CIPROFLOXACIN AN 500mg ciprofloxacin (as hydrochloride) 500 mg tablet blister pack

Main information

  • Trade name:
  • CIPROFLOXACIN AN 500mg ciprofloxacin (as hydrochloride) 500 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIPROFLOXACIN AN 500mg ciprofloxacin (as hydrochloride) 500 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 175436
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

175436

CIPROFLOXACIN AN 500mg ciprofloxacin (as hydrochloride) 500 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

16/12/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CIPROFLOXACIN AN 500mg ciprofloxacin (as hydrochloride) 500 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

1/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed below: Urinary tract infections;

Gonorrhoeal urethritis and cervicitis; Gastroenteritis; Bronchial Infections; Skin and skin structure infections; Bone and joint infections; Chronic bacterial

prostatitis of mild to moderate severity. Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to

aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical

benefit and provide the basis for this indication. Note: Typhoid and Paratyphoid infections and infections due to multi-resistant Staphylococcus aureus

are excluded from the above due to insufficient data. Because Gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the

drug of choice in cases with Gram-positive infections, such as pneumonia due to Streptococcus pneumoniae. Chronic bacterial prostatitis should be

demonstrated by microbiological evidence localising infection to the prostate. Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been

reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to

ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with Ciprofloxacin may be initiated before results of these tests are

known; once results become available, appropriate therapy should be continued. Ciprofloxacin is suitable to treat mixed infections caused by susceptible

strains of both Gram-negative and Gram-positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional

therapy should be considered.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CIPROFLOXACIN AN 500mg ciprofloxacin (as hydrochloride) 500 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, capsule shaped, film coated tablets, with a score line on

one side and debossed with 'F 22' on the other side

Active Ingredients

ciprofloxacin hydrochloride

589.172 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

Public Summary

Page 1 of

Produced at 29.11.2017 at 02:04:18 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 29.11.2017 at 02:04:18 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Ciprofloxacin AN tablets – Consumer Medicine Information

Ciprofloxacin AN CMI v2.0

Page 1

Ciprofloxacin AN tablets

Ciprofloxacin(as hydrochloride)

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

CIPROFLOXACIN AN tablets. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you taking

CIPROFLOXACIN

tablets

against the benefits they expect

it will have for you.

If

you

have

any

concerns

about

taking

this

medicine,

ask

your

doctor

or

pharmacist.

Keep

this

leaflet

with

the

medicine.

You may need to read it again.

What

CIPROFLOXACIN AN

is used for

CIPROFLOXACIN

tablets

used

treatment

infections

lungs,

skin,

bones, joints, kidneys, bladder,

prostate

bowel.

CIPROFLOXACIN

also

used to treat inhalational anthrax

infection

caused

breathing

spores

bacteria).

CIPROFLOXACIN

tablets

contain

active

ingredient,

ciprofloxacin,

which

antibiotic belonging to a group of

medicines

called

quinolones

(pronounced

kwin-o-lones).

These antibiotics work by killing

bacteria

that

causing

your infection.

CIPROFLOXACIN

will

work against infections caused

by viruses such as colds or the

flu.

Ask your doctor if you have

any questions about why this

medicine has been prescribed

for you.

Your

doctor

have

prescribed it for another reason.

Before You Take

CIPROFLOXACIN AN

When you must not take

it

Do not take CIPROFLOXACIN

AN if you have an allergy to:

ciprofloxacin,

active

ingredient

CIPROFLOXACIN AN

any of the ingredients listed

at the end of this leaflet

other

medicines

belonging

quinolone

chemical

family

(e.g.

moxifloxacin,

norfloxacin, nalidixic acid).

Some

symptoms

allergic reaction may include:

shortness of breath

wheezing

difficulty

breathing

swelling

face,

lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

Do not take CIPROFLOXACIN

AN if

you are also taking a

medicine

called

tizanidine,

a

muscle relaxant used to treat

spasticity

associated

with

multiple

sclerosis,

injury

or

diseases of the spinal cord.

CIPROFLOXACIN

interfere with tizanidine and can

lead to undesirable side effects.

Do not take this medicine after

the expiry date printed on the

pack and blister.

If it has expired return it to your

pharmacist for disposal.

Do not take this medicine if

the

packaging

is

torn

or

shows signs of tampering.

packaging

damaged,

return it to your pharmacist for

disposal.

If

you

are

not

sure

whether

you

should

start

taking

this

medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies

to

any

other

medicines,

foods,

preservatives or dyes.

Tell

your

doctor

if

you

are

pregnant

or

plan

to

become

pregnant.

CIPROFLOXACIN

recommended

pregnant

your

doctor

will

assess

benefit

required.

Medicines

similar

CIPROFLOXACIN

have

caused joint disease in immature

animals.

Tell

your

doctor

if

you

are

breastfeeding.

CIPROFLOXACIN

excreted

into

breast

milk.

Your doctor will tell you whether

should

take

temporarily

stop

breastfeeding

while you are taking the tablets.

CIPROFLOXACIN

AN

is

not

recommended

in

children

under 18 years of age except

for use in inhalational anthrax.

CIPROFLOXACIN

AN

should

be used with caution in elderly

patients

as

they

are

more

prone to side effects.

Tell your doctor if you:

suffer

from

epilepsy

Ciprofloxacin AN tablets – Consumer Medicine Information

Ciprofloxacin AN CMI v2.0

Page 2

(seizures,

convulsions),

have had a stroke, or have

kidney or liver disease

have

arrhythmias

(fast

irregular

heartbeats).

CIPROFLOXACIN AN may

increase

risk

arrhythmias,

especially

the elderly or patients with

low potassium levels

have

previously

taken

corticosteroids. You may be

at increased risk of swelling

of the tendons. Symptoms

include

restricted

movement

have myasthenia gravis, a

condition

where

muscles

become

weak.

CIPROFLOXACIN

worsen

symptoms

this condition

have

history

tendon

disorders

with

quinolones

(e.g.

moxifloxacin,

norfloxacin,

nalidixic acid) .

If

you

have

not

told

your

doctor

or

pharmacist

about

any

of

the

above,

tell

them

before

you

start

taking

CIPROFLOXACIN AN.

Taking other medicines

Tell

your

doctor

if

you

are

taking

any

other

medicines,

including those that you buy

without

a

prescription

from

your

pharmacy,

supermarket

or health food shop.

Some

medicines

may

be

affected

by

CIPROFLOXACIN

AN. These medicines include:

medicines

used

treat

arrhythmias

(fast

irregular heartbeats)

theophylline,

medicine

used to treat asthma

oral

anticoagulants,

warfarin and its metabolites,

medicines

used

stop

blood clots

glibenclamide,

medicine

used to treat diabetes

didanosine,

medicine

used to treat viral infections

cyclosporin,

medicine

used

suppress

immune system

non-steroidal

anti-

inflammatory

drugs

(NSAIDs),

medicines

used

to treat pain, arthritis and

other

inflammatory

conditions

methotrexate,

medicine

used to treat certain types

of cancers, severe psoriasis

severe

rheumatoid

arthritis

duloxetine, a medicine used

treat

depression

stress urinary incontinence

clozapine, a medicine used

to treat schizophrenia

ropinirole, a medicine used

to treat Parkinson’s disease

or restless legs syndrome

local

anaesthetic

lidocaine, a medicine used

to numb pain or cause loss

of sensation

sildenafil, a medicine used

to treat erectile dysfunction

These

medicines

affected

CIPROFLOXACIN

AN, or may affect how well it

works. You may need different

amounts

your

medicine,

you may need to take different

medicines.

Some

medicines

interfere

with

absorption

CIPROFLOXACIN

These

include:

multivitamins,

mineral

supplements,

antacids

(used for

indigestion)

other

medicines

containing

iron,

zinc,

magnesium,

aluminium or calcium

sucralfate, a medicine used

treat

duodenal

stomach ulcers

medicines used to treat HIV

infection

probenecid,

medicine

used to treat gout

omeprazole,

medicine

used

treat

stomach

ulcers and other conditions

where

stomach

produces

too much acid

sevelamer, a medicine used

to treat high blood levels of

phosphorus in patients with

kidney disease who are on

dialysis

metoclopramide,

medicine

used

relieve

nausea

vomiting,

heartburn,

stomach

pain

still

take

these

medicines while you are taking

CIPROFLOXACIN AN. However,

must

take

CIPROFLOXACIN AN at least 2

hours

before

hours

after

taking any of these medicines.

Your

doctor

pharmacist

have

more

information

medicines to be careful with or

avoid while taking this medicine.

How to take

CIPROFLOXACIN AN

Follow all directions given to

you

by

your

doctor

or

pharmacist carefully.

They

differ

from

information

contained

this

leaflet.

If you do not understand the

instructions

printed

on

the

pharmacist

label,

ask

your

doctor or pharmacist for help.

How much to take

Your

doctor

pharmacist

will

tell you how much and how often

should

take

CIPROFLOXACIN AN. This will

depend on the type of infection

and any medical conditions you

may have.

The usual adult dosage for most

infections

tablet

twice

daily for 7 to 14 days. You may

need to take your tablets for a

longer period for some types of

infection.

dose

will

determined by your doctor as it

depends

upon

type

infection you have.

When to take it

CIPROFLOXACIN

tablets

are usually taken twice a day.

Take your tablets at the same

time each day preferably on an

Ciprofloxacin AN tablets – Consumer Medicine Information

Ciprofloxacin AN CMI v2.0

Page 3

empty stomach. However, they

taken

with

without

food.

How long to take it

length

treatment

vary

from

days

longer depending on the type of

infection.

Continue

taking

CIPROFLOXACIN AN until you

have finished the blister pack

or for as long as your doctor

tells

you.

stop

taking

your

tablets

because

feeling

better.

complete

full

course

prescribed by

your doctor, the

infection

clear

completely

your

symptoms

may return.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed

and take your next dose when

you are meant to.

Otherwise, take the missed dose

as soon as you remember, and

then

back

taking

your

tablets as you would normally.

Do not take a double dose to

make

dose

missed.

If you are not sure what to do,

ask your doctor or pharmacist. If

have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

If you take too much

(overdose)

Immediately

telephone

your

doctor,

or

the

Poisons

Information Centre (telephone

13 11 26), or go to Accident

and Emergency at the nearest

hospital, if you think you or

anyone else may have taken

too

much

CIPROFLOXACIN

AN. Do this even if there are

no

signs

of

discomfort

or

poisoning.

You may need urgent medical

attention.

While you are taking

CIPROFLOXACIN AN

Things you must do

Tell all the doctors, dentists

and

pharmacists

who

are

treating

you

that

you

are

taking Ciprofloxacin AN.

Tell your doctor if you need to

have

a

surgical

or

dental

procedure that you are taking

CIPROFLOXACIN AN.

CIPROFLOXACIN

AN

may

affect

the

results

of

certain

laboratory

tests.

about to have any tests, tell your

doctor that you are taking this

medicine.

If you are about to be started

on any new medicine, remind

your

doctor

and

pharmacist

that

you

are

taking

CIPROFLOXACIN AN.

Drink plenty of water while you

taking

CIPROFLOXACIN

AN. This helps to stop crystals

forming in the urine.

If you become pregnant while

you

are

taking

CIPROFLOXACIN AN, tell your

doctor immediately.

If you develop diarrhoea, tell

your

doctor

or

pharmacist

immediately - even if it occurs

several

weeks

after

have

stopped

taking

CIPROFLOXACIN

Diarrhoea

mean

that

have

serious

condition

affecting your bowel. You may

need

urgent

medical

care.

take

medications

diarrhoea without checking with

your doctor or pharmacist.

Tell your doctor immediately if

you experience symptoms of

depression

or

self-

endangering

behaviour.

CIPROFLOXACIN AN should be

discontinued immediately.

Things you must not do

Do

not

give

your

CIPROFLOXACIN

AN

tablets

to anyone else, even if they

have

the

same

condition

as

you.

CIPROFLOXACIN

treat

other

conditions

unless your doctor tells you to.

Do

not

stop

taking

your

tablets

because

you

are

feeling

better,

unless

your

doctor told you to do so. If you

do not complete the full course

prescribed by your doctor, some

bacteria

causing

your

infection

killed.

These bacteria may continue to

grow and multiply so that your

infection

clear

completely or it may return.

Things to be careful of

Avoid excessive exposure to

direct sunlight. Your skin may

become more prone to sunburn.

If such a reaction occurs, stop

taking

CIPROFLOXACIN

immediately and tell your doctor.

Be careful driving or operating

machinery until you know how

CIPROFLOXACIN

AN

affects

you.

CIPROFLOXACIN

tablets may cause dizziness in

some

patients,

especially

after

the first few doses. Your ability

drive

and/or

operate

machinery may be impaired.

If you drink alcohol while taking

this medicine, dizziness may be

worse.

CIPROFLOXACIN

tablets

increase

stimulatory

effects of caffeine.

Side Effects

Tell your doctor or pharmacist

as soon as possible if you do

not

feel

well

while

you

are

taking CIPROFLOXACIN AN.

All medicines have side effects.

Sometimes

they

serious,

most of the time they are not. In

Ciprofloxacin AN tablets – Consumer Medicine Information

Ciprofloxacin AN CMI v2.0

Page 4

serious

cases,

need

medical attention.

Do

not

be

alarmed

by

the

following lists of side effects.

You may not experience any

of them.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following and they

worry you:

nausea

diarrhoea

These

common

side

effects of CIPROFLOXACIN AN.

They are usually mild and short-

lived.

Tell your doctor immediately,

or

go

to

the

Accident

and

Emergency

department

at

your

nearest

hospital

if

you

notice any of the following:

severe

skin

rashes,

peeling

skin

and/or

mucosal

reactions

signs of allergy such as rash,

swelling

face,

lips,

mouth, throat or other parts

body,

shortness

breath,

wheezing

trouble

breathing

fainting

yellowing

skin

eyes, also called jaundice

severe

watery

bloody

diarrhoea, even if it several

weeks

after

taking

your

tablets

fits (seizures, convulsions)

confusion,

nightmares,

hallucinations, and psychotic

reaction (even progressing to

self-endangering behaviour)

fast or irregular heart beats

visual disturbances

ringing

ear,

loss

hearing

abdominal pain/cramps. Very

rarely this can progress to a

serious

condition

accompanied

fever

fatigue.

These serious side effects are

rare. If you have them, you may

need urgent medical attention.

Photosensitivity

(getting

sunburnt

very

easily)

occasionally

occur

with

CIPROFLOXACIN AN. However,

it is temporary and staying out of

direct

sunlight

while

CIPROFLOXACIN

tablets

will prevent it from happening.

Rarely,

there

worsening of the symptoms of

myasthenia

gravis.

This

condition in which the muscles

become

weak

tire

easily,

causing drooping eyelids, double

vision, difficulty in speaking and

swallowing,

sometimes

muscle weakness in the arms or

legs.

Rarely,

Achilles

tendon

(extending from the calf to the

heel of the foot) or other tendons

have

been

torn

after

CIPROFLOXACIN

therapy.

Tell your doctor immediately if

you feel any discomfort, pain or

inflammation of a tendon.

Rarely,

experience

hyperglycaemia

(high

blood

sugar).

Symptoms

include

increased

thirst,

appetite

urination. Tell your doctor if you

experience these symptoms.

If you experience any of these

symptoms

during

treatment

with

CIPROFLOXACIN

AN

tablets,

tell

your

doctor

or

pharmacist

immediately.

CIPROFLOXACIN

AN

may

need to be discontinued.

Tell your doctor or pharmacist

if

you

notice

anything

else

that is making you feel unwell.

Other

side

effects

listed

above may also occur in some

patients.

After taking

CIPROFLOXACIN AN

Storage

Keep your tablets in the blister

pack until it is time to take

them.

If you take the tablets out of the

box or the blister pack they may

not keep well.

Keep your tablets in a cool dry

place where the temperature

stays below 25°C.

Do not store CIPROFLOXACIN

AN or any other medicine in

the bathroom, near a sink, or

on a window sill.

Do not leave it in the car.

Heat

damp

destroy

some medicines.

Keep

your

tablets

where

children cannot reach them. A

locked cupboard at least one

and a half metres above the

ground

is

a

good

place

to

store medicines.

Disposal

If your doctor tells you to stop

taking

CIPROFLOXACIN

tablets

tablets

have

passed

their

expiry

date,

your pharmacist what to do with

any that are left over.

Return any unused medicine

to your pharmacist.

Product description

What it looks like

CIPROFLOXACIN

presented in pack size of 14, 28

& 60 tablets in blister.

CIPROFLOXACIN

(AUST R 175441) White to off-

white, round shaped, film coated

tablets, with a score line on one

side and debossed with ‘F’ and

‘23’ with a score line in between

on the other side.

CIPROFLOXACIN AN 500 mg

(AUST R 175436) White to off-

white,

capsule

shaped,

film

coated tablets, with a score line

on one side and debossed with

‘F 22’ on the other side.

CIPROFLOXACIN AN 750 mg

(AUST R 175438) White to off-

white,

capsule

shaped,

film

coated tablets debossed with ‘C’

on one side and ‘93’ on the other

side.

Ciprofloxacin AN tablets – Consumer Medicine Information

Ciprofloxacin AN CMI v2.0

Page 5

Ingredients

Active Ingredient:

Ciprofloxacin (as hydrochloride)

Each tablet contains either 250,

500 & 750 mg of ciprofloxacin as

hydrochloride.

Other Ingredients:

microcrystalline cellulose

sodium starch glycollate type A

povidone

colloidal anhydrous silica

magnesium stearate

hypromellose

macrogol 400

titanium dioxide

Name

and

Address

of

the

Sponsor

Amneal

Pharma

Australia

Ltd,

12 River St

South Yarra

VIC – 3141

Australia

Date of Preparation

July 2014