TN-METOPROLOL

Main information

  • Trade name:
  • TN-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TN-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222127
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222127

TN-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

25/03/2015

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. TN-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

29/10/2015

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. TN-METOPROLOL metoprolol tartrate 50 mg film-coated 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 26.11.2017 at 12:03:41 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

TN-METOPROLOL

50 mg & 100 mg CMI v1.1

TN-METOPROLOL 50 mg & 100 mg

Metoprolol tartrate

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some of the

common questions people ask

about TN-METOPROLOL. It does

not contain all the information that

is known about

TN-METOPROLOL.

It does not take the place of talking

to your doctor and pharmacist.

All medicines have risks and

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 TN-METOPROLOL IS

FOR

TN-METOPROLOL is used:

1. to lower high blood pressure,

also called hypertension

2. to prevent a type of chest pain,

also called angina

3. after a heart attack

4. to prevent migraine headaches.

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. TN-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.

TN-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.

TN-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.

TN-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 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.

TN-METOPROLOL can be used

alone or in 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.

TN-METOPROLOL is not

recommended for use in children.

TN-METOPROLOL is only

available with a doctor's

prescription.

It is not addictive.

BEFORE YOU TAKE

TN-METOPROLOL

When you must not take it

Do not take TN-METOPROLOL if

you have an allergy to:

metoprolol (the active

ingredient) or to any of the

other ingredients of TN-

METOPROLOL listed at the

end of this leaflet

any other beta-blocker

medicines.

Some of the symptoms of an

allergic reaction may include:

rash

itching or hives on the skin

swelling of the face, lips,

tongue or other parts of the

body

shortness of breath, wheezing

or troubled breathing.

Do not take TN-METOPROLOL if

you have any of the following

medical conditions:

sudden loss of consciousness

sometimes

asthma, wheezing, difficulty

breathing or other severe lung

problems, or you have had

these problems in the past

a history of allergic problems,

including hay fever

TN-METOPROLOL

50 mg & 100 mg CMI v1.1

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

a severe drop in blood

pressure, dizziness, fast heart

beat, 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

swollen ankles and/or tiredness

due to heart disease or certain

other heart conditions

heart disorders

poor blood circulation in your

limbs(for example, very cold,

pale hands or feet, or pain in

your leg muscles when you

walk).

Undergo an operation where an

anesthetis is used during

treatment with respiratory

diseases such as asthma.

Oculomucocutaneous

syndrome(signs include severe

conjunctivitis and skin rash and

ear infection)

If you are not sure whether any

of the above medical conditions

apply to you, check with your

doctor.

Do not take TN-METOPROLOL

after the expiry date printed on

the pack or if the packaging is

torn or shows signs of

tampering.

In that case, return it to 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:

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.

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 may want to take

special precautions if you have any

of the above conditions.

Tell your doctor if you are

pregnant or intend to become

pregnant.

TN-METOPROLOL should not be

used throughout pregnancy,

especially during the first 3 months

of pregnancy, unless clearly

necessary.

TN-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.

Tell your doctor if you are

breast-feeding or intend to

breast-feed.

The active ingredient in

TN-METOPROLOL 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

TN-METOPROLOL.

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

TN-METOPROLOL 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 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

(arrhythmi

* 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

inhibitorsto 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 antidressant 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 used

to reduce the risk of blood clots

You may need to take different

amounts of your medicines or you

may need to take different

medicines.

Your doctor and pharmacist have

more information on medicines to

TN-METOPROLOL

50 mg & 100 mg CMI v1.1

be careful with or avoid while

taking TN-METOPROLOL.

HOW TO TAKE IT

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.

It does not matter if you take

TN-METOPROLOL before or after

food.

How long to take it

Continue taking

TN-METOPROLOL for as long as

your doctor tells you to.

TN-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.

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

you getting an 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 TN-METOPROLOL. 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

TN-METOPROLOL

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 TN-METOPROLOL, 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 TN-METOPROLOL, tell

your doctor immediately.

There is a chance that TN-

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

TN-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

TN-METOPROLOL

50 mg & 100 mg CMI v1.1

report any problems to your

doctor.

TN-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 TN-METOPROLOL.

This will help your doctor to

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 TN-METOPROLOL.

Tell any other doctor, dentist or

pharmacist who treats you that

you are taking

TN-METOPROLOL.

Things you must not do

Do not stop taking

TN-METOPROLOL without

telling your doctor first.

Your doctor may want to gradually

reduce the amount of

TN-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.

Do not use TN-METOPROLOL 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 TN-METOPROLOL

until you know how it affects

you.

As with other beta-blocker

medicines, TN-METOPROLOL

may cause dizziness, light-

headedness 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,

TN-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.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are taking

TN-METOPROLOL.

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 an increased chance of

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 or upset, nausea

(feeling sick) or 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

numbness, tingling in the

extremities

weight gain

hair thinning

worsening of psoriasis

muscle cramps or painful joints

a tingling sensation

abnormal triglycerides or

cholesterol values, or liver

function tests during treatment

with TN-METOPROLOL

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 of allergy such as

swelling of the face, lips or

tongue which may cause

problems with swallowing or

breathing

chest tightness, wheezing, rattly

breathing

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)

TN-METOPROLOL

50 mg & 100 mg CMI v1.1

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)

breathelessness, difficulty

breathing when lying down,

swelling of the feet or legs,

signs of heart disorders.

The above side effects could be

serious. You may 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

TN-METOPROLOL

Storage

Keep your tablets in the original

container until it is time to take

them.

Store the tablets in a cool dry

place.

Do not store TN-METOPROLOL

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.

TN-METOPROLOL 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 the

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking TN-METOPROLOL 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 TN-METOPROLOL looks

like

TN-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; one carton contains

100 tablets or 10 tablets.

TN-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; one

carton contains 60 tablets or 10

tablets.

Ingredients:

TN-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 pregelatinized - maize

Talc - purified

Magnesium stearate

Hypromellose

Macrogol 400

Titanium dioxide

Iron oxide – red (50 mg only)

NAME AND ADDRESS OF THE

SPONSOR

www.ipca.com.

IPCA PHARMA (AUSTRALIA)

PTY. LTD

6 Morotai Avenue

Ashburton VIC 3147

AUSTRALIA

This leaflet was prepared in

February 2015

Australian Registration Numbers:

50mg

AUST R 222127

100mg AUST R 222128

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