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    / Unipharm


    Active Ingredient *
    Amlodipine Besylate 5 mg, 10 mg
    Valsartan 80 mg, 160 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Coated Tablets

    28 X 5/80 mg

    not in the basket chart 71822 4625

    Coated Tablets

    28 X 5/160 mg

    not in the basket chart 71821 4626

    Coated Tablets

    28 X 10/160 mg

    not in the basket chart 71823 4627

    Related information


    Dosage

    The recommended dose is one tablet per day. Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before changing to the fixed dose combination. When clinically appropriate direct change from monotherapy to the fixed-dose combination may be considered. For convenience, patients receiving valsartan and amlodipine from separate tablets may be switched to this product containing the same component doses. The maximum dose is 10/320 mg.
    Please refer to the license holder for further details.


    Indications

    Treatment of essential hypertension. This product is indicated for patients whose blood pressure is not adequately controlled on monotherapy.


    Contra-Indications

    Allergy to the active ingredients, to a medicine of the dihydropyridine group, or to any of the other ingredients contained in the medicine; severe liver problems, such as cholestasis; severe kidney problems or are undergoing dialysis;
    pregnancy or planning to become pregnant; high levels of sugar in the blood and diabetes and an antihypertensive containing aliskiren (e.g., Rasilez) at the same time; impaired kidney function and an antihypertensive containing aliskiren (e.g., Rasilez) at the same time.


    Special Precautions

    If you suffer from several episodes of vomiting or diarrhea or are taking a diuretic (a medicine that increases the amount of urine). If you are taking other drugs or substances that increase the potassium levels in the blood (such as certain types of diuretics, salt substitutes containing potassium, potassium supplements, and the like). If you suffer from liver or kidney problems, from a problem with adrenal gland function. If a doctor has diagnosed that you are suffering from a narrowing of valves in your heart (aortic or mitral stenosis), heart failure or abnormal thickening of the heart muscle with narrowing (obstructive hypertrophic cardiomyopathy). If you underwent a kidney transplant or have been diagnosed as suffering from a narrowing of the kidney artery. you ever had swelling, mainly of the face and throat, while taking other medicines (including ACE inhibitors). If you are suffering from heart failure or have experienced a heart attack. Carefully follow the doctor’s instructions regarding the starting dosage. The doctor may also check your kidney function. If you are taking an ACE inhibitor or aliskiren.
    Please refer to the license holder for further details.


    Side Effects

    Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (rare side effects, affecting less than 1 in 1,000 patients). Occurring frequently (affecting less than 1 in 10 patients): Flu-like symptoms; nasal congestion, sore throat and discomfort when swallowing; headache; swelling of arms, palms of the hands, legs, ankles or feet; tiredness; redness and warm feeling of the face and/or the neck.
    Please refer to the license holder for further details.


    Drug interactions

    It may be necessary to change the dosage or, in some cases, to stop taking one of the medicines. It is especially important to inform the doctor or pharmacist if you are taking medicines from the following groups: medicines used to lower blood pressure, especially diuretics, ACE inhibitors or aliskiren. potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium. certain types of pain killers NSAIDs or Cox-2 inhibitors. lithium, a medicine used to treat some types of psychiatric illnesses. anticonvulsant agents (such as carbamazepine, phenobarbital, phenytoin,rimidone preparations). Nitroglycerin and other nitrates, or other medicines that belong to the vasodilator group. Tell the attending doctor or pharmacist if you are taking, or have recently taken, any other medicines that can change the amount of amlodipine in your body, especially medicines belonging to the following groups: medicines used to prevent and treat fungal skin infections (such as ketoconazole, itraconazole); medicines used to treat AIDS or infections caused by HIV (such as ritonavir, indinavir); medicines used to treat bacterial infections (such as clarithromycin, telithromycin); simvastatin (a medicine used to lower cholesterol). Report to the attending doctor or pharmacist if you are taking, or have recently taken, other medicines that can change the amount of valsartan in your body, especially medicines belonging to the following groups: certain antibiotics (rifampicin group), medicines used to protect against transplant rejection (ciclosporin) or an antiviral medicine used to treat AIDS/infections caused by HIV (ritonavir). These medicines may increase the effect of valsartan.
    Please refer to the license holder for further details.


    Pregnancy and Lactation

    Pregnancy: Do not use this product if you are pregnant or planning to become pregnant. An association between use of this product during pregnancy and severe damage to the unborn baby has been found. Therefore, it is important to refer to the doctor immediately if you think you are pregnant or are planning to become pregnant.
    Lactation: Use of this product is not recommended when breastfeeding.
    Please refer to the license holder for further details.


    Important notes

    Food: The medicine can be taken with or without food.
    Driving and using machines: 
    Like many other medicines used to treat high blood pressure, this product may in rare cases cause dizziness and affect the ability to concentrate. Therefore, before driving a vehicle, using machinery, or carrying out other activities that require concentration, make sure you know how you react to this product.
    Storage: Store the medicine at a temperature that does not exceed 25°C and in a place protected from light.


    Manufacturer
    Trima Israel Pharmaceutical Products Maabarot Ltd. Israel
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