Exforge HCT 5/160/12.5 mg 14 tablets

Exforge HCT 5/160/12.5 mg 14 tablets

Composition:
Each film-coated tablet contains:
Active substances:
- Amlodipine (as amlodipine besylate) 5 mg,
- Valsartan 160 mg,
- Hydrochlorothiazide 12.5 mg.
Excipients: Microcrystalline cellulose, Crospovidone (Type A), Colloidal anhydrous silica, Magnesium stearate.
Product Description:
Exforge HCT is a fixed-dose combination antihypertensive medicinal product containing three active substances that lower blood pressure through complementary mechanisms of action.
Amlodipine relaxes blood vessels, valsartan blocks the vasoconstrictor effects of angiotensin II, and hydrochlorothiazide promotes urinary excretion of excess fluid.
Together, these effects lead to vasodilation and effective blood pressure reduction.
The product is intended for adult patients whose blood pressure is already controlled with amlodipine, valsartan, and hydrochlorothiazide taken separately.
Indications for Use:
Treatment of essential hypertension in adult patients whose blood pressure is already adequately controlled with amlodipine, valsartan, and hydrochlorothiazide.
Dosage and Method of Administration:
For oral use.
Recommended dose: One tablet once daily.
The tablet should be taken at the same time each day, preferably in the morning.
Swallow the tablet whole with a glass of water.
The product may be taken with or without food.
Do not take with grapefruit or grapefruit juice.
Contraindications:
Exforge HCT is contraindicated in:
- pregnancy beyond the third month;
- hypersensitivity to amlodipine, valsartan, hydrochlorothiazide, sulphonamide-derived medicines, or any excipient;
- severe hepatic impairment, biliary cirrhosis, cholestasis;
- severe renal impairment, dialysis, or anuria;
- electrolyte disturbances unresponsive to treatment;
- gout;
- severe hypotension or cardiogenic shock;
- severe aortic stenosis;
- heart failure following myocardial infarction;
- concomitant use with aliskiren in patients with diabetes or renal impairment.
Precautions:
Consult a doctor before starting treatment, especially if:
- electrolyte imbalances are present;
- kidney or liver diseases are present;
- allergic reactions have occurred previously;
- heart failure or ischemic heart disease is present;
- connective tissue disorders are present (e.g., systemic lupus erythematosus);
- skin reactions to sunlight have been noted;breathing difficulties have occurred previously when taking hydrochlorothiazide.
During treatment, the doctor may regularly monitor blood pressure, kidney function, and electrolyte levels in the blood.
Adverse Reactions (Side Effects):
Very common:hypokalaemia, increased blood lipid levels.
Common: dizziness, hypotension, ankle oedema, headache, fatigue, frequent urination, nausea and vomiting.
Rare/very rare: severe allergic reactions, hepatic disorders, pancreatitis, severe skin reactions, respiratory distress.
Pregnancy and Lactation:
Exforge HCT must not be used during pregnancy beyond the third month and is not recommended during early pregnancy.
Use during breastfeeding is not recommended.
Alternative treatment should be considered.
Storage Conditions:
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the package.
Packaging:
Carton box containing 2 blisters of 7 film-coated tablets and a package leaflet.