АМЛОДИПІНА 5 mg/160 mg/12.5 mg Film-coated tablets

Зміст інструкції

1. What is Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma and what is it used for
2. What you need to know before taking Amlodipina / Valsartan / Idroclorotiazide Mylan
3. How to take Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
4. Possible side effects
5. How to store Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
6. Package Contents and Other Information

Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 5 mg/160 mg/12,5 mg film-coated tablets
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 5 mg/160 mg/25 mg film-coated tablets
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 10 mg/160 mg/12,5 mg film-coated tablets
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 10 mg/160 mg/25 mg film-coated tablets
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 10 mg/320 mg/25 mg film-coated tablets
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma is and what it is used for
• 2. What you need to know before you take Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
• 3. How to take Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
• 4. Possible side effects
• 5. How to store Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
• 6. Contents of the pack and other information

1. What is Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma and what is it used for

The Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma tablets contain three substances called
amlodipine, valsartan and hydrochlorothiazide.
All these substances help to control high blood pressure.
‐ Amlodipine belongs to a group of substances called “calcium channel blockers”.
Amlodipine prevents calcium from entering the walls of blood vessels and thus stops the
narrowing of blood vessels.
‐ Valsartan belongs to a group of substances called “angiotensin II receptor antagonists”. Angiotensin II is produced by the body and causes the narrowing of blood vessels,
thus increasing blood pressure. Valsartan works by blocking the effect
of angiotensin II.
‐ Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”.
Hydrochlorothiazide increases the elimination of urine, thus reducing blood pressure.
As a consequence of the three mechanisms, blood vessels relax and blood pressure decreases.
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma is used in the treatment of high blood pressure
in adult patients whose blood pressure is already controlled by taking amlodipine, valsartan and
hydrochlorothiazide and who may benefit from taking a single tablet containing the three
substances.

2. What you need to know before taking Amlodipina / Valsartan / Idroclorotiazide Mylan

Pharma
Do not take Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
‐ if you are pregnant for more than 3 months. (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, derivatives
of sulfonamide (medicines used to treat chest and urinary infections) or any
other component of this medicine (see section 6).
‐ If you think you may be allergic, do not take Amlodipina / Valsartan / Idroclorotiazide 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 stagnation in the liver (cholestasis).
‐ if you have severekidney problems or if you are on dialysis.
‐ if you are unable to urinate (anuria).
‐ if the levels of potassium or sodium in your blood are too low despite treatment to
increase your potassium or sodium levels in the blood.
‐ if the level of calcium in your blood is too high despite treatment to reduce its level of
calcium in the blood.
‐ if you have gout (uric acid crystals in the joints).
‐ if you have very low blood pressure (hypotension).
‐ if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition
in which your heart is unable to supply enough blood to the body).
‐ if you suffer from heart failure following a heart attack.
‐ if you suffer from diabetes or kidney function is impaired and you are being treated with a medicine that
lowers blood pressure containing aliskiren.

If any of these conditions apply to you, do not take Amlodipina / Valsartan / Idroclorotiazide
Mylan Pharma and consult your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking Amlodipina / Valsartan / Idroclorotiazide Mylan
Pharma
‐ if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness,
muscle spasms, irregular heartbeat).
‐ if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle contractions,
convulsions).
‐ if 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 contractions).
‐ if you have kidney problems, if you have had a kidney transplant or if you have been told you have a narrowing
of the renal arteries.
‐ if you have liver problems (hepatic).
‐ if you have or have had heart failure or coronary heart disease, especially if you have been prescribed
the maximum dose of Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma (10 mg/320 mg/25 mg).
‐ if you have had a heart attack. Follow your doctor's instructions for the initial dosage carefully. The
doctor may also check your kidney function.
‐ if your doctor has told you that you have a narrowing of the heart valves (called “aortic or
mitral stenosis”) or that the thickness of the heart muscle has increased abnormally (a condition
called “obstructive hypertrophic cardiomyopathy”).
‐ if you suffer from aldosteronism. This is a disease in which the adrenal glands produce too much
aldosterone hormone. In this case, the use of Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
is not recommended.
‐ if you suffer from a disease called systemic lupus erythematosus (also known as “lupus” or “SLE”).
‐ if you have diabetes (high blood sugar levels).
‐ if you have high levels of cholesterol or triglycerides in your blood.
‐ if you have skin reactions after exposure to the sun (e.g. a rash).
‐ if you have had an allergic reaction to other medicines for high blood pressure or to diuretics (a type of
medicine also known as “water pills”), especially if you suffer from asthma and allergies.
‐ if you have felt unwell (vomiting or diarrhea).
‐ if you have previously experienced swelling, especially of the face and throat, while taking other medicines
(including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop
taking Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma and contact your doctor immediately. Do not
ever take Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma again.
‐ if you experience dizziness and/or fainting during treatment with Amlodipina / Valsartan / Idroclorotiazide
Mylan Pharma, inform your doctor as soon as possible.
‐ if you have decreased vision or eye pain. These may be symptoms of fluid accumulation
in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur from hours to weeks after taking Amlodipina / Valsartan /
Idroclorotiazide Mylan Pharma. If left untreated, they can lead to permanent vision damage.
‐ if you are taking any of the following medicines used to treat high blood pressure:
‐ an “ACE inhibitor” (e.g. enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes;
‐ aliskiren.
‐ if you have had skin cancer in the past or if you are developing an unexpected skin lesion
during treatment. Treatment with hydrochlorothiazide, especially long-term use with
high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma.
The doctor may check kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in the blood at regular intervals.
See also what is reported under “Do not take Amlodipina / Valsartan / Idroclorotiazide Mylan
Pharma”.

If any of these conditions apply to you, inform your doctor.
For athletes: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
The use of Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma is not recommended in children and
adolescents under 18 years of age.

Elderly (65 years and over)
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma can be used by people 65 years and over at the
same dosage as adults and with the same methods already used in taking the three substances
called amlodipine, valsartan and hydrochlorothiazide. Elderly patients, especially those taking
the maximum dose of Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma (10 mg/320 mg/25 mg), should
have their blood pressure checked regularly.

Other medicines and Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. Your doctor may need to adjust the 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 using any of the medicines listed below:
Do not take with:
lithium (a medicine used to treat some types of depression);
medicines or substances that increase the amount of potassium in the blood. These include
potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and
heparin.
ACE inhibitors or aliskiren (see also what is reported under “Do not take Amlodipina /
Valsartan / Idroclorotiazide Mylan Pharma” and “Warnings and precautions”).
Use caution with:

• alcohol, sleeping pills and anesthetics (medicines that allow patients to undergo surgery and other procedures);
• amantadine (for Parkinson's therapy, also used for the treatment or prevention of some diseases caused by viruses);
• anticholinergic agents (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease and as support for anesthesia);
• anticonvulsant medicines and mood-stabilizing medicines 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

levels of lipids in the blood);

• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in transplantation to prevent organ rejection or for other conditions, such as rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used for cancer treatment), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart problems); verapamil, diltiazem (heart medicines); iodine contrast agents (agents used for imaging examinations) medicines used to treat diabetes (oral agents such as metformin or insulins);
• medicines used to treat gout, such as allopurinol;
• medicines that can increase blood sugar levels (beta-blockers, diazoxide);
• medicines that can induce “torsade de pointes”(irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that can reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines that can reduce the amount of potassium in the blood, 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 ulcers and inflammation of the esophagus (carbenoxolone);
• pain relievers or anti-inflammatory medicines, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors;
• muscle relaxants (medicines to relax muscles used during surgery); nitroglycerin and other nitrates or other substances called “vasodilators”;
• other medicines for the treatment of high blood pressure including methyldopa;
• rifampicin (used, for example, for the treatment of tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John's wort;
• dantrolene (infusion for severe body temperature abnormalities);
• vitamin D and calcium salts.

Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma with food, drinks and alcohol
Grapefruit and grapefruit juice should not be consumed by people who have been
prescribed Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can
cause an unpredictable increase in the blood pressure lowering effect of Amlodipina /
Valsartan / Idroclorotiazide Mylan Pharma. Consult your doctor before drinking alcohol. Alcohol can lower
your blood pressure too much and/or increase the possibility of dizziness and fainting.

Pregnancy and breastfeeding
Pregnancy

You must inform your doctorif you think you are pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking Amlodipina /
Valsartan / Idroclorotiazide Mylan Pharma before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma. Amlodipina / Valsartan / Idroclorotiazide
Mylan Pharma is not recommended in the early stages of pregnancy and should not be taken when you are
pregnant for more than 3 months as it can cause serious harm to the baby if used after the third
month of pregnancy.
Breastfeeding

Inform your doctorif you are breastfeeding or are about to start breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipina / Valsartan / Idroclorotiazide Mylan
Pharma is not recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.
Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery
This medicine may cause you to feel dizzy, drowsy, nauseous or have a headache. If you experience any of these symptoms, do not drive or use tools or machinery.

3. How to take Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor. This will help you to obtain the best results and to decrease the risk of undesirable effects.
The usual dose of Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma is one tabletper day.
‐ It is better to take the tablet every day at the same time. Morning is the best time.
‐ Swallow the tablet whole with a glass of water.
‐ Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma can be taken with or without food. Do not
take this medicine with grapefruit or grapefruit juice.
Based on your response to treatment, your doctor may suggest a lower or higher dose.
Do not take more than the prescribed dose.

If you take more Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma than you should
If you have accidentally taken too many tablets of Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma,
seek immediate medical attention. You may need medical care.

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

If you stop taking Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma
Stopping the treatment with Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma may cause a
worsening of the disease. Do not stop taking the medicine unless your doctor tells you to.

Always take the medicine even if you feel well
Those who suffer from high blood pressure often do not notice any sign of this problem.
Many feel normal. To obtain the best results and reduce the risk of undesirable effects, it is very important that you take this medicine exactly as indicated by your
doctor. Keep your appointments with your doctor even if you feel well.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with any combination containing three active ingredients, effects associated with each individual component cannot be excluded. The side effects reported with Amlodipina /
Valsartan / Idroclorotiazide Mylan Pharma or any of the three active ingredients (amlodipine, valsartan and
hydrochlorothiazide) are listed below and may occur with the use of this medicine.

Some side effects can be serious and require immediate medical attention. See 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 of faintness, light-headedness, sudden loss of consciousness) Uncommon (may affect up to 1 in 100 people):
• severe decrease in the amount of urine (decreased kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorders Very rare (may affect up to 1 in 10,000):
• sudden onset of wheezing, shortness of breath, chest pain, tightness or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat which can cause great difficulty in breathing
• severe skin reactions including rash, intense skin rash, hives, redness all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• inflammation of the pancreas, which can cause severe abdominal and back pain, accompanied by a feeling of severe discomfort
• weakness, bruising, fever and frequent infections
• stiffness

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• low potassium levels in the blood
• increased lipids in the blood

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

• sleepiness
• palpitations (feeling your heartbeat)
• flushing
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after meals
• fatigue
• headache
• frequent urination
• high levels of uric acid in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, lightheadedness when standing up
• decreased appetite
• nausea and vomiting
• itchy rash and other types of rashes
• inability to get or keep an erection

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

• fast heartbeat
• feeling of spinning
• vision disturbances
• stomach discomfort
• chest pain
• increased urea, creatinine and uric acid in the blood
• high levels of calcium, fats or sodium in the blood
• decreased potassium in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered taste
• back pain
• swelling of the joints
• cramps/weakness/muscle pain
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when getting up or after exercise
• lack of energy
• sleep disorders
• tingling or numbness
• neuropathy
• sudden and temporary loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• sore throat
• excessive sweating
• itching
• swelling, redness and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• insomnia
• altered taste
• fainting
• loss of pain sensation
• 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
• skin color change
• urinary disorders
• increased need to urinate at night
• frequent need to urinate
• discomfort or enlargement of the breasts in men
• pain
• feeling unwell
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high blood sugar levels
• worsening of diabetic metabolic status
• abdominal discomfort
• constipation
• liver disorders that can appear together with yellow skin and eyes or dark urine (hemolytic anemia)
• increased sensitivity of the skin to the sun
• purple-colored skin spots
• kidney disorders
• confusion

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

• decreased number of white blood cells in the blood
• low platelet count in the blood, which can lead to unusual bruising or a tendency to bleed (damage to red blood cells)
• swelling of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• increased liver enzymes which can lead to changes in some clinical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rash - sensitivity to light
• disorders related to stiffness, tremor and/or movement disorders
• fever, sore throat or mouth ulcers, more frequent infections (lack or low levels of
• pallor, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal destruction of red blood cells in the blood vessels or elsewhere in the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (inflammation of the pancreas)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonia)
• rash on the face, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, reddish-purple spots, fever (vasculitis)
• severe skin disease causing rash, redness of the skin, formation of blisters on lips, eyes and mouth, peeling of the skin, fever (toxic epidermal necrolysis)

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

• abnormal blood tests for kidney function, increased potassium in the blood, low levels of red blood cells in the blood
• abnormal values of red blood cells in the blood
• low levels of some types of white blood cells and platelets
• increased creatinine in the blood
• abnormal liver function tests
• severe decrease in the amount of urine eliminated
• inflammation of blood vessels
• weakness, bruising and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high blood 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 the amount of urine (possible signs of kidney disorders or renal failure)

• severe skin disease causing rash, redness of the skin, formation of blisters on lips, eyes and mouth, peeling of the skin, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blisters on the skin (sign of a condition called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system 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 Amlodipina / Valsartan / Idroclorotiazide 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 package and on the blister after Scad. The
expiry date refers to the last day of that month
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from light and moisture.
Do not use packages of Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma that are damaged or show
signs of tampering.
Do not dispose of any medicine in 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 Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma contains
Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 5 mg/160 mg/12.5 mg film-coated tablets
with film coating

• The active ingredients 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 ingredients are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc and titanium dioxide (E171).

Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 5 mg/160 mg/25 mg film-coated tablets
with film coating

• The active ingredients 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 ingredients are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 10 mg/160 mg/12.5 mg film-coated tablets
with film coating

• The active ingredients 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 ingredients 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).

Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 10 mg/160 mg/25 mg film-coated tablets
with film coating

• The active ingredients 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 ingredients are microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma 10 mg/320 mg/25 mg film-coated tablets
with film coating

• The active ingredients 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 ingredients 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 Amlodipina / Valsartan / Idroclorotiazide Mylan Pharma and package contents
Amlodipina / Valsartan / Idroclorotiazide 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. They are available
in packs containing 14, 28 or 30 film-coated tablets.
Amlodipina / Valsartan / Idroclorotiazide 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. They are available
in packs containing 14, 28 or 30 film-coated tablets.
Amlodipina / Valsartan / Idroclorotiazide 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. They are
available in packs containing 14, 28 or 30 film-coated tablets.
Amlodipina / Valsartan / Idroclorotiazide 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. They are
available in packs containing 14, 28 or 30 film-coated tablets.
Amlodipina / Valsartan / Idroclorotiazide 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. They are
available in packs containing 14, 28 or 30 film-coated tablets.

Marketing Authorisation Holder
Mylan S.p.A. – Via Vittor Pisani, 20 – 20124 Milan, 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