What is it?

Irbesartan Hydrochlorothiazide Winthrop is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as oval tablets (peach: 150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink: 300 mg irbesartan and 25 mg hydrochlorothiazide). This medicine is the same as CoAprovel, which is already authorised in the European Union (EU). The company that makes CoAprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Winthrop.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Irbesartan Hydrochlorothiazide Winthrop is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ?Essential? means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

How is it used?

Irbesartan Hydrochlorothiazide Winthrop is taken by mouth, with or without food. The dose of Irbesartan Hydrochlorothiazide Winthrop to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended. Irbesartan Hydrochlorothiazide Winthrop may be added to other treatments for hypertension.

How does it work?

Irbesartan Hydrochlorothiazide Winthrop contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan is an ?angiotensin II receptor antagonist?, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen. Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.

The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

How has it been studied?

Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel. It can be used with hydrochlorothiazide to treat hypertension. The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Winthrop. Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

What benefits has it shown during the studies?

Irbesartan Hydrochlorothiazide Winthrop was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure. Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.

What is the risk associated?

The most common side effects with Irbesartan Hydrochlorothiazide Winthrop (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles). For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Winthrop, see the Package Leaflet. Irbesartan Hydrochlorothiazide Winthrop should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Irbesartan Hydrochlorothiazide Winthrop must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Care must be taken when using Irbesartan Hydrochlorothiazide Winthrop with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in the Package Leaflet.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide Winthrop?s benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. The Committee recommended that Irbesartan Hydrochlorothiazide Winthrop be given marketing authorisation.

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