Product Description:

• Exforge tablets contain two active substances called amlodipine and valsartan. Both of these components help to 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 constriction of the blood vessels.


• Valsartan belongs to a group of medicines called " angiotensin -II receptor antagonists". 


• Angiotensin -II is produced in the body and causes the blood vessels to contract so that the blood pressure increases. 


• Valsartan works by blocking the effects of angiotensin -II.


• This means that both components help prevent blood vessels from constricting. 


• This causes the blood vessels to relax and the blood pressure to drop.


• Exforge is used to treat high blood pressure in adults who do not achieve adequate blood pressure control with either amlodipine or valsartan alone.

How To Use:

• The recommended dose is 1 tablet daily.


• Individual dose titration with the individual components is recommended before switching to a fixed dose combination.


• Direct switching from monotherapy to fixed dose combination can be considered if clinically justified. 


• Patients receiving valsartan and amlodipine as separate tablets/capsules can switch to the preparation with the same dose of the individual components.

5 mg/80 mg:

• Can be given when blood pressure is not sufficiently controlled with amlodipine 5 mg or valsartan 80 mg alone.

5 mg/160 mg:

• Can be given when blood pressure is not sufficiently controlled with amlodipine 5 mg or valsartan 160 mg alone.

10 mg/160 mg:

• Can be given when blood pressure is not sufficiently controlled with amlodipine 10 mg or valsartan 160 mg alone or with Exforge 5 mg/160 mg.

Special patient groups

Impaired liver function:

• In mild to moderately impaired liver function without cholestasis, the dose of valsartan should not exceed 80 mg. The lowest amlodipine dose should be used. 

Impaired renal function:

• Dose adjustment not necessary in mild to moderately impaired renal function ( GFR >30 ml/minute).


• In the case of moderately impaired kidney function, potassium and creatinine levels should be checked. Clinical data for severely impaired renal function are lacking.

Children:

• Safety and efficacy not established.


• Elderly ≥65 years: Exercise caution when increasing the dose. 


• The lowest amlodipine dose should be used.

Administration Take with or without food. It is recommended to swallow the tablet whole with a little water, preferably at the same time every day.

Warnings And Precautions:

Talk to your doctor before using Exforge:

• If you have been ill ( vomiting or diarrhoea ).


• If you have liver or kidney problems.


• If you have had a kidney transplant or you have been told that you have a narrowing of the blood vessels to the kidneys.


• If you have a disease affecting the adrenal glands called "primary hyperaldosteronism".


• If you have had heart failure or have had a heart attack . 


• Follow your doctor's instructions for starting dosage carefully. Your doctor may also examine your kidney function.


• If your doctor has told you that you have a narrowing of the heart valves (called "aortic or mitral stenosis") or the thickness of your heart muscle has increased abnormally (called "obstructive hypertrophic cardiomyopathy").


• If you have experienced swelling, especially of the face and neck, when using other medicines (including angiotensin-converting enzyme inhibitors ). 


• Stop taking Exforge and contact your doctor immediately if you experience these symptoms. You should never use Exforge again.


• If you use any of the following medicines for high blood pressure :


• An ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease




• Your doctor may carry out regular checks of your kidney function, blood pressure and the level of electrolytes (eg potassium) in your blood.


• See also information in the section "Do not use Exforge".


• Talk to your doctor before taking Exforge if any of this applies to you .

Children and youth:

• Use of Exforge in children and adolescents (under 18 years) is not recommended.

Ingredients:

Amlodipine/valsartan Film-coated tablets available in 3 different concentrations:

• Exforge 5 mg/80 mg film-coated tablets


• Exforge 5 mg/160 mg film-coated tablets


• Exforge 10 mg/160 mg film-coated tablets

Product Details:

• Product Type: Tablets
• Quantity: 28 Tablets
• Brand: Exforge
• Product Form: Tablets