COAPROVEL Tablet

Indication

To treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

1. COAPROVEL Tablet 150mg/12.5mg:
Irbesartan 150mg, Hydrochlorothiazide 12.5mg

Dosage

The usual dose is 1-2 tablets a day. CoAprovel will 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 CoAprovel.

Method of administration

CoAprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take CoAprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take CoAprovel until your doctor tells you otherwise.

The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.

2. COAPROVEL Tablet 300mg/12.5mg:
Irbesartan 300mg, Hydrochlorothiazide 12.5mg

Dosage

The usual dose is 1 tablets a day. CoAprovel will 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 CoAprovel.

Method of administration

CoAprovel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take CoAprovel with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take CoAprovel until your doctor tells you otherwise.

The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.

- if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of CoAprovel;

- if you are allergic (hypersensitive) to hydrochlorothiazide or any other sulfonamide-derived medicines;

- if you are more than 3 months pregnant. (It is also better to avoid CoAprovel in early pregnancy);

- if you have severe liver or kidney problems;

- if you have difficulty in producing urine;

- if our doctor determines that you have persistently high calcium or low potassium levels in your blood.

CoAprovel should not be given to children and adolescents (under 18 years).

Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/r tongue have been reported in patients taking irbesartan.

If you get any of the above symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.

Common:

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 (creatinine clearance) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).

Uncommon:

diarrhoea, 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, jaundice (yellowing of the skin and/or whites of the eyes).

Not known:

headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal, impaired kidney function, increased level of potassium in blood , allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.

Side effects associated with irbesartan alone

In addition to the side effects listed above, chest pain has 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, decreased number of red blood cells characterized 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 sin to the sun; inflammation of blood vessels; a skin disease characterize 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 muscle 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.

(See the package insert about details.)

- lithium

- potassium supplements

- salt substitutes containing potassium,

- potassium sparing medicines or other diuretics (water tablets),

- some laxatives,

- medicines for the treatment of gout,

- therapeutic vitamin D supplements,

- medicines to control heart rhythm,

- medicines for diabetes (oral agents or insulins),

- carbamazepine (a medicine for the treatment of epilepsy).

CoAprovel can be taken with or without food.

If you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking CoAprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of CoAprovel. CoAprovel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. CoAprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Tell your doctor if any of the following apply to you:

- if you get excessive vomiting or diarrhoea;

- if you suffer from kidney problems or have a kidney transplant;

- if you suffer from heart problems;

- if you suffer from liver problems;

- if you suffer from diabetes;

- if you suffer from lupus erythematosus (also known as lupus or SLE);

- if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).

You might tell your doctor if you think you are (or might become) pregnant. CoAprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage.

You should also tell your doctor:

- if you are on a low-salt diet;

- if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast fest beat which may indicate an excessive effect of hydrochlorothiazide;

- if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal;

- if you are going to have an operation (surgery) or be given anaesthetics.

The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.

CoAprovel is a combination of two active substances, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medicines known as angiotensinⅡreceptor antagonists. AngiotensinⅡis 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 to angiotensinⅡto these receptors, causing the blood vessels to relax and the blood pressure to lower.

Hydrochlorothiazide is 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 CoAprovel work together to lower blood pressure further than if either was given alone.