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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 boosts urinary output, 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, the heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Decreasing the increased 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, sulphonamide derivatives (hydrochlorothiazide-related chemicals) or any of the other ingredients of Co-Valsacor;
if they are more than 3 months pregnant. (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 potassium or sodium level 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 (for example enalapril, lisinopril, ramipril), especially if you have kidney problems associated with diabetes;
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 Co-Valsacor treatment 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
diuretics (drainage tablets), gout medicines such as allopurinol, therapeutic vitamin D and calcium supplements, medicines to treat diabetes (oral or insulin);
other blood pressure lowering drugs, such as beta-blockers or methyldopa, or those that contract your blood vessels or are stimulating the heart, noradrenaline or adrenaline;
medicines to increase blood sugar levels such as diazoxide;
medicines for the treatment of cancer, such as methotrexate or cyclophosphamide;
medicines to treat arthritis;
muscle relaxants such as tubocurarine;
anti-cholinergic drugs such as atropine or biperidine;
amantadine (a medicine used to prevent influenza);
cholestyramine and colestipol (medicines used to treat high levels of fat in the blood);
cyclosporine, a medicine used after organ transplantation to avoid rejection of organs;
some antibiotics (tetracycline), anesthetics and tranquilizers;
carbamazepine, a medicine to treat seizures;
if you are taking an ACE inhibitor or aliskiren (see also "Do not take Co-Valsacor" and "Warnings and Precautions").
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.
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.
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-VALASACOR
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 forget to take 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-Valsartan can cause side effects, although not everyone
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;
rash and difficulty in breathing.
Other side effects include:
Low blood pressure;
Dehydration (with symptoms of thirst, dry mouth and tongue, seldom urination, dark color of the urine, dry skin);
Numbness or stiffness;
Noise (for example, itching, buzzing) in the ears.
Strongly reduced urine output;
Low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, convulsions);
Low potassium level in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm);
Low level of white blood cells (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness);
The level of increased bilirubin in the blood (which may, in more severe cases, increase the yellowing of the skin and eyes);
Increase in blood urea and creatinine (which may result in impaired renal function);
Increase in blood uric acid (which may, in more severe cases, speed up the onset of gout);
Adverse reactions reported for valsartan or hydrochlorothiazide alone but not observed in Co-Valsacor:
Skin rash with or without itching along with any of the following signs and symptoms: fever, joint pain, muscle pain, swollen lymph nodes and / or flu-like symptoms;
Rash, purple-red spots, fever, itching (symptoms of blood vessel inflammation);
Low blood platelets (sometimes with unusual bleeding or bruising on the skin);
High potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm);
Allergic reactions (with symptoms such as rash, pruritus, hives, difficulty in breathing or swallowing, vertigo);
Edema, mainly on the face and throat; rash; itching;
Increased liver enzyme values;
Decrease in hemoglobin and decrease in the percentage of red blood cells in the blood (both in more severe cases speed up the development of anemia);
Severe rash and other types of rash;
Poor nausea and vomiting
Fatigue, fainting in straightening;
Blisters and swelling of the skin (due to increased sensitivity to the sun);
Constipation, discomfort of the stomach or intestine, liver disorders (yellowing of the skin or eyes);
Incorrect heart rhythm;
Sad mood (depression);
Low level of blood platelets (sometimes with bleeding or injuries under the skin).
Inflammation of the blood vessels, with symptoms such as rash, purple-red spots, fever;
Itchy or red skin;
Blistering of the lips, eyes or mouth;
Rash on the face associated with joint pain;
Fever (cutaneous lupus erythematosus);
Strong upper abdominal pain; lack or low values of different blood cells;
Severe allergic reactions;
Infection of the lungs; shortness of breath.
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-Valsacor 160 mg / 12.5 mg contains 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Each film-coated tablet of Co-Valsacor 160 mg / 25 mg 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 of Ko-Valsakor 320 mg / 25 mg contains 320 mg valsartan and 25 mg hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, croscarmellose sodium,
What Co-Valsacor looks like and what the package contains
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 red-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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