MEDOCIPRIN Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Medociprin 250 mg film-coated tablets. Medociprin 500 mg film-coated tablets.
2. Qualitative and quantitative composition
Each tablet contains the equivalent of either 250mg or 500mg ciprofloxacin as ciprofloxacin hydrochloride. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. <u>Medociprin 250 mg film-coated tablets:</u> White, round, convex film-coated tablet. <u>Medociprin 500 mg film-coated tablets:</u> White, capsule shaped film-coated tablet embossed ...
4.1. Therapeutic indications
Medociprin is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing ...
4.2. Posology and method of administration
Posology The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, ...
4.3. Contraindications
Hypersensitivity to the active substance, to other quinolone antibacterials or to any of the excipients listed in section 6.1. Concurrent administration of ciprofloxacin and tizanidine (See section 4.5). ...
4.4. Special warnings and precautions for use
The use of ciprofloxacin 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
Effects of other products on ciprofloxacin Drugs known to prolong QT interval Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong QT interval ...
4.6. Pregnancy and lactation
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or ...
4.7. Effects on ability to drive and use machines
Due to its neurological effects, ciprofloxacin may affect reaction time. Thus, the ability to drive or to operate machinery may be impaired.
4.8. Undesirable effects
The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea. ADRs derived from clinical studies and post-marketing surveillance with ciprofloxacin (oral, intravenous, and sequential ...
4.9. Overdose
An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure. Symptoms in overdose consist of dizziness, tremor, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Fluoroquinolones <b>ATC code:</b> J01MA02 Mechanism of action As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition ...
5.2. Pharmacokinetic properties
Absorption Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction. Like a number ...
6.1. List of excipients
<u>Medociprin 250mg tablets also contain:</u> maize starch, microcrystalline cellulose, crospovidone, silica colloidal anhydrous, magnesium stearate, polyethylene glycol 6000, talc. Opadry White Y-1-7000 ...
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C, in the original package.
6.5. Nature and contents of container
Blisters of polyvinylchloride (PVC) and aluminium, in a card carton with patient information leaflet; packs with 10, 14, 20 and 100 tablets are available. Plastic (PVC) securitainers with 100 and 500 loose ...
6.6. 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.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Medociprin tablets 250mg: 11476 Medociprin tablets 500mg: 11475
9. Date of first authorization / renewal of the authorization
Medociprin tablets 250mg: 05.11.1987 / 30.08.2010 Medociprin tablets 500mg: 05.11.1987 / 30.08.2010
10. Date of revision of the text
11/2020
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