METOPROLOL AN metoprolol tartrate 50mg tablet blister pack

Main information

  • Trade name:
  • METOPROLOL AN metoprolol tartrate 50mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • METOPROLOL AN metoprolol tartrate 50mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 192767
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192767

METOPROLOL AN metoprolol tartrate 50mg 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

8/01/2013

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. METOPROLOL AN metoprolol tartrate 50mg tablet blister pack

Product Type

Single Medicine Product

Effective date

11/07/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hypertension: as monotherapy or for use in combination with other antihypertensives.,Angina pectoris: for long-term prophylaxis. Glyceryl trinitrate

should be employed if necessary for alleviating acute attacks.,Confirmed or suspected myocardial infarction.,Prevention of migraine.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. METOPROLOL AN metoprolol tartrate 50mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, round, biconvex film-coated tablets with 'B' & 'L' separated by notch

break line on one side and '50' debossed on other side.

Active Ingredients

Metoprolol tartrate

50 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 28.11.2017 at 08:42:22 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

Metoprolol AN tablets – Consumer Medicine Information

Metoprolol AN CMI v1.0

Page 1

Metoprolol AN tablets

Metoprolol tartrate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the

common

questions

people

about Metoprolol AN. It does not

contain all the information that is

known about Metoprolol AN.

does

take

place

talking

your

doctor

pharmacist.

medicines

have

risks

benefits.

Your

doctor

will

have

weighed the risks of you taking

this medicine 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 Metoprolol AN

is used for

Metoprolol AN is used:

to lower high blood pressure,

also called hypertension

prevent

type

chest

pain, also called angina

after a heart attack to prevent

migraine headaches.

Hypertension

Everyone

blood

pressure.

This pressure helps to move your

blood

around

your

body.

Your

blood pressure may be different at

various

times

day,

depending on how busy you are.

have

hypertension

(high

blood pressure) when your blood

pressure

stays

higher

than

needed, even when you are calm

relaxed.

high

blood

pressure is not treated it can lead

serious

health

problems,

including

stroke,

heart

disease

and kidney failure.

There are usually no symptoms of

hypertension.

only

knowing that you have it is to have

your blood pressure checked on a

regular basis. You may feel fine

and have no symptoms but, if high

blood pressure is not treated, it

lead

serious

health

problems. Metoprolol AN helps to

lower your blood pressure.

Angina

Angina is a pain or uncomfortable

feeling

chest,

often

spreading to the arms or neck and

sometimes to the shoulders and

back. This may be caused by too

little blood and oxygen getting to

the heart. The pain of angina is

usually brought on by exercise or

stress but it can also happen while

you are resting.

Metoprolol AN helps to prevent

angina from happening. It is not

used to treat a sudden attack.

Reducing heart complications

after heart attack

After a heart attack there is a

chance

developing

complications such as an irregular

heart

beat

(also

called

arrhythmia)

another

heart

attack.

Metoprolol AN helps to prevent

these conditions from happening.

Migraine

This

throbbing

headache,

usually affecting one side of the

head and often accompanied by

nausea, vomiting and sensitivity

to light.

Metoprolol AN belongs to a group

of medicines called beta-blockers.

It works by affecting the body's

response

some

nerve

impulses, especially in the heart.

result,

decreases

heart's need for blood and oxygen

and reduces the amount of work

that the heart has to do. It also

widens the blood vessels in the

rest of the body.

Metoprolol AN can be used alone

combination

with

other

medicines to treat your condition.

Ask your doctor if you have any

questions

about

why

this

medicine has been prescribed

for you.

Your doctor may have prescribed

it for another reason.

Metoprolol

recommended for use in children.

Metoprolol AN is only available

with a doctor's prescription.

It is not addictive.

Before

you

take

Metoprolol AN

When you must not take it

Do not take Metoprolol AN if

you have an allergy to:

metoprolol

(the

active

ingredient) or

any of the

other ingredients of Metoprolol

AN listed at the end of this

leaflet

other

beta-blocker

medicines.

Some

symptoms

allergic reaction may include:

rash

itching or hives on the skin

swelling

face,

lips,

tongue or other parts of the

body

shortness of breath, wheezing

or troubled breathing.

Metoprolol AN tablets – Consumer Medicine Information

Metoprolol AN CMI v1.0

Page 2

Do not take Metoprolol AN if

you have any of the following

medical conditions:

sudden loss of consciousness

sometimes

asthma,

wheezing,

difficulty

breathing or other severe lung

problems,

have

these problems in the past

a history of allergic problems,

including hay fever

a very slow heart beat, less

than 45 to 50 beats per minute

low blood pressure

a severe blood vessel disorder

causing poor circulation in the

arms and legs

phaeochromocytoma

rare

tumour of the adrenal gland)

which

already

being

treated with other medicines

swollen

ankles

and/or

tiredness due to heart disease

certain

other

heart

conditions

If you are not sure whether any

of

the

above

medical

conditions apply to you, check

with your doctor.

Do not take Metoprolol AN after

the expiry date printed on the

pack or if the packaging is torn

or shows signs of tampering.

that

case,

return

your

pharmacist.

Do not give this medicine to a

child.

There is not enough information

on its use in children.

Before you start to take it

Tell

your

doctor

if

you

are

allergic to:

other

medicines,

foods,

dyes or preservatives

bee or wasp stings

Your doctor will want to know if

you are prone to allergies. Beta-

blocker medicines can make an

allergic reaction worse.

Tell your doctor if you have any

of

the

following

medical

conditions:

diabetes

an overactive thyroid gland

kidney problems

liver problems

chest pain when you are at

rest, or certain types of angina,

such as Prinzmetal angina or

variant angina

Your

doctor

want

take

special precautions if you have

any of the above conditions.

Tell

your

doctor

if

you

are

pregnant or intend to become

pregnant.

Metoprolol AN should not be used

throughout pregnancy, especially

during

first

months

pregnancy,

unless

clearly

necessary.

Metoprolol

AN may

affect

your

baby, especially if you take it in

the last few days before your baby

is born.

Your doctor can discuss the risks

benefits

taking

this

medicine during pregnancy.

Tell

your

doctor

if

you

are

breast-feeding

or

intend

to

breast-feed.

active

ingredient

Metoprolol AN passes into breast

milk and there is a possibility that

your baby could be affected.

If you have not told your doctor

about any of these things, tell

him/her

before

you

take

Metoprolol AN.

Taking other medicines

Tell

your

doctor

if

you

are

taking

any

other

medicines,

including

medicines

that

you

buy without a prescription from

a

pharmacy,

supermarket

or

health food shop.

Other medicines and Metoprolol

AN may interfere with each other.

These medicines include:

other beta-blocker medicines

other medicines used to treat

high blood pressure such as

calcium channel blockers and

clonidine

some medicines used to treat

angina

adrenaline

similar

substances,

which are often

found in eye or nose drops, or

some

cough

cold

medicines

other medicines used to treat

irregular

heart

beat

(arrhythmias)

medicines for diabetes

quanethidine, a medicine used

to treat certain heart conditions

some

local

general

anaesthetics

used

during

surgery

monoamine-oxidase

inhibitor

(MAOI) medicines

warfarin, a medicine used to

prevent blood clots

indomethacin, a medicine for

arthritis, pain or inflammation

cimetidine,

medicine

stomach ulcers

some

antibiotics

(e.g.

rifampicin)

some antivirals (e.g. ritonavir)

some

antihistamines

(e.g.

diphenhydramine)

some

antidressant

medications

(e.g.

fluoxetine,

paroxetine or bupropion)

some

antifungals

(e.g.

terbinafine)

You may need to take different

amounts of your medicines or you

need

take

different

medicines.

Your doctor and pharmacist have

more information on medicines to

careful

with

avoid

while

taking Metoprolol AN.

How to take it

Metoprolol AN tablets – Consumer Medicine Information

Metoprolol AN CMI v1.0

Page 3

Follow the directions given to

you

by

your

doctor

and

pharmacist carefully.

These directions may differ from

the information contained in this

leaflet.

If you do not understand the

instructions on the label, ask

your doctor or pharmacist for

help.

How much to take

High blood pressure:

The usual dose is from 50 mg to

200 mg each day, either as a

single dose or divided into two

doses.

Angina:

The usual dose is from 100 mg to

300 mg each day, divided into two

or three doses.

After a heart attack:

The usual dose is 200 mg each

day, divided into two doses.

To prevent migraine:

The usual dose is from 100 mg to

150 mg each day, divided into two

doses (morning and evening).

How to take it

Swallow the tablets whole with

a full glass of water or other

liquid.

does

matter

take

Metoprolol

before

after

food.

How long to take it

Continue taking Metoprolol AN

for as long as your doctor tells

you to.

Metoprolol

helps

control

your symptoms but it does not

cure your condition. Your doctor

will check your progress to make

sure the medicine is working and

will

decide

long

your

treatment should continue.

Talk to your doctor if you are

not sure how long you need to

take your medicine for.

If you forget to take it

If it is almost time for your next

dose (eg. within 2 or 3 hours),

skip the dose you missed and

take your next dose when you

are meant to.

Otherwise,

take

the

dose

as

soon

as

you

remember,

and

then go back to taking it as you

would normally.

Do not take a double dose to

make up for the one that you

missed.

This may increase the chance of

getting

unwanted

side

effect.

If

you

have

trouble

remembering when to take your

medicine, ask your pharmacist

for some hints.

If you take too much

Immediately

telephone

your

doctor or Poisons Information

Centre (telephone 13 11 26) for

advice, or go to Accident and

Emergency

at

your

nearest

hospital if you think that you or

anyone else may have

taken

too much Metoprolol AN. Do

this even if there are no signs

of discomfort or poisoning.

Keep

the

telephone

numbers

for these places handy.

Symptoms of an overdose may

include feeling sick and vomiting,

bluish skin and nails, very low

blood pressure, slow heart beat,

difficulty

breathing,

fainting,

convulsions (fits) or coma.

While you are taking

Metoprolol AN

Things you must do

Be

sure

to

keep

all

of

your

doctor's appointments so that

your progress can be checked.

This helps your doctor to give you

the best treatment and to prevent

unwanted

side

effects

from

happening.

If you become pregnant while

taking Metoprolol AN, tell your

doctor.

Your doctor can discuss with you

the risks and benefits of taking it

while you are pregnant.

If you have an allergic reaction

to a food, another medicine or

an insect sting while you are

taking Metoprolol AN, tell your

doctor immediately.

There is a chance that Metoprolol

could

make

allergic

reaction worse or harder to treat.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

feel

light-headed

dizzy

when

start

take

Metoprolol AN.

This

because

your

blood

pressure is falling suddenly. If this

problem doesn't go away, talk to

your doctor.

To avoid symptoms of low blood

pressure, here are some hints that

may help:

Stand up slowly to help your

body get used to the change in

position and blood pressure

If you feel dizzy, sit or lie down

until you feel better

If you feel faint, breathe deeply

and bend forward with

your

head between your knees

Take

extra

care

when

exercising, driving or standing

for long periods, especially in

hot weather. Drink plenty of

fluids, especially if you sweat a

lot.

Metoprolol AN tablets – Consumer Medicine Information

Metoprolol AN CMI v1.0

Page 4

If

you

are

being

treated

for

diabetes, make sure you check

your blood sugar regularly and

report

any

problems

to

your

doctor.

Metoprolol AN may change how

well your diabetes is controlled. It

may also prevent some of the

warning signs of low blood sugar,

such as fast heart beat, and may

make low blood sugar last longer.

dose

your

diabetes

medicines

need

changed.

If you plan to have surgery and

will need an anaesthetic, tell

your doctor or dentist that you

are taking Metoprolol AN.

This

will

help

your

doctor

prevent

unwanted

side

effects

such as a sudden drop in blood

pressure.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Metoprolol AN.

Tell any other doctor, dentist or

pharmacist who treats you that

you are taking Metoprolol AN.

Things you must not do

Do not stop taking Metoprolol

AN without telling your doctor

first.

Your doctor may want to gradually

reduce the amount of Metoprolol

AN you are taking before stopping

it completely. This helps to reduce

chance

your

condition

becoming

worse or

keep other

unwanted

heart

problems

from

happening.

Do not use Metoprolol AN to

treat

any

other

complaints

unless your doctor says you

can.

Do not give this medicine to

anyone

else,

even

if

their

symptoms seem to be similar to

yours.

Things to be careful of

Be

careful

driving,

operating

machinery or doing jobs that

require you to be alert while

you are taking Metoprolol AN

until you know how it affects

you.

with

other

beta-blocker

medicines,

Metoprolol

cause

dizziness,

light-

headedness

decreased

alertness in some people.

If

you

have

any

of

these

symptoms, do not drive or do

anything

else

that

could

be

dangerous.

Be

careful

to

dress

warmly

during cold weather, especially

if you will be outside for a long

time.

Like

other

beta-blocker

medicines, Metoprolol may make

more

sensitive

cold

temperatures,

especially

have problems with your blood

circulation. These medicines tend

to decrease blood circulation in

the skin, fingers and toes.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do

not

feel

well

while

you

are

taking Metoprolol AN.

All medicines have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical treatment if you get

some of the side effects. If you are

over 65 years of age, you may

have

increased

chance

getting 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.

Tell your doctor if you notice

any of the following side effects

and they worry you:

tiredness,

drowsiness,

decreased alertness

dizziness, spinning sensation

(vertigo), light-headedness or

fainting

headache or other aches and

pains

difficulty sleeping, nightmares

depression or other changes in

mood

confusion or loss of memory

stomach

ache

upset,

nausea

(feeling

sick)

vomiting

diarrhoea or constipation

dry or irritated eyes, blurred

vision

buzzing or ringing in the ears,

or other difficulty hearing

dry mouth

increased sweating

runny or blocked nose

problems with sexual function

weight gain

hair thinning

worsening of psoriasis

muscle cramps or painful joints

a tingling sensation

abnormal

triglycerides

cholesterol

values,

liver

function tests during treatment

with Metoprolol AN

sleepiness during the day or

troubled sleep

diarrhoea or constipation

Tell your doctor immediately or

go to Accident and Emergency

at your nearest hospital if you

notice any of the following:

signs

allergy

such

swelling of the face, lips or

tongue

which

cause

problems with swallowing or

breathing

chest

tightness,

wheezing,

rattly breathing

shortness

breath,

sometimes

with

tiredness,

Metoprolol AN tablets – Consumer Medicine Information

Metoprolol AN CMI v1.0

Page 5

weakness or reduced ability to

exercise

swelling of the feet or legs due

to fluid build-up

coldness, burning, numbness

or pain in arms and legs

chest pain

pain

behind

breastbone

(different from angina)

changes

heart

rate

(fast,

slow, irregular)

yellowing of the skin or eyes

(jaundice),

sometimes

with

pain in the abdomen

constant

"flu-like"

symptoms

(chills,

fever,

sore

throat,

aching joints, swollen glands,

tiredness or lack of energy)

unusual bleeding or bruising

skin reactions (rash, itching,

worsening of psoriasis)

symptoms

sunburn

(redness,

itching,

swelling,

blistering) that happen much

more quickly than normal

abnormal

thinking

hallucinations

(seeing

hearing

things

that

there)

The above side effects could be

serious.

need

urgent

medical attention.

Tell your doctor if you notice

anything

else

that

is

making

you feel unwell.

Other side effects not listed above

may happen in some people.

After

taking

Metoprolol AN

Storage

Keep your tablets in the original

container until it is time to take

them.

Store the tablets in a cool dry

place

where

the

temperature

stays

below

30

degrees

Celsius.

Do not store Metoprolol AN or

any

other

medicine

in

the

bathroom or near a sink.

Do not leave the tablets in the

car or on window sills.

Heat and dampness can destroy

some medicines. Metoprolol AN

will keep well if it is cool and dry.

Keep

this

medicine

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

Metoprolol

AN

or

the

expiry date on the medicine has

passed,

ask

your

pharmacist

what to do with any tablets that

are left over.

Product Description

What Metoprolol AN looks like

Metoprolol

presented

PVC/Al blister packs. The 50 mg

tablets are available in pack sizes

of 10 and 100, and the 100 mg

tablets are available in pack sizes

of 10 and 60.

Metoprolol

AN

tablets

(AUST R 192767) are pink, round,

biconvex film-coated tablets with

‘B’ and ‘L” separated by a notch

break line on one side and ‘50’

embossed on the other side.

Metoprolol AN 100 mg tablets

(AUST R 192765) are white to off

white,

round,

biconvex

film-

coated

tablets

with

‘B’

‘L”

separated by a notch break line

on one side and ‘100’ embossed

on the other side.

Ingredients:

Active Ingredient:

Metoprolol tartrate

Inactive Ingredients

tablets

also

contain

following in-active ingredients:

Lactose

Microcrystalline cellulose

Sodium starch glycollate

Colloidal anhydrous silica

Croscarmellose sodium

Pregelatinized maize starch

Purified talc

Magnesium stearate

Hypromellose

Macrogol 400

Titanium dioxide

Iron oxide – red (50 mg

only)

Name and address of

the Sponsor

Amneal Pharma Australia Pty Ltd

12 River St, South Yarra

Vic 3141, Australia

This leaflet was prepared in June

2014