Co-VALSAKOR tabl.160 mg./25 mg. 28 tablets

WHAT CO-VALSAKOR AND WHAT IT IS USED

Co-Valsakor tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

Valsartan belongs to a class of medicines known as, tangiotenzin II receptor antagonist ', which help to control high blood pressure. Angiotensin II is a substance in the body that causes the blood vessels, causing high blood pressure. Valsartan works by blocking effect pa angiotensin I. As a result, blood vessels relax and cc blood pressure is lowered.

Hndrohlortiazid belongs to a group of medicines called thiazide diurstitsi (also known as "water tablets"). Hydrochlorothiazide increases urine excretion pa, which also lowers blood pressure.

Co-Valsakor used to treat high blood pressure is not adequately controlled by either compound alone.

High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage the blood vessels in the brain, heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering high blood pressure reduces the risk of developing these diseases.

 BEFORE YOU CO-VALSAKOR

Do not take Co-Valsakor

 If you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals associated with hydrochlorothiazide) or to any of the ingredients of the Co-Valsakor,

 If you are more than 3 months. (It is also better to avoid taking Co-Valsakor in early pregnancy.

 If you have severe liver disease

 If you have severe kidney disease

 If you are unable to urinate

 If you are taking 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 have gout.

If any of these apply to you, do not take this medication and talk to your doctor.

Take special care with co-Valsakor

 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. You may need your doctor to regularly check the amount of potassium in the blood.

 If you have low potassium levels in the blood.

 If you have severe diarrhea or vomiting.

 If you are taking high doses of water tablets (diuretics).

 If you have severe heart disease.

 If you suffer from a narrowing of the renal artery.

 If you have recently received a new kidney transplant.

 If you suffer from aldosteronism. This is a disease in which your adrenal glands produce too much of the hormone aldosterone. If this applies to you, the use of Co-Valsakor not recommended. If you have liver or kidney disease.

 If you have a fever, rash and joint pain, which may be signs of systemic lupus erythematosus (CJIE, so-called autoimmune disease).

 If you have diabetes, gout, high levels of cholesterol and fats in the blood.

If you have had allergic reactions to the use of other drugs to lower blood pressure, which are members of this class (angiotensin II receptor antagonists), or if you have allergies or asthma

It can cause increased skin sensitivity to the sun.

Using Co-Valsakor in children and adolescents (under 18 years) is not recommended.

You should tell your doctor if you think you are (or might become) pregnant. Co-Valsakor not recommended in early pregnancy, and must not be taken if you are pregnant for more than three months, as it may cause serious harm to your baby if used at that stage.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription

The treatment effect of co-Valsakor may be affected if it is taken with certain other medicines. You may need to change the dose, to take other precautions, or in some cases to stop taking one of the medications. This especially applies to the following drugs: lithium, a medicine used to treat some types of mental illness, drugs that affect or can be affected by the amount of potassium in the blood, such as digoxin, a medicine to control heart rhythm, some antipsychotic drugs medicines that may increase the amount of potassium in the blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing drugs, heparin, drugs that can reduce the amount of potassium in the blood, such as corticosteroids, some laxatives diuretics (water pills), drugs for gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for diabetes (oral agents or insulin), other drugs to lower blood pressure, such as beta-blockers or methyldopa or those that constrict your blood vessels or stimulate the heart, such as. noradrenaline or adrenaline

drugs that increase blood sugar levels, such as diazoxide, drugs to treat cancer, such as methotrexate or cyclophosphamide, painkillers, medicines to treat arthritis, muscle relaxants, such as tubocurarine, anti-cholinergic drugs such as atropine or biperiden , amantadine (a medicine used to prevent flu), cholestyramine and colestipol (medicines used to treat high

fat in the blood), ciclosporin, a medicine used after organ transplantation to prevent organ rejection, certain antibiotics (tetracycline), anesthetics and sedatives, carbamazepine, medicine for seizures.

Co-administration of Valsakor with food and drink

You can take Co-Valsakor with or without food.

Avoid drinking alcohol until you talk to your doctor. Alcohol can make sure that blood pressure to drop more and / or increase your risk of dizziness or fainting.

Pregnancy and lactation

Ask your doctor or pharmacist before taking any medicine.

Pregnancy

You should tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Co-Valsakor before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Co-Valsakor. Co-Valsakor not recommended in early pregnancy, and must not be taken if you are pregnant for more than three months, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breast-feeding or before breast-feeding.

Co-Valsakor not recommended for mothers who are breast feeding, and your doctor may stop treatment for you if you want to breast-feed, especially if your baby was born prematurely novorodenoili.

Driving and operating machinery

Before driving a vehicle, use tools or operate machinery, or do other activities that require concentration, make sure you know how you affect co-Valsakor. Like many other medicines used to treat high blood pressure, Co-Valsakor can cause dizziness and affect the ability to concentrate.

Important information about some of the ingredients of Co-Valsakor

Co-Valsakor contains lactose. If your doctor tells you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

 HOW TO CO-VALSAKOR

Always take Co-Valsakor exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.

People with high blood pressure often do not notice any signs of this problem. Most may feel quite normal. It is very important for you to see your doctor even if you feel well.

Your doctor will tell you exactly how many tablets Co-Valsakor accept. Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.

Co-usual dose is one tablet Valsakor day.

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

The drug should be taken at the same time each day, usually in the morning.

You can take Co-Valsakor with or without food. Swallow the tablets with a glass of water.

If you take an overdose of Co-Valsakor

If you have severe dizziness and / or feeling that faint, lie down and contact your doctor immediately.

If you accidentally take too many tablets, contact your doctor, pharmacist or nearest hospital.

If you forget to take Co-Valsakor

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 lost.

If you stop taking Co-Valsakor

Discontinuation of co-Valsakor can worsen high blood pressure. Do not stop taking your medicine unless your doctor tells you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

 POSSIBLE SIDE EFFECTS

Like all medicines, Co-Valsakor can cause side effects.

These side effects may occur with certain frequencies, which are defined as follows:

Very common: affects more than 1 user in 10 Total: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000 not known: frequency can not be estimated from available data. Some side effects can be serious and need immediate medical attention:

You should consult with your doctor immediately if you experience symptoms of angioedema, such as:

swelling of the face, tongue or pharynx, difficulty swallowing, rash and difficulty breathing.

Other side effects include:

Uncommon

Cough

Low blood pressure Svetoboyazan

Dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin) Aching muscles Fatigue

Tingling or numbness Blurred vision

Noise (such as hissing, buzzing) in the ears

Very rare

Dizziness Diarrhea

Joint pain

Not known

Dyspnoea

Greatly reduced urinary

Low sodium in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)

Low levels of potassium in the blood (sometimes with muscle weakness, muscle cramps, abnormal heart rhythm)

Low white blood cells (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, to enhance yellowing of the skin and eyes)

Increased blood urea and creatinine (which can indicate impaired renal function)

Increasing the level of uric acid in the blood (which can, in severe cases, accelerate early gout) Syncope (fainting).

Adverse reactions reported for valsartan or hydrochlorothiazide alone occur in Co-Valsakor:

Valsartan

Uncommon

Feeling dizzy Abdominal pain

Not known

Skin rash with or without itching, along with some of the following signs and symptoms: fever, joint pain, muscle pain, swollen lymph nodes and / or flu-like symptoms

Rash, purplish-red spots, fever, itching (signs of inflammation of blood vessels)

Low level of blood platelets (sometimes with unusual bleeding or skin Sissy)

High levels of potassium in the blood (sometimes with muscle cramps, abnormal heart rhythm)

Allergic reactions (with symptoms such as rash, itching, hives, difficulty

breathing or swallowing, dizziness)

Swelling of the face and throat, rash, itching

Increase in liver enzymes

Decreased hemoglobin and reducing the percentage of red blood cells (both in the more severe cases of anemia accelerating) Renal failure.

Common Hidrohdorotiazid

Itchy rash and other types of rash Slightly Decreased appetite nausea fatigue, fainting when standing Impotence.

Rare

Blisters and swelling (due to increased sensitivity to sunlight) Constipation, stomach discomfort or intestines, liver disorders (yellowing of the skin or eyes) Headache Irregular heartbeat Sleep Disorders sad mood (depression)

Low level of blood platelets (sometimes with bleeding or bruising under the skin).

Very rare

Inflammation of the blood vessels, with symptoms such as rash, purplish-red spots, fever

Itching or red skin Blisters on the lips, eyes or mouth, skin peeling Fever

Facial rash associated with joint pain Muscle disorders

Fever (cutaneous lupus erythematosus) Severe pain in the upper abdomen, absence or low levels of diff cells

Severe allergic reactions Difficulty breathing infection of the lungs, shortness of breath.

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

 HOW TO STORE CO-VALSAKOR

Keep out of reach of children. Do not store above 30 ° C.

Store in the original package to protect from light and moisture.

Do not use valsartan / hydrochlorothiazide after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures shts help protect the environment.

 ADDITIONAL INFORMATION

What Co-Valsakor

The active substances are: valsartan and hydrochlorothiazide (valsartan, hydrochlorothiazide). Each Co-Valsartan 80 mg/12, 5 mg film-coated tablet contains 80 mg of valsartan and hydrochlorothiazide 12,5 mg.

Each Co-Valsartan 160 mg/12, 5 mg film-coated tablet contains 160 mg of valsartan and 12.5 mg hydrochlorothiazide.

Each Co-Valsartan 160 mg/25 mg film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, croscarmellose sodium, povidone K-25, silica colloidal anhydrous in the tablet core and hypromellose, titanium dioxide (E171), macrogol, red iron oxide (1 72) yellow iron oxide (E 172) - only 80 mg/12, 5 mg and 160 mg/25 mg tablets - in film coating.