Exforge 5/160 mg 28 tablets

Exforge 5/160 mg 28 tablets:

• 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 walls of blood vessels, which prevents blood vessel constriction.
• Valsartan belongs to a group of medicines called 'angiotensin II receptor antagonists'.
• Angiotensin II is produced in the body and causes constriction of blood vessels, leading to increased blood pressure.
• Valsartan works by blocking the effects of angiotensin
• This means that both ingredients help prevent blood vessel constriction.
• This causes the blood vessels to relax and blood pressure to decrease.
• Exforge is used to treat high blood pressure in adults who do not achieve adequate blood pressure control with amlodipine or valsartan alone.

Instructions for use:

• The recommended dose is one tablet daily.
• It is recommended to titrate the individual dose with individual ingredients before switching to a fixed dose formulation.
• A direct switch from monotherapy to a fixed-dose combination may be considered if clinically warranted.
• 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:

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

5mg/160mg:

• 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

Impaired liver function:

• In mild to moderate liver dysfunction 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 case of moderate renal impairment, potassium and creatinine levels should be checked. Clinical data for severe renal impairment are not available.

children:

• Safety and effectiveness have not been proven.
• Elderly people over 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 every day.

Warnings and precautions:

Talk to your doctor before using Exforge:

• If you are suffering from illness (vomiting or diarrhoea).
• If you suffer from liver or kidney problems.
• If you have had a kidney transplant or have been told that you have narrowing of the blood vessels to the kidneys.
• If you have a disease of the adrenal glands called 'primary hyperaldosteronism'.
• If you have heart failure or have had a heart attack.
• Carefully follow your doctor's instructions for starting your dose. 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 the heart muscle has increased abnormally (called "obstructive hypertrophic cardiomyopathy").
• If you experience 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 must never use Exforge  again.
• If you use any of the following medicines for high blood pressure:
• Angiotensin-converting enzyme 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 film-coated tablets.
• Exforge 5 mg/160 mg film-coated tablets.
• Exforge 10 mg/160 mg film-coated tablets.