Exforge 5/160 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 drugs called "calcium channel blockers".
• Amlodipine prevents calcium from being transferred to the walls of blood vessels, thus preventing the blood vessels from constricting.
• Valsartan belongs to a group of drugs 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 the constriction of blood vessels.
• This leads to relaxation of the blood vessels and a decrease in blood pressure.
• Exforge is used to treat high blood pressure in adults who do not achieve adequate blood pressure control with amlodipine or valsartan alone.

Usage guidelines:

• The recommended dose is one tablet daily.
• It is recommended to titrate the individual dose with the 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 ingredients.

5 mg / 80 mg:

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

5 mg / 160 mg:

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

10 mg / 160 mg:

• It can 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 cases of mild to moderate liver dysfunction without cholestasis, the valsartan dose should not exceed 80 mg. The lowest effective dose of amlodipine should be used.

Kidney dysfunction:

• Dose adjustment is not necessary in cases of 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 unavailable.

children:

• Safety and effectiveness have not been proven.
• Elderly people 65 years and older: Caution should be exercised when increasing the dose.
• The lowest dose of amlodipine should be used.
• It can be used 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:

Speak 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 that you have narrowing of the blood vessels to the kidneys.
• If you have a disease that affects the adrenal glands called "primary hyperaldosteronism".
• If you suffer from heart failure or have had a heart attack.
• Follow your doctor's instructions carefully to begin the dose. Your doctor may also check your kidney function.
• If your doctor tells 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 "hypertrophic obstructive cardiomyopathy").
• If you experience swelling, especially in the face and neck, when using other medications (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:
• ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease
• Your doctor may perform regular checks of your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.
• See also the information in the "Do not use Oxford" section.
• Speak to your doctor before taking Exforge if any of this applies to you.

Children and young people:

• 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.