VALSARTAN 80 mg /12,5 Mg Film-Coated Tablets

Содержание инструкции

1. Valsartan and Hydrochlorothiazide Zentiva 80 mg/12.5 mg film-coated tablets
   1. What is Valsartan and Hydrochlorothiazide Zentiva and what is it used for
   2. Before taking Valsartan and Hydrochlorothiazide Zentiva
   3. How to take Valsartan and Idroclorotiazide Zentiva
   4. Possible side effects
   5. How to store Valsartan and Idroclorotiazide Zentiva
   6. Other information
2. Valsartan and Hydrochlorothiazide Zentiva 160 mg/25 mg film-coated tablets
   1. What is Valsartan and Hydrochlorothiazide Zentiva and what is it used for
   2. Before taking Valsartan and Idroclorotiazide Zentiva
   3. How to take Valsartan and Idroclorotiazide Zentiva
   4. Possible side effects
   5. How to store Valsartan and Hydrochlorothiazide Zentiva
   6. Other information

Valsartan and Hydrochlorothiazide Zentiva 80 mg/12.5 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start using 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.

In this leaflet:

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

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

Valsartan and Hydrochlorothiazide Zentiva film-coated tablets contain 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 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 drugs called thiazide diuretics (also known as "water pills"). Hydrochlorothiazide increases diuresis, which also lowers blood pressure.

Valsartan and Hydrochlorothiazide Zentiva 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 levels reduces the risk of developing these
diseases.

2. Before taking Valsartan and Hydrochlorothiazide Zentiva

Do not take Valsartan and Hydrochlorothiazide Zentiva

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other components of this medicine (listed in section 6);
• if you are more than 3 monthspregnant(it is also best to avoid using Valsartan and Hydrochlorothiazide Zentiva at the beginning of pregnancy - see section “Pregnancy”);
• if you have a severe liver disease - destruction of the small bile ducts within the liver

(biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis);

• if you have a severe kidney 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, talk to your doctor and do not take
Valsartan and Hydrochlorothiazide Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Zentiva:

• if you are taking potassium-sparing drugs, potassium supplements, salt substitutes containing potassium or other drugs 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 tablets that help to eliminate water (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 on the starting dose of therapy carefully. Your doctor will 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 is not recommended;
• if you are affected by a liver or kidney disease;
• if you have decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Valsartan and Hydrochlorothiazide Zentiva. This situation can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at high risk of developing it.
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), tell your doctor. If these symptoms occur when you take Valsartan and Hydrochlorothiazide Zentiva, stop taking Valsartan and Hydrochlorothiazide Zentiva immediately and never 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 lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Valsartan and Hydrochlorothiazide Zentiva.
• if you have had allergic reactions following the use of other medicines that lower blood pressure belonging to this class (angiotensin II receptor antagonists) or suffer from allergy or asthma;
• 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 suffer from

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 reported under “Do not take Valsartan and Hydrochlorothiazide Zentiva”.
Valsartan and Hydrochlorothiazide Zentiva may cause increased sensitivity of the skin to the sun.

• 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 is not recommended at the beginning 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 section “Pregnancy”).

Children and adolescents
The use of Valsartan and Hydrochlorothiazide Zentiva in children and adolescents (under 18 years of age) is not
recommended.
For athletes: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.

Other medicines and Valsartan and Hydrochlorothiazide Zentiva
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 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 types of mental disorders;
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs and heparin;
• medicines that can reduce the amount of potassium in the blood, such as diuretics (water-eliminating tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G;
• some antibiotics (rifampicin group), a medicine used against rejection in transplantation (cyclosporine) and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines can increase the effect of Valsartan and Hydrochlorothiazide Zentiva;
• medicines that can induce “torsades 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;
• 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, an ACE inhibitor or aliskiren (see also what is reported under: “Do not take Valsartan and Hydrochlorothiazide Zentiva” and “Warnings and precautions”).
• medicines that increase blood pressure such as norepinephrine or epinephrine;
• 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 for cancer treatment), such as methotrexate or cyclophosphamide;
• pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (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 spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia);
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent some viral diseases);
• cholestyramine and colestipol (medicines used mainly to treat high lipid levels in the blood);
• cyclosporine, a medicine used for organ transplantation to prevent organ rejection;
• alcohol, sleeping pills and anesthetics (medicines with a narcotic or analgesic effect used, for example, during surgery);
• iodinated contrast agents (used for radiological examinations);

Valsartan and Hydrochlorothiazide Zentiva with food, drinks 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 a pregnancy, 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 could become pregnant).
Your doctor will advise you to stop taking Valsartan and Hydrochlorothiazide Zentiva 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. Valsartan and Hydrochlorothiazide Zentiva
is not recommended at the beginning of pregnancy, and should not be taken if you have been 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 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 can,
occasionally, cause dizziness and affect your ability to concentrate.

Valsartan and Hydrochlorothiazide Zentiva contains lactose, sorbitol and sodium
Valsartan and Hydrochlorothiazide Zentiva contains lactose and sorbitol, both sugars. If your
doctor has diagnosed you with an intolerance to certain sugars, contact him before taking 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

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to get the best results and reduce the risk of side effects.
If you have doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any signs of this condition.
Many may feel as usual. 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 Valsartan and Idroclorotiazide Zentiva tablets to take.
Based on your response to treatment, the doctor may suggest a higher or lower dose. Other
dosages of the valsartan and idroclorotiazide association are available.

• The recommended dose of Valsartan and Idroclorotiazide Zentiva 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 Idroclorotiazide Zentiva with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan and Idroclorotiazide Zentivathan 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
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.

If you stop taking Valsartan and Idroclorotiazide Zentiva
Stopping treatment with Valsartan and Idroclorotiazide Zentiva may cause a
worsening of the disease. 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
You should immediately consult your doctor if you experience symptoms of angioedema (allergic reaction), such as:

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Urticaria and difficulty breathing
• Severe skin diseases causing rash, redness of the skin, formation of blisters on 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
• Fever, sore throat, more frequent infections (agranulocytosis)

If you experience any of these symptoms, stop taking Valsartan and Idroclorotiazide Zentiva
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
• Dizziness
• Dehydration (with symptoms of thirst, dryness of the mouth and tongue, infrequent urination, dark-colored urine, dry skin)
• Muscle pain
• Fatigue
• Tingling and numbness
• Blurred vision
• Noises (e.g. whistling, ringing) in the ears Very rare (may affect up to 1 in 10,000 people):
• Vertigo
• Diarrhea
• Joint pain

Not known (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 cause fatigue, confusion, muscle contractions and/ or convulsions in severe cases
• Low level of potassium in the blood (sometimes with muscle weakness, muscle spasms, irregular heartbeat)
• 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 yellowing of the 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 reported with medicines containing valsartan or
hydrochlorothiazide alone
Valsartan

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

• Feeling of dizziness
• Abdominal pain

Not known (frequency cannot be estimated from the available data):- Skin rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle aches, swollen lymph nodes and / or flu-like symptoms

• Skin 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, 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 level and reduction of the percentage of red blood cells in the blood (both can determine, in severe cases, anemia)
• Kidney failure
• Low level of sodium in the blood (which can cause fatigue, mental 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 skin 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
• High level of sugar in the blood
• Sugar in the urine
• Worsening of the metabolic state of diabetes
• Constipation, diarrhea, stomach or intestinal disorders, liver disorders that can manifest with yellowing of the 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
• Visual disturbances Very rare (may affect up to 1 in 10,000 people):
• Inflammation of blood vessels with symptoms such as skin rashes, reddish-purple spots, fever (vasculitis)
• Skin 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 urine (hemolytic anemia)
• Fever, sore throat or mouth ulcers due to infections (leukopenia)
• Confusion, fatigue, tremor and muscle spasm, labored breathing (hypochloremic alkalosis)

Not known (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 sign of a kidney disorder or kidney failure)
• Skin rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• Muscle spasm
• Fever (pyrexia)
• Weakness (asthenia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Idroclorotiazide Zentiva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C. Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice that it is damaged or shows signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What Valsartan and Hydrochlorothiazide Zentiva contains
The active ingredients are valsartan and hydrochlorothiazide.
Each film-coated tablet of Valsartan and Hydrochlorothiazide Zentiva 80 mg/12.5 mg
contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are:

Tablet core: microcrystalline cellulose, anhydrous colloidal silicon dioxide, sorbitol (E420),
magnesium carbonate, pregelatinized maize starch, povidone K-25, sodium stearyl fumarate,
sodium lauryl sulfate, crospovidone (Kollidon CL).

Tablet coating: lactose monohydrate, hypromellose, talc, macrogol 6000, indigo
carmine (E 132), iron oxide red (E 172).

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva and contents of the pack
Valsartan and Hydrochlorothiazide Zentiva 80 mg/12.5 mg tablets are pink, cylindrical,
biconvex, film-coated.
Packs: 7, 14, 28, 30, 56, 90, 98, 100, 280 (10 x 28 or 20 x 14) 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

Manufacturer
Zentiva, k.s.
U Kabelovny 130, Dolnì Měcholupy
102 37 Praga 10, Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy:Valsartan e Idroclorotiazide Zentiva

Portugal:Valsartan + Hidroclorotiazida Zentiva 80 mg + 12,5 mg comprimidos revestidos por
pelìcula

Spain:Valsartán/Hidroclorotiazida Zentiva 80/12,5 mg comprimidos recubiertos con película EFG

This leaflet was last updated on:

Valsartan and Hydrochlorothiazide Zentiva 160 mg/25 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start to use 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.

In this leaflet:

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

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

Valsartan and Hydrochlorothiazide Zentiva film-coated tablets contain 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 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 drugs called thiazide diuretics (also known as "water pills"). Hydrochlorothiazide increases diuresis, which also lowers blood pressure.

Valsartan and Hydrochlorothiazide Zentiva 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 attack.
Lowering blood pressure to normal levels reduces the risk of developing these
diseases.

2. Before taking Valsartan and Idroclorotiazide Zentiva

Do not take Valsartan and Idroclorotiazide Zentiva

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 monthspregnant(it is also best to avoid the use of Valsartan and Idroclorotiazide Zentiva at the beginning of pregnancy - see section “Pregnancy”);
• if you have a severe liver disease - destruction of the small bile ducts within the liver

(biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis);

• if you have a severe kidney 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, talk to your doctor and do not take
Valsartan and Idroclorotiazide Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan and Idroclorotiazide Zentiva:

• if you are taking potassium-sparing drugs, potassium supplements, salt substitutes containing potassium, or other drugs that increase the amount of potassium in the blood such as heparin. Your doctor may need to check your blood potassium levels 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 tablets that help to eliminate water (diuretics);
• 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 on the starting dose of therapy. Your doctor will also check your kidney function;
• if you suffer from a narrowing of the renal arteries;
• if you have recently received a kidney transplant;
• 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 Idroclorotiazide Zentiva is not recommended;
• if you are affected by a liver or kidney disease;
• 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 pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Valsartan and Idroclorotiazide Zentiva. This situation can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at high risk of developing it;
• if you have previously experienced swelling of the tongue and face caused by an allergic reaction called angioedema when you took other medicines (including ACE inhibitors), tell your doctor. If these symptoms occur when you take Valsartan and Idroclorotiazide Zentiva, stop taking Valsartan and Idroclorotiazide Zentiva immediately and never 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 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 certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Valsartan and Idroclorotiazide Zentiva.
• if you have had allergic reactions following the use of other medicines that lower blood pressure belonging to this class (angiotensin II receptor antagonists) or suffer from allergy or asthma;
• 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 suffer from 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 Idroclorotiazide Zentiva”.
Valsartan and Idroclorotiazide Zentiva may cause increased sensitivity of the skin to the sun.

• You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). Valsartan and Idroclorotiazide Zentiva is not recommended at the beginning 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 section “Pregnancy”).

If any of these cases apply to you, talk to your doctor.

Children and adolescents
The use of Valsartan and Idroclorotiazide Zentiva in children and adolescents (under 18 years of age) is not
recommended.
For athletes: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

Other medicines and Valsartan and Idroclorotiazide Zentiva
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 Idroclorotiazide Zentiva 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 certain mental disorders;
• medicines or substances that can increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs and heparin;
• medicines that can reduce the amount of potassium in the blood, such as diuretics (water-eliminating tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G;
• some antibiotics (rifampicin group), a medicine used against rejection in transplantation (cyclosporine) and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines can increase the effect of Valsartan and Idroclorotiazide Zentiva;
• medicines that can induce “torsades 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;
• therapeutic supplements of vitamin D and calcium, medicines for the treatment of diabetes (oral antidiabetics such as metformin or insulins);
• other medicines to lower blood pressure including methyldopa an ACE inhibitor or aliskiren (see also what is stated under: “Do not take Valsartan and Idroclorotiazide Zentiva” and “Warnings and precautions”);
• medicines that increase blood pressure such as norepinephrine or epinephrine;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (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 spasm, asthma, motion sickness, muscle spasms, Parkinson's disease and to facilitate anesthesia);
• amantadine (a medicine used to treat Parkinson's disease and also 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 narcotic or analgesic effect used, for example, during surgery);
• iodinated contrast agents (used for radiological examinations);

Valsartan and Idroclorotiazide Zentiva with food, drinks 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 are pregnant or are planning a pregnancy, 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 could become pregnant).
Your doctor will advise you to stop taking Valsartan and Idroclorotiazide Zentiva 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 Idroclorotiazide Zentiva. Valsartan and Idroclorotiazide Zentiva
is not recommended at the beginning 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 Idroclorotiazide Zentiva 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 is
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 Idroclorotiazide Zentiva can,
occasionally, cause dizziness and affect your ability to concentrate.

Valsartan and Idroclorotiazide Zentiva contains lactose, sorbitol and sodium
Valsartan and Idroclorotiazide Zentiva contains lactose and sorbitol, both sugars. If your
doctor has diagnosed you with an intolerance to certain sugars, contact him before taking 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 Idroclorotiazide Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist.
This will help you to get the best results and reduce the risk of side effects.
If you have doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any signs of this condition.
Many may feel as well as usual. 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 Valsartan and Idroclorotiazide Zentiva tablets to take.
Based on your response to treatment, the doctor may suggest a higher or lower dose. Other
dosages of the valsartan and hydrochlorothiazide association are available.

• The recommended dose of Valsartan and Idroclorotiazide Zentiva 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 Idroclorotiazide Zentiva with or without food.
• Swallow the tablet with a glass of water. If you take more Valsartan and Idroclorotiazide Zentivathan 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 forget to take Valsartan and Idroclorotiazide Zentiva
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.

If you stop taking Valsartan and Idroclorotiazide Zentiva
Stopping treatment with Valsartan and Idroclorotiazide Zentiva may cause a
worsening of the disease. 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 may be serious and require immediate medical attention
You should immediately consult a doctor if you experience symptoms of angioedema (allergic reaction), such as:

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Urticaria and difficulty breathing
• Severe skin diseases causing rash, redness of the skin, formation of blisters on 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
• Fever, sore throat, more frequent infections (agranulocytosis)

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

Other side effects include:
Not common(may affect up to 1 in 100 people):

• Cough
• Low blood pressure
• Dizziness
• Dehydration (with symptoms of thirst, dryness of the mouth and tongue, infrequent urination, dark urine, dry skin)
• Muscle pain
• Fatigue
• Tingling and 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 Not known (frequency cannot be estimated based on available data):
• Difficulty breathing
• Significant decrease in the amount of urine excreted
• Low sodium levels in the blood, which can cause 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, cause yellowing of the skin and eyes)
• Increased urea and creatinine levels 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 reported with medicines containing valsartan or
hydrochlorothiazide alone.
Valsartan

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

• Feeling of dizziness
• Abdominal pain

Not known (frequency cannot be estimated based on available data):

• Skin rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle aches, swollen lymph nodes and/or flu-like symptoms
• Rash, 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, rash, itching
• Increased liver function values
• Reduction in hemoglobin levels and reduction in the percentage of red blood cells in the blood (both of which can, in severe cases, lead to anemia)
• Kidney failure
• Low sodium levels in the blood (which can cause 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 1000 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 the metabolic state of diabetes
• Constipation, diarrhea, stomach or intestinal disorders, liver disorders that can manifest with yellowing of the skin and eyes
• Irregular heartbeat
• Headache
• Sleep disorders
• Sad mood (depression)
• Low platelet levels 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 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)
• Pallor, fatigue, shortness of breath, dark urine (hemolytic anemia)
• Fever, sore throat or mouth ulcers due to infections (leukopenia)
• Confusion, tremor and muscle spasm, labored breathing (hypochloremic alkalosis) Not known(frequency cannot be estimated based on 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 sign of a kidney disorder or kidney failure)
• Rash, redness of the skin, formation of blisters on lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme)
• Muscle spasm
• Fever (pyrexia)
• Weakness (asthenia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Zentiva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C. Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice that it is damaged or shows signs of tampering.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What Valsartan and Hydrochlorothiazide Zentiva contains
The active ingredients are valsartan and hydrochlorothiazide.
Each film-coated tablet of Valsartan and Hydrochlorothiazide Zentiva 160 mg/25 mg
contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
The excipients are:

Tablet core:microcrystalline cellulose, anhydrous colloidal silicon dioxide, sorbitol (E420),
magnesium carbonate, pregelatinized maize starch, povidone K-25, sodium stearyl fumarate,
sodium lauryl sulfate, crospovidone (Kollidon CL).

Tablet coating:lactose monohydrate, hypromellose, talc, macrogol 6000, indigo
carmine (E 132), yellow and brown iron oxides (E 172).

Description of the appearance of Valsartan and Hydrochlorothiazide Zentiva and contents of the pack
Valsartan and Hydrochlorothiazide Zentiva 160 mg/25 mg tablets are brown, cylindrical in shape,
biconvex, film-coated.
Packs: 7, 14, 28, 30, 56, 90, 98, 100, 280 (10 x 28 or 20 x 14) 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

Manufacturer
Zentiva, k.s.
U Kabelovny 130, Dolnì Měcholupy
102 37 Prague 10, Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy:Valsartan e Idroclorotiazide Zentiva

Portugal:Valsartan + Hidroclorotiazida Zentiva 160 mg + 25 mg comprimidos revestidos por
pelìcula

Spain:Valsartán/Hidroclorotiazida Zentiva 160/25 mg comprimidos recubiertos con película EFG

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