Clopidogrel Lupin

Clopidogrel Lupin

Active ingredient(s): clopidogrel (as hydrogen sulfate)

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Clopidogrel Lupin. 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 Clopidogrel Lupin.

Where to find information in this leaflet:

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

1. Why am I using Clopidogrel Lupin?

Clopidogrel Lupin contains the active ingredient clopidogrel (as hydrogen sulfate). Clopidogrel Lupin 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).

Clopidogrel Lupin 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 Clopidogrel Lupin 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); or
• 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.

Some patients may not convert Clopidogrel Lupin to its active form as well as other patients. These patients may not get the same benefit from Clopidogrel Lupin. Your doctor may advise you to go for tests to determine if Clopidogrel Lupin will adequately work for you. Based on the test results, your doctor may change your dose of Clopidogrel Lupin or consider alternative treatments for you.

2. What should I know before I use Clopidogrel Lupin?

Warnings

Do not use Clopidogrel Lupin 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.
• you are breastfeeding or intend to breastfeed.
  Clopidogrel Lupin 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.

Check with your doctor if you:

• have any other medical conditions, especially:
  – 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;
  – any allergy to other antiplatelet medicines (such as ticlopidine or 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 Clopidogrel Lupin prior to surgery.
• take any medicines for any other condition.

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.

You should not take Clopidogrel Lupin if you are breastfeeding or intend to breastfeed. Clopidogrel Lupin passes into breast milk and, therefore, there is the possibility that the breast fed baby may be affected

Use in children

• Clopidogrel Lupin 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 Clopidogrel Lupin or interfere with Clopidogrel Lupin 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).
• 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 (eg. omeprazole).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Clopidogrel Lupin.

4. How do I use Clopidogrel Lupin?

How much to take

• The usual dose of Clopidogrel Lupin is one 75 mg tablet daily.
• If you are prescribed Clopidogrel Lupin 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.
• Follow the instructions provided and use Clopidogrel Lupin until your doctor tells you to stop.

When to take Clopidogrel Lupin

• You can take Clopidogrel Lupin before or after meals.
• Take Clopidogrel Lupin 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 Clopidogrel Lupin for as long as your doctor continues to prescribe it.

How to take Clopidogrel Lupin

• You should swallow the tablet with a glass of water.

If you forget to take Clopidogrel Lupin

Clopidogrel Lupin 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 use too much Clopidogrel Lupin

If you think that you have used too much Clopidogrel Lupin, 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 Clopidogrel Lupin?

Things you should do

Take Clopidogrel Lupin exactly as your doctor has prescribed, and have any blood tests promptly if your doctor orders them.

Tell all your doctors, dentists, nurses and pharmacists that you are taking Clopidogrel Lupin. Clopidogrel Lupin 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 Clopidogrel Lupin and if so, how long before surgery or dental work.

Ask your doctor whether there are any activities you should avoid while taking Clopidogrel Lupin, for example certain sports. Sometimes after an injury bleeding may occur inside your body without you knowing about it.

Call your doctor straight away if you:

• become pregnant while taking Clopidogrel Lupin.
• decide to breastfeed your baby. Your doctor may want to discuss this and change your medicine.
• are taking Clopidogrel Lupin if you are about to start on any new medicine.
• are injured while taking Clopidogrel Lupin. It may take longer than usual to stop bleeding while you are taking Clopidogrel Lupin.
• 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 Section 6. Are there any side effects?).

Remind any doctor, dentist, nurses or pharmacist you visit that you are using Clopidogrel Lupin.

Things you should not do

• Do not stop using this medicine suddenly.

Driving or using machines

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

Clopidogrel Lupin may cause dizziness in some people. Make sure you know how you react to Clopidogrel Lupin 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.

If you are feeling faint or dizzy, drinking alcohol may make faintness or dizziness worse.

Looking after your medicine

• Store below 25°C.

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place 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.

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.

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

Less serious side effects

Less serious side effects	What to do
Diarrhoea. Itching. Pain or stiffness in the joints. Things taste different.	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

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. 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.

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.

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 Clopidogrel Lupin contains

Active ingredient (main ingredient)	Clopidogrel (as clopidogrel hydrogen sulfate
Other ingredients (inactive ingredients)	Microcelac 100 (microcrystalline cellulose plus lactose) Hydroxypropyl cellulose Hydrogenated castor oil Colloidal anhydrous silica Opadry II 31K34575 Pink film-coating contains: – Lactose – Hypromellose – Titanium dioxide – Glycerol triacetate – Iron oxide red) [PI No. 106397]
Potential allergens	Lactose

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

What Clopidogrel Lupin looks like

Clopidogrel Lupin 75 mg tablets are pink coloured, round, biconvex, film-coated tablets, debossed with “Cl” on one side and plain on other side (AUST R 376880).

Who distributes Clopidogrel Lupin

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia
  ghinfo@generichealth.com.au
  +61 3 9809 7900
  www.generichealth.com.au

This leaflet was prepared in September 2021.