularly monitor their blood pressure.

Other medicines and Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to adjust your dose and/or take other precautions.
In some cases, it may be necessary to stop taking one of the medicines.
This is especially important if you are taking any of the following:

Do not take with:

lithium (a medicine used to treat certain types of depression);
medicines or substances that increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
ACE inhibitors or aliskiren (see also the sections “Do not take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma” and “Warnings and precautions”).

Use with caution:

alcohol, sedatives, and anesthetics (medicines allowing patients to undergo surgery and other procedures);
amantadine (used for anti-Parkinson therapy and also for treatment or prevention of certain viral diseases);
anticholinergic agents (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an adjunct to anesthesia);
anticonvulsant medicines and mood stabilizers used to treat epilepsy and bipolar disorder (such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
cholestyramine, colestipol, or other resins (substances mainly used to treat high blood lipid levels);
simvastatin (a medicine used to control high cholesterol levels);
cyclosporine (a medicine used in organ transplantation to prevent organ rejection or for other conditions such as rheumatoid arthritis or atopic dermatitis);
cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
digoxin or other digitalis glycosides (medicines used to treat heart problems); verapamil, diltiazem (heart medicines); iodinated contrast agents (used in imaging procedures); medicines used to treat diabetes (oral agents such as metformin or insulin);
medicines used to treat gout, such as allopurinol;
medicines that may increase blood sugar levels (beta-blockers, diazoxide);
medicines that may cause “torsade de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics;
medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
medicines that may reduce blood potassium levels, such as diuretics (“water pills”), corticosteroids, laxatives, amphotericin, or penicillin G;
medicines used to increase blood pressure, such as adrenaline or noradrenaline;
medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
medicines used for stomach ulcers and esophageal inflammation (carbenoxolone);
medicines used to relieve pain or inflammation, particularly non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors);
muscle relaxants (medicines used to relax muscles during surgical procedures); nitroglycerin and other nitrates or other substances called “vasodilators”;
other medicines used to treat high blood pressure, including methyldopa;
rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
St. John’s wort;
dantrolene (infusion for severe body temperature abnormalities);
vitamin D and calcium salts.

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma with food, drinks, and alcohol
Grapefruit and grapefruit juice must not be consumed by people who have been prescribed Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma. Consult your doctor before drinking alcohol. Alcohol may lower your blood pressure too much and/or increase the risk of dizziness and fainting.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause severe harm to the unborn child if used beyond 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 / Hydrochlorothiazide Mylan Pharma is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
This medicine may cause dizziness, drowsiness, nausea, or headache. If you experience any of these symptoms, do not drive or operate tools or machinery.

3. How to take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor. This will help you achieve the best results and reduce the risk of side effects.
The usual dose of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma is one tablet daily.
‐ It is best to take the tablet at the same time every day. Morning is the best time.
‐ Swallow the tablet whole with a glass of water.
‐ Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma may be taken with or without food. Do not take this medicine 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.

If you take more Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma than you should
If you have accidentally taken too many tablets of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma, contact a doctor immediately. You may require medical treatment.

If you forget to take Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma
If you forget to take a dose of this medicine, take it as soon as you remember, then take your next dose at the usual time. If it is almost time for your next dose, simply take the next tablet at the regular time. Do not take a double dose (two tablets together) to make up for a forgotten tablet.

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

Keep taking the medicine even if you feel well
People with high blood pressure often do not notice any symptoms. Many feel perfectly normal. To achieve the best results and reduce the risk of side effects, it is very important that you take this medicine exactly as prescribed by your doctor. Keep your doctor’s appointments even if you feel well.

If you have any doubts about how to use 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.
As with any combination containing three active substances, side effects associated with each individual component cannot be ruled out. The side effects reported with Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma or with any of the three active ingredients (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur during use of this medicine.
Some side effects may be serious and require immediate medical attention. Contact your doctor immediately if, after taking this medicine, you experience any of the following serious side effects:
Common (may affect up to 1 in 10 people):

dizziness
low blood pressure (feeling faint, sensation of emptiness in the head, sudden loss of consciousness)

Uncommon (may affect up to 1 in 100 people):

severe decrease in urine output (reduced kidney function)

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

spontaneous bleeding
irregular heartbeat
liver disorders

Very rare (may affect up to 1 in 10,000 people):

sudden onset of wheezing, shortness of breath, chest pain, breathlessness or difficulty breathing
swelling of the eyelids, face or lips
swelling of the tongue and throat which may cause severe breathing difficulties
severe skin reactions including intense skin rash, hives, widespread skin redness, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
heart attack
inflammation of the pancreas, which may cause severe abdominal and back pain associated with a strong feeling of illness
weakness, bruising, fever and frequent infections
stiffness

Other side effects may include:
Very common (may affect more than 1 in 10 people):

low blood potassium levels
increased blood lipids

Common (may affect up to 1 in 10 people):

drowsiness
palpitations (awareness of heartbeat)
flushing
swelling of the ankles (oedema)
abdominal pain
stomach discomfort after meals
fatigue
headache
frequent need to urinate
high blood uric acid levels
low blood magnesium levels
low blood sodium levels
dizziness, fainting when standing up
reduced appetite
nausea and vomiting
itchy rash and other types of skin rashes
inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 people):

fast heartbeat
sensation of dizziness
vision disturbances
stomach discomfort
chest pain
increased blood urea, creatinine and uric acid levels
high levels of calcium, fats or sodium in the blood
decreased potassium in the blood
bad breath
diarrhoea
dry mouth
weight gain
loss of appetite
altered taste
back pain
joint swelling
muscle cramps, weakness or pain
pain in the extremities
inability to stand or walk normally
weakness
abnormal coordination
dizziness when standing up or after physical exertion
lack of energy
sleep disturbances
tingling or numbness
neuropathy
sudden and temporary loss of consciousness
low blood pressure when standing up
cough
shortness of breath
throat irritation
excessive sweating
itching
swelling, redness and pain along a vein
skin redness
tremor
mood changes
anxiety
depression
insomnia
altered taste
fainting
loss of sensitivity to pain
visual disturbances
impaired vision
ringing in the ears
sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
altered bowel habits
indigestion
hair loss
skin itching
change in skin colour
urinary disorders
increased need to urinate at night
frequent need to urinate
discomfort or breast enlargement in men
pain
malaise
weight loss

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

low platelet count in the blood (sometimes with bleeding or bruising under the skin)
glucose in the urine
high blood sugar levels
worsening of diabetic metabolic state
abdominal discomfort
constipation
liver disorders which may occur together with yellowing of the skin and eyes or dark-coloured urine (haemolytic anaemia)
increased sensitivity of the skin to sunlight
purplish skin spots
kidney disorders
confusion

Very rare (may affect up to 1 in 10,000 people):

decrease in the number of white blood cells in the blood
low platelet count in the blood, which may lead to unusual bruising or tendency to bleed (damage to red blood cells)
gum swelling
abdominal swelling (gastritis)
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 skin rash (skin rash) – photosensitivity
disorders related to stiffness, tremor and/or movement disorders
fever, sore throat or mouth ulcers, more frequent infections (lack of or low levels of white blood cells)
pallor, fatigue, shortness of breath, dark-coloured urine (haemolytic anaemia, abnormal destruction of red blood cells in blood vessels or elsewhere in the body)
confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloraemic alkalosis)
severe pain in the upper abdomen (inflammation of the pancreas)
difficulty breathing with fever, cough, wheezing, breathlessness (respiratory distress, pulmonary oedema, pneumonia)
facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
severe skin disease causing skin rash, skin redness, blistering of lips, eyes and mouth, peeling of the skin, fever (toxic epidermal necrolysis)

Not known (frequency cannot be estimated from the available data):

changes in blood tests for kidney function, increased potassium in the blood, low levels of red blood cells in the blood
abnormal red blood cell values in the blood
low levels of certain types of white blood cells and platelets
increased creatinine in the blood
abnormal liver function tests
severe decrease in the amount of urine produced
inflammation of blood vessels
weakness, bruising and frequent infections (aplastic anaemia)
reduced vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
shortness of breath
severe decrease in urine output (possible signs of kidney disorders or kidney failure)
severe skin disease causing skin rash, skin redness, blistering of lips, eyes and mouth, peeling of the skin, fever (erythema multiforme)
muscle spasm
fever (pyrexia)
blister formation on the skin (sign of a disorder called bullous dermatitis)
skin and lip cancer (non-melanoma skin cancer)

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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma

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.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light and moisture.
Do not use packs of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma that are damaged or show
signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma contains
Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 5 mg/160 mg/12.5 mg film-coated tablets

The active substances are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 5 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc and titanium dioxide (E171).

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 5 mg/160 mg/25 mg film-coated tablets

The active substances are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 5 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 25 mg hydrochlorothiazide.
The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/160 mg/12.5 mg film-coated tablets

The active substances are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/160 mg/25 mg film-coated tablets

The active substances are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 160 mg valsartan and 25 mg hydrochlorothiazide.
The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/320 mg/25 mg film-coated tablets

The active substances are amlodipine (as amlodipine besilate), valsartan and hydrochlorothiazide. Each film-coated tablet contains 10 mg amlodipine (as amlodipine besilate), 320 mg valsartan and 25 mg hydrochlorothiazide.
The other components are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Description of the appearance of Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma and contents of the packaging

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 5 mg/160 mg/12.5 mg film-coated tablets
White, ovaloid, biconvex tablets, with “LLL” engraved on one side and smooth on the other. Available in packs containing 14, 28 or 30 film-coated tablets.

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 5 mg/160 mg/25 mg film-coated tablets
Yellow, ovaloid, biconvex tablets, with “LLH” engraved on one side and smooth on the other. Available in packs containing 14, 28 or 30 film-coated tablets.

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/160 mg/12.5 mg film-coated tablets
Light yellow, ovaloid, biconvex tablets, with “HLL” engraved on one side and smooth on the other. Available in packs containing 14, 28 or 30 film-coated tablets.

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/160 mg/25 mg film-coated tablets
Yellow-brown, ovaloid, biconvex tablets, with “HLH” engraved on one side and smooth on the other. Available in packs containing 14, 28 or 30 film-coated tablets.

Amlodipine / Valsartan / Hydrochlorothiazide Mylan Pharma 10 mg/320 mg/25 mg film-coated tablets
Yellow-brown, ovaloid, biconvex tablets, with “HHH” engraved on one side and smooth on the other. Available in packs containing 14, 28 or 30 film-coated tablets.

Marketing Authorization Holder
Mylan S.p.A. – Via Vittor Pisani, 20 – 20124 Milano, Italy

Manufacturer
Genepharm S.A.
18 km Marathonos Avenue
15351 Pallini Attiki
Greece
Pharmadox Healthcare Ltd.,
KW2OA Kordin Industrial
Park, Paola,
PLA 3000, Malta
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial
Estate, Hal Far, Birzebbugia,
BBG3000, Malta