Product Description:
- Senergy 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.
- Senergy 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 Senergy 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 Senergy:
- 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 Senergy and contact your doctor immediately if you experience these symptoms. You should never use Senergy 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 Senergy".
- Talk to your doctor before taking Senergy if any of this applies to you .
Children and youth:
- Use of Senergy in children and adolescents (under 18 years) is not recommended.
Ingredients:
Amlodipine/valsartan Film-coated tablets available in 3 different concentrations:
- Senergy 5 mg/160 mg film-coated tablets
- Senergy 10 mg/160 mg film-coated tablets