NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
CLEXANE® AND CLEXANE® FORTE*
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.
Why am I using Clexane?
Clexane contains the active ingredient enoxaparin sodium. Clexane is used to prevent clots from getting bigger or stopping new clots from forming following hospital procedures or illness.Clexane is also used to treat DVT and heart problems including unstable angina and heart attack when taken with aspirin. Clexane is used to stop blood clots forming in the tubes of your kidney dialysis machine.
For more information, see Section 1. Why am I using Clexane? in the full CMI.
What should I know before I use Clexane?
Do not use if you have ever had an allergic reaction to Clexane, heparin or any medicine derived from heparin, or any of the ingredients listed at the end of the CMI. Do not take Clexane if you have or have had major bleeding disorders, injury to the brain, stomach or bowel problems, or bacterial infections of the heart.
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 Clexane? in the full CMI.
What if I am taking other medicines?
Some medicines may interfere with Clexane and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
How do I use Clexane?
Your doctor will decide what dose you will receive.
Clexane is usually administered by injection under the skin. It can also be injected into the tubing of a dialysis machine or into a vein by a doctor or nurse.
More instructions and how to use Clexane can be found in Section 4. How do I use Clexane? in the full CMI.
What should I know while using Clexane?
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit that you are using Clexane.
Tell your doctor if you become pregnant.
Tell your doctor if you have an artificial heart valve.
Tell your doctor you are using Clexane if you will be having a spinal or epidural injection for anaesthesia.
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Things you should not do
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Do not stop using this medicine without checking with your doctor.
Do not mix Clexane with other injections or fluids.
Do not inject Clexane into a muscle.
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Looking after your medicine
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Store below 25°C. Do not freeze. Store in a cool dry place away from moisture, heat, or sunlight.
Keep the syringe in the pack until it is time to use it.
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For more information, see Section 5. What should I know while using Clexane? in the full CMI.
Are there any side effects?
Less serious side effects include pain, bruising, bleeding, swelling, itch, or rash at the injection site. Serious side effects include allergic reactions, signs of abnormal bleeding such as prolonged bleeding or bruising easily, nausea, gut pain, or numbness.
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: enoxaparin sodium
Consumer Medicine Information (CMI)
This leaflet provides important information about using Clexane. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using Clexane.
Where to find information in this leaflet:
1. Why am I using Clexane?
2. What should I know before I use Clexane?
3. What if I am taking other medicines?
4. How do I use Clexane?
5. What should I know while using Clexane?
6. Are there any side effects?
7. Product details
Why am I using Clexane?
Clexane contains the active ingredient enoxaparin sodium. Clexane is an anticoagulant that belongs to a group of medicines called Low Molecular Weight Heparin (LMWH).These medicines help to prevent clots from getting bigger and stopping new clots from forming.
Clexane is used to prevent clotting following hospital procedures or illness.Clexaneis also used to treat deep vein thrombosis and heart problems including unstable anginaand heart attack when taken with aspirin. Clexane is used to stop blood clots formingin the tubes of your kidney dialysis machine.
What should I know before I use Clexane?
Warnings
Do not use Clexane if:
you are allergic to enoxaparin sodium, heparin or any other medicines derived from heparin, 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, or have ever had any of the following medical conditions:
major bleeding disorders
certain types of injury to the brain including stroke
stomach or bowel problems, such as ulcers or ulcerative colitis
bacterial infections in your heart
Check with your doctor if you:
have or have had any of the following medical conditions:
major bleeding disorder or blood clotting problem including recent stroke or hereditaryblood disorders
bacterial endocarditis, an inflammation of the lining of the heart caused by bacteria
an artificial heart valve particularly in women who are pregnant
uncontrolled high blood pressure
stomach or bowel problems such as ulcers or ulcerative colitis
kidney disease
liver disease
diabetes
eye disease related to diabetes
recent surgery on the brain, spine, or eye
spinal surgery or spinal deformity
underweight or overweight
high level of potassium in your blood
take any medicines for any other condition
If your doctor is planning for you to have an anaesthetic injection in your back (spinal or epidural injection), tell your doctor you are using Clexane.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Clexane is not recommended while you are breastfeeding.
Children
Do not give Clexane to a child.
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 Clexane and affect how it works such as:
medicines used to prevent or treat blood clots, such as clopidogrel or ticlopidine
medicines containing aspirin or salicylates
Dextran 40, a medicine used to treat shock
medicines used to treat inflammatory disease, such as non-steroidal inflammatory drugs, such as ibuprofen or diclofenac, or steroids such as prednisolone
medicines which increase the level of potassium in the blood, such as potassium salts, fluid tablets and some medicines for heart problems
Your doctor will monitor your potassium levels and your ability to form blood clots if you are using any of these medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect Clexane.
How do I use Clexane?
How much to use and when to use Clexane
Follow the instructions provided and use Clexane until your doctor tells you to stop.
Your doctor will decide what dose you will receive.
Clexane is usually administered by injection under the skin.
For the prevention of blood clots
The usual dose for moderate risk patients is 20 mg once per day.
The usual dose for high risk patients is 40 mg once per day.
For the treatment of bloods clots in the leg or deep vein
The usual dose is 1 mg per kg of body weight twice per day or 1.5 mg per kg of body weight once per day.
Warfarin is usually started within 3 days of using Clexane.
For patients requiring dialysis
The usual dose is 1 mg per kg of body weight into the tubing of the dialysis machine at the start of the session.Additional doses may be needed.
For patients who have had severe heart attacks
The usual dose is:
30 mg injected into the vein and 1 mg per kg of body weight injected under the skin, then
1 mg per kg of body weight twice per day.
For patients with other types of heart disease
The usual dose is 1 mg per kg of body weight twice per day.Your doctor may change this dose as needed.
How to use Clexane
Clexane may be given by your doctor, nurse, or you.
Clexane is usually given by injection under the skin or into the tubing of a dialysis machine.It can also be given by injection into a vein. This will be done in hospital by a doctor or nurse.
Prefilled syringes
The prefilled syringes are ready to use.The air bubble in syringe should not be expelled.
Graduated Prefilled Syringes
The graduated syringes have markings indicating the volume in the syringe.The volume (mL) or mass (mg) to be injected should be precisely measured according to the dosage recommended by your doctor.
Injection Technique
The recommended site for injection is the stomach area.A different injection site should be used for each injection.
The needle on the prefilled syringe is covered in a silicon coating. Do not wipe the needle or allow the solution to crystallise on the needle as this will damage the coating.
Gently fold the skin using a thumb and finger. Hold the fold of the skin for the duration of the injection.
Introduce the whole length of the needle vertically into the thickness of the skin fold and inject Clexane.
Do not rub the injection site after administration.
Clexane is for single use only.Use only once and discard after use.
If you use too much Clexane
If you think that you have used too much Clexane or have been given too much Clexane, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26 if you are in Australia), or
(by calling 13 11 26 if you are in Australia), or
phone the National Poisons Information Centre
(by calling 0800 POISON or 0800 764 766 if you are in New Zealand), or
(by calling 0800 POISON or 0800 764 766 if you are in New Zealand), 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.
What should I know while using Clexane?
Things you should do
If you are about to be started on a new medicine tell your doctor, dentist, or pharmacistthat you are using Clexane.
Tell your doctor immediately if you become pregnant.
Tell your doctor if you have an artificial heart valve.
If you plan to have surgery tell your doctor or dentist that you are using Clexane.
Tell your doctor that you are using Clexane if your doctor is planning for you tohave an anaesthetic injection in your back (spinal or epidural injection).
Ask your doctor are there any activities, such as sports, you should avoid while usingClexane.
Tell your doctor if you experience any significant loss of weight or increase in weight.
Keep all your appointments with your doctor and any blood tests.
Remind any doctor, dentist or pharmacist you visit that you are using Clexane.
Clexane is not interchangeable with other medicines containing low molecular weight heparin medicines.
Things you should not do
Do not give Clexane to anyone else even if they have the same condition as you.
Do not use Clexane to treat any other complaints unless a doctor tells you to.
Do not stop using Clexane or change the dosage without checking with your doctor.
Do not mix Clexane with other injections or infusion fluids.Certain medicines or solutions contain ingredients that could interact with Clexane.
Do not inject Clexane into a muscle.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Clexaneaffects you.
Looking after your medicine
Store below 25°C
Do not freeze Clexane
Keep the syringes in the pack until it is time to use them
Follow the instructions in 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
do not store it 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.
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
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Less serious side effects
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What to do
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Injection site-related
Pain, bruising or irritation
Hard, Inflamed nodules
Itchy, red rash
Bleeding
Itchy skin
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Speak to your doctor if you have any of these less serious side effects and they worryyou.
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Serious side effects
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Serious side effects
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What to do
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Allergy-related
Difficulty in breathing, symptoms of hayfever, feeling faint, itching hives, blisters, or other symptoms of allergy
Injection site-related:
Painful itchy red/purple rash
Bleeding-related:
Bleeding, including nose bleeds or prolonged bleeding from cuts
Bruising more easily than normal
Red or dark brown urine, red or black bowel motions
A fine widespread rash, especially noticeable on your mouth or eyes or sudden onset of white or blue colour in fingers in toes suggesting poor blood supply
Spinal or epidural injection-related
Pain in the middle of your back
Numbness and weakness in your legs
Gut problems
Problems passing urine
Other
Nausea, diarrhoea, fever
Swelling of the hands, ankles, or feet.
Severe abdominal pain, chest pain and headache
Numbness (paralysis), problems with coordination, dizziness, tiredness, light-headedness,
Blurred vision, confusion or difficulty speaking
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Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
These side effects are rare.
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Tell your doctor or pharmacist if you notice anything else that may be making youfeel 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 stoptaking any of your medicines.
Product details
This medicine is only available with a doctor’s prescription.
What Clexane contains
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Active ingredient
(main ingredient)
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enoxaparin sodium
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Other ingredients
(inactive ingredients)
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water for injections
nitrogen
It also contains materials of porcine (pig) origin).
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Potential allergens
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enoxaparin sodium
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Do not take this medicine if you are allergic to any of these ingredients.
What Clexane looks like
Clexane is clear, colourless to pale yellow solution for injection.
It is available in the following syringes:
Ready to use Prefilled Syringes
20 mg of enoxaparin sodium per 0.2 mL (pack of 10)
40 mg of enoxaparin sodium per 0.4 mL (pack of 10)
Ready to use Prefilled Syringes with graduated markings
60 mg of enoxaparin sodium per 0.6 mL (pack of 10)
80 mg of enoxaparin sodium per 0.8 mL (pack of 10)
100 mg of enoxaparin sodium per 1.0 mL (pack of 10)
120 mg of enoxaparin sodium per 0.8 mL (pack of 10)
150 mg of enoxaparin sodium per 1.0 mL (pack of 10)
Who distributes Clexane
In Australia:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806
In New Zealand:
sanofi-aventis new zealand limited
Level 8, 56 Cawley Street
Ellerslie, Auckland 1051
Freecall No: 0800 283 684
This leaflet was prepared in August 2020.
Australian Registration Numbers
Pre-filled Syringes#
20 mg Aust R 42965
40 mg Aust R 42962
60 mg Aust R 56709
80 mg Aust R 56710
100 mg Aust R 56711
120 mg Aust R 74173
150 mg Aust R 74175
Prefilled syringes with safety lock system
20 mg Aust R 221717
40 mg Aust R 221718
60 mg Aust R 221719
80 mg Aust R 221720
100 mg Aust R 221721
120 mg Aust R 221722
150 mg Aust R 221723
# Not marketed
* Subsequent references to Clexane refer to both Clexane and Clexane Forte.
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