Ciprofloxacin Teva 500 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciprofloxacin

Available from:

Teva Pharma B.V.

ATC code:

J01MA; J01MA02

INN (International Name):

Ciprofloxacin

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Fluoroquinolones; ciprofloxacin

Authorization status:

Marketed

Authorization date:

2007-04-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPROFLOXACIN TEVA 250 MG FILM-COATED TABLETS
CIPROFLOXACIN TEVA 500 MG FILM-COATED TABLETS
ciprofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET:
1.
What Ciprofloxacin Teva is and what it is used for
2.
What you need to know before you take Ciprofloxacin Teva
3.
How to take Ciprofloxacin Teva
4.
Possible side effects
5.
How to store Ciprofloxacin Teva
6.
Contents of the pack and other information
1. WHAT CIPROFLOXACIN TEVA IS AND WHAT IT IS USED FOR
Ciprofloxacin Teva contains the active substance ciprofloxacin.
Ciprofloxacin Teva is an antibiotic
belonging to the fluoroquinolone family. Ciprofloxacin Teva works by
killing bacteria that cause
infections. It only works with specific strains of bacteria.
_Adults _
Ciprofloxacin Teva is used in adults to treat the following bacterial
infections:
• respiratory tract infections
• long lasting or recurring ear or sinus infections
• urinary tract infections
• genital tract infections in men and women
• gastro-intestinal tract infections and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• to prevent infections due to the bacterium
_Neisseria meningitidis _
• anthrax inhalation exposure
Ciprofloxacin Teva may be used in the management of patients with low
white blood cell counts
(neutropenia) who have a fever that is suspected to be due to a
bacterial infection.
If you have a severe infection or one that is caused by more than one
type of bact

Summary of Product characteristics

Health Products Regulatory Authority
07 July 2022
CRN00CMF1
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin Teva 500 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
500 mg: Each tablet contains 500 mg ciprofloxacin as ciprofloxacin
hydrochloride.
Excipient with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, capsule shaped film-coated tablets, debossed “CIP 500” and
breakline on one side and plain on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ciprofloxacin 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 before commencing therapy. Consideration
should be given to official guidance on the appropriate use of
antibacterial agents.
_Adults_
• Lower respiratory tract infections due to Gram-negative bacteria
- exacerbation of chronic obstructive pulmonary disease
In exacerbation of chronic obstructive pulmonary disease ciprofloxacin
should be used only when it is considered inappropriate
to use other antibacterial agents that are commonly recommended for
the treatment of these infections.
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
- pneumonia
• Chronic suppurative otitis media
• Acute exacerbation of chronic sinusitis especially if these are
caused by Gram-negative bacteria
•Urinary tract infection
Uncomplicated acute cystitis
In uncomplicated acute cystitis ciprofloxacin should be used only when
it is considered inappropriate to use other antibacterial
agents that are commonly recommended for the treatment of these
infections.

Acute pyelonephritis

Complicated urinary tract infections

Bacterial prostatitis
• Genital tract in