Patient leaflet - Fondaparinux Sodium DR Reddys 10 mg / 0.8 ml solution for injection in Pre-filled syringe

1. What Fondaparinux sodium is and what it is used for

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).

2. What you need to know before you use Fondaparinux sodium

Do not use Fondaparinux sodium:

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.

Warnings and precautions

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

Tell your doctor if any of these apply to you.

Children and adolescents

Fondaparinux has not been tested in children and adolescents under the age of 17 years.

Other medicines and Fondaparinux sodium

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines you bought without a prescription. Some other medicines may affect the way that Fondaparinux sodium works or be affected by Fondaparinux sodium.

Pregnancy and breastfeeding

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.

Fondaparinux sodium contains sodium

This medicineal product contains less than 1 mmol 23 mg of sodium (23 mg) perin each dose, that is and therefore is to say essentially ‘sodium-free’.

3. How to use Fondaparinux sodium

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You should inject at about the same time each day.

How Fondaparinux sodium is given

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 5 mg, 7.5 mg and 10 mg doses. For step -by -step instructions please see over the page.

Do not inject Fondaparinux sodium into muscle.

How long should Fondaparinux sodium be taken for

You should continue Fondaparinux sodium treatment for as long as your

doctor has told you, since Fondaparinux sodium prevents development of a serious condition.

If you use more Fondaparinux sodium than you should

Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.

If you forget to use Fondaparinux sodium

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 using Fondaparinux sodium

If you stop the treatment before your doctor told you to, the blood clot may be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for

Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Fondaparinux sodium. Signs include:

swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing
collapse

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.

bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums, blood in urine, coughing up blood, bleeding from eyes, bleeding in joint spaces, internal bleeding in uterus)
localised collection of blood (in any organ/body tissue)
anaemia (a reduction in the number of red blood cells)
bruising

Uncommon side effects

These may affect up to 1 in 100 people treated with Fondaparinux sodium.

swelling (oedema)
headache
pain
chest pain
breathlessness
rash or itchy skin
oozing from operation wound site
fever
feeling sick or being sick (nausea or vomiting)
low number of red blood cells (anaemia)
low number of platelets (blood cells necessary for blood clotting)
increase in some chemical (enzymes) produced by the liver

Rare side effects

These may affect up to 1 in every 1000 people treated with Fondaparinux sodium.

allergic reaction (including itching, swelling, rash)
internal bleeding in the brain, liver or abdomen
anxiety or confusion
fainting or dizziness, low blood pressure
drowsiness or tiredness
flushing
coughing
pain and swelling at injection site
wound infection
increase in the amount of non-protein nitrogen in the blood
leg pain or stomach pain
indigestion
diarrhoea or constipation
increase in bilirubin (a substance produced by the liver) in the blood
reduction in potassium in your blood
pain around the upper part of the stomach or heartburn Reporting of side effects

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 Yellow Card Scheme website 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 Fondaparinux sodium

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.

Do not use 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.

Disposal of syringes:

Do not throw away any medicines or syringes via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Fondaparinux sodium contains

The active substance is:

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.

What Fondaparinux sodium looks like and contents of the pack

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 strengths of the medicinal product can be identified by a different coloured plunger rod:

Fondaparinux sodium 5 mg/0.4 ml: syringe with an orange plunger rod and an automatic safety system

Fondaparinux sodium 7.5 mg/0.6 ml: syringe with a magenta plunger rod and an automatic safety system

Fondaparinux sodium 10 mg/0.8 ml: syringe with a violet plunger rod and an automatic safety system

Marketing Authorisation Holder and Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 410 Cambridge Science Park, Milton Road, Cambridge, CB4 0PE, United Kingdom

This leaflet was last revised in 08/2025

Instructions for self-administration The different parts of Fondaparinux sodium safety syringe are: 1. Rigid Needle Shield 2. Plunger 3. Finger-grip 4. Safety shield
			Syringe BEFORE USE	Syringe AFTER USE
			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.	Figure A.
			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.
		Figure B.
	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).	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).
		Figure D.
	7. Inject all of the medicine in the syringe by pressing down on the plunger as far as it goes. (Figure E).	Figure E.
	8. Remove the syringe from the injection site keeping your finger on the plunger.	Figure F.
	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.
Figure G. 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.

Your weight

Usual dose

Below 50 kg

5 mg once a day

7.5 mg once a day

10 mg once a day. This dose may be reduced to 7.5 mg once a day if you have moderate kidney disease.

Between 50 kg and 100 kg

Over 100 kg

150xxxxxxx

160 mm

Active substance	Fondaparinux sodium
Strength	10 mg / 0.8 ml
Pharmaceutical form	The solution is a clear and colourless to slightly yellow liquid. pH value: between 5.7 and 7.5. Osmolality: between 255 and 315 mOsm/kg of water.
Excipients	Sodium chloride, Water for injections, Hydrochloric acid (for pH-adjustment), Sodium hydroxide (for pH-adjustment)
Shelf life	2 years.
Storage	This medicinal product does not require any special storage conditions.
Drug group (ATC)	Antithrombotic agents B Blood and blood forming organ drugs B01 Antithrombotic agents B01A Antithrombotic agents B01AX Other antithrombotic agents B01AX05 fondaparinux
Marketing authorisation	PL 08553/0553 (first authorised 8 December 2020)
Marketing authorisation holder	Dr. Reddy´s Laboratories (UK) Ltd.

Fondaparinux Sodium DR Reddys 10 mg / 0.8 ml solution for injection in Pre-filled syringe – patient leaflet, side effects, dosage