Arixtra 1,5 mg/0,3 ml sol iny en jeringa precargada

Label: information for the user

Arixtra 1.5 mg/0.3 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 the 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 blood clots in blood vessels near the surface of the skin of the legs (superficial venous thrombosis).

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
  • hemorrhagic disorders
  • recent cerebral hemorrhage(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; therefore, it is considered essentially "sodium-free".

The Arixtra syringe contains latex

The needle shield of the syringe contains 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 every 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 prospectus.
• 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, as 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 compensate for the missed doses.
• Consult your doctor or pharmacist if in doubt.

If you interrupt the treatment with Arixtra

If you interrupt the 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 the 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)
• Ecchymoses

Uncommon 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 surgical wound
• fever
• reduction or increase in the number of platelets (blood cells necessary for coagulation)
• increase in some chemicals (enzymes) produced by the liver.

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
• syncope or dizziness, low blood pressure
• drowsiness or fatigue
• flushing
• cough
• leg pain or stomach pain
• diarrhea or constipationor
• indigestion
• pain and inflammation at the injection site
• wound infection
• 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

Reporting of 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 on 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:

Medicines or syringes should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Arixtra

• The active ingredient is 1.5 mg of fondaparinux sodium in 0.3 ml of injectable solution
• The other components are sodium chloride, water for injection, 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 package

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

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

Responsible manufacturer:

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 authorization holder.

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 anautomaticneedle protection system and the other has amanualneedle protection system.

Components of the syringes:

?Plunger

?Grip zone (with fingers)

• Needle safety cap

Figure 1.Syringe with anautomaticneedle protection system

Syringe with amanualneedle protection system

DESCRIPTION OF THE METHOD OF USE OF ARIXTRAInstructions for use

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

When there are different instructions between syringes, they will be clearly specified.

1. Wash your handsthoroughly with water and soap and dry them with a towel.

1. Remove the syringe from the package and check that:

• the expiration date has not passed
• the solution is transparent and colorless and does not contain particles
• the syringe has not been opened or damaged

4. Clean the injection site with an alcohol-soaked swab or cotton ball.

Syringe with manual system

9. After the injection, hold the syringe by the safety cap of the needle with one hand, grasp the grip zone with the other hand and pull it back. This action releases the safety cap. Slide the safety cap over the syringe body until it is blocked in a position that covers the needle as shown in Figure3.

Do not dispose of the used needle in the trash. Dispose of it according to the instructions given by your doctor or pharmacist