Arixtra 5 mg/0,4 ml sol iny en jeringa precargada

Label: Information for the User

Arixtra 5 mg/0.4 ml Injectable Solution

Arixtra 7.5 mg/0.6 ml Injectable Solution

Arixtra 10 mg/0.8 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 read 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 to treat or help prevent the formation of blood clots in blood vessels(an antithrombotic agent). Arixtra contains a synthetic substance calledfondaparinux sodium. This inhibits the effect of the coagulation factor Xa “ten-A” in the blood and thus prevents the formation of unwanted blood clots (thrombi) in blood vessels.

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

Do not use Arixtra:

• if you are allergicto fondaparinux sodium or to any of the other ingredients of this medication(listed in section 6).
• if you are bleeding heavily
• if you have a bacterial infection of the heart
• 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 similar heparin medications that cause a decrease in blood 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 ophthalmological surgery;

• if you have severe liver disease
• if you have kidney disease
• if you are 75 years or older.

• 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 may 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. In case of doubt, consult your doctor or pharmacist.

It should be injected approximately at the same hour every 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 5 mg, 7.5 mg, and 10 mg doses.For adetailed description of the use of Arixtra, see the end of the package insert.
• Do notinject Arixtra into a muscle (intramuscularly).

For how long you should use Arixtra

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

If you inject more Arixtra than you should

Get in touch with your doctor or pharmacist immediately, as 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 compensate for the missed doses.
• In case of doubt,get in touch with your doctor or pharmacist.

If you interrupt treatment with Arixtra

If you interrupt treatment before your doctor has indicated, 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 interrupting treatment, get in touch withyour doctor or pharmacist.

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

Like all medicines, this medicine may 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 site 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(decrease in the number of red blood cells)
• bruising

Rare side effects

These may affectup to 1 in 100 patientstreated with Arixtra.

• swelling (edema)
• headache
• pain
• chest pain
• difficulty breathing
• skin rash or itching
• exudation from the surgical wound
• fever
• feeling or being dizzy (nausea or vomiting)
• 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
• internal bleeding in the brain, liver or abdomen
• anxiety or confusion
• syncope or dizziness, low blood pressure
• drowsiness or fatigue
• 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
• diarrhea or constipation
• increase in bilirubin (a substance produced by the liver) 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 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 perceive the presence of particles or a change in coloration in the solution
• if you observe that the syringe is damaged
• if the syringe has been opened and is not going to be used 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:

• 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 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 or slightly yellowish 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. Some package sizes may only 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.