Trivals: detailed information

Patient Information Leaflet: Information for the User

AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAAZIDE DOC 5 mg/160 mg/12.5 mg film-coated tablets
10 mg/320 mg/25 mg film-coated tablets
Generic Medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist. See section 4.

Contents of this leaflet

What AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC is and what it is used for
What you need to know before taking AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC
How to take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC
Possible side effects
How to store AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC
Contents of the pack and other information

1. What AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC is and what it is used for

AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC tablets contain three active 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, thereby 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 urine output, thereby reducing blood pressure. As a result of these three mechanisms, blood vessels relax and blood pressure decreases.

AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC is used for the treatment of high blood pressure in adult patients whose blood pressure is already controlled with a combination of amlodipine, valsartan, and hydrochlorothiazide, and who may benefit from taking a single tablet containing all three substances.

2. What you should know before taking AMLODIPINE/VALSARTAN/

HYDROCHLOROTHIAZIDE DOC

Do not take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC

if you are more than 3 months pregnant. (It is recommended to avoid taking AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC even in the early stages of pregnancy – see section Pregnancy.)
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 to any of the other components of this medicine (see section 6). If you think you may be allergic, do not take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC and consult your doctor.
if you have liver problems, destruction of the small bile ducts in the liver (biliary cirrhosis), or 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 your blood potassium or sodium levels.
if your blood calcium level is too high despite treatment to reduce your blood calcium level.
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 is unable to 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 DOC and consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking AMLODIPINE/VALSARTAN/
HYDROCHLOROTHIAZIDE DOC

if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat).
if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle twitching, or seizures).
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 cramps).
if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the renal arteries.
if you have liver (hepatic) problems.
if you have or have had heart failure or coronary artery disease, especially if you have been prescribed the maximum dose of AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC (10 mg/320 mg/25 mg).
if you have had a heart attack. Follow your doctor’s instructions carefully regarding initial dosing. 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 is abnormally increased (a condition called “obstructive hypertrophic cardiomyopathy”).
if you suffer from hyperaldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC 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 cholesterol or triglyceride levels in your blood.
if you have skin reactions after sun exposure (e.g., skin rash).
if 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 and allergies.
if you have felt unwell (vomiting or diarrhea).
if you have previously experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking AMLODIPINE/VALSARTAN/ HYDROCHLOROTHIAZIDE DOC immediately and contact your doctor. You must never take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC again.
if you experience dizziness and/or fainting while being treated with AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC, inform your doctor as soon as possible.
if 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 pressure in the eye, which may occur from a few hours to a week after taking AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC generics. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.
if 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.
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancers. Protect your skin from sun and UV exposure while taking AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also the section “Do not take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC”.
If any of these conditions apply to you, inform your doctor.
Children and adolescents
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC is not recommended for use in children and adolescents under 18 years of age.
Elderly (65 years and over)
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC may be used by individuals aged 65 years and over at the same dosage and in the same manner as the individual components amlodipine, valsartan, and hydrochlorothiazide. Elderly patients, especially those taking the maximum dose of AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC (10 mg/320 mg/25 mg), should regularly monitor their blood pressure.
Other medicines and AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC
Inform 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 discontinue one of the medicines. This is particularly important if you are taking any of the following medicines:
Do not take with:

lithium (a medicine used to treat certain types of depression);
medicines or substances that increase blood potassium levels. These include 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 DOC” and “Warnings and precautions”).
Use with caution:
alcohol, sedatives, and anesthetics (medicines that allow patients to undergo surgery and other procedures);
amantadine (for anti-Parkinson therapy, also used 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 lipid levels 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 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 (imaging agents); 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 tablets), 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 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 surgery); nitroglycerin and other nitrates or other substances called “vasodilators”;
other medicines for treating 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 DOC with food, drinks, and alcohol
Grapefruit and grapefruit juice must not be consumed by people who have been prescribed AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC. 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 DOC before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious 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 DOC 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.
Ask your doctor or pharmacist for advice 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.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC

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/HYDROCHLOROTHIAZIDE DOC is one tablet per day.

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 DOC may be taken with or without food.
Do not take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC 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 DOC than you should
If you have accidentally taken too many tablets of AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC, contact a doctor immediately. You may require medical treatment.

If you forget to take AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC
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 usual time. Do not take a double dose (two tablets together) to make up for a forgotten tablet.

If you stop taking AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC
Stopping treatment with AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC may cause your condition to worsen. Do not stop taking the 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 everybody gets them.
As with any combination containing three active substances, side effects associated with each individual component cannot be excluded. The side effects reported with AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC or with any of the three active ingredients (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur when using AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE DOC.
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, lightheadedness, 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 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 severe difficulty in breathing -
severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, skin 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 possible side effects include:

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

low potassium levels in the blood
increased lipid levels in the blood

Common (may affect up to 1 in 10 people)

drowsiness -
palpitations (awareness of your heartbeat) -
flushing -
swelling of the ankles (oedema) -
abdominal pain -
stomach discomfort after meals -
fatigue -
headache -
frequent need to urinate -
high levels of uric acid in the blood -
low magnesium levels in the blood -
low sodium levels in the blood -
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 disorders -
stomach discomfort -
chest pain -
increased blood urea, creatinine and uric acid levels -
high levels of calcium, fats or sodium in the blood -
decreased potassium levels in the blood -
bad breath -
diarrhoea -
dry mouth -
weight gain -
loss of appetite -
altered taste -
back pain -
joint swelling -
muscle cramps/weakness/muscle pain -
pain in the extremities -
inability to stand or walk normally -
weakness -
abnormal coordination -
dizziness when standing up or after physical exercise -
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 -
lack of sleep -
altered taste -
fainting -
loss of sensitivity to pain -
visual disorders -
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 (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 which may occur together with yellowing of the skin and eyes or dark-coloured urine (haemolytic anaemia) -
increased sensitivity of the skin to sunlight -
purple-coloured skin spots -
kidney disorders -
confusion -

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

decreased 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) -
swelling of the gums -
abdominal swelling (gastritis) -
inflammation of the liver (hepatitis) -
yellowing of the skin (jaundice) -
increased liver enzymes which may lead to changes in certain clinical tests -
increased muscle tension -
inflammation of blood vessels, often with skin rash -
light sensitivity -
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) -
paleness, 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 twitching and spasms, rapid breathing (hypochloraemic alkalosis) -
severe pain in the upper part of the stomach (pancreatitis) -
difficulty breathing with fever, cough, wheezing, shortness of breath (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 rash, redness of the skin, blistering on lips, eyes and mouth, skin peeling, fever (toxic epidermal necrolysis) -

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

changes in blood tests for kidney function, increased potassium levels in the blood, low levels of red blood cells in the blood -
abnormal red blood cell test values -
low levels of certain types of white blood cells and platelets -
increased creatinine levels in the blood -
abnormal liver function tests -
severe decrease in urine output -
inflammation of blood vessels -
weakness, bruising and frequent infections (aplastic anaemia) -
decreased 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 rash, redness of the skin, blistering on lips, eyes and mouth, skin peeling, fever (erythema multiforme) -
muscle spasm -
fever (pyrexia) -
blistering of 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 AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC

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
Scad or 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 moisture.
Do not use packages of AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC that are damaged or show signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC contains
AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 5 mg/160 mg/12.5 mg film-coated tablets
The active substances of AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 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:
Tablet core: microcrystalline cellulose, hydroxypropyl cellulose, low-substituted, anhydrous colloidal silica, magnesium stearate, talc.
Coating: polyvinyl alcohol (E102), titanium dioxide (E171), talc (E553b), macrogol 4000 (E1521), methacrylic acid-ethyl acrylate copolymer (1:1), sodium bicarbonate (E500(ii)).

AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 10 mg/320 mg/25 mg film-coated tablets
The active substances of AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 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:
Tablet core: microcrystalline cellulose, hydroxypropyl cellulose, low-substituted, anhydrous colloidal silica, magnesium stearate, talc.
Coating: polyvinyl alcohol (E102), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), macrogol 4000 (E1521), methacrylic acid-ethyl acrylate copolymer (1:1), sodium bicarbonate (E500(ii)), red iron oxide (E172).

Description of the appearance of AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC and contents of the package
AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 5 mg/160 mg/12.5 mg film-coated tablets are white, oval-shaped, 7.70 mm x 16 mm, with "C12" engraved on one side.
AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 10 mg/320 mg/25 mg film-coated tablets are dark yellow, oval-shaped, 9.70 mm x 20 mm, with "C72" engraved on one side.
AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 5 mg/160 mg/12.5 mg is available in packs of 28 tablets.
AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC 10 mg/320 mg/25 mg is available in packs of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Doc Generici S.r.l., via Turati, 40, 20121 Milano, Italy

Manufacturer
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

This medicinal product has been authorized in the European Economic Area Member States under the following names:
Sweden: Amlodipine/Valsartan/Hydroklortiazid DOC 5 mg/160 mg/12.5 mg film-coated tablets
Amlodipine/Valsartan/Hydroklortiazid DOC 10 mg/320 mg/25 mg film-coated tablets
Italy: AMLODIPINA/VALSARTAN/IDROCLOROTIAZIDE DOC