AMESOL Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Amesol 250 mg film-coated tablets. Amesol 500 mg film-coated tablets.
2. Qualitative and quantitative composition
Amesol 250 mg film-coated tablets contain 250 mg levofloxacin as active substance corresponding to 256.23 mg of levofloxacin hemihydrate. Amesol 500 mg film-coated tablets contain 500 mg levofloxacin as ...
3. Pharmaceutical form
Film-coated tablet. <u>Amesol 250 mg film-coated tablets:</u> Peach, round, convex, scored on one side, embossed MC on the other side film coated tablets. The tablet can be divided into equal doses <u> ...
4.1. Therapeutic indications
Amesol is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): Acute bacterial sinusitis. Acute exacerbation of chronic obstructive pulmonary disease including ...
4.2. Posology and method of administration
Amesol tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Amesol tablets may also be used ...
4.3. Contraindications
Amesol tablets must not be used: in patients hypersensitive to levofloxacin or other quinolones or any of the excipients listed in section 6.1, in patients with epilepsy, in patients with history of tendon ...
4.4. Special warnings and precautions for use
The use of levofloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment ...
4.5. Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on Amesol Iron salts, zinc salts, magnesium- or aluminium-containing antacids, didanosine Levofloxacin absorption is significantly reduced when iron salts, or magnesium- ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...
4.7. 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 ...
4.8. 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 ...
4.9. Overdose
Symptoms According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdose of levofloxacin ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> fluoroquinolones <b>ATC code:</b> J01MA12 Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic drug ...
5.2. Pharmacokinetic properties
Absorption Orally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1-2h. The absolute bioavailability is 99-100%. Food has little ...
5.3. 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. ...
6.1. List of excipients
<u>Core:</u> Microcrystalline cellulose Hypromellose Crospovidone Magnesium stearate <u>Coating:</u> Titanium dioxide (E171) Hypromellose Macrogol (Polyethylene glycol) 6000 Talc Iron oxide red (E172) ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
60 months.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
Amesol 250 mg film-coated tablets are packed in blisters of PVC/Alu of: 3, 5, 7, 10, 50, 90, 100, 200 and 300 tablets. Amesol 500 mg film-coated tablets are packed in blisters of PVC/Alu of: 3, 5, 7, 10, ...
6.6. Special precautions for disposal and other handling
None. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Amesol 250 mg film-coated tablets: 21561 Amesol 500 mg film-coated tablets: 21562
9. Date of first authorization / renewal of the authorization
Amesol 250 mg film-coated tablets: 01/11/2012 / 01/11/2017 Amesol 500 mg film-coated tablets: 01/11/2012 / 01/11/2017
10. Date of revision of the text
10/2020 30/10/2020
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