Co-Valsacor 320 mg. / 25 mg. 30 tablets

WHAT CO-VALSACOR IS AND WHAT IT IS USED FOR
Co-Valsacor film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both substances help to control high blood pressure (hypertension).

Valsartan belongs to a class of medicines known as "angiotensin II receptor antagonists" that help control high blood pressure. Angiotensin II is a substance in the body that causes the blood vessels to contract, causing an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, the blood vessels are relaxed and the blood pressure decreases.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as "drainage tablets"). Hydrochlorothiazide strengthens urinary excretion, which also lowers blood pressure.
Co-Valsacor is used to treat high blood pressure, which is not adequately controlled by each of the substances alone.
High blood pressure increases the load on the heart and arteries. If not treated, 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. Decreasing high blood pressure reduces the risk of developing these diseases.

2. BEFORE YOU TAKE CO-VALSACOR
Do not take Co-Valsacor:

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (hydrochlorothiazide-related chemicals) or any of the other ingredients of Co-Valsacor;
if they are pregnant for more than 3 months. (It is also better to avoid taking Co-Valsacor at the beginning of pregnancy - see section "Pregnancy");
if you have severe liver disease;
if you have severe kidney disease;
if you are not able to urinate;
if you are being treated for an artificial kidney;
if the level of potassium or sodium in the blood is lower than normal or if the blood calcium level is higher than normal despite the treatment;
if you have gout;
if you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering medication containing aliskiren.
If any of the above apply to you, do not take this medicine and talk to your doctor.

Take special care with Co-Valsacor
Talk to your doctor or pharmacist before taking Co-Valsacor.

if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in your blood, such as heparin. Your doctor may need to check the amount of potassium in the blood regularly;
if you have low potassium levels in the blood;
if you have severe diarrhea or vomiting;
if you take high doses of drainage tablets (diuretics);
if you have severe heart disease;
if you suffer from narrowing of the renal artery;
if you recently grafted a new kidney;
if you suffer from hyperaldosteronism. This is a disease in which your adrenal glands produce too much of the aldosterone hormone. If this applies to you, the use of Co-Valsacor is not recommended;
if you have liver or kidney disease;
if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, the so-called autoimmune disease);
if you have diabetes, gout, high levels of cholesterol and fat in the blood;
if you have had allergic reactions with other blood pressure lowering medicines (angiotensin II receptor antagonists) or if you have an allergy or asthma;
it may cause increased skin sensitivity to the sun;
if you are taking any of the following medicines used for pressure:
ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have kidney problems associated with diabetes;
aliskiren.
Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg potassium) in your blood.
See also the information titled "Do not take Co-Valsacor".

The use of Co-Valsacor in children and adolescents (under 18 years of age) is not recommended.
You should tell your doctor if you think you are (or might be) pregnant. Co-Valsacor is not recommended in early pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section "Pregnancy").

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 with Co-Valsacor may be affected if taken together with some other medicines. It may be necessary to change the dose, take other precautions or in some cases stop at
Take Co-Valsacor with food and drink
You can take Co-Valsacor, with or without food.
Avoid taking alcohol while talking to your doctor. Alcohol can make your blood pressure fall further and / or increase your risk of dizziness or seizure.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy
You should tell your doctor if you think you are (or might be) pregnant.
Your doctor will usually advise you to stop taking Co-Valsacor before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Co-Valsacor. Co-Valsacor is not recommended in early pregnancy and should not be taken if you are more than 3 months pregnant, 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 you start breast-feeding.
Co-Valsacor is not recommended for mothers who are breast-feeding and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Before driving vehicles, using tools or using machines, or performing other activities requiring concentration, make sure you know how Co-Valsacor affects you. Like many other medicines used to treat high blood pressure, Co-Valsacor can cause dizziness and affect the ability to concentrate.

Important information about some of the ingredients of Co-Valsacor
Co-Valsacor contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE CO-VALCASE
Always take Co-Valsacor exactly as your doctor has told you. This will help you get better results and reduce the risk of side effects. If you are not sure, ask your doctor or pharmacist.
People with high blood pressure often do not notice some signs of this problem. Most can feel quite normal. It is therefore very important for you to visit your doctor, even if you are feeling well.
Your doctor will tell you exactly how many Co-Valsacor tablets to take. Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.

The usual dose of Co-Valsacor is one tablet per day.
Do not change the dose or stop taking tablets without consulting your doctor.
The medicine should be taken at the same time each day, usually in the morning.
You can take Co-Valsacor with or without food.
Swallow the tablet with a glass of water.
If you take more Co-Valsacor than you should
If you have severe dizziness and / or feel faint, lie down and contact your doctor immediately.
If you have accidentally taken too many tablets, contact your doctor, pharmacist or nearest hospital.

If you forget to take Co-Valsacor
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the dose.
Do not take a double dose to make up for a missed dose.

If you stop taking Co-Valsacor
Stopping treatment with Co-Valsacor may lead to a worsening of your elevated blood pressure. Do not stop taking the medicine unless your doctor tells 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, Co-Valsacor can cause side effects, although not everyone gets them.

These side effects may occur at certain frequencies that are defined as follows:

Very common: affects more than 1 user in 10;
Common: 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 the available data.
Some side effects can be serious and require immediate medical attention:
You should consult your doctor immediately if you experience symptoms of angioedema, such as:

swelling of the face, tongue or pharynx;
difficulty in swallowing;
rash and difficulty in breathing.
Other side effects include:
Uncommon:

Coughing;
Low blood pressure;
Light-weighting;
Dehydration (with symptoms of thirst, dry mouth and tongue, seldom urination, dark urine color, dry skin);
Muscle pain;
Fatigue;
Numbness or stiffness;
Blurred vision;
Noise (for example, itching, buzzing) in the ears.
Very rare:

Dizziness;
Diarrhea;
Joint pain.
Not known:

Difficulty breathing;
Severely reduced urine output;
Low sodium levels in the blood (sometimes with nausea, fatigue,
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CO-VALSACOR
Keep out of the reach and sight of children.
Store below 30 ° C.
Store in the original package in order to protect from light and moisture.
Do not use Co-Valsacor 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 your unnecessary medicines. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
What Co-Valsacor contains
The active substances are: valsartan and hydrochlorothiazide (valsartcm, hydrochlorothiazide).
Each film-coated tablet of Co-Valsacor 80 mg / 12.5 mg contains 80 mg valsartan and 12.5 mg hydrochlorothiazide.
Each film-coated tablet of Co-Valsakor 160 mg / 12.5 mg contains 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Each film-coated tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide.
Each film-coated tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide.
Each film-coated tablet contains 320 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 (E172) only in 80 mg / 12.5 mg, 160 mg / 12.5 mg, 160 mg / 25 mg and 320 mg / 12.5 mg tablets, yellow iron oxide (E172) 160 mg / 25 mg and 320 mg / 25 mg tablets - in the film coat.

What Co-Valsacor looks like and contents of the pack
Co-Valsacor 80 mg / 12.5 mg film-coated tablets are pink, oval, biconvex.
Co-Valsakor 160 mg / 12.5 mg film-coated tablets are reddish-brown, oval, biconvex.
Co-Valsakor 160 mg / 25 mg film-coated tablets are light brown, oval, biconvex.
Co-Valsacor 320 mg / 12.5 mg film-coated tablets are pink, oval, biconvex.
Co-Valsacor 320 mg / 25 mg film-coated tablets are pale yellow, oval, biconvex, scored on one side. The tablet can be divided into equal parts.

Co-Valsacor 80 mg / 12.5 mg, 160 mg / 12.5 mg and 160 mg / 25 mg film-coated tablets are available in cartons of 14, 28, 30, 56, 60, 84, 90, 98, 280, 56 x 1, 98 x 1, 280 x 1 film-coated tablets in blisters.
Co-Valsacor 320 mg / 12.5 mg and 320 mg / 25 mg film-coated tablets are available in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 280, 56x1, 98x1 and 280x1 film-coated tablets in blisters.
Not all packs may be marketed.

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