LETROZOLE / GLENMARK Film-coated tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Letrozole 2.5 mg Film-coated tablets.
Qualitative and quantitative composition
Active substance: Letrozole. Each film coated tablet contains 2.5 mg letrozole. Excipients with known effect: Each tablet contains 85.0 mg of lactose. For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Film-coated tablet. Dark yellow coloured, round shaped, slightly biconvex bevel edged, approx. 6mm in diameter film-coated tablets debossed with 5 on one side and H on the other side.
Therapeutic indications
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who ...
Posology and method of administration
Posology Adult and elderly patients The recommended dose of Letrozole is 2.5 mg once daily. No dose adjustment is required for elderly patients. In patients with advanced or metastatic breast cancer, treatment ...
Contraindications
*Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Premenopausal endocrine status. Pregnancy (see section 4.6). Breast-feeding (see section 4.6).
Special warnings and precautions for use
Menopausal status In patients whose menopausal status is unclear, luteinising hormone (LH), follicle-stimulating hormone (FSH) and/or oestradiol levels should be measured before initiating treatment with ...
Interaction with other medicinal products and other forms of interaction
Metabolism of letrozole is partly mediated via CYP2A6 and CYP3A4. Cimetidine, a weak, unspecific inhibitor of CYP450 enzymes, did not affect the plasma concentrations of letrozole. The effect of potent ...
Fertility, pregnancy and lactation
Women of perimenopausal status or child-bearing potential Letrozole 2.5 mg Film-coated tablets should only be used in women with a clearly established postmenopausal status (see section 4.4). As there ...
Effects on ability to drive and use machines
Letrozole 2.5 mg Film-coated tablets has minor influence on the ability to drive and use machines. Since fatigue and dizziness have been observed with the use of Letrozole 2.5 mg Film-coated tablets and ...
Undesirable effects
Summary of the safety profile The frequencies of adverse reactions for Letrozole are mainly based on data collected from clinical trials. Up to approximately one third of the patients treated with Letrozole ...
Overdose
Isolated cases of overdose with Letrozole have been reported. No specific treatment for overdose is known; treatment should be symptomatic and supportive.
Pharmacodynamic properties
Pharmacotherapeutic group: Endocrine therapy. Hormone antagonist and related agents: aromatase inhibitor ATC code: L02BG04 Pharmacodynamic effects The elimination of oestrogen-mediated growth stimulation ...
Pharmacokinetic properties
Absorption Letrozole is rapidly and completely absorbed from the gastrointestinal tract (mean absolute bioavailability: 99.9%). Food slightly decreases the rate of absorption (median t<sub>max</sub> 1 ...
Preclinical safety data
In a variety of preclinical safety studies conducted in standard animal species, there was no evidence of systemic or target organ toxicity. Letrozole showed a low degree of acute toxicity in rodents exposed ...
List of excipients
Core tablets: Lactose monohydrate Croscarmellose sodium Povidone Silica, colloidal anhydrousmagnesium stearate Tablet coating: Hypromellose (464) Iron oxide, yellow (E172) Titanium dioxide (E171) Macrogols ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminium/Aluminium blister packs and PVC/PE/PVDC/aluminium blister packs. Pack sizes: 10, 14, 28, 30, 90, 98 or 100 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
Marketing authorization number(s)
PL 25258/0198
Date of first authorization / renewal of the authorization
18/02/2016
Date of revision of the text
October 2018
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