Product Description:
Exforge tablets contain two active substances called amlodipine and valsartan. Both components help control high blood pressure.
Amlodipine belongs to a group of medicines called "calcium channel blockers."
Amlodipine prevents calcium from moving into the blood vessel walls, which prevents the blood vessels from constricting.
Valsartan belongs to a group of medicines called "angiotensin II receptor antagonists."
Angiotensin II is produced in the body and causes blood vessels to constrict, leading to an increase in blood pressure.
Valsartan works by blocking the effects of angiotensin II.
This means that both components help prevent the blood vessels from tightening.
As a result, the blood vessels relax and blood pressure is lowered.
Exforge is used to treat high blood pressure in adults whose blood pressure is not sufficiently controlled with amlodipine or valsartan alone.
Instructions for Use:
The recommended dose is one tablet per day.
Individual dose titration with the single components is recommended before switching to the fixed-dose combination.
A direct switch from monotherapy to the fixed-dose combination may be considered if clinically warranted.
Patients receiving valsartan and amlodipine as separate tablets/capsules may switch to the preparation containing the same doses of the individual components.
5 mg / 80 mg:
Can be administered when blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
5 mg / 160 mg:
Can be administered when blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
10 mg / 160 mg:
Can be administered when blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Exforge 5 mg / 160 mg.
Special Patient Groups:
Liver Impairment:
In cases of mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. The lowest dose of amlodipine should be used.
Renal Impairment:
Dosage adjustment is not necessary for mild to moderate renal impairment (GFR > 30 ml/min).
In cases of moderate renal impairment, potassium and creatinine levels should be monitored. Clinical data for severe renal impairment are not available.
Children:
Safety and efficacy have not been established.
Elderly (65 years and older): Caution should be exercised when increasing the dose.
The lowest dose of amlodipine should be used.
Use with or without food. It is recommended to swallow the tablet whole with some water, preferably at the same time each day.
Warnings and Precautions:
Talk to your doctor before using Exforge:
If you are suffering from an illness (vomiting or diarrhea).
If you have liver or kidney problems.
If you have had a kidney transplant or have been told you have narrowing of the blood vessels to the kidneys.
If you have a disease affecting the adrenal glands called "primary hyperaldosteronism."
If you have heart failure or have had a heart attack.
Follow your doctor's instructions for starting the dose carefully. Your doctor may also check your kidney function.
If your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (called "obstructive hypertrophic cardiomyopathy").
If you experience swelling, particularly of the face and neck, when using other medicines (including ACE inhibitors).
Stop taking Exforge and contact your doctor immediately if you experience these symptoms. You should not use Exforge again.
If you are using any of the following medicines for high blood pressure:
ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
Your doctor may perform regular checks of your kidney function, blood pressure, and the level of electrolytes (such as potassium) in your blood.
Also see the information in the "Do not use Exforge" section.
Talk to your doctor before taking Exforge if any of these apply to you.
Children and Adolescents:
Exforge is not recommended for use in children and adolescents (under 18 years of age).
Product Details:
Brand: Exforge
Concentration: 10/160 mg
Quantity: 28 Tablets
Product Type: Tablets
