- enoxaparin sodium
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL04425/0187.
Clexane pre-filled syringes
Package leaflet: Information for the user
Clexane® Syringes, 2,000 IU (20 mg)/0.2 ml solution for injection in pre-ﬁlled syringes
Clexane® Syringes, 4,000 IU (40 mg)/0.4 ml solution for injection in pre-ﬁlled syringes
Clexane® Syringes, 6,000 IU (60 mg)/0.6 ml solution for injection in pre-ﬁlled syringes
Clexane® Syringes, 8,000 IU (80 mg)/0.8 ml solution for injection in pre-ﬁlled syringes
Clexane® Syringes, 10,000 IU (100 mg)/1 ml solution for injection in pre-ﬁlled syringes
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Clexane Syringes are and what they are used for
2. What you need to know before you use Clexane Syringes
3. How to use Clexane Syringes
4. Possible side effects
5. How to store Clexane Syringes
6. Contents of the pack and other information
1. WHAT CLEXANE SYRINGES ARE AND WHAT THEY ARE USED FOR
Clexane Syringes contain the active substance called enoxaparin sodium. This belongs to a group of medicines called ‘low molecular weight heparin’ or LMWH.
How Clexane Syringes work
Clexane Syringes work in two ways:
1) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stops them from causing you harm.
2) Stopping new blood clots from forming in your blood.
What Clexane Syringes are used for
Clexane Syringes can be used to:
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLEXANE SYRINGES
Do not use Clexane Syringes if:
Do not use Clexane Syringes if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Clexane Syringes.
Warnings and precautions
Clexane Syringes should not be interchanged with other ‘low molecular weight heparins’ such as nadroparin, tinzaparin or dalteparin. This is because they are not exactly the same and do not have the same activity and instructions for use.
Talk to your doctor or pharmacist before using Clexane Syringes if:
For patients receiving doses higher than 210 mg/ day, this medicine contains more than 24 mg sodium (main component of cooking/table salt) in each dose. This is equivalent to 1.2% of the recommended maximum daily intake of sodium for an adult.
Tests and checks
You may have a blood test before you start using this medicine and at intervals while you are using it; this is to check the level of the clotting cells (platelets) and potassium in your blood.
Use in children and adolescents
The safety and efficacy of Clexane Syringes has not been evaluated in children or adolescents.
Other medicines and Clexane Syringes
Tell your doctor or pharmacist if you are taking or might take any other medicines.
Operations and anaesthetics
If you are going to have a spinal or lumbar puncture, or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are using Clexane Syringes.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots. Your doctor should discuss this with you.
If you are breast-feeding or plan to breast-feed, you should ask your doctor for advice before taking this medicine.
Driving and using machines
Clexane Syringes do not affect the ability to drive and operate machinery.
It is advised that the trade name and batch number of the product you are using are recorded by your healthcare professional.
3. HOW TO USE CLEXANE SYRINGES
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Having this medicine
How much will be given to you
1) Treating blood clots that are in your blood
2) Stopping blood clots from forming in your blood during operations or periods of limited mobility due to an illness
3) Stopping blood clots when you have unstable angina or after you have had a heart attack
NSTEMI (Non-ST segment Elevation Myocardial Infarction) type of heart attack:
STEMI (ST segment Elevation Myocardial Infarction) type of heart attack if you are under 75 years old:
STEMI type of heart attack if you are 75 years old or older:
For patients that have an operation called percutaneous coronary intervention (PCI):
4) Stopping blood clots from forming in the tubes of your dialysis machine
Giving yourself an injection of Clexane Syringes
If you are able to give Clexane Syringes to yourself, your doctor or nurse will show you how to do this. Do not try to inject yourself if you have not been trained how to do so. If you are not sure what to do, talk to your doctor or nurse immediately. Performing the injection properly under the skin (called “subcutaneous injection”) will help reduce pain and bruising at the injection site.
Before injecting yourself with Clexane Syringes
Instructions on injecting yourself with Clexane Syringes:
Preparing the injection site
1) Choose an area on the right or left side of your stomach. This should be at least 5 centimetres away from your belly button and out towards your sides.
2) Wash your hands. Cleanse (do not rub) the area that you will inject with an alcohol swab or soap and water.
3) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
Selecting your dose
1) Carefully pull off the needle cap from the syringe. Throw away the cap.
2) When the amount of medication in the syringe already matches your prescribed dose, there is no need to adjust the dose. You are now ready to inject.
3) When the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed dose. In that case, you can get rid of any extra medicine by holding the syringe pointing down (to keep the air bubble in the syringe) and ejecting the extra amount into a container.
4) A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by tapping on the syringe with the needle pointing down. You are now ready to inject.
1) Hold the syringe in the hand you write with (like a pencil). With your other hand, gently pinch the cleaned area of your stomach between your forefinger and thumb to make a fold in the skin.
2) Hold the syringe so that the needle is pointing straight down (vertically at a 90° angle). Insert the full length of the needle into the skin fold.
3) Press down on the plunger with your thumb. This will send the medication into the fatty tissue of the stomach. Complete the injection using all of the medicine in the syringe.
4) Remove the needle from the injection site by pulling it straight out. A protective sleeve will automatically cover the needle. You can now let go of the skin fold. The safety system only releases the protective sleeve when the syringe has been emptied by pressing the plunger all the way down.
When you have finished
1) To avoid bruising, do not rub the injection site after you have injected yourself.
2) Drop the used syringe into a sharps container. Close the container lid tightly and place the container out of reach of children. When the container is full, dispose of it as your doctor or pharmacist has instructed.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Changing anticoagulant medicine
If you use more Clexane Syringes than you should
If you think that you have used too much or too little Clexane Syringes, tell your doctor or pharmacist or nurse immediately, even if you have no signs of a problem. If a child accidentally injects or swallows Clexane Syringes, take them to a hospital causualty department straight away.
If you forget to use Clexane Syringes
If you forget to give yourself a dose, have it as soon as you remember. Do not give yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary will help to make sure you do not miss a dose.
If you stop using Clexane Syringes
It is important for you to keep having Clexane Syringes injections until your doctor decides to stop them. If you stop, you could get a blood clot which can be very dangerous.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop using Clexane Syringes and talk to a doctor or nurse straight away if you get any signs of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, oral cavity, throat or eyes).
Like other similar medicines to reduce blood clotting, Clexane Syringes may cause bleeding . This may be life-threatening. In some cases the bleeding may not be obvious.
Talk to your doctor straight away if:
Your doctor may decide to keep you under closer observation or change your medicine.
You should tell your doctor straight away:
Your doctor may request you perform a blood test to check your platelet count.
Other side effects
Very common ( may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CLEXANE SYRINGES
Do not store above 25°C. Do not freeze.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice a breach in the syringe, particulate matters in the solution, or an abnormal colour of the solution (see “What Clexane Syringes look like and contents of the pack”).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Clexane Syringes contain
What Clexane Syringes look like and contents of the pack
Clexane Syringes is a clear, colourless to yellowish solution for injection in a glass pre-filled syringe (with an automatic safety system).
It is supplied in packs of 2, 5, 6, 10, 12, 20, 24, 30, 50, 100 pre-filled syringes, and in multi-packs of 3 x 10, 9 x 10, 100 x 10, and 200 x 10 pre-filled syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in September 2020
Other sources of information
Detailed and recent information about this product is available by scanning the QR code which is present on the box, with a smartphone. The same information is also available at the following URL: www.clexanepatientsupport.co.uk
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525
+44 (0)845 023 0441