Arbavasc HCT®

Arbavasc HCT<sup>®</sup>

Arbavasc HCT®

Valsartan/Amlodipine/Hydrochlorothiazide

Arbavasc HCT®

Valsartan/Amlodipine/Hydrochlorothiazide

(160/5/12.5mg), (160/5/25mg), (160/10/12.5mg), (160/10/25mg)

 

Product leaflet summary

Therapeutic Indications

Arbavasc HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide and who may benefit from taking one tablet containing all three substances.

 

Dosage and Administration

The usual dose of Arbavasc HCT is one tablet per day

It is best to take the tablet at the same time each day. Morning is the best time.

Swallow the tablet whole with a glass of water.

 

Contraindications

– If you are more than 3 months pregnant. (It is also recommended to avoid Arbavasc HCT in early pregnancy – see Pregnancy section.)

– If you are allergic to amlodipine or to any other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, do not take Arbavasc HCT and talk to your doctor.

– If you have liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the buildup of bile in the liver (cholestasis).

– If you have severe kidney problems or if you are having dialysis.

– If you are unable to produce urine (anuria).

– If the level of potassium or sodium in your blood is too low despite treatment to increase the potassium or sodium levels in your blood.

– If the level of calcium in your blood is too high despite treatment to reduce the calcium levels in your blood.

– If you have gout (uric acid crystals in the joints).

– If you have severe low blood pressure (hypotension).

– If you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).

– If you suffer from heart failure after a heart attack.

If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

 

Pregnancy and Lactation

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Arbavasc HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Arbavasc HCT. Arbavasc HCT 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. Arbavasc HCT 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 a newborn, or was born prematurely. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Arbavasc HCT 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 a newborn, or was born prematurely.

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

 

Ability to Drive and Use Machinery

This medicine may make you feel dizzy, drowsy, and nauseous or have a headache. If you experience these symptoms, do not drive or use tools or machines.

 

Package Presentation:

Blisters of 28 tablets contained in a carton.