Exforge 5/160 mg Tablet 28pcs

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