FAMOTIDINE AN famotidine 20mg film-coated tablet blister pack

Main information

  • Trade name:
  • FAMOTIDINE AN famotidine 20mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FAMOTIDINE AN famotidine 20mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186280
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186280

FAMOTIDINE AN famotidine 20mg 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

25/06/2012

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. FAMOTIDINE AN famotidine 20mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

24/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Symptomatic relief of heartburn, dyspepsia and indigestion due to gastro-oesophageal reflux in adults over 18 years of age. Famotidine is indicated for

the treatment of duodenal ulcer; benign gastric ulcer; Zollinger-Ellison syndrome; prevention of relapses of duodenal ulceration. Short-term (no more

than 12 weeks) symptomatic relief of gastro-oesophageal reflux not responsive to conservative measures. Healing of oesophageal erosion or ulceration

associated with gastro-oesophageal reflux disease. Prevention of relapses of symptoms and erosions or ulcerations associated with gastro-oesophageal

reflux disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

60 tablets

(S4) Prescription Only Medicine

Components

1. FAMOTIDINE AN famotidine 20mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A biege, round, biconvex, film coated tablet embossed with '20' on one side

and plain on the other.

Active Ingredients

Famotidine

20 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 1 of

Produced at 29.11.2017 at 03:11:48 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

Famotidine AN tablets – Consumer Medicine Information

Famotidine AN CMI v2.0

Page 1

Famotidine AN tablets

Famotidine

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Famotidine AN.

does

contain

available information. It does not

take the place of talking to your

doctor or pharmacist.

All medicines have benefits and

risks. Your doctor has weighed

risks

taking

Famotidine

against

benefits they expect it will have

for you.

If

you

have

any

concerns

about

taking

this

medicine,

talk

to

your

doctor

or

pharmacist.

Keep

this

leaflet

with

your

medicine.

You may need to read it again.

What Famotidine AN

is used for

Famotidine AN tablets belong to

a group of medicines called H

antagonists. They are used for:

Treat stomach and duodenal

ulcer

disease

(also

known

peptic

ulcer)

stop

ulcers coming back.

Treat

Zollinger-Ellison

Syndrome

(rare

condition

caused

much

acid

production in the stomach).

Famotidine AN works by reducing

the amount of acid in the stomach

thereby reducing the pain and

allowing the ulcer to heal.

Your

doctor

have

prescribed

Famotidine

another reason. Ask your doctor

if you have any questions as to

this

medicine

been

prescribed for you.

Do not take Famotidine AN to

treat

any

other

complaints

unless

your

doctor

has

instructed you to do so.

Famotidine AN is only available

with a doctor’s prescription.

Famotidine

should

given to children under 18 years

there

limited

experience

with

famotidine in children.

There

evidence

that

Famotidine

tablets

addictive.

Before You Take

Famotidine AN

Do not take Famotidine

AN if:

You

have

an

allergy

to

famotidine or to any of the

ingredients

listed

at

the

end

of

this

leaflet.

Symptoms

of

an

allergic

reaction

may

include,

shortness

of

breath,

swelling of the tongue or

face,

skin

rash

and

itchiness.

You are breast-feeding or

plan

to

breast-feed.

Famotidine

AN

passes

into breast milk. There is a

possibility

that

this

may

affect

your

breast-fed

baby.

The expiry date (EXP) on

the pack has passed.

take

this

medicine

after the date has passed it

may have no effect at all, or

worse,

entirely

unexpected effect.

The packaging is torn or

shows signs of tampering.

If you are not sure whether you

should take Famotidine AN, talk

to your doctor or pharmacist

Tell your doctor if:

pregnant,

plan

become

pregnant

breastfeed.

Like

most

medcines, Famotidine AN is

recommended

during pregnancy.

You have kidney disease

allergic

medicine

You are allergic to any other

substances such as foods,

dyes or preservatives.

You have or have ever had

any other health problems.

If you have not told your doctor or

pharmacist

about

above, tell them before you start

taking Famotidine AN.

Taking other medicines

Tell

your

doctor

if

you

are

taking

any

other

medicines,

including

any

that

you

buy

without a prescription from a

pharmacy,

supermarket

or

health food shop.

Some medicines may affect the

other

medicines

work.

Famotidine

been

shown

interfere

with

other

medicines.

How to take

Famotidine AN

Carefully follow all directions

given to you by your doctor

and

pharmacist.

They

differ

from

information

contained in this leaflet.

understand

instructions on the box, ask your

doctor or pharmacist for help.

Famotidine AN tablets – Consumer Medicine Information

Famotidine AN CMI v2.0

Page 2

How much to take

dosage

depends

disease

that

suffering

from. Your doctor or pharmacist

will

tell

many

Famotidine

tablets

take

and how often to take them.

When to take it

It is preferable for you to take the

tablets at the same time each

day. It will help you to remember

when to take your tablets.

Famotidine AN tablets should be

swallowed whole with a glass of

water and may be taken before

or after food.

How long to take it

For peptic ulcers (ulcers in the

stomach or duodenum), you will

need

take

Famotidine

tablets for 4 to 8 weeks. Do not

stop taking the tablets too early

as your ulcer may reoccur. In

some

cases,

need

more than 8 weeks treatment.

treatment

reflux

disease

Zollinger-Ellison

Syndrome, you will need to take

Famotidine

tablets

longer period.

Your doctor will advise you how

long to take your tablets

If you forget to take it

If it is almost time to take your

next dose, skip the dose that you

missed and take your next dose

when

meant

Otherwise take it as soon as you

remember,

then

back

taking your tablets as usual.

If you are not too sure whether

skip

dose,

talk

your

doctor or pharmacist.

Do not take a double dose to

make

up

for

the

dose

you

missed.

If you have trouble remembering

take

your

tablets,

your

pharmacist for some hints.

If you take too much

(overdose)

Immediately

telephone

your

doctor

or

the

Poisons

Information Centre (telephone

13 11 26) for advice, or go to

Accident

and

Emergency

at

the

nearest

hospital,

if

you

think you or anyone else may

have

taken

too

much

Famotidine AN. Do this even if

there

are

no

signs

of

discomfort or poisoning.

You may need urgent medical

attention.

Keep

telephone

numbers

of

these places/services handy.

While you are taking

Famotidine AN

Things you must do

If you are pregnant or likely to

become pregnant while you are

taking Famotidine AN tablets, tell

your doctor.

If you are about to start taking a

medicine

tell

your

doctor

pharmacist

that

taking Famotidine AN tablets.

If

your

stomach

discomfort

continues, tell your doctor. If

your

symptoms

continue

for

more

than

5

days,

or

your

symptoms come back within

two

weeks

of

completing

a

course of Famotidine AN, tell

your doctor or pharmacist

Things you must not do

Do

not

stop

taking

your

tablets

because

you

are

feeling better, unless advised

to do so by your doctor.

If you do not complete the full

course

prescribed

your

doctor,

your

symptoms

return

Do not give Famotidine AN to

anyone else even if they have

the same condition as you.

Do not use Famotidine

AN to

treat

other

complaints

unless your doctor tells you to.

Things to be careful of

Be careful driving or operating

machinery until you know how

Famotidine AN affects you.

Famotidine

tablets

normally

cause

problems

with your ability to drive a car or

operate machinery. However, as

with

many

other

medicines,

Famotidine

cause

dizziness in some people.

Make sure you know how you

react to Famotidine AN before

drive

operate

machinery.

Things

that

may

help

your condition

Some

self-help

measures

suggested below may help your

condition. Talk to your doctor or

pharmacist

about

these

measures

more

information.

Alcohol – your pharmacist or

doctor

advise

limit your alcohol intake

Asprin

many

other

medicines

used

treat

arthritis/period

pain/headaches

these

medicines

irritate

stomach

make

your

condition

worse.

Your

pharmacist

doctor

suggest other medicines you

can take.

Caffeine – yur pharmacist or

doctor

advise

limit

number

drinks

which contain caffeine, such

as coffee, tea, cocoa, and

cola

drinks

because

these

contain ingredients that may

irritate your stomach.

Eating habits – eat smaller,

more

frequent

meals.

slowly and chew your food

carefully. Try not to rush at

meal times.

Food

avoid

foods

that

cause you pain or discomfort

Smoking – your pharmacist

or doctor may advise you to

stop smoking or at least cut

Famotidine AN tablets – Consumer Medicine Information

Famotidine AN CMI v2.0

Page 3

down on smoking.

Weight – your pharmacist or

doctor

suggest

losing

some

weight

help

your

condition.

Side Effects

Check

with

your

doctor

or

pharmacist

as

soon

as

possible

if

you

have

any

problems while you are taking

Famotidine AN, even if you do

not

think

that

the

problems

are

connected

with

the

medicine or are not listed in

this leaflet.

Like

medicines,

Famotidine

cause

side

effects.

they occur, most are likely to be

minor and temporary. However,

some may be serious and need

medical attention.

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:

Headache

Dizziness

Diarrhoea,

constipation,

nausea, vomiting, abdominal

discomfort,

anorexia,

mouth

Fever, fatigue

Irregular or rapid heart beat,

palpitations

Muscle pain, cramps, painful

joints

Hallucinations,

confusion,

agitation,

depression,

anxiety,

inability

sleep,

sleeplessness, tingling in the

fingers

toes,

decreased

sex drive, fits

Breathing difficulties caused

by narrowing of the airways

Ringing in the ears

Taste disorders

Acne, dry skin, flushing, loss

of hair

These

generally

mild

side

effects.

Rarely,

more

serious

side

effects

may

occur.

If

you

experience

any

of

the

following,

stop

taking

Famotidine

AN,

tell

your

doctor

immediately

or

go

to

casualty

at

your

nearest

hospital:

Swelling

face,

lips,

mouth or throat which may

cause difficulty in swallowing

or breathing

Swelling of the hands, feet

or ankles

severe

skin

reaction

(skin rash, itchiness)

Hives or nettle rash (pinkish,

itchy swellings on the skin)

Yellowing of the skin and/or

eyes, also called jaundice

These

some

serious side effects. If you have

them, you may have an allergic

reaction to Famotidine AN. You

need

urgent

medical

attention

hospitalisation.

These side effects are rare

Other

side

effects

not

listed

above may also occur in some

patients. Tell your doctor or

pharmacist if you notice any

of these effects.

Do not be alarmed by this list of

possible

side

effects

not experience any of them.

After taking

Famotidine AN

Storage

Keep your tablets in the blister

pack

until

it

is

time

to

take

them. If you take the tablets out of

the blisters they may not keep as

well.

Keep Famotidine AN in a cool

dry

place

away

from

direct

sunlight where the temperature

stays below 30

0

C.

Do not store Famotidine AN or

any

other

medicine

in

the

bathroom or near a sink.

Do not leave Famotidine AN in

the car or on windowsills.

Heat and dampness can destroy

some medicines.

Keep Famotidine AN where

children cannot reach it.

A locked cupboard at least one-

and-a-half

metres

above

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking Famotidine AN, or your

tablets

have

passed

their

expiry

date,

ask

your

pharmacist

what

to

do

with

any that are left over.

Product description

What it looks like

Famotidine AN 20 mg & 40 mg

tablets

presented

pack

sizes of 30 & 100 tablets in a

PVC/PVDC/Al blister.

Famotidine AN 20 mg (AUST R

186280)

Beige,

round,

biconvex

tablets

with ‘20’ on one face and plain

on the other side.

Famotidine AN 40 mg (AUST R

186281)

Brown, round, biconvex tablets

with ‘40’ on one face and plain

on the other side.

Ingredients

Active Ingredient:

Famotidine

Each tablet may contain either

10mg or 20 mg of Famotidine

Other Ingredients:

Pregelatinised maize starch

Microcrystalline cellulose

Magnesium stearate

Purified talc

Opadry Buff OY-3690 (20

Opadry Buff OY-3682 (40

Please read this leaflet carefully

before

start

taking

Famotidine AN. You may wish to

keep it to read again.

Famotidine AN tablets – Consumer Medicine Information

Famotidine AN CMI v2.0

Page 4

Name

and

Address

of

the

Sponsor

Amneal Pharma Australia Pty

12 River St

South Yarra

Vic - 3141

Australia

Date of Preparation

September 2014