Arixtra 7,5 mg/0,6 ml sol iny en jeringa precargada

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 time 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 a detailed 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

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 the missed doses.
• In case of doubt,contact 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, contactyour 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 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:

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

Frequent 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, eye bleeding, joint space bleeding, 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

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
• coughing

•pain and inflammation at the injection site

• wound infection

•increase in blood nitrogen non-protein

•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 about the safety of this medicine.

Do not use this medication:

• after the expiration date shown on the label and packaging

• if you notice the presence of particles or a change in coloration in the solution

• if the syringe is damaged

• if the syringe has been opened and is not to be used immediately.

Disposal of Syringes

Medications or syringes should not be disposed of through the drains or 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 pack

Arixtra is a transparent and colourless 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 needlestick injuries after use.

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

Marketing authorisation holder and responsible person for manufacture

Marketing authorisation holder:

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

Responsible person for manufacture:

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

Date of the last revision 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.

Types of safety syringes:

There are two types of safety syringes for Arixtra, designed to protect against accidental needlestick injuries after use. One type of syringe has an automatic needle protection system and the other has a manual needle protection system.

Components of the syringes:

?Plunger

?Grip zone (with fingers)

• Needle safety cap

Figure 1.Syringe with an automatic needle protection system

Syringe with a manual needle protection system

Figure 2. Syringe with a manual needle 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 is a different instruction between syringes, it will be clearly specified.

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

• Remove the syringe from the pack and check that::

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

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

If it is not possible to inject into the lower abdomen, ask your doctor.

Figure A

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

1. Remove the needle protector: first turning it (see figure

B1) and then pulling it out from the syringe body(see figureB2).

Dispose of the needle protector.

Important note

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

1. It is common to find a small air bubble in the syringe.Do not try to remove this air bubblebefore applying the injectionas some of the medicine may be lost.

1. Gently pinch the skin that has been cleaned previously to form a fold. Hold the foldbetween your thumb and index finger throughout the injection (see figureC).

1. Hold the syringe firmly by the grip zone.Insert the needle into the foldto its full length at a right angle (see figureD).

Figure B1

Figure B

Figure C

Figure D

• Inject ALL the contents of the syringe by pressing the plunger down to the maximum(see figureE).

Figure E

Syringe with automatic safety system

1. Release the plungerand the needle will automaticallymove from the skin to a safety cap where it will be permanently blocked (see figureF).

Figure F

Syringe with manual safety system

9. After the injection, hold the syringe by the needle safety cap 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 along 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 waste bin.Dispose of it according to the instructions given by your doctor or pharmacist.