TERRY

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS METOPROLOL metoprolol tartrate 100mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS METOPROLOL metoprolol tartrate 100mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210515
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210515

TERRY WHITE CHEMISTS METOPROLOL metoprolol tartrate 100mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

3/04/2014

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. TERRY WHITE CHEMISTS METOPROLOL metoprolol tartrate 100mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

27/07/2016

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

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. TERRY WHITE CHEMISTS METOPROLOL metoprolol tartrate 100mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, round, biconvex film-coated tablets with 'B' & 'L'

separated by notch break line on one side and '100' debossed on other side

Active Ingredients

Metoprolol tartrate

100 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 27.11.2017 at 09:44:09 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

Terry White Chemists

Metoprolol Tablets

Contains the active ingredient metoprolol tartrate

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some of the

common questions about metoprolol.

It does not contain all the

information. It does not take the

place of talking to your doctor and

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is Terry

White chemists Metoprolol tablets. It

contains the active ingredient

metoprolol.

It is used:

to treat high blood pressure, also

called hypertension

to prevent a type of chest pain,

also called angina

after a heart attack

to prevent migraine headaches.

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.

How it works

Hypertension

Everyone has blood pressure. This

pressure helps to move your blood

around your body. Your blood

pressure may be different at various

times of the day, depending on how

busy you are.

You have hypertension (high blood

pressure) when your blood pressure

stays higher than is needed, even

when you are calm and relaxed. If

high blood pressure is not treated it

can lead to serious health problems,

including stroke, heart disease and

kidney failure.

There are usually no symptoms of

hypertension. The only way of

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 can lead to

serious health problems. Metoprolol

helps to lower your blood pressure.

Angina

Angina is a pain or uncomfortable

feeling in the 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 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

of developing complications such as

an irregular heart beat (also called an

arrhythmia) or another heart attack.

Metoprolol helps to prevent these

conditions from happening.

Migraine

This is a throbbing headache, usually

affecting one side of the head and

often accompanied by nausea,

vomiting and sensitivity to light.

Metoprolol belongs to a group of

medicines called beta-blockers. It

works by affecting the body's

response to some nerve impulses,

especially in the heart. As a result, it

decreases the heart's need for blood

TERRY WHITE CHEMISTS METOPROLOL TARTRATE TABLETS

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 can be used alone or in

combination with other medicines to

treat your condition.

Metoprolol is only available with a

doctor's prescription.

There is no evidence that this

medicine is addictive.

Use in children

Metoprolol is not recommended for

use in children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

sudden loss of consciousness

sometimes

asthma, wheezing, difficulty

breathing or other severe lung

problems

a history of allergic problems,

including hay fever

a very slow heartbeat, less than

45 to 50 beats per minute

low blood pressure

a severe blood vessel disorder

causing poor circulation in the

arms and legs, severe drop in

blood pressure, dizziness, fast

heartbeat, rapid and shallow

breathing, cold clammy skin

phaeochromocytoma (a rare

tumour of the adrenal gland)

which is not already being treated

with other medicines

sudden and oppressive chest pain,

sign of heart attack

irregular heart beat (without

functioning pacemaker)

heart disorders

swollen ankles and/or tiredness

due to heart disease or certain

other heart conditions

poor blood circulation in your

limbs (for example, very cold,

pale hands or feet, or pain in your

leg muscles when you walk

shock.

If you are not sure whether any of

the above medical conditions apply

to you, check with your doctor.

You are hypersensitive to, or

have had an allergic reaction to,

metoprolol, any other beta-

blocker medicine, or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any 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.

You have or have had any

medical conditions, especially the

following:

diabetes

an overactive thyroid gland

kidney problems

liver problems

a heart attack

chest pain when you are at rest, or

certain types of angina, such as

Prinzmetal angina or variant

angina

oculomucocutaneous syndrome

(signs include severe

conjunctivitis and skin rash and

ear infection).

You are going to have an

operation where an anaesthetic is

used.

You are currently pregnant or you

plan to become pregnant.

Immediately inform your

doctor if you become pregnant.

Metoprolol should not be used

throughout pregnancy, especially

during the first 3 months of

pregnancy, unless clearly

necessary.

Metoprolol 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

and benefits of taking this

medicine during pregnancy.

You are currently breastfeeding

or you plan to breastfeed.

The active ingredient in

metoprolol passes into breast

milk and there is a possibility that

your baby could be affected.

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.

Some medicines may interact with

metoprolol. These include:

other beta-blocker medicines

TERRY WHITE CHEMISTS METOPROLOL TARTRATE TABLETS

other medicines used to treat high

blood pressure such as calcium

channel blockers, clonidine and

hydralazine

some medicines used to treat

angina

adrenaline or similar substances,

which are often found in eye or

nose drops, or in some cough and

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 and general

anaesthetics used during surgery

monoamine-oxidase inhibitor

(MAOI) medicines

warfarin, a medicine used to

prevent blood clots

non-steroidal anti-inflammatory

drugs such as COX-2 inhibitors to

relieve pain or inflammation

indomethacin, a medicine for

arthritis, pain or inflammation

cimetidine, a medicine for

stomach ulcers

some antibiotics (e.g. rifampicin)

some antivirals (e.g. ritonavir)

some antihistamines (e.g.

diphenhydramine)

some antidepressant medications

(e.g. fluoxetine, paroxetine or

bupropion)

some antifungals (e.g.

terbinafine)

ergot alkaloids, a class of

medicines used in the prevention

and treatment of migraine

headaches

dipyridamole, a medicine use to

reduce the risk of blood clots.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with metoprolol.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

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.

It does not matter if you take

metoprolol before or after food.

How long to take it

Continue taking metoprolol for as

long as your doctor tells you.

Metoprolol helps to 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

how long your treatment should

continue.

Talk to your doctor if you are not

sure how long you need to take your

medicine for.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time for your next

dose, skip the missed dose and take

your next dose at the usual time.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine 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 you

getting an unwanted side effect.

If you have trouble remembering

when to take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or Poisons

Information Centre (telephone 13

11 26) for advice. Alternatively, go

to Accident and Emergency at

your nearest hospital.

Do this even if there are no signs or

discomfort or poisoning. You may

need urgent medical attention.

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),

coma or death.

While you are taking

this medicine

Things you must do

Tell your doctor, dentist or

pharmacist that you are taking this

medicine if:

you are about to be started on any

new medicine

TERRY WHITE CHEMISTS METOPROLOL TARTRATE TABLETS

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breastfeed

you are about to have any blood

tests

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, tell your doctor

immediately.

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, tell your doctor

immediately.

There is a chance that metoprolol

could make the 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.

You may feel light-headed or dizzy

when you start to take metoprolol.

This is 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.

If you are being treated for

diabetes, make sure you check

your blood sugar regularly and

report any problems to your

doctor.

Metoprolol 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. The dose of your

diabetes medicines may need to be

changed.

If you plan to have surgery and

will need an anaesthetic, tell your

doctor or dentist that you are

taking metoprolol.

This will help your doctor to prevent

unwanted side effects such as a

sudden drop in blood pressure.

Tell any other doctor, dentist or

pharmacist who treats you that

you are taking metoprolol.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Your doctor may want to

gradually reduce the amount of

metoprolol you are taking before

stopping it completely. This helps

to reduce the chance of your

condition becoming worse or

keep other unwanted heart

problems from happening.

Things to be careful of

Be careful driving, operating

machinery or doing jobs that

require you to be alert while you

are taking metoprolol until you

know how it affects you.

As with other beta-blocker

medicines, metoprolol may cause

dizziness, lightheadedness or

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 you more

sensitive to cold temperatures,

especially if you have problems with

your blood circulation. These

medicines tend to decrease blood

circulation in the skin, fingers and

toes.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking metoprolol or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

If you are over 65 years of age, you

may have an increased chance of

getting side effects.

Tell your doctor if you notice any

of the following:

tiredness, drowsiness, decreased

alertness

dizziness, spinning sensation

(vertigo), light-headedness

headache or other aches and pains

difficulty sleeping, nightmares

stomach ache or upset, nausea

(feeling sick) or vomiting

diarrhoea or constipation

dry or irritated eyes, blurred

vision

dry mouth

increased sweating

runny or blocked nose

abnormal triglycerides or

cholesterol values, or liver

TERRY WHITE CHEMISTS METOPROLOL TARTRATE TABLETS

function tests during treatment

with metoprolol

sleepiness during the day or

troubled sleep

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention.

fainting

depression or other changes in

mood

confusion or loss of memory

buzzing or ringing in the ears, or

other difficulty hearing

problems with sexual function

weight gain

hair thinning

worsening of psoriasis

muscle cramps or painful joints

a tingling sensation

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

shortness of breath, sometimes

with tiredness, 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 the breastbone

(different from angina)

changes in 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 of sunburn (redness,

itching, swelling, blistering) that

happen much more quickly than

normal

abnormal thinking or

hallucinations (seeing or hearing

things that are not there)

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to metoprolol, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and Disposal

Storage

Keep your tablets in the original

container until it is time to take them.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will

stay below 30°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it in the

car or on window sills.

Heat and dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

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

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What Terry White Chemists

Metoprolol looks like

Metoprolol 50 mg tablets 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;

A blister pack contains 10 tablets or

100 tablets.

Metoprolol 100 mg tablets are white

to off white, round, biconvex film-

coated tablets with 'B' and 'L'

separated by a notch break line on

one side and '100' embossed on the

other side;

A blister pack contains 10 tablets or

60 tablets.

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients:

Metoprolol contains 50 mg or 100

mg of metoprolol tartrate as the

active ingredient.

The tablets also contain the following

in-active ingredients:

Lactose

Cellulose- microcrystalline

Sodium starch glycollate

Silica-colloidal anhydrous

Croscarmellose sodium

Starch pregelatinised - maize

Talc - purified

Magnesium stearate

Hypromellose

Macrogol 400

Titanium dioxide

Iron oxide - red (50 mg only)

TERRY WHITE CHEMISTS METOPROLOL TARTRATE TABLETS

Australian Registration

Numbers:

TWC Metoprolol 50mg Tablets

blister pack (Clear PVC/Al): AUST

R 210514.

TWC Metoprolol 100mg Tablets

blister pack (Clear PVC/Al): AUST

R 210515.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was prepared in

November 2015

TERRY WHITE CHEMISTS METOPROLOL TARTRATE TABLETS

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