Enoxaparin Winthrop

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

enoxaparin sodium
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Enoxaparin Winthrop.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Enoxaparin Winthrop against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What Enoxaparin Winthrop is used for

Enoxaparin Winthrop is used in a number of medical conditions. It is used to:
treat blood clots
treat certain types of heart disease (eg. angina and heart attacks), when used with aspirin
prevent blood clots forming after an operation, during hospitalisation or extended bed rest or during purification of the blood by an artificial kidney (haemodialysis).
Enoxaparin Winthrop is one of a group of medicines called low molecular weight heparins (LMWH). These medicines work by reducing blood clotting activity.
Your doctor may have prescribed Enoxaparin Winthrop for another reason.
Ask your doctor if you have any questions about why Enoxaparin Winthrop has been prescribed for you.
There is no evidence that Enoxaparin Winthrop is addictive.
This medicine is only available with a doctor's prescription.

Before you are given it

When you must not use it

Do not use Enoxaparin Winthrop if you have an allergy to Enoxaparin Winthrop, heparin or its derivatives including other LMWHs. Some signs and symptoms of an allergic reaction can include swelling of the face, lips or tongue, wheezing or troubled breathing, skin rash, itching hives, blisters or peeling skin.
Do not use Enoxaparin Winthrop if you have, or have ever had any of the following medical conditions:
major blood disorders
certain types of stroke
stomach or bowel problems such as ulcers or ulcerative colitis
bacterial infections in your heart.
Do not give Enoxaparin Winthrop to a child.
The safety and effectiveness of Enoxaparin Winthrop has not been established in children.
Do not use Enoxaparin Winthrop after the expiry date printed on the syringe.
Do not use Enoxaparin Winthrop if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start using Enoxaparin Winthrop, talk to your doctor or pharmacist.

Before you are given it

Tell your doctor or pharmacist if you have allergies to:
heparin or its derivatives, including other LMWHs
any other medicines
any other substances, such as foods, preservatives or dyes.
Tell your doctor or pharmacist if you have or have had any of the following medical conditions:
major bleeding disorder or blood clotting problem, including a recent stroke or hereditary blood disorders
bacterial endocarditis, inflammation of the lining of the heart caused by bacteria
stomach or bowel problems such as ulcers or ulcerative colitis
kidney or liver disease
uncontrolled high blood pressure
diabetic related eye disease
recently undergone brain, spinal or eye surgery
history of spinal surgery or spinal deformity
an artificial heart valve
obesity
If you have not told your doctor or pharmacist about any of the above, tell them before you start using Enoxaparin Winthrop.
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.
Like most LMWHs, Enoxaparin Winthrop is not recommended to be used during pregnancy. If there is a need to consider Enoxaparin Winthrop during your pregnancy, your doctor or pharmacist will discuss with you the benefits and risks of using it.
Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed.
Like most LMWHs, Enoxaparin Winthrop is not recommended while you are breastfeeding. If there is a need to consider Enoxaparin Winthrop while you are breastfeeding, your doctor or pharmacist will discuss with you the benefits and risks of using it.
Tell your doctor that you are using Enoxaparin Winthrop if your doctor is planning for you to have an anaesthetic injection in your back (spinal or epidural injection).
If you have not told your doctor or pharmacist about any of the above, tell them before you start using Enoxaparin Winthrop.

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 shop.
Some medicines and Enoxaparin Winthrop may interfere with each other. These include:
medicines or substances used to prevent and treat blood clots
medicines containing aspirin or salicylates
Dextran 40, a medicine use to treat shock
medicines used to treat inflammatory disease, such as oral non-steroidal anti-inflammatory medicines or corticosteroids.
If any of these medicines are used while using Enoxaparin Winthrop, careful monitoring of your blood clotting factors is required by your doctor.
These medicines may be affected by Enoxaparin Winthrop or may affect how well it works. You may need to use different amounts of your medicine or you may need to use different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while using Enoxaparin Winthrop.

How to use it

How much to use

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.
For the prevention of blood clots, the following are the usual doses, which are administered by injection under the skin once a day:
moderate risk patients: 20mg
high risk patients: 40mg
For the treatment of blood clots which have formed in the leg/deep vein,
the usual dose is 1mg/kg body weight twice a day or 1.5mg/kg body weight once a day injected under the skin. Warfarin sodium therapy is usually started within 72 hours of Enoxaparin Winthrop by your doctor.
For patients that require dialysis,
the usual dose is 1mg/kg into the tubing of the dialysis machine at the start of the session. Additional doses may be given if required.
For treatment of severe heart attacks,
the usual dose is 30mg injected into a vein plus 1mg/kg injected under the skin, followed by 1mg/kg injected under the skin twice a day.
For treatment of certain other types of heart disease,
the usual dose is 1 mg/kg injected under the skin twice a day.
These doses of Enoxaparin Winthrop may be changed by your doctor. Your doctor will decide when and how much you will be given.

How to use it

Enoxaparin Winthrop is usually given by an injection under the skin or into the tubing of the dialysis machine. The recommended site for injection is the stomach area. A different injection site should be used for each injection. Do not rub the injection site after administration.
It may be given by your doctor, nurse or yourself. Your doctor will tell you how you will be given your injection.
Enoxaparin Winthrop can also be given by an injection into a vein. This will be done in hospital by your doctor or nurse.
Prefilled Syringes
The prefilled syringes are ready for use. The air bubble in the syringe should not be expelled.
Graduated Prefilled Syringes
When using the 60mg, 80mg, 100mg, 120mg and 150mg graduated syringes, the volume to be injected should be measured precisely according to the dosage recommended by your doctor.
Injection Technique
The whole length of the syringe needle should be introduced vertically into the thickness of a skin fold gently held between the operator's thumb and finger. This skin fold should be held throughout the duration of the injection.
Enoxaparin Winthrop does not contain any antimicrobial agents, so must be used once only and any residue discarded.

How long to use it

Your doctor will tell you how long you will be using Enoxaparin Winthrop.

If you use too much (overdose)

As Enoxaparin Winthrop is often given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, some patients may self-inject Enoxaparin Winthrop.
Tell your doctor or nurse or telephone the Poisons Information Centre in Australia (13 11 26) or the National Poisons Information Centre in NZ (0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have injected too much Enoxaparin Winthrop.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are using it

Things you must do

Use Enoxaparin Winthrop exactly as your doctor has prescribed.
If you become pregnant while using Enoxaparin Winthrop tell your doctor immediately.
Tell your doctor if you have an artificial heart valve.
If you are about to be started on any new medicine tell your doctor, dentist or pharmacist that you are using Enoxaparin Winthrop.
Tell any other doctors, dentists or pharmacists who are treating you that you are using Enoxaparin Winthrop.
If you plan to have surgery, tell your doctor or dentist that you are using Enoxaparin Winthrop.
Tell your doctor that you are using Enoxaparin Winthrop if your doctor is planning for you to have an anaesthetic injection in your back (spinal or epidural injection).

Things you must not do

Do not give Enoxaparin Winthrop to anyone else, even if they have the same condition as you.
Do not use Enoxaparin Winthrop to treat any other complaints, unless your doctor tells you to.
Do not stop using Enoxaparin Winthrop, or lower the dosage, without checking with your doctor or pharmacist.
Do not mix Enoxaparin Winthrop with other injections or infusion fluids.
Certain medicines or solutions contain ingredients that can interact with Enoxaparin Winthrop. If you need an injection of Enoxaparin Winthrop into a vein, your doctor or nurse will make sure it is not mixed with any medicines or solutions with which it can interact.
Do not inject Enoxaparin Winthrop into a muscle.

Things to be careful of

Enoxaparin Winthrop is not interchangeable with other low molecular weight heparins (LMWH) products.
Ask your doctor whether there are any activities you should avoid while using Enoxaparin Winthrop, for example certain sports.
Sometimes after an injury bleeding may occur inside your body without you knowing about it.
Be sure to keep all of your doctor appointments. Your doctor will check your progress and may want to take some blood tests from time to time.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Enoxaparin Winthrop.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
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, bruising or irritation at the injection site after Enoxaparin Winthrop has been given
hard inflamed nodules at the injection site
itchy red rash at the injection site
bleeding at the injection site
itchy skin
If any of the following happen, stop using Enoxaparin Winthrop and tell your doctor immediately or go to the Emergency Department at your nearest hospital:
painful itchy red/purple rash at the injection site
difficulty in breathing, symptoms of hayfever, feeling faint, itching hives, blisters or other symptoms of allergy
bleeding (including nose bleeds or prolonged bleeding from cuts), bruising more easily than normal, red or dark brown urine, red or black bowel motions
numbness (paralysis), problems with coordination, dizziness, tiredness, light-headedness, blurred vision, confusion or difficulty speaking
severe abdominal, chest pain and headache
nausea, diarrhoea, fever
swelling of the hands, ankles or feet
a fine widespread rash, especially noticeable on your mouth or eyes or sudden onset of white or blue colour in fingers or toes suggesting poor blood supply.
If you need to have had an anaesthetic injection in your back (spinal or epidural injection) while taking Enoxaparin Winthrop, this should be done in a hospital. Tell your doctor immediately if any of the following happen after an anaesthetic injection in your back:
pain in the middle of your back (midline back pain)
numbness and weakness in your legs (sensory and motor deficits)
intestinal problems and problems in passing urine
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Keep Enoxaparin Winthrop in a cool dry place where the temperature stays below 25°C.
Keep the syringes in the pack until it is time to use them.
Do not freeze Enoxaparin Winthrop.
Do not leave Enoxaparin Winthrop in the car.
Keep Enoxaparin Winthrop away from direct sunlight.
Do not store Enoxaparin Winthrop or any other medicine in the bathroom, near a sink or stove or on a windowsill.
Heat, light and dampness can destroy some medicines.
Keep Enoxaparin Winthrop where children cannot reach it.
A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Enoxaparin Winthrop or you find that the syringes have passed their expiry date, ask your doctor or pharmacist what to do with any that are left over.
Return any unused medicine to your pharmacist.

Product description

What it looks like

Enoxaparin Winthrop is available in the following range of presentations:
Ready to use Prefilled Syringes:
20mg/0.2mL, 10's
40mg/0.4mL, 10's
Ready to use Prefilled Syringes with graduated markings:
60mg/0.6mL, 10's
80mg/0.8mL, 10's
100mg/1.0mL, 10's
120mg/0.8mL, 10's
150mg/1.0mL, 10's

Ingredients

Active Ingredient:
Enoxaparin Winthrop contains enoxaparin sodium.
Inactive Ingredients:
Enoxaparin Winthrop also contains water for injections.

Sponsor

Enoxaparin Winthrop is distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
 
This leaflet was prepared in October 2017
Australian Register Numbers:
Pre-filled Syringes
20mg-AUST R 293887
40mg-AUST R 293888
60mg-AUST R 293889
80mg-AUST R 293890
100mg-AUST R 293891
120mg-AUST R 293892#
150mg-AUST R 293893#
Pre-filled syringes with automatic safety lock system #
20mg-AUST R 293894
40mg-AUST R 293895
60mg-AUST R 293896
80mg-AUST R 293897
100mg-AUST R 293898
120mg-AUST R 293899
150mg-AUST R 293900
# Not marketed in Australia
* Subsequent references to "ENOXAPARIN WINTHROP" refer to both ENOXAPARIN WINTHROP and ENOXAPARIN WINTHROP FORTE.
enoxaparin-winthrop-ccdsv12-cmiv1-oct17