ARIXTRA 5 mg/0.4 mL Injectable Solution, Prefilled Syringe

Introduction

Package Leaflet: Information for the User

Arixtra 5 mg/0.4 ml Solution for Injection

Arixtra 7.5 mg/0.6 ml Solution for Injection

Arixtra 10 mg/0.8 ml Solution for Injection

sodium fondaparinux

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet.You may need to read it again.
• If you have any further questions,ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Arixtra and what is it used for
2. What you need to know before you use Arixtra
3. How to use Arixtra
4. Possible side effects
5. Storage of Arixtra
6. Contents of the pack and further information

1. What is Arixtra and what is it used for

Arixtra is a medicine used to treat or help prevent the formation of blood clots in blood vessels (an antithrombotic agent).Arixtra contains a synthetic substance called sodium fondaparinux. This stops the effect of coagulation factor Xa in the blood and thus prevents the formation of unwanted blood clots (thrombi) in blood vessels.

Arixtra is used to treat adults who have blood clots in the blood vessels of their legs (deep vein thrombosis)and/or lungs (pulmonary embolism).

2. What you need to know before you use Arixtra

Do not use Arixtra:

• to sodium fondaparinux or any of the other ingredients of this medicine (listed in section 6).

• Tell your doctorif you think any of these situations apply to you. If so, you must notuse Arixtra.

Arixtra.

Warnings and precautions:

Talk to your doctor or pharmacist before you start using Arixtra:

• (haemorrhage), such as

• stomach ulcer
• bleeding disorders
• recent bleeding in the brain(intracranial haemorrhage)
• recent brain, spinal or eye surgery;

• Tell your doctorif any of these situations apply to you.

Children and adolescents

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

Using Arixtra with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

The use of other medicines may affect how Arixtra works or be affected by Arixtra.

Pregnancy and breast-feeding

Arixtra should not be given to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Arixtra. If you are pregnant, or think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Arixtra contains sodium

This medicine contains less than 23 mg of sodium per dose; it is essentially “sodium-free”.

The Arixtra syringe contains latex

The needle protector of the syringe contains latex, which may cause allergic reactions in people sensitive to latex.

Tell your doctorif you are allergic to latex before being treated with Arixtra.

3. How to use Arixtra

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

It should be injected at approximately the same time each day.

How to administer Arixtra

• Arixtra is given by injection under the skin (subcutaneously) in a skin fold of the lower abdominal area. The syringes are pre-filled with the exact dose that you need. There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.For a detailed description of how to use Arixtra, see the end of this leaflet.
• Do notinject Arixtra into a muscle (intramuscularly).

For how long should you use Arixtra

You should use Arixtra for the period of time that your doctor has told you, as Arixtra prevents you from having a serious illness.

If you inject more Arixtra than you should

Contact your doctor or pharmacist immediately because there is an increased risk of bleeding.

If you forget to use Arixtra

• Administer the dose as soon as you remember. Do not inject a double dose to make up for forgotten doses.
• In case of doubt,contact your doctor or pharmacist.

If you stop using Arixtra

If you stop treatment before your doctor has told you to, the blood clot may not have been treated properly and you may be at risk of developing a new blood clot in a vein in your leg or in the lung. Before stopping treatment, contactyour doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Symptoms to look out for

Severe allergic reactions(anaphylaxis): are very rare (up to 1 in 10,000) in patients using Arixtra. The symptoms include:

• swelling, sometimes of the face or mouth (angioedema), which can cause difficulty in swallowing or breathing
• collapse.

• Contact a doctor immediatelyif you experience these symptoms. Stop using Arixtra.

Common side effects

These may affect more than 1 in 100 patientstreated with Arixtra.

• bleeding(e.g. from the area where the operation was performed, from a stomach ulcer, nosebleeds, blood in the urine, coughing up blood, eye bleeding, bleeding into joints, internal bleeding in the uterus)
• localised accumulation of blood(in any organ or body tissue)
• anaemia(reduction in the number of red blood cells)
• bruising

Uncommon side effects

These may affect up to 1 in 100 patientstreated with Arixtra.

• swelling (oedema)
• headache
• pain
• chest pain
• difficulty breathing
• skin rash or itching
• wound secretion
• fever
• feeling or being sick (nausea or vomiting)
• reduction or increase in the number of platelets (blood cells needed for clotting) increase in some chemicals (enzymes) produced by the liver

Rare side effects

These may affect up to 1 in 1,000 patientstreated with Arixtra.

• allergic reaction
• internal bleeding in the brain, liver or abdomen
• anxiety or confusion
• fainting or dizziness, low blood pressure
• sleepiness or tiredness
• flushing
• cough
• pain and inflammation at the injection site
• wound infection
• increase in blood of the amount of non-protein nitrogen
• leg pain or stomach pain
• indigestion
• diarrhoea or constipation
• increase in bilirubin (a substance produced by the liver) in the blood
• reduction of potassium in the blood
• pain around the top of the stomach or heartburn

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Arixtra

• Keep this medicine out of the sight and reach of children.
• Store below 25°C. Do not freeze.
• It is not necessary to store Arixtra in the refrigerator.

Do not use this medicine:

• after the expiry date which is stated on the label and carton.
• if you notice the presence of particles or a change in the colour of the solution.
• if the syringe is damaged.
• if the syringe has been opened and is not to be used immediately.

Disposal of syringes

Medicines or syringes should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines or syringes no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Arixtra Composition

The active ingredient:

• 5 mg of fondaparinux sodium in 0.4 ml of injectable solution
• 7.5 mg of fondaparinux sodium in 0.6 ml of injectable solution
• 10 mg of fondaparinux sodium in 0.8 ml of injectable solution

The other components are sodium chloride, water for injectable preparations, and hydrochloric acid and/or sodium hydroxide to adjust the pH (see section 2).

Arixtra does not contain any animal products.

Product Appearance and Container Contents

Arixtra is a clear and colorless or slightly yellowish injectable solution. It is presented in a pre-filled syringe for single use, equipped with a safety system that helps prevent accidental needlesticks after use.

It is presented in packs of 2, 7, 10, and 20 pre-filled syringes. Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer:

Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder.

Drawing 3. Syringe with a manualneedle protection system with the safety cap covering the needle AFTER USE

USE

Types of Safety Syringes:

There are two types of safety syringes for Arixtra, designed to protect against accidental needlesticks after use. One type of syringe has an automaticneedle protection system and the other has a manualsystem.

Syringe Components:

• Needle protector

? Plunger

? Grip zone (with fingers)

• Needle safety cap

Drawing 1.Syringe with an automaticneedle protection system

Syringe with a manualneedle protection system

Drawing 2. Syringe with a manualneedle protection system

DESCRIPTION OF ARIXTRA USE MODEInstructions for Use

These instructions apply to both types of syringes (with automatic and manual needle protection systems).

When there is a different instruction between syringes, it will be specified clearly.

• Wash your handscarefully with water and soap and dry them with a towel.

• Remove the syringe from the packaging and check that:

• the expiration date has not passed
• the solution is clear and colorless and does not contain particles

• the syringe has not been opened or damaged

• Sit or lie down in a comfortable position.Select a point in the lower abdomen (belly), at least 5 cm below the navel (drawing A).

For each injection, alternate the left and right sidesof the lower abdomen. This will help reduce discomfort at the injection site.

If injection in the lower abdomen is not possible, ask your doctor.

Drawing A

1. Clean the injection area with a swab or cotton ball soaked in alcohol.

1. Remove the needle protector: first by twisting (drawing

B1) and then by pulling out from the syringe body (drawing B2).

Discard the needle protector.

Important Note

1. Do not touch the needleand prevent it from coming into contact with any surface before injection.

1. It is normal to find a small air bubble in the syringe. Do not try to eliminate this air bubblebefore applying the injectionas you may lose part of the medication.

1. Gently pinch the skinthat you previously cleaned until a fold is formed. Hold the fold between your thumb and index finger throughout the injection (drawing C).

1. Hold the syringe firmlyby the grip zone. Insert the needle into the skin fold at a right angle (drawing D).

Drawing B1

Drawing B

Drawing C

Drawing D

• Inject the entire contents of the syringeby pressing the plunger down to the maximum (drawing E).

Drawing E

Syringe with automatic system

1. Release the plungerand the needle will automatically move from the skin into a safety cap where it will be permanently locked (drawing F).

Drawing F

Syringe with manual system

1. After injection, hold the syringe by the needle safety cap with the fingers of one hand, grasp the grip zone with the fingers of the other hand, and pull back. This action releases the cap. Slide the cap along the syringe body until it is locked in a position that covers the needle, as shown in drawing 3.

Do not dispose of the used needlein the trash can.Dispose of it following the instructions given by your doctor or pharmacist.