CIPROFLOXACIN Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Ciprofloxacin 250 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains Ciprofloxacin hydrochloride equivalent to Ciprofloxacin 250 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White, round film-coated tablets debossed with 250 on one side and plain on the other side.
Therapeutic indications
Ciprofloxacin 250 mg film-coated tablets are 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 ...
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, ...
Contraindications
Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in section 6.1. Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).
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 ...
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 the QT ...
Pregnancy and lactation
Pregnancy The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or foeto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or ...
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.
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 ...
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, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Fluoroquinolones ATC code: J01MA02 Mechanism of action As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both ...
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 ...
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 ...
List of excipients
Core tablet: Microcrystalline cellulose Maize starch Magnesium stearate Talc Colloidal anhydrous silica Sodium starch glycollate (Type A) Film-coating: Hypromellose Titanium dioxide (E171) Macrogol 400 ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
The tablets are available in blisters comprising of: PVdC coated PVC as blister forming material with aluminium foil backing or Cold form blister laminate (Structure from outer to inner side: oriented ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom
Marketing authorization number(s)
PL 14894/0022
Date of first authorization / renewal of the authorization
15 December 2000
Date of revision of the text
04/02/2019
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