AMOXIL Capsule (2023)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | GlaxoSmithKline UK |
|---|---|
| Διεύθυνση | Stockley Park West, Uxbridge, Middlesex, UB11 1BT |
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Περιεχόμενα
Name of the medicinal product
Amoxicillin 500 mg Capsules.
Qualitative and quantitative composition
Amoxicillin trihydrate equivalent to 500mg Amoxycillin per capsule. For a full list of excipients, see section 6.1.
Pharmaceutical form
Hard Capsules. White to off-white granular powder filled in hard gelatine capsule shells size 0. Scarlet colour cap, buff colour body printed with AMOXY on cap and 500 on body.
Therapeutic indications
Amoxicillin is indicated for the treatment of the following infections in adults and children (see section 4.2, 4.4 and 5.1). Acute bacterial sinusitis Acute streptococcal tonsillitis and pharyngitis ...
Posology and method of administration
Posology The dose of Amoxicillin that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents (see section ...
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 ...
Special warnings and precautions for use
Hypersensitivity reactions Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillin and cephalosporins or other beta-lactam ...
Interaction with other medicinal products and other forms of interaction
Oral anticoagulants Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, in the literature there are rare cases of increased international ...
Fertility, 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 ...
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 ...
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 ...
Overdose
Symptoms and signs of overdose Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbances of the fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> penicillins with extended spectrum <b>ATC code:</b> J01CA04 Mechanism of action Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or ...
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 ...
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 ...
List of excipients
Magnesium Stearate (E572) Silica Colloidal Anhydrous Capsule shell components <u>Body:</u> Iron Oxide Red (E172) Iron Oxide Yellow (E172) Titanium Dioxide (El71) To 100% Gelatin <u>Cap:</u> Indigo Carmine ...
Incompatibilities
Not applicable.
Shelf life
3 years: Polypropylene/polyethylene containers. 2 years: Blister strips.
Special precautions for storage
Do not store above 25°C. Store in the original package and keep containers tightly closed.
Nature and contents of container
Polypropylene/polyethylene containers and tamper evident closures/1000, 500, 100, 21, 20 and 15 capsules. <u>Blister strips:</u> 15 and 21 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
Marketing authorization number(s)
PL 16363/0045
Date of first authorization / renewal of the authorization
08/04/2002 / 04/02/2009
Date of revision of the text
22/02/2023
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