PLAVICOR 75

PLAVICOR 75

Active ingredient(s): clopidogrel

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Plavicor. 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 Plavicor.

Where to find information in this leaflet:

1. Why am I using Plavicor?
2. What should I know before I use Plavicor?
3. What if I am taking other medicines?
4. How do I use Plavicor?
5. What should I know while using Plavicor?
6. Are there any side effects?
7. Product details

1. Why am I using Plavicor?

Plavicor contains the active ingredient clopidogrel. Plavicor belongs to a group of medicines called antiplatelet 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.

2. What should I know before I use Plavicor?

Warnings

Do not use Plavicor if:

• you are allergic to clopidogrel, or any of the ingredients listed at the end of this leaflet.
• always check the ingredients to make sure you can use this medicine.
• 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

Check with your doctor if you:

• have or have had 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)
  – rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
• take any medicines for any other condition
• are allergic to other antiplatelet medicines (such as ticlopidine, prasugrel)
• 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 Plavicor prior to surgery

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?

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.

Pregnancy and breastfeeding

Check with 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.

Do not use Plavicor if you are breastfeeding or intend to breastfeed. Plavicor passes into breast milk and, therefore, there is the possibility that the breast fed baby may be affected.

Children

• Plavicor 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 be affected by Plavicor or may interfere with Plavicor 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 antiinflammatory 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 call opiates
• rosuvastatin (used to lower your cholesterol level)

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 Plavicor.

4. How do I use Plavicor?

How much to take / use

• Your doctor will tell you how many tablets to take each day
• 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 (either one 300 mg tablet or four 75 mg tablets), then one 75 mg tablet daily
• Follow the instructions provided and use Plavicor until your doctor tells you to stop

When to take / use Plavicor

• 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.

If you forget to use Plavicor

Plavicor should be used regularly at the same time each day. If you miss your dose at the usual time, 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.

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 Plavicor

If you think that you have used too much Plavicor, 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 Plavicor?

Things you should do

Call your doctor straight away if you:

• become pregnant while taking Plavicor
• decide to breast feed your baby. Your doctor may want to discuss this and change your medicine.
• are about to start on any new medicine
• are injured while taking Plavicor. It may take longer than usual to stop bleeding while you are taking Plavicor
• 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 Plavicor 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 Plavicor, for example certain sports. Sometimes after an injury bleeding may occur inside your body without you knowing about it.

Remind any doctor, dentist, nurse or pharmacist you visit that you are using 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.

Things you should not do

• Do not stop using this medicine suddenly
• Do not take Plavicor to treat any other complaint unless your doctor says it is safe
• Do not give this medicine to anyone else

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Plavicor affects you.

Plavicor may cause faintness or dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may make faintness or dizziness worse.

Looking after your medicine

• Keep your tablets in the blister pack until it is time to take them
• If you take the tablets out of the box or the blister pack they may 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 (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. If you use this product after the expiry date has passed, it may not work.

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

Less serious side effects	What to do
diarrhoea itching pain or stiffness in the joints things taste different hunger trembling flushing a fast, pounding heartbeat	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Bleeding related: bloody or black bowel motions diarrhoea with blood, mucus, stomach pain and fever 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 Head and neurology: faintness or dizziness light-headedness or blurred vision slurred speech or other difficulty in speaking headache (severe and continuing) confusion or hallucinations numbness (paralysis) or problems with co-ordination Skin and face: rash or hives red or purple spots visible through your skin itching, inflamed, cracking or red skin swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing yellowing of the skin or the whites of the eyes Gastrointestinal: abdominal or stomach pain nausea or vomiting weight loss pale stools and dark urine with vomiting and stomach pain Hormone related: breast enlargement in men General body: fever or other signs of infection, such as a sore throat chills, sweating or clammy skin fever, muscle weakness, loss of appetite and fatigue muscle pain anaemia (being tired and looking pale) tightness of the chest, wheezing, coughing or difficulty breathing

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

NOTE: If you take both Plavicor and aspirin the risk of side effects related to bleeding may be increased.

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 Plavicor contains

Active ingredient (main ingredient)	clopidogrel
Other ingredients (inactive ingredients)	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]
Potential allergens	n/a

Do not take this medicine if you are allergic to any of these ingredients.

What Plavicor looks like

Plavicor 75 tablets come as pink coloured, round, biconvex, film coated tablets, debossed with “Cl” on one side and plain on the other side.

Plavicor 75 is available in blister packs containing 4, 7, 14, 28♦, 30, 50, 56, 84, 112 and 280 tablets. (Aust R 187039).

Plavicor 75 is also available in bottles containing 30, 90, 112 and 120 tablets. (Aust R 187038).

♦Marketed pack

Who distributes Plavicor

Pharmacor Pty Ltd
Suite 803, Level 8, Tower A, The Zenith,
821 Pacific Highway,
Chatswood, NSW, 2067
Australia

This leaflet was prepared in November 2023.