Ciprofloxacin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciprofloxacin hydrochloride

Available from:

Strides Pharma UK Ltd

ATC code:

J01MA02

INN (International Name):

Ciprofloxacin hydrochloride

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011200; GTIN: 5031676004264

Patient Information leaflet

Front & Back Printing. To be supplied in the Unfolded size.
PC-TSG/2020/420 - Record Number: 277758
BLACK
1042138
1039860
1
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9.0
Pack Insert
180 x 480 mm
Strides Pharma UK Ltd.
CIPROFLOXACIN 250 MG, 500 MG AND 750 MG TABLETS
60 GSM paper
PRINTING CLARITY TO BE CLEAR AND SHARP.
PACKAGE LEAFLET:
INFORMATION FOR THE USER
CIPROFLOXACIN 250 MG,
500 MG AND 750 MG TABLETS
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 further questions, please ask your doctor or
your 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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Ciprofloxacin is and what is it used for
2. What you need to know before you take Ciprofloxacin
Tablets
3. How to take Ciprofloxacin Tablets
4. Possible side effects
5. How to store Ciprofloxacin Tablets
6. Contents of the pack and other information
The name of this medicine is Ciprofloxacin 250 mg, 500 mg
or 750 mg Film-coated Tablets.
1. WHAT CIPROFLOXACIN IS AND WHAT IS IT USED FOR?
Ciprofloxacin
belongs
to
a
group
of
antibiotics
called
fluoroquinolones. It works by killing some types of bacteria
that can cause infections.
Ciprofloxacin is used to treat bacterial infections including:
•
Lung infections such as pneumonia
•
Infections of the bladder and kidneys
•
Severe gastro-enteritis
•
Infections in the abdomen around the gut
•
Infections of the gall bladder and bile
•
Infections of the skin and spreading infections under the
skin
•
Infections in the womb and tubes leading to the ovaries
and in the area around these organs
•
Infections of the genital organs, including gonorrhoea
(a sexually transmitted disease) and inflammation of the
prost

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ciprofloxacin 500mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 582 mg ciprofloxacin hydrochloride equivalent to
500 mg
Ciprofloxacin (INN).
For Excipients see section 6.1
3
PHARMACEUTICAL FORM
Coated tablet
Off-white capsule shaped biconvex film coated tablet scored on both
sides
4.1 THERAPEUTIC INDICATIONS
_ADULTS: _
Ciprofloxacin is indicated for the treatment of the following
infections when
caused by ciprofloxacin-susceptible pathogens:
−
Respiratory tract infections. Ciprofloxacin may be indicated for
treating pneumonia due to gram-negative pathogens. In pneumococcal
pneumonia treated in an outpatient setting, Ciprofloxacin is not the
drug of first choice.
−
Uncomplicated acute cystitis: In uncomplicated acute cystitis
Ciprofloxacin tablets 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
−
Infections of the genital organs including acute uncomplicated
gonorrhoea, prostatitis
−
Severe gastro-enteritis
−
Skin and soft tissue infections
−
Gonoccocal urethritis and cervicitis due to susceptible _Neisseria _
_gonorrhoeae_
−
Infections of the bones and joints
−
Severe systemic infections: peritonitis.
−
Ciprofloxacin may be used in the management of neutropenic patients
with fever that is suspected to be due to a bacterial infection
−
Intra-abdominal infections: intra-abdominal abscess
−
Infections of the biliary tract: cholangitis, cholecystitis, empyema
of
the gall bladder
−
Pelvic infections: salpingitis, endometritis, pelvic inflammatory
disease
−
Ciprofloxacin is also indicated for prophylaxis against infections in
elective upper gastro-intestinal tract surgery and endoscopic
procedures where there is an increased risk of infection.
_CHILDREN AND ADOLESCENTS: _
Ciprofloxacin is indicated fo