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SPC, UK: Ciproxin Tablets 250mg (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Bayer plc
Διεύθυνση :
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
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Δωρεάν εγγραφή

Name of the medicinal product

Ciproxin 250 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride). For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Round, nearly white to slightly yellowish tablets marked with CIP score 250 on one side and a Bayer cross on the reverse side. The tablets can be divided into equal halves.

Therapeutic indications

Ciproxin 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 to ciprofloxacin ...

Posology and method of administration

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, in children ...

Contraindications

Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1). Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).

Special warnings and precautions for use

Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive ...

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 ...

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 ...

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 Ciproxin (oral, intravenous, and sequential therapy) ...

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

Tablet core: Cellulose microcrystalline Crospovidone Maize starch Magnesium stearate Silica colloidal anhydrous Film-coat: Hypromellose Macrogol 4000 Titanium dioxide (E171)

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

One of the following primary packaging materials is used: Transparent colourless or white opaque PVC/PVDC/Aluminum blister Transparent colourless or white opaque PP/Aluminum blister Aluminum/Aluminum blister ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Bayer Plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom

Marketing authorization number(s)

PL 00010/0146

Date of first authorization / renewal of the authorization

3 February 1987 / 9 October 2010

Date of revision of the text

9 October 2010