Label: information for the user

Arixtra 2.5 mg/0.5 ml injectable solution

fondaparinux sodium

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Arixtra is a medication that helps prevent the formation of blood clots in blood vessels(an antithrombotic agent).

Arixtra contains a synthetic substance called fondaparinux sodium. This substance prevents the effect of the factor Xa “ten-A” in the blood and thus prevents the formation of unwanted blood clots (thrombi) in blood vessels.

Arixtra is used for:

• preventing the formation of blood clots in blood vessels of the legs or lungs after orthopedic surgery, such as hip or knee surgery, or abdominal surgery
• preventing the formation of blood clots during and shortly after a period of restricted mobility due to an acute illness.
• treating some types of heart attack and severe angina (pain caused by narrowing of the heart arteries).
• treating blood clots in blood vessels near the surface of the skin of the legs (superficial venous thrombosisl

Do not use Arixtra:

• if you are allergicto fondaparinux sodium or to any of the other ingredients of thismedication (listed in section 6).
• if you are bleeding heavily
• if you have a bacterial heart infection
• if you have severe kidney disease.

• Inform your doctorif you think you are affected by any of these situations. If so, youmust notuse

Arixtra.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Arixtra:

• if you have had complications previously during treatment with heparin or heparin-like medications that cause a decrease in platelet count (heparin-induced thrombocytopenia)
• if you have an uncontrolled risk of bleeding(hemorrhage), such as:

• peptic ulcer
• bleeding disorders
• recent brain bleeding(intracranial hemorrhage)
• recent cerebral, spinal, or eye surgery

• if you have severe liver disease
• if you have kidney disease
• if you are 75 years or older
• if you weigh less than 50 kg

• Inform your doctorif you are affected by any of these situations.

Children and adolescents

Arixtra has not been tested in children or adolescents under 17 years.

Use of Arixtra with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription. The use of other medications may affect how Arixtra works or be affected by Arixtra.

Pregnancy and breastfeeding

Arixtra should not be prescribed to pregnant women unless strictly necessary. Breastfeeding is not recommended during treatment with Arixtra. If you are pregnant, or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication.

Arixtra contains sodium

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

The Arixtra syringe may contain latex

The needle shield of the syringe may contain latex, which can cause allergic reactions in people sensitive to latex.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 2.5 mg once a day, injected approximately at the same time each day.

If you have a kidney disease, the dose may be reduced to 1.5 mg once a day. How to administer Arixtra

• Arixtra is administered by subcutaneous injection in a skin fold formed in the lower abdominal area. The syringes are preloaded with the exact dose you need. There are different syringes for 2.5 mg and 1.5 mg doses. For a detailed description of the use of Arixtra see the end of the package insert To treat some types of heart attacks, a healthcare professional may administer the first dose intravenously.
• Do not inject Arixtra into a muscle.

For how long you should use Arixtra

You should use Arixtra for the period of time your doctor has indicated, as Arixtra prevents you from suffering a serious disease.

If you inject more Arixtra than you should

Contact your doctor or pharmacist immediately because there is a higher 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 the missed doses.
• Consult your doctor or pharmacist if in doubt.

If you interrupt treatment with Arixtra

If you interrupt treatment before your doctor has indicated, you are at risk of developing a blood clot in a vein in your leg or in the lung. Before interrupting treatment, contact your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Symptoms to be aware of

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 causes difficulty swallowing or breathing
• collapse.

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

Common side effects

These may affectmore than 1 in 100 patientstreated with Arixtra.

• bleeding(for example from the area where the operation was performed, from an existing stomach ulceror from the nose, gums,blood in the urine, coughing up blood, bleeding in the eyes, bleeding in the joints, internal bleeding in the uterus)
• localized accumulation of blood(in any organ or body tissue)

• anemia(a reduction in the number of red blood cells)
• bruising

Rare side effects

These may affectup to 1 in 100 patientstreated with Arixtra.

• swelling (edema)
• feeling or being dizzy (nausea or vomiting)
• headache
• pain
• chest pain
• difficulty breathing
• skin rash or itching
• exudation from the wound of the operation
• fever
• reduction or increase in the number of platelets (blood cells necessary for coagulation)
• increase in some chemicals (enzymes) produced by the liver.

Very rare side effects

These may affectup to 1 in 1,000 patientstreated with Arixtra.

• allergic reaction (including itching, swelling, rash)
• internal bleeding in the brain, liver or abdomen
• anxiety or confusion
• low blood pressure or fainting
• drowsiness or fatigue
• flushing
• cough
• leg pain or stomach pain
• diarrhea or constipation
• indigestion
• pain and inflammation at the injection site
• infection of wounds
• increase in bilirubin (a substance produced by the liver) in the blood
• increase in the amount of non-protein nitrogen in the blood
• reduction of potassium in the blood
• pain around the upper part of the stomach or heartburn

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children
• Store below 25°C. Do not freeze
• Arixtra does not need to be stored in the refrigerator

Do not use this medication:

• after the expiration date that appears on the label and the packaging
• if you notice particles in the solution, or if the solution is discolored
• if you observe that the syringe is damaged
• if you have opened the syringe and are not going to use it immediately.

Disposal of Syringes:

Medications or syringes should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Arixtra

• The active ingredient is 2.5 mg of fondaparinux sodium in 0.3 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

Appearance of the product and contents of the pack

Arixtra is a transparent and colourless injectable solution. It is presented in a pre-filled syringe for single use, equipped with a safety system that contributes to preventing accidental needlestick injuries after use. It is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes. Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

Marketing authorisation holder:

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

Responsible person for manufacturing:

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

Last review date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder.

Tipos de jeringas de seguridad:

Hay dos tipos de jeringas de seguridad para Arixtra, diseñadas para proteger de los pinchazos accidentales después de su uso. Un tipo de jeringas tiene un sistemaautomáticode protección de la aguja y el otro tiene un sistemamanual.

Componentes de las jeringas:

?Émbolo

?Zona de sujeción (con los dedos)

• Capuchón de seguridad de la aguja

Dibujo 1.Jeringa con un sistemaautomáticode protección de la aguja

Jeringa con un sistemamanualde protección de la aguja

Dibujo 2. Jeringa con un sistemamanualdeprotección de la aguja

DESCRIPCIÓN DEL MODO DE EMPLEO DE ARIXTRAInstrucciones de uso

Estas instrucciones sirven para los dos tipos de jeringas (con sistema automático y con sistema manual de protección de la aguja).

Cuando haya una instrucción diferente entre jeringas se especificará claramente.

1. Lávese cuidadosamente las manoscon agua y jabón y séquelas con una toalla.

1. Saque la jeringa del envase y revise que:

1. Siéntese o recuéstese en una posición cómoda.Seleccione un punto en la zona inferior del abdomen (vientre), al menos a 5 cm por debajo del ombligo (dibujoA).

Para cada inyecciónalterne el lado izquierdo y derechode la zona inferior del abdomen. Esto ayudará a reducir las molestias en el lugar de inyección.

Si no es posible la inyección en la zona inferior del abdomen, pregunte a su médico.

Dibujo A

4. Limpie el área de inyección con una toallita o algodón impregnado en alcohol.

1. Retire el protector de la aguja: primero girándolo (dibujo

B1) y luego tirando hacia fuera desde el cuerpo de la jeringa(dibujoB2).

Deseche el protector de la aguja.

Nota importante

• No toque la agujae impida que se ponga en contactocon cualquier superficie antes de la inyección.

• Es habitual hallar una pequeña burbuja de aire en la jeringa.No trate de eliminar esta burbuja de aireantes de aplicar la inyecciónya que se podría perderparte del medicamento.

1. Pellizque suavemente la piel que ha limpiado previamente hasta formar un pliegue. Sujete el pliegueentre el pulgar y el índice durante toda la inyección (dibujoC).

1. Sostenga firmemente la jeringa por la zona de sujeción.Inserte la aguja en toda su longitud dentro del pliegue cutáneo formando un ángulo recto (dibujoD).

Dibujo B1

Dibujo B2

Dibujo C

Dibujo D

1. Inyecte TODO el contenido de la jeringa presionando hacia abajo el émbolo hasta el máximo(dibujoE).

Dibujo E

Jeringa con sistema automático

1. Suelte el émboloy la aguja se desplazará automáticamentedesde la piel hasta un capuchón de seguridad donde quedará bloqueada permanentemente (dibujoF).

Dibujo F

Jeringa con sistema manual

9. Después de la inyección sujete la jeringa por el capuchón de seguridad de la aguja con los dedos de unamano, agarre con los dedos de la otra mano la zona de sujeción y tire hacia atrás. Esta acción libera al capuchón. Deslice el capuchón por el cuerpo de la jeringa hasta que quede bloqueado en una posición que cubra a la aguja tal y como se muestra en el dibujo3.

No deposite la aguja empleada en el cubo de la basura. Deséchela siguiendo las instrucciones que lehaya dado su médico o farmacéutico.