ARIXTRA 1.5 MG / 0.3 ML SOLUTION FOR INJECTION PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

1 What Arixtra is and what it is used for

2 What you need to know before you use Arixtra

3 How to use Arixtra

4 Possible side effects

5 How to store Arixtra

6 Contents of the pack and other information

1

What Arixtra is and what it is used for

Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).

Arixtra contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.

Arixtra is used to:

• prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery
• prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness.
• treat blood clots in blood vessels that are near the surface of the skin of the legs (superficial-vein thrombosis).

What you need to know before you use Arixtra

Do not use Arixtra:

• if you are allergic to fondaparinux sodium or to any of the other ingredients of this medicine (listed in section 6)
• if you are bleeding excessively
• if you have a bacterial heart infection
• if you have very severe kidney disease.

■+ Tell your doctor if you think any of these applies to you.

If they do, you must not use Arixtra.

Take special care with Arixtra:

Talk to your doctor or pharmacist before taking Arixtra:

• if you have a risk of uncontrolled bleeding (haemorrhage) including:
• stomach ulcer
• bleeding disorders
• recent bleeding into the brain (intracranial bleeding)
• recent surgery on the brain, spine or eye
• if you have severe liver disease
• if you have kidney disease
• if you are 75 years old or older
• if you weigh less than 50 kg.

• ■+ Tell your doctor if any of these applies to you.

Children and adolescents

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

Other medicines and Arixtra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you bought without a prescription. Some other medicines may affect the way that Arixtra works or be affected by Arixtra.

Pregnancy and breast-feeding

Arixtra should not be prescribed to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Arixtra. If you are pregnant , or breast-feeding , think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Arixtra contains sodium

This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.

Arixtra syringe contains latex

The syringe needle shield contains latex that has the potential to cause allergic reactions in latex sensitive individuals.

• ■+ Tell your doctor if you are allergic to latex before being treated with Arixtra.

3

How to use Arixtra

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

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

How Arixtra is given

• Arixtra is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area. The syringes are pre-filled with the exact dose you need. There are different syringes for the 2.5 mg and 1.5 mg doses. For step-by-step instructions please see over the page
• Do not inject Arixtra into muscle.

How long should Arixtra be taken for

You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.

If you inject too much Arixtra

Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.

If you forget to take Arixtra

• Take the dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose.
• If you are not sure what to do, ask your doctor or pharmacist.

Don’t stop using Arixtra without advice

If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung.

Contact your doctor or pharmacist before stopping.

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

4

Possible side effects

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

Conditions you need to look out for

• Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Arixtra. Signs include: swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing
• collapse.

■+ Contact a doctor immediately if you get these symptoms. Stop taking Arixtra.

Common side effects

These may affect more than 1 in 100 people treated with Arixtra.

• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums)
• anaemia (a reduction in the number of red blood cells).

Uncommon side effects

These may affect up to 1 in 100 people treated with Arixtra.

• bruising or swelling (oedema)
• feeling sick or being sick (nausea or vomiting)
• chest pain
• breathlessness
• rash or itchy skin
• oozing from operation wound site
• fever
• reduction or increase in the number of platelets (blood cells necessary for blood clotting)
• increase in some chemicals (enzymes) produced by the liver.

Rare side effects

These may affect up to 1 in every 1000 people treated with Arixtra.

• allergic reaction (including itching, swelling, rash)
• internal bleeding in the brain or abdomen
• anxiety or confusion
• headache
• fainting or dizziness, low blood pressure
• drowsiness or tiredness
• flushing
• coughing
• leg pain or stomach pain
• diarrhoea or constipation
• indigestion
• wound infection
• increase in bilirubin (a substance produced by the liver) in the blood
• reduction in potassium in your blood.

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 Yellow Card Scheme at:.

By reporting side effects you can help provide more information on the safety of this medicine.

5

How to store Arixtra

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• Keep this medicine out of the sight and reach of children
• Store below 25°C. Do not freeze
• Arixtra does not need to be kept in the fridge. I

Do not use this medicine:

• after the expiry date shown on the label and carton
• if you notice any particles in the solution, or if the solution is discoloured
• if you notice that the syringe is damaged
• if you have opened a syringe and you do not use it straightaway.

Disposal of syringes:

Do not throw away any medicines or syringes via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6

Contents of the pack and other information

What Arixtra contains

• The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
• The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH (see section 2).

Arixtra does not contain any animal products.

What Arixtra looks like and contents of the pack

Arixtra is a clear and colourless solution for injection.

It is supplied in a pre-filled, single-use syringe fitted with a safety system to help prevent needle stick injuries after use. It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Mylan Products Ltd. 20 Station Close, Potters Bar, Herts,

EN6 1TL, United Kingdom

Manufacturer:

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

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Instructions for use

These instructions are for both types of syringes (automatic and manual needle protection system). Where the instruction for a syringe is different this is clearly stated.

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