Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Iscover?
Iscover contains the active ingredient clopidogrel. Iscover 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. For more information, see
Section
1. Why am I using Iscover? in the full CMI.
2. What should I know before I use Iscover?
Do not use if you have ever had an allergic reaction to Iscover or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use Iscover? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Iscover?
Take Iscover only as prescribed by your doctor and follow his or her directions carefully.
5. What should I know while using Iscover?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Iscover.
Iscover may increase the risk of bleeding during an operation or some dental work.
Tell your doctor immediately if you are injured while taking Iscover. It may take
longer than usual to stop bleeding while you are taking Iscover.
Tell your doctor that you are taking Iscover if you are about to start on any new
medicine.
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Things you should not do
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Do not use Iscover during pregnancy.
Do not use Iscover if you are breast feeding or intend to breast feed.
Do not stop using this medicine suddenly.
Do not take Iscover if you have a medical condition that is causing bleeding such
as a stomach ulcer or bleeding within your head.
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Driving or using machines
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Iscover may cause faintness or dizziness in some people. Make sure you know how you
react to Iscover 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.
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Looking after your medicine
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Keep Iscover in a cool, dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Like other medicines Iscover can cause some side effects. Most are likely to be minor
and temporary. However, some may be serious and need medical attention such as bleeding
or bruising more easily, blood in the urine and in the eye, coughing up blood, diarrhoea
with blood, tightness of the chest, swelling of the face, lips, mouth, tongue or throat
which may cause difficulty swallowing or breathing. For more information, including
what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
Clopidogrel (clop-id-o(h)-grel)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Iscover. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Iscover.
Where to find information in this leaflet:
1. Why am I using Iscover?
Iscover contains the active ingredient clopidogrel. Iscover 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).
Iscover 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 Iscover 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.
Iscover is only available on a doctor's prescription.
2. What should I know before I use Iscover?
Warnings
Do not use Iscover if:
you are allergic to clopidogrel, or any of the ingredients listed 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.
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 Iscover to treat any other complaint unless your doctor says it is safe.
Do not give this medicine to anyone else.
Check with your doctor if you:
have any other medical conditions, especially the following:
bleeding disorders or blood clotting problems
liver or kidney 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
recent surgery (including dental surgery)
allergic to other antiplatelet medicines (such as ticlopidine, prasugrel)
rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption
take any medicines for any other condition
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 Iscover prior to surgery
If you have not told your doctor about any of the above, tell him/her before you start
taking Iscover.
Some patients may not convert Iscover to its active form as well as other patients.
These patients may not get the same benefit from Iscover. Your doctor may advise you
to go for tests to determine if Iscover will adequately work for you. Based on the
test results, your doctor may change your dose of Iscover or consider alternative
treatments for you.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Do not use Iscover during pregnancy unless in the opinion of your doctor there is
a clear need.
Your doctor will discuss the possible risks and benefits of taking Iscover during
pregnancy.
Do not use Iscover if you are breast feeding or intend to breast feed. Iscover passes into breast milk and, therefore, there is the possibility that the
breast fed baby may be affected.
Use in Children
Iscover is not recommended for children as its safety and effectiveness in children
have not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with
Iscover and affect how it works. 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 medicines used to treat infections (eg ciprofloxacin, chloramphenicol, fluconazole
and voriconazole)
Some antidepressant medicines.
medicines used to treat epilepsy (e.g. carbamazepine, oxcarbazepine and phenytoin)
medicines used to treat diabetes (eg. 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)
certain type of pain relief medicines called opiates
rosuvastatin (used to lower your cholesterol level)
These medicines may be affected by Iscover or affect how well Iscover works.
Your doctor may need to change the amount of your medicines, or you may need to take
different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Iscover.
4. How do I use Iscover?
How much to take
Your doctor will tell you how many tablets to take each day. Take Iscover 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 Iscover is one 75 mg tablet daily.
If you are prescribed Iscover for the treatment of Acute Coronary Syndrome, you may
receive a starting dose of 300 mg (either one 300 mg tablet or four 75 mg tablets),
then one 75 mg tablet daily.
When to take use Iscover
You can take Iscover before or after meals. You should swallow the tablet with a glass
of water.
You should take Iscover for as long as your doctor continues to prescribe it.
If you forget to use Iscover
Iscover should be used regularly at 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.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
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 use too much Iscover
If you think that you have used too much Iscover, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Iscover?
Things you should do
Call your doctor straight away if you:
if you become pregnant while taking Iscover.
if you decide to breast feed your baby. Your doctor may want to discuss this and change
your medicine.
if you are about to start on any new medicine
if you are injured while taking Iscover. It may take longer than usual to stop bleeding
while you are taking Iscover.
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)
Take Iscover exactly as your doctor has prescribed, and have any blood tests promptly
if your doctor orders them.
Ask your doctor whether there are any activities you should avoid while taking Iscover,
for example certain sports. Sometimes after an injury bleeding may occur inside your
body without you knowing about it.
Remind any doctor, dentist or pharmacist you visit that you are using Iscover. Iscover
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 Iscover and if so, how long before surgery or dental work.
Things you should not do
Do not stop using this medicine suddenly without telling your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Iscover
affects you.
Iscover may cause faintness or dizziness in some people. Make sure you know how you
react to Iscover 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.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
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.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place where the temperature stays below 25°C away from moisture,
heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one and a half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Iscover contains
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Active ingredient
(main ingredient)
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clopidogrel (75 mg)
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Other ingredients
(inactive ingredients)
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mannitol
macrogol 6000
microcrystalline cellulose
hydrogenated castor oil
hyprolose
carnauba wax
OPADRY II complete film coating system 32K14834 Pink. The coating contains lactose
monohydrate.
(Note: Iscover does not contain any salicylates)
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Do not take this medicine if you are allergic to any of these ingredients.
What Iscover looks like
Iscover 75mg tablets come as pink, round tablets with '75' engraved on one side and
'1171' on the other side (AUST R 79021).
A box contains 28 tablets.
Who distributes Iscover
Iscover is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Rd,
Macquarie Park NSW 2113
This leaflet was prepared in May 2022.
® Iscover is a registered trademark of sanofi-aventis.
iscover-ccdsv29-cmiv8-02may22