VALSARTAN 160 mg /12.5 Mg Film-Coated Tablets

Абдулла Альхасан

Абдулла Альхасан – врач-терапевт с международной клинической практикой в Великобритании и Италии. Проводит онлайн-консультации для взрослых пациентов, сочетая современный медицинский подход с вниманием к индивидуальным особенностям каждого случая.

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Инструкция по применению VALSARTAN E IDROKLOROTIATSIDE TSENTIVA ITALIA

Содержание инструкции

Valsartan and Hydrochlorothiazide Zentiva Italia
Valsartan and Hydrochlorothiazide Zentiva Italia
Valsartan and Hydrochlorothiazide Zentiva Italia

Valsartan and Hydrochlorothiazide Zentiva Italia

160 mg/12.5 mg film-coated tablets
Generic medicine

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 only for you. Do not give it to other people, 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, tell your doctor or pharmacist. See section 4. Contents of this leaflet:

1. What Valsartan and Hydrochlorothiazide Zentiva Italia is and what it is used for
2. What you need to know before you take Valsartan and Hydrochlorothiazide Zentiva Italia
3. How to take Valsartan and Hydrochlorothiazide Zentiva Italia
4. Possible side effects
5. How to store Valsartan and Hydrochlorothiazide Zentiva Italia
6. Contents of the pack and other information

1. What is Valsartan and Hydrochlorothiazide Zentiva Italia and what is it used for

Valsartan and Hydrochlorothiazide Zentiva Italia film-coated tablets contains two active ingredients,
called valsartan and hydrochlorothiazide. Both of these active ingredients help to control high blood
pressure (hypertension).

Valsartanbelongs to a class of medicines known as "angiotensin II receptor antagonists", which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the contraction of blood vessels, thus leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as "water pills"). Hydrochlorothiazide increases diuresis, which also lowers blood pressure.

Valsartan and Hydrochlorothiazide Zentiva Italia is used for the treatment of high blood
pressure that is not adequately controlled by a single active ingredient.
High blood pressure increases the workload of the heart and arteries. If left untreated,
it can damage the blood vessels of the brain, heart and kidneys, and can cause stroke, heart
failure or kidney failure. High blood pressure increases the risk of heart attacks.
Reducing blood pressure to normal values reduces the risk of developing these conditions.

2. Cosa deve sapere prima di prendere Valsartan e Idroclorotiazide Zentiva Italia

Non prenda Valsartan e Idroclorotiazide Zentiva Italia:

se è allergico (ipersensibile) a valsartan, idroclorotiazide, derivatives of sulfonamides (substances chemically related to hydrochlorothiazide), soy, peanuts or to any of the other components of this medicine (listed in section 6);

Pagina 1di 28

se è in stato di gravidanzadapiù di 3 mesi(it is also better to avoid the use of Valsartan and Hydrochlorothiazide Zentiva Italia in the early stages of pregnancy - see section “Pregnancy”);
se ha una graveliver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile stagnation in the liver (cholestasis);
se ha una gravekidney disease;
se è unable to produce urine (anuria);
se è undergoing treatment with an artificial kidney;
se il livello di potassio o di sodio nel sangue è inferiore alla norma, or if the level of calcium in the blood is higher than normal, despite treatment;
se soffre di gotta;
se soffre di diabete o la sua funzione renale è compromessa ed è in trattamento con un medicinale che abbassa la pressione del sangue, containing aliskiren.

Se una qualsiasi di queste condizioni la riguarda, informi il medico e non assuma questo
medicinale .
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Zentiva Italia:

se sta assumendo potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in the blood such as heparin. The doctor may need to check the amount of potassium in your blood regularly;
se ha bassi livelli di potassio nel sangue;
in case of diarrhea or severe vomiting;
se sta assumendo alte dosi di compresse drenanti (diuretics);
se ha una grave heart disease;
se soffre di insufficienza cardiaca o ha subito un attacco di cuore. Follow the doctor's instructions carefully for the initial dosage. The doctor may also check your kidney function;
se soffre di un restringimento delle arterie renali;
se ha recentemente ricevuto un nuovo rene;
se soffre di iperaldosteronismo. This is a disease in which the adrenal glands produce an excessive amount of the hormone aldosterone. If this is your case, the use of Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended;
se è affetto da una malattia del fegato o dei reni;
se ha già avuto swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking Valsartan and Hydrochlorothiazide Zentiva Italia, stop taking Valsartan and Hydrochlorothiazide Zentiva Italia immediately and do not take it again. See also section 4, “Possible side effects”;
se ha febbre, eruzioni cutanee e dolore articolare, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease);
se ha il diabete, la gotta, elevati livelli di colesterolo o trigliceridi nel sangue;
se ha avuto in passato il cancro della pelle o se sta sviluppando una lesione della pelle imprevista durante il trattamento. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Valsartan and Hydrochlorothiazide Zentiva Italia.
se ha avuto reazioni allergiche in seguito all’uso di altri medicinali che abbassano la pressione sanguigna appartenenti a questa classe di medicinali (angiotensin II receptor antagonists) or if you suffer from allergies or asthma;
se ha una diminuzione della vista o dolori agli occhi. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in

Pagina 2di 28
eye pressure and can occur within hours to weeks after taking Valsartan and
Hydrochlorothiazide Zentiva Italia. If left untreated, they can lead to permanent vision loss.
If you have previously had an allergy to penicillin or a sulfonamide, you may be at higher
risk of developing this condition;

se sta assumendo uno dei seguenti medicinali usati per trattare la pressione sanguigna alta:
an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
aliskiren. The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia” and “Warnings and precautions”.

Valsartan and Hydrochlorothiazide Zentiva Italia may cause increased sensitivity of the skin to
sun.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to the baby if taken during this period (see section “Pregnancy”).

Children and adolescents
The use of Valsartan and Hydrochlorothiazide Zentiva Italia in children and adolescents (under 18 years of
age) is not recommended.

For athletes: the use of the medicine without therapeutic need constitutes
doping and may still result in positive doping tests.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide Zentiva Italia is
taken with certain other medicines. Your doctor may need to change the dose and/or
take other precautions, or in some cases, stop taking one of the medicines. This
is especially true for the following medicines:

lithium, a medicine used to treat some types of mental disorders;
medicines or substances that can increase the levels of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin;
medicines that can reduce the amount of potassium in the blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G;
alcuni antibiotici (rifampicina group), a medicine used to prevent organ rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines can enhance the effect of Valsartan and Hydrochlorothiazide Zentiva Italia;
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 for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone;
vitamin D for therapeutic use and calcium supplements;
medicines for the treatment of diabetes (oral antidiabetics such as metformin or insulins);

Pagina 3di 28

altri medicinali per abbassare la pressione del sangue, incluso metildopa;
medicines that increase blood pressure, such as norepinephrine or epinephrine;
digoxin or other cardiac glycosides (medicines used to treat heart problems);
medicines that can increase blood sugar levels, such as diazoxide or beta-blockers;
cytotoxic medicines (used for cancer treatment) such as methotrexate or cyclophosphamide;
pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid > 3 g;
muscle relaxants, such as tubocurarine;
anticolinergic medicines (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);
amantadine (a medicine used to treat Parkinson's disease and also used to treat or prevent some diseases caused by viruses);
cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in the blood);
cyclosporine, a medicine used for organ transplantation to prevent organ rejection;
alcohol, sleeping pills and anesthetics (medicines with a sedative or pain-relieving effect used for example in surgery);
iodinated contrast media (agents used in diagnostic imaging).
if you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia" and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide Zentiva Italia with food, beverages and alcohol
Avoid drinking alcohol before talking to your doctor. Alcohol can lower your blood
pressure further and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or might become pregnant).
Your doctor will usually advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva
Italia before becoming pregnant or as soon as you find out you are pregnant and will advise
you to take another medicine instead of Valsartan and Hydrochlorothiazide Zentiva Italia. Valsartan and
Hydrochlorothiazide Zentiva Italia is not recommended in early pregnancy, and should not be
taken if you are pregnant for more than three months, as the medicine could cause serious harm to
the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding.
Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended for mothers who are
breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if the baby
is newborn or premature.

Driving and operating machinery
Before driving a vehicle, using tools or machinery or performing other activities that require
concentration, make sure you know how this medicine affects you. Like many other
medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva Italia
can occasionally cause dizziness and affect your ability to concentrate.
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Valsartan and Hydrochlorothiazide Zentiva Italia contains lactose, soybean oil, yellow sunset and
sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
If you are allergic to peanuts or soy, do not take this medicine.
Valsartan and Hydrochlorothiazide Zentiva Italia 160 mg/12,5 mg also contains Yellow Sunset FCF
(E110) which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is
essentially ‘sodium-free’ .

3. How to take Valsartan and Idroclorotiazide Zentiva Italia

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to get the best results and to lower the risk of undesirable effects.
If you have doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any sign of this condition.
Many may feel quite well. For this reason, it is very important that you maintain
regular appointments with your doctor, even when you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Idroclorotiazide Zentiva Italia
to take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

The recommended dose of Valsartan and Idroclorotiazide Zentiva Italia is one tablet a day.
Do not change the dose or stop taking the tablets without consulting your doctor.
The medicine must be taken at the same time each day, usually in the morning.
You can take Valsartan and Idroclorotiazide Zentiva Italia with or without food.
Swallow the tablet with a glass of water. If you take more Valsartan and Idroclorotiazide Zentiva Italiathan you shouldIf you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist or a hospital.

If you stop taking Valsartan and Idroclorotiazide Zentiva Italia
Stopping treatment with Valsartan and Idroclorotiazide Zentiva Italia may cause a
worsening of high blood pressure. Do not stop taking the medicine unless
your doctor tells you to.
If you have any doubts about the use of this medicine, ask 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 may be serious and require immediate medical attention:

See your doctor immediately ifyou have symptoms of angioedema (allergic reaction), such as:
swelling of the face, tongue or throat

Page 5of 28

difficulty swallowing
urticaria and difficulty breathing.
Severe skin disease causing rash, redness of the skin, formation of blisters on the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis).
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 or myopia).
Fever, sore throat, more frequent infections (agranulocytosis).

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide
Zentiva Italia and contact your doctor immediately (see also section 2, “Warnings and
precautions”).
Other side effects include:

Uncommon (may affect up to 1 in 100 people)

cough
low blood pressure
mild mental dizziness
dehydration (with symptoms of thirst, dryness of the mouth and tongue, infrequent urination, dark-colored urine, dry skin)
muscle pain
fatigue
tingling or numbness
blurred vision
noises (e.g. whistling, ringing) in the ears.

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

dizziness
diarrhea
joint pain.

Frequency not known (the frequency cannot be estimated from the available data)

difficulty breathing
significant decrease in the amount of urine excreted
low sodium levels in the blood (which can lead to fatigue, confusion, muscle contractions and/or convulsions in severe cases)
low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
low white blood cell levels in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
increased bilirubin levels in the blood (which can, in severe cases, determine yellowing of the skin and eyes)
increased levels of urea and creatinine in the blood (which may indicate abnormal kidney function)
increased uric acid levels in the blood (which can, in severe cases, cause gout)
syncope (fainting).

The following side effects have been detected with medicines containing only valsartan or only
hydrochlorothiazide:
Valsartan
Page 6of 28

Uncommon (may affect up to 1 in 100 people)

feeling of dizziness
abdominal pain.

Frequency not known (the frequency cannot be estimated from the available data)

skin blisters (signs of bullous dermatitis)
rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
rashes, reddish-purple spots, fever, itching (symptoms of inflammation of blood vessels)
low platelet levels in the blood (sometimes with unusual bleeding or bruising)
high potassium levels in the blood (sometimes with muscle spasms, irregular heartbeat)
allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
swelling especially of the face and throat, rashes, itching
increased liver function values
reduction of hemoglobin levels and reduction of the percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
kidney failure
low sodium levels in the blood (which can lead to fatigue, confusion, muscle contractions and/or convulsions in severe cases).

Hydrochlorothiazide

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)

low sodium levels in the blood
low magnesium levels in the blood
high uric acid levels in the blood
itchy rash and other types of rash
loss of appetite
mild nausea and vomiting
dizziness, fainting when getting up
inability to achieve or maintain an erection. Rare (may affect up to 1 in 1,000 people)
swelling and blistering of the skin (due to increased sensitivity to the sun)
high calcium levels in the blood
high sugar levels in the blood
sugar in the urine
worsening of metabolic diabetic state
constipation, diarrhea, stomach or intestinal disorders, liver disorders that can occur together with yellow skin and eyes
irregular heartbeat
headache
sleep disturbances
sad mood (depression)
low platelet levels in the blood (sometimes with bleeding or bruising under the skin)
dizziness
tingling or numbness
vision disturbances.

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

inflammation of blood vessels with symptoms such as rash, reddish-purple spots, fever (vasculitis)
rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
severe pain in the upper abdomen (pancreatitis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress including pneumonia and pulmonary edema)
paleness, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
fever, sore throat or mouth ulcers caused by infections (leukopenia)
confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis). Frequency not known (the frequency cannot be estimated from the available data)
Skin and lip cancer (non-melanoma skin cancer)
weakness, bruising and frequent infections (aplastic anemia)
severe decrease in the amount of urine (possible signs of kidney disorders or kidney failure)
rash, redness of the skin, formation of blisters on the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
muscle spasms
fever (pyrexia)
weakness (asthenia). Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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.

5How to store Valsartan and Idroclorotiazide Zentiva Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box, container of
tablets or blister after EXP. The expiry date refers to the last day of that month.
PVC/PE/PVDC-Al blister: Do not store above 30°C.
Polyethylene tablet containers: This medicine does not require any special
storage conditions.
Do not dispose of any medicine via water 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 Valsartan and Hydrochlorothiazide Zentiva Italia contains
The active ingredients are valsartan and hydrochlorothiazide.
Page 8of 28
Each film-coated tablet of Valsartan and Hydrochlorothiazide Zentiva Italia 160 mg/12.5 mg
contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
povidone K29 – K32, talc, magnesium stearate, anhydrous colloidal silica.

Tablet coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171),
red iron oxide (E172), sunset yellow FCF aluminium lake (E110), lecithin (containing oil
of soya) (E332).

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva Italia and package contents
Valsartan and Hydrochlorothiazide Zentiva Italia 160 mg/12.5 mg: film-coated tablets, red in colour,
oval, biconvex, 15 x 6 mm, imprinted with “V” on one side and “H” on the other side.
Packs:
Blisters: 7, 10, 14, 20, 28, 30, 56, 90, 98 or 100 film-coated tablets.
Tablet container: 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milano

Manufacturers
Actavis Ltd.
Bulebel Industrial Estate
Malta
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
2600 Dupnitsa,
Bulgaria
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10 - Dolní Měcholupy
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany Valsartan Zentiva comp 160 mg/ 12,5 mg Filtabletten
Italy Valsartan e Idroclorotiazide Zentiva Italia
Portugal Valsartan + Hidroclorothiazida Zentiva
Page 9of 28

Valsartan and Hydrochlorothiazide Zentiva Italia

320 mg/12.5 mg film-coated tablets
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 Valsartan and Hydrochlorothiazide Zentiva Italia is and what it is used for
2. What you need to know before you take Valsartan and Hydrochlorothiazide Zentiva Italia
3. How to take Valsartan and Hydrochlorothiazide Zentiva Italia
4. Possible side effects
5. How to store Valsartan and Hydrochlorothiazide Zentiva Italia
6. Contents of the pack and other information

1. What is Valsartan and Hydrochlorothiazide Zentiva Italia and what is it used for

Valsartanbelongs to a class of medicines known as "angiotensin II receptor antagonists", which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the blood vessels to contract, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases diuresis, which also lowers blood pressure.

Valsartan and Hydrochlorothiazide Zentiva Italia is used for the treatment of high blood pressure
that is not adequately controlled by a single active ingredient.
High blood pressure increases the workload of the heart and arteries. If left untreated,
it can damage the blood vessels of the brain, heart and kidneys, and can lead to stroke, heart
failure or kidney failure. High blood pressure increases the risk of heart attacks.
Reducing blood pressure to normal levels reduces the risk of developing these conditions.
Page 10of 28

2. What you need to know before taking Valsartan and Hydrochlorothiazide Zentiva Italia

Do not take Valsartan and Hydrochlorothiazide Zentiva Italia:

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide), soy, peanuts or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnantfor more than 3 months(it is also best to avoid using Valsartan and Hydrochlorothiazide Zentiva Italia in the early stages of pregnancy - see section “Pregnancy”);
if you have a severeliver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile stagnation in the liver (cholestasis);
if you have a severekidney disease;
if you are unable to produce urine (anuria);
if you are undergoing treatment with an artificial kidney;
if the level of potassium or sodium in the blood is lower than normal, or if the level of calcium in the blood is higher than normal, despite treatment;
if you suffer from gout;
if you suffer from diabetes or your 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, tell your doctor and do not take this
medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Zentiva Italia:

if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in the blood such as heparin. Your doctor may need to check the amount of potassium in your blood regularly;
if you have low levels of potassium in the blood;
in case of diarrhea or severe vomiting;
if you are taking high doses of water tablets (diuretics);
if you have a severe heart disease;
if you suffer from heart failure or have had a heart attack. Follow your doctor's instructions for the initial dose carefully. Your doctor may also check your kidney function;
if you suffer from a narrowing of the renal arteries;
if you have recently received a new kidney;
if you suffer from hyperaldosteronism. This is a condition in which the adrenal glands produce an excessive amount of the hormone aldosterone. If this is the case, the use of Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended;
if you are affected by a liver or kidney disease;
if you have previously had swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking Valsartan and Hydrochlorothiazide Zentiva Italia, stop taking Valsartan and Hydrochlorothiazide Zentiva Italia immediately and do not take it again. See also section 4, “Possible side effects”;
if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease);
if you have diabetes, gout, high levels of cholesterol or triglycerides in the blood;
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 some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while
taking Valsartan and Hydrochlorothiazide Zentiva Italia.

Page 11of 28
if you have had allergic reactions following the use of other medicines that lower blood pressure belonging to this class of medicines (angiotensin II receptor antagonists) or if you suffer from allergy or asthma;

if you have blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva Italia. If left untreated, they can lead to permanent vision loss. If you have previously had an allergy to penicillin or a sulfonamide, you may be at higher risk of developing this condition;
if you are taking one of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia” and “Warnings and precautions”.

Valsartan and Hydrochlorothiazide Zentiva Italia can cause increased sensitivity of the skin to
sunlight.
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended in the early
stages of pregnancy and should not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to the baby if taken during this period (see the section “Pregnancy”).

If any of these conditions apply to you, tell your doctor.
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Zentiva Italia in children and adolescents (under 18 years of age)
is not recommended.

For athletes: the use of the medicine without therapeutic need constitutes
doping and may still result in a positive doping test.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide Zentiva Italia is
taken together with certain other medicines. Your doctor may need to change the dose and/or
take other precautions, or in some cases, stop taking one of the medicines. This
is especially true for the following medicines:

lithium, a medicine used to treat some mental disorders;
medicines or substances that can increase the levels of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin;
medicines that can reduce the amount of potassium in the blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G;
some antibiotics (rifampicin group), a medicine used to prevent organ rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS infection

Page 12of 28
(ritonavir). These medicines can enhance the effect of Valsartan and Hydrochlorothiazide Zentiva
Italia;

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 for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone;
vitamin D for therapeutic use and calcium supplements;
medicines for the treatment of diabetes (oral antidiabetics such as metformin or insulins);
other medicines to lower blood pressure, including methyldopa;
medicines that increase blood pressure, such as noradrenaline or adrenaline;
digoxin or other cardiac glycosides (medicines used to treat heart problems);
medicines that can increase blood sugar levels, such as diazoxide or beta-blockers;
cytotoxic medicines (used for cancer treatment) such as methotrexate or cyclophosphamide;
pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid > 3 g;
muscle relaxants, such as tubocurarine;
anticholinergic medicines (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);
amantadine (a medicine used to treat Parkinson's disease and also used to prevent some viral diseases);
cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in the blood);
cyclosporine, a medicine used for organ transplantation to prevent organ rejection;
alcohol, sleeping pills and anesthetics (medicines with a sedative or analgesic effect used for example in surgery);
iodinated contrast media (agents used in diagnostic imaging);
if you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia" and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide Zentiva Italia with food, beverages and alcohol
Avoid drinking alcohol before talking to your doctor. Alcohol can further lower your
blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or might become pregnant).
Your doctor will generally advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva
Italia before becoming pregnant or as soon as you find out you are pregnant and will advise you
to take another medicine instead of Valsartan and Hydrochlorothiazide Zentiva Italia. Valsartan and
Hydrochlorothiazide Zentiva Italia is not recommended in the early stages of pregnancy, and should not be
taken if you are pregnant for more than three months, as the medicine could cause serious harm to the
baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding.
Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended for mothers who are breastfeeding, and your doctor
may choose another treatment if you wish to breastfeed, especially if the baby is
newborn or premature.
Page 13of 28
Driving and using machines
Before driving a vehicle, using tools or machines or performing other activities that require
concentration, make sure you know how this medicine affects you. Like many other
medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva Italia
can occasionally cause dizziness and affect your ability to concentrate.

Valsartan and Hydrochlorothiazide Zentiva Italia contains lactose, soybean oil and sodium
If your doctor has told you that you have an intolerance to some sugars, contact them before taking
this medicine.
If you are allergic to peanuts or soy, do not take this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially
‘sodium-free’

3. How to take Valsartan and Idroclorotiazide Zentiva Italia

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to get the best results and to reduce the risk of undesirable effects.
If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any signs of this condition.
Many may feel quite well. For this reason, it is very important that you maintain
regular appointments with your doctor, even when you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Idroclorotiazide Zentiva Italia
to take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

The recommended dose of Valsartan and Idroclorotiazide Zentiva Italia is one tablet a day.
Do not change the dose or stop taking the tablets without consulting your doctor.
The medicine must be taken at the same time each day, usually in the morning.
You can take Valsartan and Idroclorotiazide Zentiva Italia with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Idroclorotiazide Zentiva Italiathan you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have
accidentally taken too many tablets, contact your doctor, pharmacist or a hospital.

If you forget to take Valsartan and Idroclorotiazide Zentiva Italia
If you forget to take a dose, take it as soon as you remember. However, if it is almost time to
take the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.
Page 14of 28
If you stop taking Valsartan and Idroclorotiazide Zentiva Italia
Stopping treatment with Valsartan and Idroclorotiazide Zentiva Italia may cause a
worsening of high blood pressure. Do not stop taking the medicine unless
your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:

See your doctor immediately if you have symptoms of angioedema (allergic reaction), such as:
swelling of the face, tongue or throat
difficulty swallowing
hives and difficulty breathing.
Severe skin disease causing rash, redness of the skin, blistering of the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis).
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 or myopia).
Fever, sore throat, more frequent infections (agranulocytosis).

These side effects are very rare or with unknown frequency.

Not common (may affect up to 1 in 100 people)

cough
low blood pressure
mild mental dizziness
dehydration (with symptoms of thirst, dryness of the mouth and tongue, infrequent urination, dark urine, dry skin)
muscle pain
fatigue
tingling or numbness
blurred vision
noises (e.g. whistling, ringing) in the ears. Very rare (may affect up to 1 in 10,000 people)
dizziness
diarrhea
joint pain.

Frequency not known (the frequency cannot be estimated from the available data)

difficulty breathing
significant decrease in the amount of urine excreted
low level of sodium in the blood (which can lead to fatigue, confusion, muscle contractions and/or convulsions in severe cases)

Page 15of 28

low level of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
low level of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
increased level of bilirubin in the blood (which can, in severe cases, determine yellow skin and eyes)
increased level of urea and creatinine in the blood (which may indicate abnormal kidney function)
increased level of uric acid in the blood (which can, in severe cases, cause gout)
syncope (fainting).

The following side effects have been detected with medicines containing only valsartan or only
hydrochlorothiazide:
Valsartan

Not common (may affect up to 1 in 100 people)

feeling of dizziness
abdominal pain.

Frequency not known (the frequency cannot be estimated from the available data)

skin blisters (signs of bullous dermatitis)
rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
rashes, reddish-purple spots, fever, itching (symptoms of inflammation of blood vessels)
low level of platelets in the blood (sometimes with unusual bleeding or bruising)
high level of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)
allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
swelling especially of the face and throat, rashes, itching
increased liver function values
reduction of hemoglobin level and reduction of the percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
kidney failure
low level of sodium in the blood (which can lead to fatigue, confusion, muscle contractions and/or convulsions in severe cases).

Hydrochlorothiazide

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

low level of potassium in the blood
increased lipids in the blood.

Common (may affect up to 1 in 10 people)

low level of sodium in the blood
low level of magnesium in the blood
high level of uric acid in the blood
itchy rash and other types of rash
loss of appetite
mild nausea and vomiting
dizziness, fainting when getting up
inability to achieve or maintain an erection. Rare (may affect up to 1 in 1,000 people)
swelling and blistering of the skin (due to increased sensitivity to the sun)
high level of calcium in the blood

Page 16of 28

high level of sugar in the blood
sugar in the urine
worsening of metabolic diabetic state
constipation, diarrhea, stomach or intestinal disorders, liver disorders that can occur together with yellow skin and eyes
irregular heartbeat
headache
sleep disorders
sad mood (depression)
low level of platelets in the blood (sometimes with bleeding or bruising under the skin)
dizziness
tingling or numbness
vision disorders.

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

inflammation of blood vessels with symptoms such as rashes, reddish-purple spots, fever (vasculitis)
rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
severe pain in the upper abdomen (pancreatitis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress including pneumonia and pulmonary edema)
fever, sore throat, more frequent infections (agranulocytosis)
paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)
confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis).

Frequency not known (the frequency cannot be estimated from the available data)

skin cancer and lip cancer (non-melanoma skin cancer)
weakness, bruising and frequent infections (aplastic anemia)
severe decrease in the amount of urine (possible signs of kidney disorders or kidney failure)
rash, redness of the skin, blistering of the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
muscle spasms
fever (pyrexia)
weakness (asthenia). Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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. 6How to store Valsartan and Idroclorotiazide Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date of expiry stated on the pack, on the blister pack or on the bottle after EXP. The date of expiry refers to the last day of that month.
PVC/PE/PVDC-Al blister: Do not store above 25°C.
Page 17of 28
Tablet containers in polyethylene: This medicine does not require any special storage conditions.
Do not dispose of medicines via water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Valsartan and Hydrochlorothiazide Zentiva Italia contains
The active ingredients are valsartan and hydrochlorothiazide.
Each film-coated tablet of Valsartan and Hydrochlorothiazide Zentiva Italia 320 mg/12.5 mg
contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
povidone K29 – K32, talc, magnesium stearate, anhydrous colloidal silica.

Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350,
yellow iron oxide (E172), lecithin (containing soybean oil) (E332), red iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva Italia and contents of the
pack
Valsartan and Hydrochlorothiazide Zentiva Italia 320 mg/12.5 mg: film-coated tablets, oval, biconvex, pink in colour,
18.9 x 7.5 mm, imprinted with “V” on one side and “H” on the other side.
Packs:
Blisters: 7, 10, 14, 20, 28, 30, 56, 90, 98 or 100 film-coated tablets.
Tablet container: 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milano
Page 18of 28
Manufacturers
Actavis Ltd.
Bulebel Industrial Estate
Malta
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa,
Bulgaria
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10 - Dolní Měcholupy
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany Valsartan Zentiva comp 320 mg/ 12,5 mg Filtabletten
Italy Valsartan and Hydrochlorothiazide Zentiva Italia
Poland VALTAP HCT
Page 19of 28

Не уверены, подходит ли вам это лекарство?
Обсудите симптомы и варианты лечения с врачом онлайн.

Valsartan and Hydrochlorothiazide Zentiva Italia

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 is Valsartan and Hydrochlorothiazide Zentiva Italia and what it is used for
2. What you need to know before you take Valsartan and Hydrochlorothiazide Zentiva Italia
3. How to take Valsartan and Hydrochlorothiazide Zentiva Italia
4. Possible side effects
5. How to store Valsartan and Hydrochlorothiazide Zentiva Italia
6. Contents of the pack and other information

1. What is Valsartan and Hydrochlorothiazide Zentiva Italia and what is it used for

Valsartanbelongs to a class of medicines known as "angiotensin II receptor antagonists", which help to control high blood pressure. Angiotensin II is a substance present in the body that causes the constriction of blood vessels, thus leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. Consequently, blood vessels relax and blood pressure decreases.
Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases diuresis, which also lowers blood pressure.

Valsartan and Hydrochlorothiazide Zentiva Italia is used for the treatment of high blood
pressure not adequately controlled by a single active ingredient.
High blood pressure increases the workload of the heart and arteries. If left untreated,
it can damage the blood vessels of the brain, heart and kidneys, and can lead to stroke, heart
failure or kidney failure. High blood pressure increases the risk of heart attacks.
Reducing blood pressure to normal values reduces the risk of developing these conditions.

2. What you need to know before taking Valsartan and Hydrochlorothiazide Zentiva Italia

Do not take Valsartan and Hydrochlorothiazide Zentiva Italia:

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals related to hydrochlorothiazide), soy, peanuts or any of the other ingredients of this medicine (listed in section 6);

Page 20of 28

if you are pregnantformore than 3 months(it is also better to avoid using Valsartan and Hydrochlorothiazide Zentiva Italia in the early stages of pregnancy - see section “Pregnancy”);
if you have a severeliver disease, destruction of the small bile ducts inside the liver (biliary cirrhosis) leading to bile stagnation in the liver (cholestasis);
if you have a severekidney disease;
if you are unable to produce urine (anuria);
if you are undergoing treatment with an artificial kidney;
if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your blood is higher than normal, despite treatment;
if you suffer from gout;
if you suffer from diabetes or your 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 this medicine and informyour doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Zentiva Italia:

if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in the blood such as heparin. Your doctor may need to check the amount of potassium in your blood regularly;
if you have low levels of potassium in your blood;
in case of diarrhea or severe vomiting;
if you are taking high doses of diuretic tablets (water tablets);
if you have a severe heart disease;
if you suffer from heart failure or have had a heart attack. Carefully follow your doctor's instructions for the initial dose. Your doctor may also check your kidney function;
if you suffer from a narrowing of the renal arteries;
if you have recently received a new kidney;
if you suffer from hyperaldosteronism. This is a condition in which the adrenal glands produce an excessive amount of the hormone aldosterone. If this is the case, the use of Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended;
if you suffer from a liver or kidney disease;
if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while you are taking Valsartan and Hydrochlorothiazide Zentiva Italia, stop taking Valsartan and Hydrochlorothiazide Zentiva Italia immediately and do not take it again. See also section 4, “Possible side effects”;
if you have fever, skin rashes and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease);
if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood;
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 some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Valsartan and Hydrochlorothiazide Zentiva Italia.
if you have had allergic reactions following the use of other medicines that lower blood pressure belonging to this class of medicines (angiotensin II receptor antagonists) or if you suffer from allergies or asthma;

Page 21of 28

if you have blurred 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 within hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva Italia. If left untreated, they can lead to permanent vision loss. If you have previously had an allergy to penicillin or a sulfonamide, you may be at higher risk of developing this condition;
the medicine may cause increased sensitivity of the skin to the sun;
if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
aliskiren.
if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol). Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Valsartan and Hydrochlorothiazide Zentiva Italia” and “Warnings and precautions”.

You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended in early pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken during this period (see section “Pregnancy”).

If any of these conditions apply to you, inform your doctor.
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Zentiva Italia in children and adolescents (under 18 years of age) is not recommended.

For athletes: the use of the medicine without a therapeutic need constitutes
doping and may still result in a positive doping test.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of the treatment may be affected if Valsartan and Hydrochlorothiazide Zentiva Italia is taken together with certain other medicines. Your doctor may need to adjust the dose and/or take other precautions, or in some cases, stop taking one of the medicines. This is especially true for the following medicines:

lithium, a medicine used to treat some mental disorders;
medicines or substances that can increase the levels of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin;
medicines that can reduce the amount of potassium in the blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G;
some antibiotics (rifampicin group), a medicine used to prevent organ rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines can enhance the effect of Valsartan and Hydrochlorothiazide Zentiva Italia;
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;

Page 22of 28

medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone;
therapeutic vitamin D and calcium supplements;
medicines for the treatment of diabetes (oral antidiabetics such as metformin or insulins);
other medicines to lower blood pressure, including methyldopa;
medicines that increase blood pressure, such as norepinephrine or epinephrine;
digoxin or other cardiac glycosides (medicines used to treat heart problems);
medicines that can increase blood sugar levels, such as diazoxide or beta-blockers;
cytotoxic medicines (used to treat cancer) such as methotrexate or cyclophosphamide;
pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid > 3 g;
muscle relaxants, such as tubocurarine;
anticholinergic medicines (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);
amantadine (a medicine used to treat Parkinson's disease and also used to treat or prevent some diseases caused by viruses);
cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in the blood);
cyclosporine, a medicine used for organ transplantation to prevent organ rejection;
alcohol, hypnotics and anesthetics (medicines with a sedative or analgesic effect used for example in surgery);
iodinated contrast media (agents used in diagnostic imaging).
if you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia" and "Warnings and precautions”).

Valsartan and Hydrochlorothiazide Zentiva Italia with food, beverages and alcohol
Avoid drinking alcohol before talking to your doctor. Alcohol can further lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or might become pregnant).
Your doctor will generally advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva Italia before trying to become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valsartan and Hydrochlorothiazide Zentiva Italia. Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as the medicine could cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding.
Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Before driving a vehicle, using tools or machines or performing other activities that require concentration, make sure you know how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva Italia can occasionally cause dizziness and affect your ability to concentrate.
Page 23of 28
Valsartan and Hydrochlorothiazide Zentiva Italia contains lactose, soybean oil and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
If you are allergic to peanuts or soy, do not take this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free’.

3. How to take Valsartan and Hydrochlorothiazide Zentiva Italia

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to get the best results and to reduce the risk of undesirable effects.
If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any signs of this condition.
Many may feel quite well. For this reason, it is very important that you maintain
regular appointments with your doctor, even when you feel well.
The doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Zentiva Italia
to take. Based on your response to treatment, the doctor may suggest a higher or
lower dose.

The recommended dose of Valsartan and Hydrochlorothiazide Zentiva Italia is one tablet a day.
Do not change the dose or stop taking the tablets without consulting your doctor.
The medicine should be taken at the same time each day, usually in the morning.
You can take Valsartan and Hydrochlorothiazide Zentiva Italia with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide Zentiva Italiathan you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you
have accidentally taken too many tablets, contact your doctor, pharmacist or a hospital.

If you forget to take Valsartan and Hydrochlorothiazide Zentiva Italia
If you forget to take a dose, take it as soon as you remember. However, if it is almost time to
take the next dose, skip the forgotten dose.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Valsartan and Hydrochlorothiazide Zentiva Italia
Stopping treatment with Valsartan and Hydrochlorothiazide Zentiva Italia may cause a
worsening of high blood pressure. Do not stop taking the medicine unless
your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

See your doctor immediately if you have symptoms of angioedema (allergic reaction), such as:
swelling of the face, tongue or throat
difficulty swallowing
urticaria and difficulty breathing.

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Severe skin disease causing skin rash, redness of the skin, formation of blisters on the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis).
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 or myopia).
Fever, sore throat, more frequent infections (agranulocytosis). These side effects are very rare or with unknown frequency.

Uncommon (may affect up to 1 in 100 people)

cough
low blood pressure
mild mental dizziness
dehydration (with symptoms of thirst, dryness of the mouth and tongue, infrequent urination, dark-colored urine, dry skin)
muscle pain
fatigue
tingling or numbness
blurred vision
noises (e.g. whistling, ringing) in the ears.

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

dizziness
diarrhea
joint pain.

Frequency not known (the frequency cannot be estimated from the available data)

difficulty breathing
significant decrease in the amount of urine excreted
low sodium levels in the blood (which can lead to fatigue, confusion, muscle contractions and/or convulsions in severe cases)
low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
low levels of white blood cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
increased levels of bilirubin in the blood (which can, in severe cases, cause yellowing of the skin and eyes)
increased levels of urea and creatinine in the blood (which may indicate abnormal kidney function)
increased levels of uric acid in the blood (which can, in severe cases, cause gout)
syncope (fainting).

The following side effects have been detected with medicines containing only valsartan or only
hydrochlorothiazide:
Valsartan

Uncommon (may affect up to 1 in 100 people)

feeling of dizziness

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abdominal pain.

Frequency not known (the frequency cannot be estimated from the available data)

skin blisters (signs of bullous dermatitis)
rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
rashes, reddish-purple spots, fever, itching (symptoms of inflammation of blood vessels)
low levels of platelets in the blood (sometimes with unusual bleeding or bruising)
high potassium levels in the blood (sometimes with muscle spasms, irregular heartbeat)
allergic reactions (with symptoms such as skin rashes, itching, urticaria, difficulty breathing or swallowing, dizziness)
swelling especially of the face and throat, skin rashes, itching
increased liver function values
reduction of hemoglobin levels and reduction of the percentage of red blood cells in the blood (which, in severe cases, can both cause anemia)
kidney failure
low sodium levels in the blood (which can lead to fatigue, confusion, muscle contractions and/or convulsions in severe cases).

Hydrochlorothiazide

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)

low sodium levels in the blood
low magnesium levels in the blood
high uric acid levels in the blood
itchy rash and other types of rash
loss of appetite
mild nausea and vomiting
dizziness, fainting when standing up
inability to achieve or maintain an erection.

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

swelling and blistering of the skin (due to increased sensitivity to the sun)
high calcium levels in the blood
high sugar levels in the blood
sugar in the urine
worsening of metabolic diabetic state
constipation, diarrhea, stomach or intestinal disorders, liver disorders that can occur together with yellow skin and eyes
irregular heartbeat
headache
sleep disturbances
sad mood (depression)
low levels of platelets in the blood (sometimes with bleeding or bruising under the skin)
dizziness
tingling or numbness
vision disorders. Very rare (may affect up to 1 in 10,000 people)
inflammation of blood vessels with symptoms such as rashes, reddish-purple spots,

Page 26of 28
fever (vasculitis)

rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
severe pain in the upper abdomen (pancreatitis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress including pneumonia and pulmonary edema)
pallor, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
fever, sore throat or mouth ulcers caused by infections (leukopenia)
confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis).

Frequency not known (the frequency cannot be estimated from the available data)

skin cancer and lip cancer (non-melanoma skin cancer)
weakness, bruising and frequent infections (aplastic anemia)
severe decrease in the amount of urine (possible signs of kidney disorders or kidney failure)
rash, redness of the skin, formation of blisters on the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
muscle spasms
fever (pyrexia)
weakness (asthenia). Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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. 7How to store Valsartan and Idroclorotiazide Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, on the blister pack or on the bottle after EXP. The expiry date refers to the last day of that month.
PVC/PE/PVDC-Al blister: Do not store above 30°C.
Polyethylene container for tablets: This medicine does not require any special storage conditions.
Do not dispose of medicines via water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Valsartan and Hydrochlorothiazide Zentiva Italia contains
The active ingredients are valsartan and hydrochlorothiazide.
Each film-coated tablet of Valsartan and Hydrochlorothiazide Zentiva Italia 320 mg/25 mg
contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
The other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
Page 27of 28
povidone K29 – K32, talc, magnesium stearate, anhydrous colloidal silica.

Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350,
yellow iron oxide (E172), lecithin (containing soybean oil) (E332), red iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva Italia and contents of the
pack
Valsartan and Hydrochlorothiazide Zentiva Italia 320 mg/25 mg: film-coated tablets, yellow in
colour, oval, biconvex, 18.9 x 7.5 mm, notched on one side and on the edges, imprinted with “V” on
one side and “H” on the other side.
The tablet can be divided into two equal doses.
Packs:
Blisters: 7, 10, 14, 20, 28, 30, 56, 90, 98 or 100 film-coated tablets.
Tablet container: 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milano

Manufacturers
Actavis Ltd.
Bulebel Industrial Estate
Malta
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa,
Bulgaria
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10 - Dolní Měcholupy
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany Valsartan Zentiva comp 320 mg/ 25 mg Filtabletten
Italy Valsartan e Idroclorotiazide Zentiva Italia
Poland VALTAP HCT
Page 28of 28

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Страна регистрации
Италия
Форма выпуска
Film-coated tablet, 160MG/12,5MG
Код АТХ
C09DA03
Действующее вещество
valsartan and diuretics
Отпускается по рецепту
Да
Производитель
ZENTIVA ITALIA S.R.L.
Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
Аналоги VALSARTAN E IDROKLOROTIATSIDE TSENTIVA ITALIA
KOMBISARTAN
Форма выпуска: Coated tablet, 80 MG/12,5 MG
Действующее вещество: valsartan and diuretics
Производитель: A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.
Отпускается по рецепту
KORIXIL
Действующее вещество: valsartan and diuretics
Производитель: SANDOZ S.P.A.
Отпускается по рецепту
KOTAREG
Действующее вещество: valsartan and diuretics
Производитель: NOVARTIS FARMA S.P.A.
Отпускается по рецепту

Аналоги VALSARTAN E IDROKLOROTIATSIDE TSENTIVA ITALIA в других странах

Лекарства с тем же действующим веществом, доступные в других странах.