Exforge 10/160 mg 28 tablets

Product Description:

• Exforge tablets contain two active ingredients called amlodipine and valsartan. Both ingredients 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, preventing blood vessel constriction.
• 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 increased blood pressure.
• Valsartan works by blocking the effects of angiotensin.
• This means that both components help prevent blood vessel constriction.
• This causes blood vessels to relax and blood pressure to drop.
• Exforge is used to treat high blood pressure in adults who do not achieve adequate blood pressure control with amlodipine or valsartan alone.

Directions for use:

• The recommended dosage is one tablet daily.
• It is recommended to titrate the individual dose with the individual components before switching to a fixed dose formulation.
• A direct switch from monotherapy to a fixed-dose combination may be considered if clinically justified.
• Patients receiving valsartan and amlodipine as separate tablets/capsules may be switched to the preparation with the same dose of the individual components.

5 mg/80 mg:

• It may be given when blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.

5 mg/160 mg:

• It may be given when blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.

10 mg/160 mg:

• It may be given when blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Exforge 5 mg/160 mg.
• Special groups of patients

Liver dysfunction:

• In mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. The lowest dose of amlodipine should be used.

Kidney dysfunction:

• Dose adjustment is not necessary in mild to moderate renal impairment (GFR > 30 ml/min).
• In cases of mild renal impairment, potassium and creatinine levels should be checked. Clinical data for severe renal impairment are lacking.

children:

• Safety and effectiveness have not been established.
• Elderly 65 years: 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 a little water, preferably at the same time each day.

Warnings and Precautions:

Talk to your doctor before using Exforge:

• If you are sick (vomiting or diarrhea).
• If you have liver or kidney problems.
• If you have had a kidney transplant or have been told that you have narrowed blood vessels to your kidneys.
• If you have a disease of the adrenal glands called primary hyperaldosteronism.
• If you have heart failure or have had a heart attack.
• Follow your doctor's instructions carefully when starting your dose. Your doctor may also check your kidney function.
• If your doctor tells you that you have narrowing of your heart valves (called aortic or mitral stenosis) or that your heart muscle has become abnormally thick (called hypertrophic obstructive cardiomyopathy).
• If you experience swelling, especially in 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 medications for high blood pressure:
• Angiotensin-converting enzyme (ACE) inhibitors (such as enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease
• Your doctor may do regular checks of your kidney function, blood pressure, and the level of electrolytes (such as potassium) in your blood.
• See also the information in the "Do not use Exforge" section.
• Talk to your doctor before taking Exforge if any of this applies to you.

Children and youth:

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

the components:

Amlodipine/Valsartan film-coated tablets are available in 3 different strengths:

• Exforge 5 mg/80 mg coated tablets.
• Exforge 5 mg/160 mg coated tablets.
• Exforge 10 mg/160 mg coated tablets.