Valsartan and hydrochlorothiazide Zentiva Italia: detailed information

Valsartan and Hydrochlorothiazide Zentiva Italia
160 mg/12.5 mg film-coated tablets
Equivalent 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 doubts, consult 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, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

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

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

Valsartan belongs to a class of medicines known as "angiotensin II receptor antagonists", which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases urine production, which also helps lower blood pressure.

Valsartan and Hydrochlorothiazide Zentiva Italia is used to treat high blood pressure that is not
adequately controlled by a single active substance.
High blood pressure increases the workload on the heart and arteries. If left untreated, it can
damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or
kidney failure. High blood pressure increases the risk of heart attacks.
Lowering blood pressure to normal levels 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 (chemically related substances to hydrochlorothiazide), soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
if you are more than 3 months pregnant (it is also better to avoid using Valsartan and Hydrochlorothiazide Zentiva Italia in early pregnancy - see section “Pregnancy”);
if you have severe liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis);
if you have severe kidney disease;
if you are unable to produce urine (anuria);
if you are undergoing treatment with an artificial kidney;
if your blood potassium or sodium levels are below normal, or if your blood calcium level is above normal, despite treatment;
if you suffer from gout;
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, inform 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, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood such as heparin. Your doctor may need to regularly monitor your blood potassium levels;
if you have low levels of potassium in your blood;
in case of diarrhoea or severe vomiting;
if you are taking high doses of diuretic tablets (diuretics);
if you have severe heart disease;
if you suffer from heart failure or have had a heart attack. Follow your doctor's instructions carefully regarding the initial dosage. Your doctor may also monitor your kidney function;
if you suffer from 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 excessive amounts of the hormone aldosterone. If this applies to you, use of Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended;
if you have liver or kidney disease;
if you have previously experienced swelling of the tongue and face due to 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 it 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, or elevated cholesterol or triglyceride levels in the blood;
if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Valsartan and Hydrochlorothiazide Zentiva Italia.
if you have had allergic reactions when using other medicines that lower blood pressure belonging to this class of medicines (angiotensin II receptor antagonists) or if you suffer from allergies or asthma;
if you experience vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva Italia. If untreated, they may lead to permanent vision loss.
If you previously had an allergy to penicillin or a sulfonamide, you may be at 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. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the section "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia".

Valsartan and Hydrochlorothiazide Zentiva Italia may cause increased skin sensitivity to sunlight.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken 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 those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be affected if Valsartan and Hydrochlorothiazide Zentiva Italia is taken together with certain other medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions, or in some cases, discontinue one of the medicines. This is especially important for the following medicines:

lithium, a medicine used to treat certain psychiatric disorders;
medicines or substances that may increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
medicines that may reduce potassium levels in the blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
certain antibiotics (rifampicin group), a medicine used to prevent organ rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide Zentiva Italia;
medicines that may induce "torsade de pointes" (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics;
medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone;
therapeutic vitamin D and calcium supplements;
medicines for treating diabetes (oral antidiabetics such as metformin or insulin);

Page 3 of 28

other medicines to lower blood pressure, including methyldopa;
medicines that increase blood pressure, such as noradrenaline or adrenaline;
digoxin or other digitalis glycosides (medicines used to treat heart problems);
medicines that may increase blood sugar levels, such as diazoxide or beta-blockers;
cytotoxic medicines (used to treat cancer) such as methotrexate or cyclophosphamide;
painkillers 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 (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as support during anaesthesia);
amantadine (a medicine used to treat Parkinson's disease and also used to treat or prevent certain viral diseases);
cholestyramine and colestipol (medicines mainly used to treat high lipid levels in the blood);
cyclosporine, a medicine used in organ transplantation to prevent organ rejection;
alcohol, sedatives, and anaesthetics (medicines with sleep-inducing or pain-relieving effects used, for example, in surgery);
iodinated contrast agents (substances used in medical 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, drinks, and alcohol
Avoid consuming alcohol before speaking with your doctor. Alcohol may 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, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant).
Your doctor will usually advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva Italia before becoming pregnant or as soon as pregnancy is confirmed and will recommend an alternative medicine instead of Valsartan and Hydrochlorothiazide Zentiva Italia. Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating tools or machinery, or performing other activities requiring concentration, make sure you are aware of how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva Italia may occasionally cause dizziness and affect your ability to concentrate.
Page 4 of 28
Valsartan and Hydrochlorothiazide Zentiva Italia contains lactose, soybean oil, sunset yellow, and
sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 Sunset Yellow FCF (E110), which may cause allergic reactions.
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 Hydrochlorothiazide Zentiva Italia

Take this medicine exactly as instructed by your doctor or pharmacist.
This will help you achieve the best results and reduce the risk of side 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 people may feel quite well. For this reason, it is very important that you keep regular
appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Zentiva Italia
to take. Depending on your response to treatment, your doctor may recommend a higher or
lower dose.

The recommended dose of Valsartan and Hydrochlorothiazide Zentiva Italia is one tablet daily.
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 may 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 Italia than 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 go to 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 for
your next dose, skip the missed 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 your
high blood pressure to worsen. Do not stop taking this medicine unless your doctor tells you to.
If you have any questions about how to use 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 a doctor immediately if you have symptoms of angioedema (an allergic reaction), such as:
swelling of the face, tongue or throat
difficulty swallowing
hives and difficulty breathing.
Serious skin disease causing rash, redness of the skin, blistering around the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis).
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 or myopia).
Fever, sore throat, more frequent infections (agranulocytosis).

These side effects are very rare or their frequency is unknown.
If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide 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 confusion
dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark-coloured urine, dry skin)
muscle pain
fatigue
tingling or numbness
blurred vision
noises (e.g. ringing, buzzing) in the ears.

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

dizziness
diarrhoea
joint pain.

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

difficulty breathing
marked decrease in the amount of urine passed
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases)
low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
low white blood cell count 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 may, in severe cases, cause yellowing of the skin and eyes)
increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
increased uric acid levels in the blood (which may, in severe cases, cause gout)
syncope (fainting).

The following side effects have been reported with medicines containing only valsartan or only hydrochlorothiazide:
Valsartan
Uncommon (may affect up to 1 in 100 people)

feeling dizzy
abdominal pain.

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

skin blisters (signs of bullous dermatitis)
skin rash with or without itching together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
skin rashes, red-purple spots, fever, itching (symptoms of inflammation of blood vessels)
low platelet count 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, hives, difficulty breathing or swallowing, dizziness)
swelling, especially of the face and throat, skin rashes, itching
increased liver function test values
reduced haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may both cause anaemia)
renal failure
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases).

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

low potassium levels in the blood
increased blood lipids.

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 skin rash and other types of skin rash
reduced appetite
mild nausea and vomiting
dizziness, fainting when standing up
inability to achieve or maintain erection.
Rare (may affect up to 1 in 1,000 people)
swelling and blistering of the skin (due to increased sensitivity to sunlight)
high calcium levels in the blood
high blood sugar levels
sugar in the urine
worsening of metabolic diabetic state
constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may occur together with yellowing of the skin and eyes
irregular heartbeat
headache
sleep disturbances
feeling sad (depression)
low platelet count in the blood (sometimes with bleeding or bruising under the skin)
dizziness
tingling or numbness
vision disturbances.

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

inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
skin 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 oedema)
paleness, fatigue, shortness of breath, dark-coloured urine (haemolytic anaemia)
fever, sore throat or mouth ulcers caused by infections (leucopenia)
confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloraemic alkalosis).
Frequency not known (frequency cannot be estimated from the available data)
Skin and lip cancer (non-melanoma skin cancer)
weakness, bruising and frequent infections (aplastic anaemia)
severe decrease in the amount of urine (possible signs of kidney problems or kidney failure)
skin rash, redness of the skin, blistering around the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
muscle spasms
fever (pyrexia)
weakness (asthenia).

Reporting of side effects
If you experience any side effects, 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. Reporting side effects can help provide more information on the safety of this medicine.

5 How to store Valsartan and Hydrochlorothiazide 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 carton, container or blister pack 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 medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Zentiva Italia contains
The active substances are valsartan and hydrochlorothiazide.
Page 8 of 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 components are:
Tablet core: microcrystalline cellulose, monohydrate lactose, croscarmellose sodium, 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 soybean oil) (E332).

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

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milan, Italy

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 authorized in the European Economic Area countries under the following names:
Germany Valsartan Zentiva comp 160 mg/12.5 mg Filmtablatten
Italy Valsartan and Hydrochlorothiazide Zentiva Italia
Portugal Valsartan + Hydrochlorothiazide Zentiva

Page 9 of 28
Valsartan and Hydrochlorothiazide Zentiva Italia
320 mg/12.5 mg film-coated tablets
Equivalent medicine

Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Valsartan and Hydrochlorothiazide Zentiva Italia is and what it is used for
What you need to know before taking Valsartan and Hydrochlorothiazide Zentiva Italia
How to take Valsartan and Hydrochlorothiazide Zentiva Italia
Possible side effects
How to store Valsartan and Hydrochlorothiazide Zentiva Italia
Package contents and other information

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

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

Valsartan belongs to a class of medicines known as "angiotensin II receptor antagonists", which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as "water tablets"). Hydrochlorothiazide increases urine production, which also helps lower blood pressure.

Valsartan and Hydrochlorothiazide Zentiva Italia is used to treat high blood pressure that is not adequately controlled by a single active substance.
High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.
Page 10 of 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 (chemically related substances to hydrochlorothiazide), soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
if you are more than 3 months pregnant (it is also better to avoid use of Valsartan and Hydrochlorothiazide Zentiva Italia in early pregnancy – see section “Pregnancy”);
if you have severe liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis);
if you have severe kidney disease;
if you are unable to produce urine (anuria);
if you are undergoing treatment with an artificial kidney;
if your blood potassium or sodium levels are below normal, or if your blood calcium levels are above normal despite treatment;
if you suffer from gout;
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, inform 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, potassium-containing salt substitutes, or other medicines that increase blood potassium levels such as heparin. Your doctor may need to regularly monitor your blood potassium levels;
if you have low blood potassium levels;
in case of diarrhoea or severe vomiting;
if you are taking high doses of diuretic tablets (diuretics);
if you have severe heart disease;
if you suffer from heart failure or have had a heart attack. Follow your doctor’s instructions carefully regarding initial dosing. Your doctor may also monitor your kidney function;
if you have narrowing of the renal arteries;
if you have recently received a new kidney;
if you have hyperaldosteronism. This is a condition in which the adrenal glands produce excessive amounts of the hormone aldosterone. If this applies to you, use of Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended;
if you have liver or kidney disease;
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide Zentiva Italia, stop taking it immediately and do not restart it later. 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, or elevated cholesterol or triglyceride levels in the blood;
if you have previously had skin cancer or develop 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Valsartan and Hydrochlorothiazide Zentiva Italia.
if you have had allergic reactions after using other blood pressure-lowering medicines belonging to this class of drugs (angiotensin II receptor antagonists) or if you suffer from allergy or asthma;
if you experience vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva Italia. If untreated, they may lead to permanent vision loss. If you previously had an allergy to penicillin or a sulfonamide, you may be at 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), especially if you have kidney problems related to diabetes;
aliskiren. Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also the section "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia".

Valsartan and Hydrochlorothiazide Zentiva Italia may increase skin sensitivity to sunlight.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may 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 those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be altered if Valsartan and Hydrochlorothiazide Zentiva Italia is taken together with certain other medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions, or in some cases, discontinue one of the medicines. This is particularly important for the following medicines:

lithium, a medicine used to treat certain psychiatric disorders;
medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
medicines that may reduce blood potassium levels, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
certain antibiotics (rifampicin group), a medicine used to prevent organ rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide Zentiva Italia;
medicines that may induce “torsades 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 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 insulin);
other blood pressure-lowering medicines, including methyldopa;
medicines that may increase blood pressure, such as noradrenaline or adrenaline;
digoxin or other digitalis glycosides (medicines used to treat heart problems);
medicines that may increase blood glucose levels, such as diazoxide or beta-blockers;
cytotoxic medicines (used in cancer treatment) such as methotrexate or cyclophosphamide;
painkillers 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 (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an adjunct to anaesthesia);
amantadine (a medicine used to treat Parkinson’s disease and also used to prevent certain viral diseases);
cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels);
cyclosporine, a medicine used in organ transplantation to prevent organ rejection;
alcohol, sedatives, and anaesthetics (medicines with soporific or pain-relieving effects, used, for example, in surgery);
iodinated contrast agents (used in medical imaging);
if you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take Valsartan and Hydrochlorothiazide Zentiva Italia" and "Warnings and precautions").

Valsartan and Hydrochlorothiazide Zentiva Italia with food, drinks and alcohol
Avoid consuming alcohol before discussing it with your doctor. Alcohol may 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant).
Your doctor will usually advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva Italia before trying to become pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended in early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Page 13 of 28
Driving and using machines
Before driving, operating tools or machinery, or performing other activities requiring concentration, ensure you understand how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva Italia may occasionally cause dizziness and affect your ability to concentrate.
Valsartan and Hydrochlorothiazide Zentiva Italia contains lactose, soybean oil 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.
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 Hydrochlorothiazide Zentiva Italia

Take this medicine exactly as your doctor or pharmacist has told you.
This will help you achieve the best results and reduce the risk of side effects.
If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms.
Many may feel quite well. For this reason, it is very important that you keep
regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Zentiva Italia
you should take. Depending on your response to treatment, your doctor may recommend a higher or
lower dose.

The recommended dose of Valsartan and Hydrochlorothiazide Zentiva Italia is one tablet daily.
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 may 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 Italia than 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 for your
next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.
Page 14 of 28
If you stop taking Valsartan and Hydrochlorothiazide Zentiva Italia
Stopping treatment with Valsartan and Hydrochlorothiazide Zentiva Italia could cause your high blood
pressure to worsen. Do not stop taking the medicine unless your doctor tells you to.
If you have any questions about how to use 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 can be serious and require immediate medical attention:

Seek medical help immediately if you experience symptoms of angioedema (an allergic reaction), such as:
swelling of the face, tongue or throat
difficulty swallowing
hives and breathing difficulties.
Severe skin disease causing rash, redness of the skin, blistering around the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis).
Decreased vision or eye pain due to increased 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 their frequency is unknown.
If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide
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 such as thirst, dry mouth and tongue, infrequent urination, dark-coloured urine, dry skin)
muscle pain
fatigue
tingling or numbness
blurred vision
noises (e.g. ringing, buzzing) in the ears. Very rare (may affect up to 1 in 10,000 people)
dizziness
diarrhoea
joint pain.

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

difficulty breathing
marked decrease in the amount of urine produced
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases)

Page 15 of 28

low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
increased uric acid levels in the blood (which may, in severe cases, trigger gout)
syncope (fainting).

The following side effects have been reported with medicines containing only valsartan or only
hydrochlorothiazide:
Valsartan
Uncommon (may affect up to 1 in 100 people)

feeling dizzy
abdominal pain.

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

skin blisters (signs of bullous dermatitis)
rash with or without itching together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
skin rashes, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
low platelet count in the blood (sometimes with unusual bleeding or bruising)
high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
allergic reactions (with symptoms such as skin rashes, itching, hives, difficulty breathing or swallowing, dizziness)
swelling, especially of the face and throat, skin rashes, itching
elevated liver function test values
reduced haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may both cause anaemia)
kidney failure
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases).

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

low potassium levels in the blood
increased blood lipids.

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 skin rash
reduced 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 sunlight)
high calcium levels in the blood

Page 16 of 28

high blood sugar levels
sugar in the urine
worsening of metabolic diabetic state
constipation, diarrhoea, stomach or intestinal disturbances, liver disorders which may occur together with yellowing of the skin and eyes
irregular heartbeat
headache
sleep disturbances
feeling sad (depression)
low platelet count in the blood (sometimes with bleeding or bruising under the skin)
dizziness
tingling or numbness
vision disturbances.

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

inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
severe upper abdominal pain (pancreatitis)
difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress including pneumonia and pulmonary oedema)
fever, sore throat, more frequent infections (agranulocytosis)
paleness, fatigue, shortness of breath, dark-coloured urine (haemolytic anaemia)
confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloraemic alkalosis).

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

skin and lip cancer (non-melanoma skin cancer)
weakness, bruising and frequent infections (aplastic anaemia)
severe decrease in urine output (possible signs of kidney problems or kidney failure)
skin rash, redness of the skin, blistering around the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
muscle cramps
fever (pyrexia)
weakness (asthenia). 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. 6 How to store Valsartan and Hydrochlorothiazide 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 carton, container or blister after EXP. The expiry date refers to the last day of that month.
PVC/PE/PVDC-Al blister: Do not store above 25°C.
Page 17 of 28
Polyethylene tablet containers: This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva Italia and the
package contents
Valsartan and Hydrochlorothiazide Zentiva Italia 320 mg/12.5 mg: pink, oval, biconvex film-coated tablets, 18.9 x 7.5 mm, marked with "V" on one side and "H" on the other side.
Pack sizes:
Blister packs: 7, 10, 14, 20, 28, 30, 56, 90, 98 or 100 film-coated tablets.
Bottle: 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milano
Page 18 of 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 authorized in the European Economic Area countries under the
following names:
Germany Valsartan Zentiva comp 320 mg/12.5 mg Filmtablatten
Italy Valsartan and Hydrochlorothiazide Zentiva Italia
Poland VALTAP HCT
Page 19 of 28

Valsartan and Hydrochlorothiazide Zentiva Italia
320 mg/25 mg film-coated tablets
Generic medicine

Read all of this leaflet carefully before taking this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Valsartan and Hydrochlorothiazide Zentiva Italia is and what it is used for
What you need to know before taking Valsartan and Hydrochlorothiazide Zentiva Italia
How to take Valsartan and Hydrochlorothiazide Zentiva Italia
Possible side effects
How to store Valsartan and Hydrochlorothiazide Zentiva Italia
Package contents and other information

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

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

Valsartan and Hydrochlorothiazide Zentiva Italia is used to treat high blood pressure
that is not adequately controlled by a single active substance.
High blood pressure increases the workload on the heart and arteries. If left untreated,
it can damage the blood vessels in the brain, heart, and kidneys, and may lead to stroke,
heart failure, or kidney failure. High blood pressure increases the risk of heart attacks.
Lowering blood pressure to normal levels 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, sulphonamide derivatives (chemically related substances to hydrochlorothiazide), soy, peanuts, or to any of the other ingredients of this medicine (listed in section 6);

Page 20 of 28

if you are more than 3 months pregnant (it is also better to avoid using Valsartan and Hydrochlorothiazide Zentiva Italia in early pregnancy – see section “Pregnancy”);
if you have severe liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis);
if you have severe kidney disease;
if you are unable to produce urine (anuria);
if you are undergoing treatment with an artificial kidney;
if your blood potassium or sodium levels are below normal, or if your blood calcium level is above normal, despite treatment;
if you suffer from gout;
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 this medicine and inform your 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, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood such as heparin. Your doctor may need to regularly monitor your blood potassium levels;
if you have low blood potassium levels;
if you have diarrhoea or severe vomiting;
if you are taking high doses of diuretic tablets (water tablets);
if you have severe heart disease;
if you suffer from heart failure or have recently had a heart attack. Follow your doctor’s instructions carefully regarding initial dosing. Your doctor may also monitor your kidney function;
if you have narrowing of the renal arteries;
if you have recently received a kidney transplant;
if you suffer from hyperaldosteronism – a condition in which the adrenal glands produce excessive amounts of the hormone aldosterone. If this applies to you, the use of Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended;
if you have liver or kidney disease;
if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide Zentiva Italia, stop taking the medicine 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, an autoimmune disease);
if you have diabetes, gout, or elevated cholesterol or triglyceride levels in the blood;
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 cancer and lip cancer. Protect your skin from sun and UV exposure while taking Valsartan and Hydrochlorothiazide Zentiva Italia.
if you have had allergic reactions after taking other medicines used to lower blood pressure belonging to this class of medicines (angiotensin II receptor antagonists) or if you suffer from allergies or asthma;

Page 21 of 28

if you experience vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which can occur within hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva Italia. If untreated, these may lead to permanent vision loss. If you previously had an allergy to penicillin or a sulphonamide, you may be at higher risk of developing this condition;
this medicine may cause increased skin sensitivity to sunlight;
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 are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol). Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also the section “Do not take Valsartan and Hydrochlorothiazide Zentiva Italia”.

You must 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 must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn 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 those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Valsartan and Hydrochlorothiazide Zentiva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of treatment may be altered 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, discontinue one of the medicines. This is particularly important for the following medicines:

lithium, a medicine used to treat certain psychiatric disorders;
medicines or substances that can increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
medicines that can reduce blood potassium levels, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
certain antibiotics (rifampicin group), a medicine used to prevent organ rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may enhance the effect of Valsartan and Hydrochlorothiazide Zentiva Italia;
medicines that may cause "torsade de pointes" (an irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics;
medicines that can reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;

Page 22 of 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 insulin);
other medicines to lower blood pressure, including methyldopa;
medicines that can increase blood pressure, such as noradrenaline or adrenaline;
digoxin or other digitalis 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;
painkillers 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 (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as support during anaesthesia);
amantadine (a medicine used to treat Parkinson’s disease and also used to treat or prevent certain viral diseases);
cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels);
cyclosporine, a medicine used after organ transplantation to prevent organ rejection;
alcohol, sedatives, and anaesthetics (medicines with sleep-inducing or pain-relieving effects used, for example, in surgery);
iodinated contrast agents (substances used in medical 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, drinks and alcohol
Avoid consuming alcohol before speaking with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or could become pregnant).
Your doctor will usually advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva Italia before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended in early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Valsartan and Hydrochlorothiazide Zentiva Italia is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Before driving, operating tools or machinery, or performing other activities requiring concentration, make sure you are aware of how this medicine affects you. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Zentiva Italia may occasionally cause dizziness and affect your ability to concentrate.
Page 23 of 28
Valsartan and Hydrochlorothiazide Zentiva Italia contains lactose, soybean oil 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.
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 Hydrochlorothiazide Zentiva Italia

Take this medicine exactly as instructed by your doctor or pharmacist.
This will help you achieve the best results and reduce the risk of side effects.
If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms.
Many may feel quite well. For this reason, it is very important that you keep
regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Zentiva Italia
to take. Depending on your response to treatment, your doctor may recommend a higher or
lower dose.

The recommended dose of Valsartan and Hydrochlorothiazide Zentiva Italia is one tablet daily.
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 may 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 Italia than 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 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 for your next dose, skip the missed 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 your high blood pressure to worsen. Do not stop taking the medicine unless your doctor tells you to.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention:

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

Page 24 of 28

Severe skin disease causing rash, redness of the skin, blistering around the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis).
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 or myopia).
Fever, sore throat, more frequent infections (agranulocytosis). These side effects are very rare or their frequency is not known.

If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide
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, dry mouth and tongue, infrequent urination, dark-coloured urine, dry skin)
muscle pain
fatigue
tingling or numbness
blurred vision
noises (e.g. ringing, buzzing) in the ears.

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

dizziness
diarrhoea
joint pain.

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

difficulty breathing
marked decrease in the amount of urine produced
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases)
low potassium levels in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
low white blood cell count 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 may, in severe cases, cause yellowing of the skin and eyes)
increased blood urea nitrogen and creatinine levels in the blood (which may indicate abnormal kidney function)
increased uric acid levels in the blood (which may, in severe cases, trigger gout)
syncope (fainting).

The following side effects have been reported with medicines containing only valsartan or only
hydrochlorothiazide:
Valsartan
Uncommon (may affect up to 1 in 100 people)

feeling of dizziness

Page 25 of 28

abdominal pain.

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

skin blisters (signs of bullous dermatitis)
skin rash with or without itching together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
skin rashes, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
low platelet count in the blood (sometimes with unusual bleeding or bruising)
high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
allergic reactions (with symptoms such as rashes, itching, hives, difficulty breathing or swallowing, dizziness)
swelling, especially of the face and throat, skin rashes, itching
elevated liver function test values
reduced haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may both cause anaemia)
renal failure
low sodium levels in the blood (which may lead to fatigue, confusion, muscle cramps and/or seizures in severe cases).

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

low potassium levels in the blood
increased blood lipids.

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 skin rash
reduced appetite
mild nausea and vomiting
dizziness, fainting when standing up
inability to achieve or maintain erection.

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

swelling and blistering of the skin (due to increased sensitivity to sunlight)
high calcium levels in the blood
high blood sugar levels
sugar in the urine
worsening of metabolic diabetic state
constipation, diarrhoea, stomach or intestinal disorders, liver disorders which may occur together with yellowing of the skin and eyes
irregular heartbeat
headache
sleep disturbances
depressed mood (depression)
low platelet count in the blood (sometimes with bleeding or bruising under the skin)
dizziness
tingling or numbness
vision disturbances.

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

inflammation of blood vessels with symptoms such as skin rashes, red-purple spots,

Page 26 of 28
fever (vasculitis)

skin 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 oedema)
paleness, fatigue, shortness of breath, dark-coloured urine (haemolytic anaemia)
fever, sore throat or mouth ulcers caused by infections (leucopenia)
confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis).

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

skin and lip cancer (non-melanoma skin cancer)
weakness, bruising and frequent infections (aplastic anaemia)
severe decrease in the amount of urine (possible signs of kidney problems or kidney failure)
skin rash, redness of the skin, blistering around the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
muscle spasms
fever (pyrexia)
weakness (asthenia).

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.

7 How to store Valsartan and Hydrochlorothiazide 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 carton, container or blister pack 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 medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Zentiva Italia contains
The active substances 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 components are:
Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose,
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povidone K29–K32, talc, magnesium stearate, anhydrous colloidal silicon dioxide.
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 pack
contents
Valsartan and Hydrochlorothiazide Zentiva Italia 320 mg/25 mg: yellow, oval, biconvex, film-coated tablets, 18.9 x 7.5 mm, scored on one side and on the edges, printed with "V" on one side and "H" on the other side.
The tablet can be divided into two equal doses.
Pack sizes:
Blister packs: 7, 10, 14, 20, 28, 30, 56, 90, 98 or 100 film-coated tablets.
Bottle: 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milan, Italy
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 authorized in the European Economic Area Member States under the
following names:
Germany Valsartan Zentiva comp 320 mg/25 mg Filmtablatten
Italy Valsartan e Idroclorotiazide Zentiva Italia
Poland VALTAP HCT
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