Vivazac Plus 150mg/12.5mg 30 Tab

Product Description:

• VIVAZAC PLUSis a combination of two active substances, irbesartan and
• Irbesartanbelongs to a group of medicines known as angiotensin-II receptor antagonists.
• Angiotensin-II is a substance produced in the body that binds to
• receptors in blood vessels causing them to tighten.
• This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
• Hydrochlorothiazideis one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
• The two active ingredients in VIVAZAC PLUS work together to lower blood pressure further than if either was given alone.

Therapeutic indications:

• VIVAZAC PLUSis used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

How to use:

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

• The recommended dose of VIVAZAC PLUS is one or two tablets a day.
• VIVAZAC PLUSwill usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
• Your doctor will instruct you how to switch from the previous treatment to VIVAZAC PLUS .

Method of administration

• VIVAZAC PLUSis for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take VIVAZAC PLUS with or without food. In VIVAZAC PLUS 150/12.5mg the score line is not intended for breaking the tablet. It is important that you continue to take VIVAZAC PLUS until youruntil yourdoctor tells you otherwise.
• The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
• Children should not take VIVAZAC PLUS .
• VIVAZAC PLUSshould not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
• If you take more VIVAZAC PLUS than you should
• If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take VIVAZAC PLUS

• If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking VIVAZAC PLUS

• Do not stop taking VIVAZAC PLUS Tablets unless your doctor tells you to.
• Treatment with VIVAZAC PLUS Tablets should be stopped gradually, especially if you have been taking a high dose, unless your doctor has told you otherwise. Stopping treatment suddenly may cause effects such as an increase in heart rate and high blood pressure. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Caution & Warnings:

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Some of these effects may be serious and may require medical attention.
• Rare cases of allergic skin reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.
• If you get any of the above symptoms or get short of breath, stop taking VIVAZAC PLUS and contact your doctor immediately.
• The frequency of the side effects listed below is defined using the following convention:

Common:may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Side

• effects reported in patients treated with VIVAZAC PLUS were:
• Common side effects (may affect up to 1 in 10 people): Nausea/vomiting. Abnormal urination. Fatigue. Dizziness (including when getting up from a lying or sitting position). Blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
• If any of these side effects causes you problems, talk to your doctor.

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

• Low blood pressure. Fainting. Heart rate increased. Flushing. Swelling. Sexual dysfunction (problems with sexual performance). Blood tests may show lowered levels of potassium and sodium in your blood.
• If any of these side effects causes you problems, talk to your doctor. Side effects reported since the launch of drug:

Some undesirable effects have been reported since marketing of drug. Undesirable effects where the frequency is not known are:

• headache, ringing in the ears,
• cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
• As for any combination of two active substances, side effects associated with each individual component cannot be excluded.

Side effects associated with irbesartan alone

• In addition to the side effects listed above, chest pain and decrease in the number
• of platelets (a blood cell essential for the clotting of the blood) have also been reported.

Side effects associated with hydrochlorothiazide alone

• Loss of appetite.
• Stomach irritation.
• Stomach cramps.
• Constipation.
• Jaundice (yellowing of the skin and/or whites of the eyes).
• Inflammation of the pancreas characterized by severe upper stomach pain, often with nausea and vomiting.
• Sleep disorders.
• Depression.
• Blurred vision.
• Lack of white blood cells, which can result in frequent infections, fever.
• Decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness,headaches, being short of breath when exercising, dizziness and looking pale.
• Kidney disease.
• Lung problems including pneumonia or build-up of fluid in the lungs.
• Increased sensitivity of the skin to the sun.
• Inflammation of blood vessels.
• A skin disease characterized by the peeling of the skin all over the body.
• Cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions.
• Weakness and muscles spasm.
• Altered heart rate.
• Reduced blood pressure after a change in body position.
• Swelling of the salivary glands.
• High sugar levels in the blood.
• Sugar in the urine.
• Increases in some kinds of blood fat
• High uric acid levels in the blood, which may cause gout.
• It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Ingredients:

What VIVAZAC PLUS contains

• The active substances are: irbesartan and hydrochlorothiazide.