PLIDOGREL

Main information

  • Trade name:
  • PLIDOGREL clopidogrel (as besilate) 75 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PLIDOGREL clopidogrel (as besilate) 75 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218326
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218326

PLIDOGREL clopidogrel (as besilate) 75 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

16/10/2014

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. PLIDOGREL clopidogrel (as besilate) 75 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

13/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of

symptomatic atherosclerotic disease. Acute Coronary Syndrome: Plidogrel is indicated in combination with aspirin for patients with: Unstable angina or

non-ST-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or

refractory ischaemia). Plidogrel is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation

(surgical or PCI, with or without stent); ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population,

Plidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically

treated patients eligible for thrombolytic therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. PLIDOGREL clopidogrel (as besilate) 75 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, round, biconvex tablet

Active Ingredients

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:04:52 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

clopidogrel besilate

112.1 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 26.11.2017 at 05:04:52 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

PLIDOGREL- Consumer Medicine Information

Page 1 of 4

Plidogrel

Tablets

Clopidogrel

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Plidogrel tablets.

It does not contain all the available

information. Some of the

information it contains may not

apply to you.

It does not take the place of talking

to your doctor or pharmacist.

All medicines have benefits and

risks. In deciding to give you

Plidogrel, your doctor has weighed

the risks of you taking Plidogrel

against the expected benefits it will

have for you.

Always follow the instructions

that your doctor and pharmacist

give you about Plidogrel tablets

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

What is Plidogrel used

for

Plidogrel contains the medicine

clopidogrel. Plidogrel belongs to a

group of medicines called anti-

platelet medicines.

Platelets are very small blood cells

which clump together during blood

clotting. By preventing this

clumping, anti-platelet medicines

reduce the chances of blood clots

forming (a process called

thrombosis).

Plidogrel is used to prevent blood

clots forming in hardened blood

vessels (a process known as

atherothrombosis) which can lead to

events such as stroke, heart attack or

death.

You may have been prescribed

Plidogrel to help prevent blood clots

forming and to reduce the risk of

stroke, heart attack and death

because:

You have previously suffered a

heart attack, stroke or have a

condition known as peripheral

arterial disease (leg pain on

walking or at rest).

You have suffered Acute

Coronary Syndrome (either a

severe type of chest pain called

unstable angina, or a heart

attack). In this case you may also

be prescribed aspirin.

Your doctor may have prescribed

this medicine for another use.

If you want more information, ask

your doctor.

Plidogrel is only available on a

doctor's prescription.

Before you take

Plidogrel

When you must not take it

You should not take Plidogrel if:

you are allergic to clopidogrel

or any of the ingredients listed

under 'Product Description' at

the end of this leaflet

you have a medical condition

that is causing bleeding such as

a stomach ulcer or bleeding

within your head

you suffer from severe liver

disease

you are breast feeding or

intend to breast feed. Plidogrel

passes

into breast milk and,

therefore, there is the

possibility that the

breast fed

baby may be affected

the packaging shows signs of

tampering

the expiry date on the pack has

passed. If you use this product

after the expiry date has

passed, it may not work.

Do not take Plidogrel to treat any

other complaint unless your

doctor says it is safe. Do not give

this medicine to anyone else.

Plidogrel is not recommended for

children as its safety and

effectiveness in children have not

been established.

Before you start to take

Plidogrel

You must tell your doctor if:

You are pregnant or intend to

become pregnant. Your doctor

will discuss the possible risks

and benefits of taking Plidogrel

during pregnancy.

You are planning to have an

operation (including dental

surgery) in the next two weeks.

Your doctor will decide

whether or not you need to

stop

Plidogrel prior to surgery.

If you have or have had any

medical conditions, especially

the following:

bleeding disorders or blood

clotting problems

any illness or disability that

was caused by bleeding, for

example impaired sight or

vision because of bleeding

within the eye

recent serious injury

PLIDOGREL- Consumer Medicine Information

Page 2 of 4

recent surgery (including

dental surgery)

any form of liver disease

allergic to other antiplatelet

medicines (such as

ticlopidine, prasugrel)

If you have not told your doctor

about any of the above, tell them

before you start taking Plidogrel.

Some patients may not convert

Plidogrel to its active form as well

as other patients. These patients may

not get the same benefit from

Plidogrel. Your doctor may advise

you to go for tests to determine if

Plidogrel will adequately work for

you. Based on the test results, your

doctor may change your dose of

Plidogrel or consider alternative

treatments for you.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food store.

Some medicines and Plidogrel may

interfere with each other. These

include:

medicines that "thin the blood".

The most common examples of

these include aspirin, heparins

and warfarin. There are others so

please check with your doctor

Non-steroidal anti- inflammatory

drugs (NSAIDs) - medicines

used to treat arthritis, period

pain, aches and pains

medicines used to treat stomach

ulcers or reflux disease (also

called heartburn)

some antidepressant medicines

phenytoin - a medicine used to

treat epilepsy

medicines used to treat diabetes

(e.g. tolbutamide, repaglinide)

medicines used to treat breast

cancer (e.g. tamoxifen,

paclitaxel)

fluvastatin - a medicine used to

lower cholesterol

medicines used to prevent gastric

reflux - proton pump inhibitors

(e.g. omeprazole).

These medicines may be affected by

Plidogrel or affect how well

Plidogrel works.

Your doctor may need to change the

amount of your medicines, or you

may need to take different

medicines.

If you are unsure about any

medicine you are taking you

should check with your doctor or

pharmacist. They will have more

information on medicines to be

careful with or avoid while taking

Plidogrel.

How to take Plidogrel

How to take it

Your doctor will tell you how many

tablets to take each day.

Take Plidogrel only as prescribed

by your doctor and follow his or

her directions carefully.

They may differ from the

information contained in this leaflet.

The usual dose of Plidogrel is one

75 mg tablet daily.

If you are prescribed Plidogrel for

the treatment of Acute Coronary

Syndrome, you may receive a

starting dose of 300 mg (four 75 mg

tablets), then one 75 mg tablet daily.

You can take Plidogrel before or

after meals. You should swallow

the tablet with a glass of water

Take Plidogrel at about the same

time each day.

Taking your tablet at the same time

each day will have the best effect. It

will also help you to remember

when to take it.

You should take Plidogrel for as

long as your doctor continues to

prescribe it.

If you forget to take it

If you miss a dose, take it as soon

as you remember. If it is almost

time for your next dose, skip the

dose you missed and take your

next dose when you are meant to.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or the Poisons Information

Centre (telephone 13 11 26), or go

to the Emergency Department at

your nearest hospital, if you think

that you or anyone else may have

taken too much Plidogrel. Do this

even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are taking

Plidogrel

Things you must do

Take Plidogrel exactly as your

doctor has prescribed, and

have any blood tests promptly

if your doctor orders them.

Tell your doctor if you become

pregnant while taking

Plidogrel.

Tell your doctor if you decide

to breast feed your baby.

Your doctor may want to discuss

this and change your medicine.

Tell your doctor that you are

taking Plidogrel if you are

about to start on any new

medicine.

PLIDOGREL- Consumer Medicine Information

Page 3 of 4

Tell all your doctors, dentists,

nurses and pharmacists that

you are taking Plidogrel.

Plidogrel may increase the risk

of

bleeding during an

operation or some dental work.

Therefore, treatment may need to be

stopped before surgery. Your doctor

will decide whether to stop Plidogrel

and if so, how long before surgery

or dental work.

Ask your doctor whether there

are any activities you should

avoid while taking Plidogrel,

for example certain sports.

Sometimes after an injury bleeding

may occur inside your body without

you knowing about it.

Tell your doctor immediately if

you are injured while taking

Plidogrel.

It may take longer than usual to stop

bleeding while you are taking

Plidogrel.

Tell your doctor immediately if

you notice any of the following:

abnormal bruising or bleeding

abnormal nose bleeds

bloody or black bowel

motions

red or purple blotches on your

skin

swelling of the face, lips,

mouth, tongue or throat which

may cause difficulty

swallowing or breathing (see

also 'Side effects' section)

Do not suddenly stop taking

Plidogrel without telling your

doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

Plidogrel affects you.

As with other medicines, Plidogrel

may cause faintness or dizziness in

some people. Make sure you know

how you react to Plidogrel before

you drive a car or operate

machinery, or do anything else that

could be dangerous if you are faint

or dizzy. If this occurs, do not drive.

If you drink alcohol, faintness or

dizziness may be worse.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Plidogrel tablets.

Like other medicines Plidogrel can

cause some side effects. 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:

diarrhoea

itching

pain or stiffness in the joints

things taste different.

Tell your doctor immediately if

you notice any of the following:

(NOTE: If you take both Plidogrel

and aspirin the risk of side effects

related to bleeding may be

increased.)

bloody or black bowel motions

diarrhoea with blood, mucus,

stomach pain and fever

abdominal or stomach pain

vomiting of blood or vomit that

looks like coffee grounds

coughing up blood

blood in the urine

blood in the eyes

unusually heavy bleeding or

oozing from cuts or wounds

bleeding (including nose bleeds)

or bruising more easily than

normal

unusually heavy or unexpected

menstrual bleeding

breast enlargement in men

numbness (paralysis) or

problems with co-ordination

nausea or vomiting

faintness or dizziness

light-headedness or blurred

vision

slurred speech or other difficulty

in speaking

headache (severe and continuing)

confusion or hallucinations

fever or other signs of infection,

such as a sore throat

rash or hives

chills, sweating or clammy skin

fever, muscle weakness, loss of

appetite and fatigue

muscle pain

weight loss

anaemia (being tired and looking

pale)

red or purple spots visible

through your skin

itching, inflamed, cracking or red

skin

tightness of the chest, wheezing,

coughing or difficulty breathing

yellowing of the skin or the

whites of the eyes, pale stools

and dark urine with vomiting and

stomach pain

swelling of the face, lips, mouth,

tongue or throat which may

cause difficulty in swallowing or

breathing.

These could be more serious side

effects - you may need urgent

medical attention.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice any

other effects.

Do not be alarmed by this list of

side effects. Most people do not

experience any of them.

After using Plidogrel

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take your tablets out of the

box or blister pack they will not

keep well.

Keep Plidogrel in a cool, dry place

where the temperature stays

PLIDOGREL- Consumer Medicine Information

Page 4 of 4

below

25°C.

Heat and dampness can destroy

some medicines. Do not leave

Plidogrel in the car on hot days.

Do not store Plidogrel or any

other medication in the bathroom

or near a sink.

Keep Plidogrel where young

children cannot reach it.

A locked cupboard at least one and a

half meters above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking Plidogrel, ask your

pharmacist what to do with any

tablets that are left over.

Product description

What it looks like

Plidogrel 75mg tablets come as pink

round tablets.

AUST R 218326

A box contains 28 tablets.

Active Ingredient:

clopidogrel 75 mg

Other Ingredients:

mannitol

polyethylene glycol monomethyl

ether

microcrystalline cellulose

hydroxypropylcellulose

crospovidone

citric acid monohydrate

stearic acid

talc

Opadry II pink 32K14834 which

contains

Hypromellose

iron oxide red (E 172)

lactose monohydrate

glycerol triacetate

titanium dioxide (E 171).

Supplier

Plidogrel is supplied in Australia by:

Arrow Pharma Pty Ltd

15-17 Chapel Street

Cremorne VIC 3121

Australia

This leaflet was prepared in May

2016.

23-10-2013

Danish Pharmacovigilance Update, 29 August 2013

Danish Pharmacovigilance Update, 29 August 2013

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Danish Medicines Agency

29-10-2018

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