MEDOCLOR Hard capsule, Granules for oral suspension (2020)
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Περιεχόμενα
1. Name of the medicinal product
Medoclor 250 mg capsules Medoclor 500 mg capsules. Medoclor 125 mg/5 ml, granules for oral suspension. Medoclor Forte 250 mg/5 ml, granules for oral suspension.
2. Qualitative and quantitative composition
Each capsule contains either 250mg or 500mg of cefaclor. Following reconstitution, each 5ml of suspension contains either 125mg or 250mg of cefaclor. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Hard gelatin capsule. Granules for oral suspension. Medoclor 250 mg are lilac-ivory hard gelatine capsules size 2 or lilac-ivory hard gelatine capsules size 2 printed MEDOCLOR 250. Medoclor 500 mg are ...
4.1. Therapeutic indications
Medoclor is indicated in children and adults for the treatment of mild infections caused by microorganisms sensitive to cefaclor (see sections 4.4 and 5.1): Acute otitis media Acute bacterial sinusitis ...
4.2. Posology and method of administration
Posology Medoclor should be administered for at least 10 days in the treatment of infections caused by β-hemolytic streptococci. Adults The usual dosage is 250mg administered every eight hours, but in ...
4.3. Contraindications
Hypersensitivity to the active substance, other cephalosporins or to any of the excipients listed in section 6.1. Neonates (children less than 1 month) (see section 2-Paediatric population).
4.4. Special warnings and precautions for use
Medoclor is not suitable for the empiric treatment of respiratory infections because of the limited sensitivity of key-causing microorganisms. Before starting the treatment with cefaclor, the patient should ...
4.5. Interaction with other medicinal products and other forms of interaction
Treatment with cefaclor can prevent a false positive response to glucose in the urine with the use of copper reagents (e.g., Benedict or Fehling) and Clinitest tablets, but not with enzyme-based testing ...
4.6. Pregnancy and lactation
Pregnancy Extensive experience with the use of cefaclor in human pregnancy does not indicate an increased incidence of birth defects. There is no evidence of harm in animal experiments. If cefaclor is ...
4.7. Effects on ability to drive and use machines
There are no data on the effect of cefaclor on the drive and the ability to operate machines.
4.8. Undesirable effects
The following side effects may occur with the use of cefaclor. Adverse reactions are ranked according to MedDRA system/organ classification. The frequency of each updating is displayed, using the following ...
4.9. Overdose
Symptoms Symptoms of overdose include nausea, vomiting, epigastric pain and diarrhea. The severity of the last two is dose-dependent. Other symptoms like an allergic reaction or any other intoxication ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Second-generation cephalosporins, Other Beta-Lactam Antibacterials <b>ATC code:</b> J01DC04 Cefaclor is a semi-synthetic bactericidal and broad-spectrum beta-lactam antibiotic ...
5.2. Pharmacokinetic properties
Absorption Cefaclor is rapidly absorbed either on an empty stomach or with meals. Following doses of 250 mg, 500 mg or 1000 mg, mean peak of about 7, 13 and 23 micrograms per ml occur in the blood after ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans. These data are from conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental ...
6.1. List of excipients
The suspensions also contain xanthan gum, methocel a-15lv (methylcellulose), erythrosine lake (E127), sugar, dimethicone, sodium lauryl sulphate, pregelatinised starch, strawberry flavour and highly purified ...
6.2. Incompatibilities
None known.
6.3. Shelf life
<u>Capsules:</u> 36 months. <u>Granules for oral suspension:</u> 24 months. Following reconstitution 14 days at 2°C-8°C or 7 days below 25°C.
6.4. Special precautions for storage
<u>Capsules:</u> Store below 30°C <u>Granules for suspension:</u> Store in the original package before reconstitution. For storage conditions after reconstitution of the medicinal product, see section ...
6.5. Nature and contents of container
Capsules are in combination blisters of aluminium foil and polyvinylchloride film. Cartons of 16, 500 or 1000 capsules, with a patient information leaflet, are available. Medoclor 500mg capsules are also ...
6.6. Special precautions for disposal and other handling
<u>Capsules:</u> No special requirements for disposal. <u>Granules for suspension:</u> To reconstitute add potable water to the line on the label. Replace cap and shake vigorously. Allow any foam to settle ...
7. Marketing authorization holder
Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus.
8. Marketing authorization number(s)
Medoclor 250mg capsules: M.L.No. 19932 Medoclor 500mg capsules: M.L.No. 16461 Medoclor 125mg/5ml granules for oral suspension: M.L.No. 14606 Medoclor Forte 250mg/5ml granules for oral suspension: M.L.No. ...
9. Date of first authorization / renewal of the authorization
Medoclor 250mg capsules: 20.12.2005 / 18.10.2012 Medoclor 500mg capsules: 29.12.1995 / 06.11.2012 Medoclor 125mg/5ml Suspension: 31.01.1994 / 24.09.2010 Medoclor Forte 250mg/5ml Suspension: 31.01.1994 ...
10. Date of revision of the text
26/11/2020
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