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SPC, UK: LETROZOLE / GLENMARK Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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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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