AMOXAPEN Film-coated tablet (2017)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Amoxapen 250 mg film-coated tablets. Amoxapen 500 mg film-coated tablets.

2. Qualitative and quantitative composition

Amoxapen 250 mg film-coated tablets: Each film-coated tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin. Amoxapen 500 mg film-coated tablets: Each film-coated tablet ...

3. Pharmaceutical form

Film-coated tablet. Amoxapen 250 mg film-coated tablets: Light-orange, round, scored film-coated tablets. Amoxapen 500 mg film-coated tablets: Light-orange, round, film-coated tablets, scored ...

4.1. Therapeutic indications

Amoxapen is indicated for the treatment of the following infections in adults and children (see section 4.2, 4.4, 5.1): acute bacteria sinusitis. acute otitis media. acute streptococcal tonsillitis and ...

4.2. Posology and method of administration

Posology The dose of Amoxapen that is selected to treat an individual infection should take into account: the expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) ...

4.3. Contraindications

Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients listed in section 6.1. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another ...

4.4. Special warnings and precautions for use

Hypersensitivity reactions Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam ...

4.5. Interaction with other medicinal products and other forms of interaction

Probenecid Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels ...

4.6. Pregnancy and lactation

Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ...

4.8. Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash. The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin, presented by MedDRA ...

4.9. Overdose

Symptoms and signs of overdose Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use; Beta-lactam antibacterials, penicillins ATC code: J01CA04 Mechanism of action Amoxapen is a semisynthetic penicillin (beta-lactam ...

5.2. Pharmacokinetic properties

Absorption Amoxicillin fully dissociates in aqueous solution at physiological pH. It is rapidly and well absorbed by the oral route of administration. Following oral administration, amoxicillin is approximately ...

5.3. Preclinical safety data

Non clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. Carcinogenicity studies ...

6.1. List of excipients

Core: Microcrystalline cellulose Sodium lauryl sulphate Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate Povidone Glycerol Coating: Hypromellose Polyethylene glycol 400 ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that ...

6.5. Nature and contents of container

Amoxapen 250 mg film-coated tablets: PVC/Aluminium blisters. Pack-sizes of 20 film-coated tablets. PP containers with PE closure. Pack-sizes of 100 and 1000 film-coated tablets. Amoxapen 500 ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Amoxapen 250 mg film-coated tablets: 14284 Amoxapen 500 mg film-coated tablets: 20036

9. Date of first authorization / renewal of the authorization

Amoxapen 250 mg film-coated tablets: Date of first authorization: 03 August 1993 Date of latest renewal: 20 November 2009 Amoxapen 500 mg film-coated tablets: Date of first authorization: ...

10. Date of revision of the text

29/08/2017

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