(Clopidogrel Tablets 75)
Consumer Medicine Information
Please read this leaflet carefully before you start taking Plavicor. You may wish to keep it to read again.
What is in this leaflet
This leaflet answers some common questions about Plavicor.
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 Plavicor, your doctor has weighed the risks of you taking Plavicor against the expected benefits it will have for you.
Always follow the instructions that your doctor and pharmacist give you about Plavicor.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
What Plavicor is used for
Plavicor contains the medicine clopidogrel. Plavicor 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).
Plavicor 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 Plavicor 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.
Plavicor is only available on a doctor's prescription.
Before you take Plavicor
When you must not take it
You should not take Plavicor 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. Plavicor 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 Plavicor to treat any other complaint unless your doctor says it is safe. Do not give this medicine to anyone else.
Plavicor is not recommended for children as its safety and effectiveness in children has not been established.
Before you start to take Plavicor
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 Plavicor 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 taking Plavicor 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
– recent surgery (including dental surgery)
– any form of liver disease
If you have not told your doctor about any of the above, tell him/ her before you start taking Plavicor.
Some patients may not convert Plavicor to its active form as well as other patients. These patients may not get the same benefit from Plavicor. Your doctor may advise you to go for tests to determine if Plavicor will adequately work for you. Based on the test results, your doctor may change your dose of Plavicor 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 Plavicor 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).
- phenytoin – a medicine used to treat epilepsy.
- tolbutamide – a medicine used to treat diabetes.
- tamoxifen – a medicine used to treat breast cancer.
- 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 Plavicor or affect how well Plavicor 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 Plavicor.
How to take Plavicor
How to take it
Your doctor will tell you how many tablets to take each day. Take Plavicor 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 Plavicor is one 75 mg tablet daily.
If you are prescribed Plavicor 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 Plavicor before or after meals. You should swallow the tablet with a glass of water.
Take Plavicor 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 Plavicor for as long as your doctor continues to prescribe it.
If you forget to take Plavicor
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 Plavicor. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking Plavicor
Things you must do
- Take Plavicor 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 Plavicor.
- 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 Plavicor if you are about to start on any new medicine.
- Tell all your doctors, dentists, nurses and pharmacists that you are taking Plavicor. Plavicor 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 Plavicor and if so, how long before surgery or dental work.
- Ask your doctor whether there are any activities you should avoid while taking Plavicor, 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 Plavicor.
It may take longer than usual to stop bleeding while you are taking Plavicor.
- 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 you 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 Plavicor without telling your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how Plavicor affects you.
As with other medicines, Plavicor may cause faintness or dizziness in some people. Make sure you know how you react to Plavicor 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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Plavicor.
Like other medicines Plavicor 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:
- 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 Plavicor 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 and stomach pain
- vomiting of blood or vomit that looks like coffee grounds
- coughing of 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
- 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 Plavicor
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 Plavicor in a cool, dry place where the temperature stays below 25°C. Heat and dampness can destroy some medicines. Do not leave Plavicor in the car on hot days.
Do not store Plavicor or any other medication in the bathroom or near a sink.
Keep Plavicor 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.
If your doctor tells you to stop taking Plavicor, ask your pharmacist what to do with any that are left over.
What it looks like
Plavicor 75 tablets comes as Pink coloured, round, biconvex, film coated tablets, debossed with “Cl” on one side and plain on other side.
Plavicor 75 is available in blister packs containing 4, 7, 14, 28*, 30, 50, 56, 84, 112 and 280 tablets.
Plavicor 75 is also available in bottles containing 30, 90*#, 112 and 120 tablets.
* Marketed pack
# Hospital pharmacies only
75 mg strength contains 75 mg of Clopidogrel
- microcelac 100 (microcrystalline cellulose + lactose)
- hydroxypropyl cellulose
- hydrogenated castor oil
- colloidal anhydrous silica
- The coating contains Opadry II 31K34575 Pink (lactose, hypromellose, titanium dioxide, glycerol triacetate and iron oxide red) [PI No. 106397]
Name and Address of the Sponsor
Pharmacor Pty. Ltd.
Dee Why NSW 2099
AUST R 187039 (Blister Pack)
AUST R 187038 (Bottle Pack)
Date of first inclusion in the ARTG
17th May 2012
Published by MIMS April 2015