CLARITHROMYCIN AN clarithromycin 250mg film-coated tablet blister pack

Main information

  • Trade name:
  • CLARITHROMYCIN AN clarithromycin 250mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLARITHROMYCIN AN clarithromycin 250mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184263
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184263

CLARITHROMYCIN AN clarithromycin 250mg film-coated 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

6/06/2012

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. CLARITHROMYCIN AN clarithromycin 250mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

20/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Clarithromycin (CLARITHROMYCIN AN) is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe

infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. Acute streptococcal pharyngitis; 2.

Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila and Streptococcus pneumoniae; 3.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes; 4. Disseminated or localised mycobacterial

infections due to Mycobacterium avium or Mycobacterium intracellulare and skin and skin structure infections due to Mycobacterium chelonae.

Clarithromycin should be used in combination with other antimycobacterial agents. 5. Prevention of disseminated Mycobacterium avium complex

infection in HIV-infected adults with CD4 lymphocyte counts of <75 cells/mm'3 (See Precautions). Disseminated infection due to Mycobacterium avium

complex should be excluded by a negative blood culture prior to commencement of prophylaxis. 6. Acute bacterial exacerbation of chronic bronchitis due

to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae; 7. Combination therapy for treatment of peptic ulcer disease associated

with Helicobacter pylori infection. Clarithromycin (CLARITHROMYCIN AN) is indicated for use in children for the treatment of mild to moderately severe

infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. Acute streptococcal pharyngitis and

tonsillitis caused by Streptococcus pyogenes; 2. Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma

pneumoniae and Legionella pneumophila; 3. Skin and skin structure infections (eg impetigo); 4. Disseminated or localised infections due to

Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV infection or AIDS; 5. Acute otitis media.

NOTE: 1. Penicillins are the drug of first choice in the treatment of acute otitis media. 2. Penicillin is the usual drug of choice in the treatment and

prevention of streptococcal infections including prophylaxis of rheumatic fever. Clarithromycin appears to be as effective as phenoxymethylpenicillin in

the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of

rheumatic fever are not available at present. 3. There is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young

children. 4. The data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

5 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

100 tablets

(S4) Prescription Only Medicine

2 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

14 tablets

(S4) Prescription Only Medicine

Components

1. CLARITHROMYCIN AN clarithromycin 250mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Bright yellow, capsule-shaped tablet with "CLA" engraved on one side, and

"250" engraved on the other.

Active Ingredients

Public Summary

Page 1 of

Produced at 29.11.2017 at 04:55:17 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

Clarithromycin

250 mg

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

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 04:55:17 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

Clarithromycin AN tablets – Consumer Medicine Information

Doc ID: 51.AN.M.1.0

Page 1

Clarithromycin AN tablets

Clarithromycin

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Clarithromycin AN tablets.

does

contain

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

CLARITHROMYCIN AN 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

CLARITHROMYCIN

AN is used for

CLARITHROMYCIN AN is used

to

treat

certain

bacterial

infections,

including

the

following:

respiratory tract infections

skin infections

peptic ulcer

CLARITHROMYCIN AN is also

used

prevent

specific

bacterial

infection

associated

with HIV infection.

Your doctor, however, may have

prescribed

CLARITHROMYCIN

another

purpose.

your

doctor

have

questions

about

CLARITHROMYCIN

been prescribed for you.

CLARITHROMYCIN

AN

is

an

antibiotic that belongs to the

group

of

medicines

called

macrolides.

These

medicines

work

by

killing or stopping the growth

of

bacteria

which

cause

infections.

CLARITHROMYCIN AN will not

work

against

infections

caused

by

viruses,

such

as

colds or flu.

CLARITHROMYCIN

AN

is

available only with a doctor’s

prescription.

CLARITHROMYCIN AN to treat

peptic ulcer

Peptic ulcers are associated with

an infection in the intestine and

stomach

bacteria

called

Helicobacter

pylori

(H.

pylori).

Nearly

patients

with

peptic

ulcers

infected

with

this

bacteria.

The H. pylori infection can be

treated

with

combination

CLARITHROMYCIN

(clarithromycin),

another

antibiotic

(amoxycillin)

another

medicine

called

omeprazole (used to control the

acidity of the stomach).

However, the best combination

tablets

treat

H.

pylori

infection is yet to be determined.

Your doctor will determine the

best combination for you.

If your symptoms return, consult

your doctor. It is possible that

CLARITHROMYCIN AN may no

longer be effective in killing the

H. pylori infection and a different

antibiotic may be needed.

Before You Take

CLARITHROMYCIN

AN

When you must not take

it

Do

not

take

CLARITHROMYCIN AN if:

1.

You

have

ever

had

an

allergic

reaction

to

medicines

containing

clarithromycin or to other

antibiotics

from

the

macrolide

family.

These

may include:

erythromycin

(EES,

Erythrocin,

Eryc,

Emycin, EMU-V)

roxithromycin

(Rulide,

Biaxsig)

azithromycin

(Zithromax)

2.

You are allergic to any of

the ingredients listed at the

end of this leaflet.

3.

If

you

have

an

allergic

reaction

to

CLARITHROMYCIN AN you

may

have

some

of

the

following symptoms:

rash

itching or hives

swelling

of

the

face,

lips,

tongue

or

other

parts of the body

shortness

of

breath,

wheezing or difficulty in

breathing

4.

You

have

severe

liver

problems

or

poor

kidney

function.

5.

You have an irregular heart

beat.

6.

The

packaging

is

torn

or

shows

any

signs

of

tampering.

7.

The

use

by

date

(Exp.)

printed

on

the

pack

has

passed.

expired

damaged

return

your

pharmacist for disposal.

Do

not

take

Clarithromycin AN tablets – Consumer Medicine Information

Doc ID: 51.AN.M.1.0

Page 2

CLARITHROMYCIN AN if you

are

taking

the

following

medicines:

astemizole or terfenadine

(commonly used to treat

allergy symptoms – these

medicines

may

be

available

without

prescription)

cisapride (used to relieve

certain

stomach

problems)

pimozide

(used

to

treat

schizophrenia)

ergotamine

or

dihydroergotamine

(used

to treat headaches)

lovastatin

or

simvastatin

(used

to

treat

high

cholesterol)

Before you start to take it

Tell your doctor if:

You are pregnant or plan to

become

pregnant.

Your

doctor

will discuss the risks

benefits

taking

CLARITHROMYCIN

when pregnant.

2.

You

are

breastfeeding

or

wish

to

breastfeed.

Your

doctor will discuss the risks

benefits

taking

CLARITHROMYCIN

when breastfeeding.

You

have,

or

have

ever

had,

any

other

health

problems

or

medical

conditions,

including

liver

problems

poor

kidney

function.

4.

You

are

allergic

to

any

other

medicines,

foods,

dyes or preservatives.

5.

You

have

myasthenia

gravis, a condition in which

the muscles become weak

and tire easily.

If

you

have

not

told

your

doctor about any of the above,

tell

them

before

you

start

taking

or

are

given

CLARITHROMYCIN AN.

Taking other medicines

Tell your doctor or pharmacist

if

you

are

taking

any

other

medicines,

including

medicines

that

you

buy

without

a

prescription

from

your

pharmacy,

supermarket

or health food shop.

Some

medicines

may

affect

the

way

CLARITHROMYCIN

AN works. These include the

following medicines:

digoxin,

quinidine,

disopyramide (used to treat

heart failure)

warfarin

(used

to

prevent

blood clotting)

phenytoin,

carbamazepine,

hexobarbital,

sodium

valproate

(used

to

treat

epilepsy)

theophylline (used to treat

asthma)

triazolam,

midazolam,

alprazolam

(used

to

treat

sleeplessness and anxiety)

cilostazol

(used

to

treat

poor circulation)

rosuvastatin,

atorvastatin

(used

to

treat

high

cholesterol)

methylprednisolone

(a

corticosteroid)

vinblastine

(used

to

treat

cancer)

sildenafil,

tadalafil,

vardenafil

(used

to

treat

erectile

dysfunction

in

adult males)

cyclosporin,

tacrolimus

(medicines

affecting

the

immune system)

medicines used to treat HIV

infection

rifabutin,

rifampicin

(used

to treat some infections)

repaglinide,

nateglinide,

pioglitazone,

and

rosiglitazone (used to treat

diabetes)

insulin

(used

to

treat

diabetes)

colchicine

(used

to

treat

gout)

verapamil

(used

to

treat

high blood pressure)

fluoxetine

(used

to

treat

depression)

omeprazole (used to treat

stomach problems)

tolterodine

(used

to

treat

bladder problems)

herbal medicines such as

St John’s Wort

These

medicines

affected by CLARITHROMYCIN

affect

well

CLARITHROMYCIN

works.

Your doctor or pharmacist can

tell you what to do if you are

taking any of these medicines.

They also have a more complete

list of medicines to be careful

with

avoid

while

taking

CLARITHROMYCIN AN.

How to take

CLARITHROMYCIN

AN

Your doctor will tell you how

much to take and when to take

it. Take CLARITHROMYCIN AN

exactly

as

directed

by

your

doctor.

This

differ

from

information

contained

this

leaflet.

How much to take

The

dose

of

CLARITHROMYCIN

AN

will

depend on the infection to be

treated.

respiratory

tract

infections

skin

infections,

usual

adult

dose

CLARITHROMYCIN AN 250 mg

tablet twice a day.

For more severe infections, the

dose can be increased to two

CLARITHROMYCIN AN 250 mg

tablet twice a day.

Your

doctor

will

adjust

amount

frequency

your

doses according to the infection

being treated and the severity of

your condition.

If you do not understand the

instructions on the pack, ask

your doctor or pharmacist for

help.

How to take it

CLARITHROMYCIN AN tablets

should

be

swallowed

whole

Clarithromycin AN tablets – Consumer Medicine Information

Doc ID: 51.AN.M.1.0

Page 3

with a glass of water.

How long to take it

Keep

taking

CLARITHROMYCIN

AN

until

you finish the pack or for as

long as your doctor tells you.

If you are being treated for an

infection,

CLARITHROMYCIN

AN is usually taken for one or

two weeks.

Do

not

stop

taking

CLARITHROMYCIN AN, even if

you

feel

better

after

a

few

days, unless advised by your

doctor. Your infection may not

clear

completely

stop

taking your medicine too soon.

Check with your doctor if you are

not sure how long you should be

taking CLARITHROMYCIN AN

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 go back

to taking your tablets as you

would normally.

Do not take a double dose to

make

up

for

the

dose

you

missed.

If

you

miss

more

than

one

dose, or are not sure what to

do, check with your doctor or

pharmacist.

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

CLARITHROMYCIN

AN. Do this even if there are

no

signs

of

discomfort

or

poisoning.

You

may

need

urgent medical attention. Keep

telephone numbers for these

places/services handy.

take

much

CLARITHROMYCIN

develop

severe

gastrointestinal symptoms, liver

problems, or allergic reactions.

While you are taking

CLARITHROMYCIN

AN

Things you must do

If

you

are

taking

CLARITHROMYCIN AN for an

infection and your symptoms

do not improve within a few

days, or if they become worse,

tell your doctor.

If you become pregnant while

taking CLARITHROMYCIN AN,

tell your doctor.

If

you

get

severe

diarrhoea,

tell your doctor or pharmacist

immediately. Do this even if it

occurs

several

weeks

after

stopping

CLARITHROMYCIN

AN. Diarrhoea may mean that

have

serious

condition

affecting your bowel. You may

need

urgent

medical

care.

not take any medicine to stop

your

diarrhoea

without

first

checking with your doctor.

If you have to have any urine

tests, tell your doctor you are

taking CLARITHROMYCIN AN

as it may affect the results of

some laboratory tests.

If you are about to start taking

a

new

medicine,

tell

your

doctor or pharmacist that you

are taking CLARITHROMYCIN

AN.

Tell all the doctors, dentists

and

pharmacists

who

are

treating

you

that

you

are

taking CLARITHROMYCIN AN.

Things you must not do

Do not use CLARITHROMYCIN

AN

to

treat

any

other

complaints unless your doctor

says so.

Do

not

give

CLARITHROMYCIN

AN

to

anyone

else,

even

if

their

symptoms

seem

similar

to

yours.

Things to be careful of

Be careful driving or operating

machinery until you know how

CLARITHROMYCIN AN affects

you.

Side Effects

Tell your doctor or pharmacist

as soon as possible if you do

not

feel

well

while

you

are

taking CLARITHROMYCIN AN.

CLARITHROMYCIN

treats

infections in most people, but it

may have unwanted side effects

in some people.

medicines

have

side

effects.

Sometimes

they

serious, most of the time they

are not. You may need medical

treatment if you get some of the

side effects.

Do not be alarmed by this list

of possible side effects. You

may

not

experience

any

of

them.

Ask your doctor or pharmacist

to answer any questions you

may have.

While you are taking

Clarithromycin AN

Tell

your

doctor

if

you

experience

any

of

the

following and they worry you:

stomach cramps and pains

nausea,

vomiting

severe diarrhoea

oral thrush or vaginal thrush

change in taste sensation

headache

Tell your doctor immediately if

you

notice

any

of

the

following,

as

you

may

need

urgent medical care:

Clarithromycin AN tablets – Consumer Medicine Information

Doc ID: 51.AN.M.1.0

Page 4

yellowing of the eyes or skin

(jaundice)

feeling generally unwell and

having poor appetite

hearing disturbances

chest pain

dizziness,

confusion,

hallucinations, convulsions

any type of skin rash, itching,

hives

severe

diarrhoea,

especially

if bloody

severe upper stomach pain,

with

nausea

vomiting

(pancreatitis)

Stop

taking

CLARITHROMYCIN AN and tell

your doctor immediately or go

to

casualty

at

your

nearest

hospital if any of the following

happen:

swelling

face,

lips,

mouth, throat or neck which

cause

difficulty

swallowing

breathing

sudden collapse

After you have finished

taking Clarithromycin AN

Tell your doctor immediately if

you

notice

any

of

the

following side effects, even if

they occur several weeks after

stopping

treatment

with

CLARITHROMYCIN AN:

severe stomach or abdominal

cramps

watery and severe diarrhoea,

which may also be bloody

fever,

combination

with

one or both of the above.

These are rare but serious side

effects. You may have a serious

condition

affecting

your

bowel

need

urgent

medical care.

Do

not

take

any

diarrhoea

medicine

without

first

checking with your doctor.

Other

side

effects

listed

above may also occur in some

patients.

your

doctor

pharmacist for more information

about side effects, as they have

more

complete

list

side

effects.

Inform

your

doctor

promptly

about

these

other symptoms. If the condition

persists

worsens,

seek

medical

attention.

alarmed by this list of possible

side effects. They do not occur

often

unlikely

experience any of them.

Tell

your

doctor

notice

anything that is making you feel

unwell while you are taking, or

soon

after

have

finished

taking

CLARITHROMYCIN

even if it is not on this list.

After taking

CLARITHROMYCIN

AN

Storage

Keep

your

medicine

where

children cannot reach them. A

locked

cupboard

least

metres above the ground is a

good place to store medicines.

Keep

pack

away

from

sources of heat.

Keep

CLARITHROMYCIN

AN

tablets

in

a

cool

dry

place,

protected

from

light,

where

the

temperature

stays

below

30°C.

Do

not

keep

CLARITHROMYCIN AN or any

other

medicine

in

the

bathroom or near a sink. Do

not

leave

CLARITHROMYCIN

AN in the car or on window

sills. Heat and dampness can

destroy some medicines.

Disposal

If your doctor tells you to stop

taking

CLARITHROMYCIN

or your medicine has passed its

expiry date, ask your pharmacist

what to do with any medicine

that is left over.

Product description

What it looks like

CLARITHROMYCIN AN 250 mg

tablets

(AUST

184263)

bright

yellow,

capsule

shaped

tablets with ‘CLA’ engraved on

one side and ‘250’ engraved on

the other side.

Ingredients

Active Ingredient:

active

ingredient

CLARITHROMYCIN

tablets

clarithromycin.

Each

tablet

contains

clarithromycin.

Other Ingredients:

croscarmellose sodium,

pregelatinised maize starch,

microcrystalline cellulose,

povidone,

stearic acid,

magnesium stearate,

colloidal anhydrous silica,

quinoline yellow,

Opadry

White

Y-1-7000

hypromellose,

quinoline yellow,

aluminium lake,

vanillin flavour.

CLARITHROMYCIN

tablets

do not contain lactose or gluten.

Name

and

Address

of

the

Sponsor

Amneal Pharma Australia Pty

12 River Street

South Yarra 3141

Australia

Date of Preparation

January 2014

Doc ID: 51.AN.M.1.0