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SPC, UK: LEVOFLOXACIN Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Levofloxacin 250 mg Film-coated Tablets.

Qualitative and quantitative composition

Each film coated tablet contains 250 mg of levofloxacin as active substance corresponding to 256.23 mg of levofloxacin hemihydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. For 250 mg tablets: Pink coloured, capsule shaped, biconvex, film coated tablet with break line on both sides. Debossed L and F either side of the break line on one face. The tablet ...

Therapeutic indications

Levofloxacin Tablets is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): Acute bacterial sinusitis. Acute exacerbations of chronic bronchitis. Community-acquired ...

Posology and method of administration

Levofloxacin Tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen. Treatment time The duration ...

Contraindications

Levofloxacin Tablets must not be used: In patients hypersensitive to levofloxacin or other quinolones or to any of the excipients listed in section 6.1. In patients with epilepsy. In patients with history ...

Special warnings and precautions for use

Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population. Therefore, fluoroquinolones should only be used ...

Interaction with other medicinal products and other forms of interaction

Effect of other medicinal products on levofloxacin Iron salts, zinc salts, magnesium- or aluminium-containing antacids, didanosine Levofloxacin absorption is significantly reduced when iron salts, or magnesium- ...

Fertility, pregnancy and lactation

Pregnancy There are limited amount of data with respect to the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity ...

Effects on ability to drive and use machines

Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patients ability to concentrate and react, and therefore may constitute a risk in situations where these ...

Undesirable effects

The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience. Frequencies are defined using the following convention: very common ...

Overdose

According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of levofloxacin are ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiifectives for systemic use – Antibacterials for systemic use – Quinolone antibasterials – Fluoroquinolones ATC code: J01MA12 Levofloxacin is a synthetic antibacterial agent ...

Pharmacokinetic properties

Absorption Orally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1-2 h. The absolute bioavailability is 99-100%. Food has little ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential and toxicity to reproduction and development. ...

List of excipients

Tablet core: Povidone Crospovidone (Type-B) Cellulose microcrystalline Magnesium stearate Silica colloidal anhydrous Tablet coating: Hypromellose E5 Talc Titanium dioxide (E171) Macrogol 400 Yellow ferric ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Tablets are packed in PVC/aluminium blisters. For 250 mg, the tablets are provided in pack sizes of 1, 2, 3, 5, 7, 10, 30, 50 and 200 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4 HF, United Kingdom

Marketing authorization number(s)

PL 20075/0297

Date of first authorization / renewal of the authorization

02/06/2011

Date of revision of the text

25/01/2019

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