DISTACLOR Capsule (2018)
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Περιεχόμενα
Name of the medicinal product
Distaclor 500mg capsules. Cefaclor 500mg capsules.
Qualitative and quantitative composition
Each capsule contains as the active ingredient, cefaclor monohydrate Ph.Eur. equivalent to 500mg of cefaclor base.
Pharmaceutical form
Capsule, Size 0 with opaque purple cap and opaque grey body.
Therapeutic indications
Distaclor is indicated for the treatment of the following infections due to susceptible micro-organisms: Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, ...
Posology and method of administration
Posology Adults The usual adult dosage is 250mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4g per day have been administered ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to other cephalosporins.
Special warnings and precautions for use
Warnings Before instituting therapy with cefaclor, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other ...
Interaction with other medicinal products and other forms of interaction
There have been rare reports of increased prothrombin time, with or without clinical bleeding, in patients receiving cefaclor and warfarin concomitantly. It is recommended that in such patients, regular ...
Pregnancy and lactation
Pregnancy Animal studies have shown no evidence of impaired fertility or teratogenicity. However, since there are no adequate or well-controlled studies in pregnant women, caution should be exercised when ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Gastro-intestinal: The most frequent side-effect has been diarrhoea. It is rarely severe enough to warrant cessation of therapy. Colitis, including rare instances of pseudomembranous colitis, has been ...
Overdose
Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated. Treatment Unless 5 times the normal total daily dose has been ingested, gastro-intestinal decontamination will not ...
Pharmacodynamic properties
Pharmacotherapeutic group: Second-generation cephalosporins antibiotics ATC code: J01DC04 Mechanism of action <u>Cefaclor is active against the following organisms <em>in vitro</em>:</u> Alpha- and beta-haemolytic ...
Pharmacokinetic properties
Absorption Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Magnesium Stearate Dimeticone Starch Flowable Erythrosine Patent Blue V Black Iron Oxide Titanium Dioxide Gelatin
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 25°C. Keep the container tightly closed in order to protect from light.
Nature and contents of container
High density polyethylene bottles with screw caps containing 20, 50 or 100 capsules or UPVC/Aluminium foil blister packs containing 14 or 21 capsules or PVC/PCTFE/Aluminium foil blister packs containing ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Flynn Pharma Limited, Marine House Clanwilliam Place, Dublin 2, Ireland
Marketing authorization number(s)
PL 13621/0008
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 August 1978 Date of latest renewal: 30 September 2005
Date of revision of the text
12/02/2018
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