Avonex 30 micrograms/0,5 ml Solution

The active substance in Avonex is a protein called interferon beta - 1a. Interferons are natural substances made in your body to help protect you from infections and diseases. The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.

Avonex is used to treat Multiple Sclerosis (MS). Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS. Everyone has their own set of MS symptoms. These can include:

• Feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness, numbness in the face, arms or legs
• Acute or chronic pain, bladder and bowel problems, sexual problems and problems seeing things
• Difficulty in thinking and concentrating, depression.

MS also tends to flare up from time to time: this is called a relapse. Avonex works best when you use it at the same time, once a week, on a regular basis. Do not stop your Avonex treatment without speaking to your neurologist. Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS. Your doctor will advise you for how long you can use Avonex or when to stop.

Do not use AVONEX:

• If you are allergic to interferon beta, or any of the other ingredients of Avonex (listed in section 6).
• If you have severe depression or think about committing suicide. Talk to a doctor straightaway if any of these apply to you.

Because Avonex is based on a protein, there is a small chance of an allergic reaction.

Warnings and precautions

Talk to your doctor before using Avonex if you have or have had in the past:

• Depression or problems affecting your moods
• Thoughts about committing suicide.
• Epilepsy or other seizure disorders not controlled by medication
• Serious kidney or liver problems
• A low number of white blood cells or platelets, which can cause an increased risk of infection, bleeding or anaemia
• Heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (dysrhythmias).

Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex.

Do not share medicines prescribed for you with any other person. Always use Avonex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose is one injection of Avonex, once a week. Try to use Avonex at the same time on the same day each week.

Avonex is not to be used in children below the age of 18 years.

You can inject Avonex yourself without the help of your doctor, if they have trained you to do this. The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX).

If you have trouble handling the syringe, ask your doctor who may be able to help.

Your doctor will tell you how long you need to keep using Avonex. It is important to continue using Avonex regularly. Do not make changes unless your doctor tells you.

If you miss your usual weekly dose, inject a dose as soon as you can. Then leave a week before using Avonex again. Continue injecting on this new day every week. If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day. Do not use two injections to make up for a missed injection.

Avonex can have side effects. Not all side effects reported for Avonex are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using Avonex, please consult your healthcare provider for advice.

Serious side effects: get medical help

Serious allergic reactions

• Swelling of the face, lips or tongue
• Difficulty breathing
• A rash.

Call a doctor immediately. Do not use any more Avonex until you have spoken to a doctor.

Depression

If you get any symptoms of depression:

• Feeling unusually sad, anxious or worthless.

Call a doctor immediately.

Liver problems

If you get any of these symptoms:

• Yellowing of your skin or the whites of your eyes (jaundice)
• Itching all over
• Feeling sick, being sick (nausea and vomiting)
• Easy bruising of the skin.

Call a doctor immediately as they may be signs of a possible liver problem.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label. Store in a refrigerator (between 2 ºC and 8 °C). Do not freeze. Store in the original package (sealed plastic tray) in order to protect from light. Avonex can also be stored at room temperature (between 15 °C and 30 °C) for up to one week.

Do NOT use Avonex if you notice:

• The pre-filled syringe is broken.
• The sealed plastic tray is damaged or opened.
• The solution is coloured or you can see particles floating in it.
• The tamper evident cap has been broken.

Return all unused medicines to your pharmacist. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.