VALZAP H 160 mg. / 12.5 mg. 28 tablets

WHAT VALZAP H AND WHAT IT IS USED

VALZAP H tablet contains two active substances, valsartan and hydrochlorothiazide. Both medicinal veshtestvat helping to control high blood pressure.

Valsartan belongs to the group of medicines called blockers angiotensin II receptors which help to control high blood pressure. Angiotensin II is a substance produced by the body and causing the constriction of blood vessels. This leads to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. This leads to dilation of blood vessels and lower blood pressure.

Hydrochlorothiazide is a diuretic (also known as "water tablets"), which reduces the amount of salt and water in the body by increasing the amount of urine. With continued use helps to reduce and control high blood pressure.

VALZAP H is used to treat high blood pressure (hypertension), when the condition is not adequately controlled by the use of valsartan alone. 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 may lead to stroke, heart failure or renal insufficiency. High blood pressure increases the risk of heart attack. Lowering of blood pressure to normal levels reduces the risk of razvivanv of these diseases.

2. BEFORE YOU TAKE VALZAP H

Do not take VALZAP H

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other ingredients of VALZAP H

if you are pregnant after the third month of pregnancy (it would be better to avoid VALZAP H in early pregnancy - see. section "Pregnancy and lactation")

if you have severe liver disease

If you have severe kidney disease

-if you have problems with urination

• If you are treated with an artificial kidney (dialysis)

despite treatment if you have low levels of potassium or sodium in the blood and too high calcium levels

if you have gout

Take special care with VALZAP H

? if you are taking medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. It may need checking the amount of potassium in your blood at regular intervals.

-if potassium levels in your blood are low

if you have diarrhea or severe vomiting

-If you are taking high doses of water pills (diuretics)

If you have severe heart disease

-if you suffer from a narrowing of the renal artery

-if you have recently undergone kidney transplantation (received a new kidney)

if you suffer from aldosteronism. This is a disease in which the adrenal glands produce large amounts of the hormone aldosterone. If this is applicable to you, not recommended for use VALZAP H

if you have liver or kidney disease

if fever, rash and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, a so-called autoimmune disease)

Aki suffer from diabetes, high levels of cholesterol, fat or uric acid in the blood

If you have had allergic reactions with the use of other blood pressure-lowering agents of this class (angiotensin blockers-ll receptor) or if you have other allergies or asthma.

You should inform your doctor if you are (or might become) pregnant. VALZAP H is not recommended for use in early pregnancy can seriously harm your baby after 3 months of pregnancy (see. Section "Pregnancy and lactation"). The use of VALZAP H can lead to a positive result in doping control due the hydrochlorothiazide. If any of these is applicable to your condition, tell your doctor before taking VALZAP N.
Taking other medicines

Please tell your doctor or pharmacist

if you are taking or have recently taken any other

medicines, including medicines obtained without a prescription.

The effect of treatment may be impaired if VALZAP H is taken with certain other medicines. You may need a dose adjustment or, in some cases, discontinuation of one of the drugs. This is especially true for the following drugs:

- Lithium, a medicine used for the treatment of

depression

medicines that affect or may affect the level of potassium in the blood, medicines to control heart rhythm, such as digoxin, potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, other drugs that may increase or reduce the amount of potassium in your blood such as heparin corticosteroids

some laxatives

- Other diuretics (water tablets), medicines to treat gout such as allopurinol, vitamin D and calcium supplements, medicines for the treatment of diabetes (oral agents or insulin).

• other medicines to lower blood pressure, such as beta blockers or methyldopa, or medicines that narrow blood vessels

or stimulate the heart to adrenaline or noradrenaline

drugs that increase blood sugar levels as diazoxide

drugs for the treatment of cancer such as cyclophosphamide or methotrexate

• painkillers

• medicines for the treatment of arthritis

medicines to relax the muscles as tubocurarine

anti-cholinergic drugs such as atropine or

Biperiden

amantadine (a medicine to prevent flu)

cholestyramine and colestipol (lerastva used to treat high levels of fats in the blood)

cyclosporine, a drug administered in organ transplantation to prevent organ rejection

certain antibiotics (tetracyclines), anesthetics and sedatives.

Taking VALZAP H with food and drink

You can take VALZAP H with or without food.

Alcohol can cause further

lowering blood pressure and / or increasing

the risk of dizziness or fainting.

Children and young people (under 18 years)

Not recommend the use of VALZAP H in children
and youth.

Adults (65 and over)

You can use H VALZAP if you are 65 years old or more.
Pregnancy and lactation

Ask your doctor or pharmacist before taking any medicine.

• Be sure to tell your doctor if you think you are (or might become) pregnant.

Your doctor will normally advise you to stop taking VALZAP H before you become pregnant or as soon as you become pregnant and will advise you to take another medicine instead VALZAP N. VALZAP H is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy because it may cause serious harm to your baby if used after 3 months of pregnancy.

• Tell your doctor if you are breast-feeding or breast-feeding, VALZAP H is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you. if wish to breastfeed, especially if the child is a newborn or preterm.
Driving and using machines

No studies on the effect of valsartan / hydrochlorothiazide on ability to drive and use machines. Like other medicines used to treat high blood pressure, rarely VALZAP H can cause dizziness and affect the ability to concentrate. Before drive, use tools or perform other activities that require concentration. make sure you know how you act VALZAP N.

Important information about some of the ingredients

VALZAP H contains lactose and sorbitol - both sugars. If your doctor has told you that you suffer from an intolerance to some sugars, talk to him / her before taking this medicine. A dose of this product contains less than 1 mmol sodium (23 mg), i.e. he is "free of sodium."

3. HOW TO TAKE VALZAP H

Always take VALZAP H exactly as you have been told by your doctor. This will help you achieve the best results and reduce the risk of side effects. If you're not sure, ask your doctor or pharmacist.

People with high blood pressure often do not notice the signs of this problem. Many of them feel normal. This makes regular check ups important, even if you feel better. Your doctor will tell you exactly how many tablets VALZAP H should take. Depending on how you tolerate the treatment, your doctor may reduce or increase the dose.

H VALZAP usual dose is one tablet daily

Do not change your dose or stop taking the tablets without consulting your doctor

• The medicine should be taken at the same time of day, usually morning

You can take VALZAP H with or without food

Swallow the tablet with a glass of water

If you take more dose VALZAP H

If you accidentally taken too many tablets, contact your doctor, pharmacist or hospital.
If you experience severe dizziness and / or fainting, lie down and immediately contact your doctor. If you forget to take VALZAP H if you forget to take this medicine, take your dose as soon as you remember. However, if it is almost time for your next dose, skip the one you have forgotten to take.

Do not take a double dose to make up the missed dose.

If you stop taking VALZAP H

Stopping the use of VALZAP H may worsen your condition. Do not stop taking your medicine unless your doctor has told you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VALZAP H can cause side effects, although not everybody gets them. The following side effects have been observed on the active substances valsartan and hydrochlorothiazide (active substances VALZAP H). Some of these side effects may be similar to symptoms caused by your specific condition. Others may not occur and are not related to your treatment. Some symptoms can be serious and need immediate medical attention:
You should visit your doctor immediately if you experience symptoms of angioedema, such as:

swollen face, tongue or necked

difficulty swallowing

hives and difficulty breathing
Other side effects include:
Usually the frequency of side effects are defined as follows:

Very common: affects more than 1 patient in 10 common: affects 1 to 10 patients in 100 uncommon: affects 1 in 10 patients out of 1000 rare side effects affect 1 in 10 patients out of 10 000

very rare: affects less than 1 in 10,000 patients

Not known: frequency can not be

estimated from the available data.

Common:

-vazpalenie nose and throat • diarrhea

-umora
Uncommon:

infections of the upper respiratory tract

urinary tract infections

-virusni infections, rhinitis

dizziness

worsening vision

pain in the stomach and chest

cough

nausea

heartburn (stomach upset) after meals

pain in the arms and legs

sprains and strains

stiffness

a strong urge to urinate

-anormalni results in tests of kidney function


Low levels of potassium or sodium in the blood

Rare:

dizziness

noise in the ears

low blood pressure

muscle pain and muscle weakness

sweating
Very rare:

low platelet count, which leads to easier karveneinaranyavane

low levels of red blood cells

swelling of the face, lips, tongue or throat that may cause difficulty in breathing, swallowing or speaking

abnormal heart rhythm

rash

itch

inflammation of the blood vessels in the skin

bleeding

Overall swelling

Hair Loss

Side effects observed with valsartan and hydrochlorothiazide separately, but VAL3AP H were observed:
Some symptoms can be serious and need immediate medical attention: Hydrochlorothiazide, one of the active substances of VALZAP H can rarely affect white blood cells, decreased resistance to infections. If you get an infection with symptoms such as fever with deterioration of general condition or fever and signs of local infection such as sore throat, mouth or problems with urination, immediately contact your doctor. It is necessary to take a blood sample, to exclude the shortage of white blood cells (agranulocytosis). It is important to tell your doctor about your treatment.
Other adverse effects:
Valsartan:
Uncommon:

back pain

inflammation of the sinuses

weakness

watery eyes and itching

-chervenina and swelling

nosebleeds

sad mood (depression)

• muscle cramps

, violations sleep Rare:

• severe stabbing or dull pain around the individual nerves

Very rare:

-bolka in the stomach such as gastritis, or gastric irritation

-bolka joints

renal function

Hydrochlorothiazide:

Common:

itchy rash and other types of rash

lack of appetite

less nausea and vomiting

dizziness

- Fainting

impotence
Rare:

swelling or blistering of the skin (due to increased sensitivity to the sun)

constipation

discomfort of the stomach or intestines

• liver disorders (yellow skin or eyes)

abnormal heart rhythm

headache

sleep disturbances

lightly colored urine

sad mood (depression)

tingling or numbness in the hands or feet

visually impaired

reduced levels of platelets (sometimes accompanied by bleeding lesions and subcutaneous)

Very rare:

inflammation of blood vessels with symptoms such as rash, with purple red spots, fever

-sarbezh or redness of the skin

-izprishtvane the lips, eyes or mouth, skin peeling

temperature

-obriv the person associated with joint pain

muscle disorder, fever (cutaneous lupus erythematosus)

severe pain in the upper stomach

Missing or low levels of various blood cells

• severe allergic reactions

• difficulty breathing

lung infection

• shortness of breath

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5 HOW LA STORE VALZAP H

-Sahranyavayte Of reach of children.

-Do Not use VALZAP H after the expiry date stated on the carton / blister. The expiry date refers to the last day of that month.

Do not store above 30 ° C Store in the original package to protect from moisture.