APROVEL Tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aprovel 75 mg tablets.
Qualitative and quantitative composition
Each tablet contains 75 mg of irbesartan. Excipient with known effect: 15.37 mg of lactose monohydrate per tablet. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Therapeutic indications
Aprovel is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part ...
Posology and method of administration
Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Aprovel at a dose of 150 mg once daily generally provides a better 24-hour blood pressure control ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second and third trimesters of pregnancy (see sections 4.4 and 4.6). The concomitant use of Aprovel with aliskiren-containing ...
Special warnings and precautions for use
Intravascular volume depletion Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, ...
Interaction with other medicinal products and other forms of interaction
Diuretics and other antihypertensive agents Other antihypertensive agents may increase the hypotensive effects of irbesartan; however Aprovel has been safely administered with other antihypertensive agents, ...
Fertility, pregnancy and lactation
Pregnancy The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections ...
Effects on ability to drive and use machines
Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that dizziness ...
Undesirable effects
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%). Discontinuation due to ...
Overdose
Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Angiotensin-II antagonists, plain <b>ATC code:</b> C09CA04 Mechanism of action Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT<sub>1 ...
Pharmacokinetic properties
Absorption After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%. Concomitant food intake does not significantly influence the ...
Preclinical safety data
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses. In non-clinical safety studies, high doses of irbesartan (≥250 mg/kg/day in rats and ≥ 100 mg/kg/day in ...
List of excipients
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Poloxamer 188
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Cartons of 14 tablets in PVC/PVDC/Aluminium blisters. Cartons of 28 tablets in PVC/PVDC/Aluminium blisters. Cartons of 56 tablets in PVC/PVDC/Aluminium blisters. Cartons of 98 tablets in PVC/PVDC/Aluminium ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Marketing authorization number(s)
EU/1/97/046/001-003 EU/1/97/046/010 EU/1/97/046/013
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007
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