Interferon alfa-2b 30million units/1.2ml solution for injection pre-filled disposable devices

Interferon alfa-2b (rbe) is a form of a natural chemical called interferon which is found in the body. Interferon is one of the chemicals in the body which helps the immune system to work properly. Interferon alfa-2b (rbe) works by killing certain types of cancer-cells or by stopping viruses from making copies of themselves.

Interferon alfa-2b (rbe) is used to treat many types of cancers including leukaemia, lymphoma, myeloma, melanoma and carcinoid tumours. It is also used to treat hepatitis B or hepatitis C infections. Interferon alfa-2b (rbe) may be used in combination with other medicines to treat some of these conditions.

Other information about Interferon alfa-2b (rbe):

Interferon alfa-2b (rbe) needs to be injected. Your prescriber or another healthcare professional may give you your injections. If you are going to have this medicine for a long time or if you need to have injections very often your prescriber will show you how to inject this medicine yourself. If you are injecting this medicine yourself then follow the instructions from your prescriber.

There should also be instructions on how to inject this medicine in the Patient Information Leaflet that comes with this medicine or on the pharmacy label.

The pharmacy label on your medicine tells you how much medicine you should have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. You should not change the dose of your medicine unless you are told to do so by your prescriber.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Some medicines work best if they are taken at a specific time of day. If someone is giving you this injection, the person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

If you are injecting this medicine yourself, make sure that you find out from your prescriber the best time to have Interferon alfa-2b (rbe).

This medicine needs to be injected. Your prescriber may give you your injections or you may be shown how to inject the medicine yourself. If you are injecting this medicine yourself, follow the instructions from your prescriber and the information on the pharmacy label. There should also be further information in the Patient Information Leaflet that comes with this medicine.

If you have any concerns about this medicine or about the process of having it you should talk to someone who is involved in your medical care.

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

The person who is responsible for giving you your medicine will make sure that you are given the correct dose of your medicine. If you inject the medicine yourself, make sure that you do not take any extra doses as this could cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

If you are having any problems having your medicine you must speak to your prescriber. If you are not having any problems having this medicine then do not stop having it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

If you are injecting this medicine yourself, read the pharmacy label to find out how you should look after your medicine. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions.

Do not use the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Specific information about how to look after Interferon alfa-2b (rbe) can be found in the Patient Information Leaflet that comes with this medicine. Make sure that the medicine is out of the sight and reach of children.

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Interferon alfa-2b (rbe) is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for children or adolescents who have or have had depression, thoughts of committing suicide or who have attempted to commit suicide.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Interferon alfa-2b (rbe) can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Interferon alfa-2b (rbe) has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Interferon alfa-2b (rbe)

• behavioural changes
• blood problems
• blurred vision
• chest pain
• chills
• concentration problems
• diarrhoea
• difficulty sleeping
• difficulty speaking
• dry mouth
• faster breathing rate
• feeling agitated
• feeling anxious
• feeling dizzy
• feeling irritable
• feeling nervous
• flu or flu-like symptoms
• general feeling of being unwell
• growth suppression in children and adolescents
• hair loss
• headaches
• hyperactivity
• hypersensitivity to external stimuli such as light, noise and physical contact
• indigestion
• infections
• inflammation of the mouth
• injection site problems including pain, inflammation, necrosis or skin problems at the injection site
• itching
• loss of appetite
• lung problems - some of these may be fatal. You must immediately seek medical advice if you develop a fever, cough or breathing difficulties
• lymphadenopathy
• muscle pain or tenderness
• muscle, joint and bone pain
• nail problems
• nausea
• oedema
• paleness
• pharyngitis
• psychiatric or central nervous system problems - these problems can occur after you have stopped having Interferon alfa-2b (rbe). You or your carer must seek immediate medical advice if you: are depressed; are aggressive; are confused; have changes in your emotional or mental state; have thoughts of committing homicide or suicide; or if you have attempted suicide
• rectal problems
• rigors
• skin problems including acne, bruising, dry skin, redness, dermatitis, photosensitivity reactions, skin colour changes
• skin rash or rashes
• sleepwalking
• sneezing
• stomach pain
• strange dreams
• sweating
• tiredness
• vomiting
• weakness
• weight loss

Common: More than 1 in 100 people who have Interferon alfa-2b (rbe)

• arthritis
• breast pain or discomfort
• bronchitis
• constipation
• decreased libido
• dehydration
• eczema
• eye or eyesight problems or worsening of eye or eyesight problems - you must seek immediate medical advice if you have other problems with vision, eye pain or inflammation and production of tears
• faster heart rate
• flushing
• hypoaesthesia
• liver problems - some of these may be fatal
• loose stools
• menstrual problems including heavy, long or painful menstrual periods or amenorrhoea
• metabolic problems
• migraine
• nose problems such as irritation, nose bleeds, blocked or runny nose
• palpitations
• paraesthesiae
• psoriasis or worsening of psoriasis
• raised blood pressure
• rhinitis
• sinusitis
• sleepiness
• sleeping problems
• taste changes
• thirst
• thyroid problems
• tinnitus
• tongue swelling
• tremors
• vaginal problems
• vertigo

Uncommon: More than 1 in 1000 people who have Interferon alfa-2b (rbe)

• neuropathies

Rare: More than 1 in 10,000 people who have Interferon alfa-2b (rbe)

• heart problems such as heart attack
• pneumonia which may be fatal

Very common: More than 1 in 10 children who have Interferon alfa-2b (rbe)

• apathy
• blood problems
• changes in emotions
• depression
• diarrhoea
• feeling dizzy
• feeling irritable
• fever
• flu or flu-like symptoms
• general feeling of being unwell
• hair loss
• headaches
• infections
• injection site problems including pain, inflammation, necrosis or skin problems at the injection site
• loss of appetite
• muscle pain or tenderness
• muscle, joint and bone pain
• nausea
• pharyngitis
• reduced growth
• rigors
• skin rash or rashes
• sleeping problems
• stomach pain
• thyroid problems
• tiredness
• vomiting

Common: More than 1 in 100 children who have Interferon alfa-2b (rbe)

• acne
• aggressive behaviour
• apathy
• appetite gain
• behavioural changes
• bruising
• chest pain
• concentration problems
• confusion
• constipation
• eye or eyesight problems or worsening of eye or eyesight problems - you must seek immediate medical advice if you have other problems with vision, eye pain and production of tears
• feeling agitated
• feeling anxious
• feeling nervous
• flushing
• gastroenteritis
• gastrointestinal problems including gastrooesophageal reflux
• high levels of cholesterol or other lipids in the blood
• hoarse voice
• hyperaesthesia
• hypoaesthesia
• indigestion
• inflammation of the mouth
• liver problems - some of these may be fatal
• loose stools
• lung problems - some of these may be fatal. You must immediately seek medical advice if you develop a fever, cough or breathing difficulties
• menstrual problems including heavy, long or painful menstrual periods or amenorrhoea
• nail problems
• neoplasms
• nose problems such as irritation, nose bleeds, blocked or runny nose
• oedema
• paleness
• paraesthesiae
• rectal problems
• redness of the skin
• skin problems including acne, bruising, itching, dry skin, eczema, redness, dermatitis, photosensitivity reactions, skin colour changes
• skin wounds
• sleepiness
• sleeping problems
• sneezing
• strange dreams
• sweating
• testicular pain
• thoughts of committing suicide
• tongue swelling
• tooth abscess
• tooth problems
• tremors
• urinary problems such as urinary incontinence, bedwetting or urinating more often
• urinary tract infection
• vaginal problems
• virilism
• weakness

Very rare: Fewer than 1 in 10,000 people who have Interferon alfa-2b (rbe)

• appetite gain
• back pain
• bleeding from the gums
• bone marrow problems
• brain or central nervous system problems
• cerebrovascular problems
• circulation problems
• colitis
• diabetes or worsening of diabetes
• ear or hearing problems including loss of hearing
• erythema multiforme
• facial oedema
• hallucinations
• high levels of cholesterol or other lipids in the blood
• increased blood sugar levels
• inflammation of the muscles
• kidney problems
• leg cramps
• lowered blood pressure
• pancreatitis
• psychosis or psychotic-like behaviour
• reduced conscious level
• rhabdomyolysis
• seizures
• Stevens-Johnson syndrome
• stroke
• toxic epidermal necrolysis

The frequency of these side-effects is unknown

• abnormal laboratory test results
• autoimmune problems or worsening of autoimmune problems including unexplained or easy bruising of the skin or mucous membrane, lupus or lupus-like problems, rheumatoid arthritis or vasculitis - if any symptoms persists seek immediate advice.
• coma
• fluid around the heart
• hypersensitivity reactions - seek immediate medical advice if you develop urticaria, angioedema, bronchoconstriction or anaphylaxis
• irregular heart rate
• reduced fertility
• tooth problems

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Interferon alfa-2b (rbe):

The following types of medicine may interact with Interferon alfa-2b (rbe):

If you are taking Interferon alfa-2b (rbe) and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Interferon alfa-2b (rbe):

If you have been prescribed Interferon alfa-2b (rbe) you should only take something on the above list on the specific advice of your prescriber or pharmacist.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Interferon alfa-2b (rbe):

You must not drive or operate machinery while you are taking Interferon alfa-2b (rbe).

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Interferon alfa-2b (rbe):

Alcohol can interact with certain medicines.

In the case of Interferon alfa-2b (rbe):

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Interferon alfa-2b (rbe):

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Interferon alfa-2b (rbe), then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Interferon alfa-2b (rbe):

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They may also be used to prolong the life of the medicine.

This medicine contains interferon alfa-2b (rbe).

We are unable to list all of the ingredients for your medicine here. For a full list, you should refer to the patient information leaflet that comes with this medicine or ask your prescriber. You should check that you are able to take the ingredients of your medicine, especially if you have any allergies.

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Interferon alfa-2b (rbe) before, do not take Interferon alfa-2b (rbe). Talk to your prescriber, pharmacist or nurse as soon as possible.