TERBINAFINE ACCORD Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Terbinafine 250mg Tablets.
Qualitative and quantitative composition
Each tablet contains 250 mg terbinafine, as terbinafine hydrochloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, round, flat, 11 mm tablets, scored on both sides with side scores, marked T above and 1 below the score on one side.
Therapeutic indications
Treatment of Terbinafine tablets sensitive fungal infections such as Tinea corporis, Tinea cruris and Tinea pedis (caused by Dematophytes see Section 5.1) is considered appropriate due to the site, severity ...
Posology and method of administration
Posology Adults 250mg once daily. Renal impairment Use of Terbinafine tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population (see ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment. Severe hepatic impairment.
Special warnings and precautions for use
Liver function Terbinafine tablets are not recommended for patients with chronic or active hepatic disease. Before prescribing Terbinafine tablets, liver function test should be performed. Hepatotoxicity ...
Interaction with other medicinal products and other forms of interaction
The plasma clearance of Terbinafine tablets may be accelerated by drugs which induce metabolism (such as rifampicin) and may be inhibited by drugs which inhibit cytochrome P450 (such as cimetidine). Where ...
Fertility, pregnancy and lactation
Pregnancy Foetal toxicity and fertility studies in animals suggest no adverse effects. Since clinical experience in pregnant women is very limited, Terbinafine tablets should not be used during pregnancy ...
Effects on ability to drive and use machines
No studies on the effects of Terbinafine tablets treatment on the ability to drive and use machines have been performed. Patients who experience dizziness as an undesirable effect should avoid driving ...
Undesirable effects
The following adverse reactions have been observed in the clinical trials or during post marketing experience. Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, ...
Overdose
Few cases of overdose (up to 5g) have been reported, giving rise to headache, nausea, epigastric pain and dizziness. Recommended treatment for overdose consists of eliminating the active substance, primarily ...
Pharmacodynamic properties
Pharmacotherapeutic group: Dermatologicals; antifungals for systemic use ATC code: D01BA02 Terbinafine tablets is an allylamine which has a broad spectrum of antifungal activity. At low concentrations ...
Pharmacokinetic properties
Absorption A single oral dose of 250mg Terbinafine tablets results in mean peak plasma concentrations of 0.97 mcg/ml within 2 hours after administration. The absorption half-life is 0.8 hours and the distribution ...
Preclinical safety data
The approximate LD<sub>50</sub> value of Terbinafine tablets is over 4 g/kg in both mice and rats. In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species ...
List of excipients
Magnesium stearate Silica, colloidal anhydrous Croscarmellose sodium Hypromellose Microcrystalline cellulose
Incompatibilities
Not applicable.
Shelf life
Shelf life Al/PVC-PVdC blister: 3 years. HDPE tablet container with LDPE cap: 18 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Al/PVC-PVdC blister and HDPE tablet container with LDPE cap. <u>Pack Sizes:</u> HDPE bottles: 14, 28, 500 tablets. Blisters: 7, 14, 20, 28, 30, 42, 50, 60, 84, 90, 98, 100, 50 1 (unit dose) tablets. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 00142/0628
Date of first authorization / renewal of the authorization
26/02/2009
Date of revision of the text
24<sup>th</sup> August 2018
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