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: PL 08553/0551.
Fondaparinux sodium 5 mg/0.4 ml, 7.5 mg/0.6 ml, 10 mg/0.8 ml Solution for Injection in Pre-Filled Syringe
Fondaparinux sodium 5 mg/0.4 ml Solution for Injection in Pre-Filled Syringe
Fondaparinux sodium 7.5 mg/0.6 ml Solution for Injection in Pre-Filled Syringe
Fondaparinux sodium 10 mg/0.8 ml Solution for Injection in Pre-Filled Syringe
1. What Fondaparinux sodium is and what it is used for
2. What you need to know before you use Fondaparinux sodium
3. How to use Fondaparinux sodium
4. Possible side effects
5. How to store Fondaparinux sodium
6. Contents of the pack and other information
Fondaparinux sodium is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Fondaparinux sodium solution contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.
Fondaparinux sodium is used to treat adults with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism).
Tell your doctor if you think any of these apply to you. If they do, you must not use Fondaparinux.
Talk to your doctor, pharmacist or nurse before using Fondaparinux sodium:
Tell your doctor if any of these apply to you.
Fondaparinux has not been tested in children and adolescents under the age of 17 years.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some other medicines may affect the way that Fondaparinux sodium works or be affected by Fondaparinux sodium.
Fondaparinux sodium should not be prescribed to pregnant women unless clearly necessary. Breastfeeding is not recommended during treatment with Fondaparinux sodium. If you are pregnant, or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your weight Usual dose
Below 50 kg 5 mg once a day
Between 50 kg and 100 kg 7.5 mg once a day
Over 100 kg 10 mg once a day. This dose may be reduced to 7.5 mg once a day if you have moderate kidney disease.
You should inject at about the same time each day.
You should continue Fondaparinux sodium treatment for as long as your doctor has told you, since Fondaparinux sodium prevents development of a serious condition.
Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.
If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung. Contact your doctor or pharmacist before stopping.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Fondaparinux sodium. Signs include:
Contact a doctor immediately if you get these symptoms. Stop taking Fondaparinux sodium.
Common side effects
These may affect more than 1 in 100 people treated with Fondaparinux sodium.
Uncommon side effects
These may affect up to 1 in 100 people treated with Fondaparinux sodium.
Rare side effects
These may affect up to 1 in every 1000 people treated with Fondaparinux sodium.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the
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.
Do not throw away any medicines and syringes via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The other ingredients are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH.
Fondaparinux sodium is a clear and colourless to slightly yellow solution for injection. It is supplied in a pre-filled syringe. It is available in packs of 2, 7, 10, 20 and 30 pre-filled syringes (not all pack sizes may be marketed).
This leaflet was last revised in 10/2018
The different parts of Fondaparinux sodium safety syringe are:
1. Rigid Needle Shield
4. Safety shield
1. Wash your hands thoroughly with soap and water. Towel dry.
2. Sit or lie down in a comfortable position. Choose a spot on the lower stomach area (abdomen), at least 2 inches below your belly button (Figure A). Change (alternate) between using the left and right side of the lower abdomen for each injection. If you have any questions talk to your nurse or doctor.
3. Clean the injection area with an alcohol swab.
4. Remove the needle shield by pulling it straight off the syringe (Figure B). Discard the needle shield.
To prevent infection, do not touch the needle or let it come in contact with any surface before the injection. A small air bubble in the syringe is normal. To be sure that you do not lose any medicine from the syringe, do not try to remove air bubbles from the syringe before giving the injection.
5. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger of one hand during the entire injection (Figure C).
6. Hold the syringe firmly in your other hand using the finger-grip. Insert the full length of the needle directly up and down (at an angle of 90°) into the skin fold (Figure D).
7. Inject all of the medicine in the syringe by pressing down on the plunger as far as it goes. (Figure E).
8. Remove the syringe from the injection site keeping your finger on the plunger.
9. Orient the needle away from you and others, and activate the safety shield by firmly pushing the plunger. The protective sleeve will automatically cover the needle and an audible "click" will be heard to confirm shield activation.
Follow the instructions given to you by your nurse or doctor about the right way to throw away used syringes and needles. There may be state laws about the right way to dispose of used syringes, needles, and disposal containers.