Fondaparinux sodium Dr. Reddy's 10 mg/0.8 ml Solution For Injection in Pre-Filled Syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to fondaparinux sodium or to any of the other ingredients of this medicine listed in section 6
• if you are bleeding excessively
• if you have a bacterial heart infection
• if you have very severe kidney disease.

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:

• if you have previously had complications during treatment with heparin or heparin-like medicines causing a fall in the number of blood platelets (heparin-induced thrombocytopenia)
• if you have a risk of uncontrolled bleeding (haemorrhage) including:
  • stomach ulcer
  • bleeding disorders
  • recent bleeding into the brain (intracranial bleeding)
  • recent surgery on the brain, spine or eye
• if you have severe liver disease
• if you have kidney disease
• if you are 75 years old or older
• if you weigh less than 50 kg.

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.

• Fondaparinux sodium is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area. The syringes are pre-filled with the exact dose you need. There are different syringes for the 2.5 mg and 1.5 mg doses. For step -by -step instructions please see over the page.
• Do not inject Fondaparinux sodium into muscle.

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.

• Take the dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose.
• If you are not sure what to do, ask your doctor or pharmacist.

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 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.

• after the expiry date which is stated on the label and carton after “EXP”. The expiry date refers to the last day of that month
• if you notice any particles in the solution, or if the solution is discoloured
• if you notice that the syringe is damaged
• if you have opened a syringe and you do not use it straightaway.

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.

• 5 mg fondaparinux sodium in 0.4 ml solution for injection
• 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
• 10 mg fondaparinux sodium in 0.8 ml solution for injection

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).

The different parts of Fondaparinux sodium safety syringe are:

1. Rigid Needle Shield
2. Plunger
3. Finger-grip
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.

NOTE:

• The safety system can only be activated once the syringe has been emptied.
• Activation of the safety system must be done only after removing the needle from the patient’s skin.
• Do not replace the needle shield after injection.
• The safety system should not be sterilized.
• Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.