VIPROLOX Film-coated tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Viprolox 250 mg Film-coated tablets. Viprolox 500 mg Film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains ciprofloxacin 250 mg (as hydrochloride). Each film-coated tablet contains ciprofloxacin 500 mg (as hydrochloride). For the full list of excipients, see section 6.1

3. Pharmaceutical form

Film-coated tablets. Viprolox 250 mg tablets are white, oblong, 14.3 6.3 mm film-coated tablets, scored on both sides. Viprolox 500 mg tablets are white, oblong, 17.3 8.3 mm film-coated tablets, scored ...

4.1. Therapeutic indications

Viprolox 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 ...

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 quinolones or to any of the excipients listed in section 6.1. Concomitant 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

Pharmacotherapeutic group: Fluoroquinolones ATC code: 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

Tablet core: Hydroxypropyl cellulose Sodium starch glycolate Magnesium stearate Film-coat: Hydroxypropylmethyl cellulose Polythene glycol 400 Titanium dioxide

6.2. Incompatibilities

None.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25ºC. Protect from light and humidity.

6.5. Nature and contents of container

Blisters of Aluminum/PVC. Viprolox 250 mg: 10 tablets. Viprolox 500 mg: 10, 50 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

None.

7. Marketing authorization holder

Delorbis Pharmaceuticals Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

8. Marketing authorization number(s)

Viprolox 250 – 017552 Viprolox 500 – 017553

9. Date of first authorization / renewal of the authorization

Viprolox 250 – 11-02-1998/10-02-2008 Viprolox 500 – 11-02-1998/10-02-2008

10. Date of revision of the text

25/11/2020

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