APROVEL Tablet (2023)
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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 ...
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 con...
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 ...
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 restr...
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 antihypertensiv...
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 (s...
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 di...
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...
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 mi...
Pharmacodynamic properties
Pharmacotherapeutic group:
Angiotensin-II antagonists, plain
ATC code:
C09CA04
Mechanism of action
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT
1
) antagonis...
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 ...
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/da...
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/PVD...
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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