RoActemra 200mg/10ml concentrate for solution for infusion vials

RoActemra is a monoclonal antibody that is an immunosuppressant. It is used to treat rheumatoid arthritis.

In rheumatoid arthritis, the immune system attacks the lining on the inside of joints. This causes joint inflammation, pain, and stiffness. The joints slowly become damaged and eventually may need to be replaced.

RoActemra works by inactivating certain types of chemicals in the immune system. This helps stop the immune system from attacking the joints and can help to slow the progression of rheumatoid arthritis.

RoActemra is usually only used when treatment with other medicines for rheumatoid arthritis have not worked. RoActemra is given in combination with another medicine called methotrexate.

Because RoActemra reduces the activity of the immune system, it may increase your chances of getting a serious infection. If you are having treatment with RoActemra your medical team will tell you how to recognise symptoms of infection. You must seek immediate medical advice if you develop any signs of infection while being treated with RoActemra.

Other information about RoActemra:

RoActemra is usually given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

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

Your prescriber will advise you when you need to have your injections. It is usually only given every four weeks. It is a good idea to make a note of the date that your next injection is due so that you do not miss any of your appointments.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

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

In the case of RoActemra, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

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

As RoActemra will be given to you as an injection, it will usually be stored by the medical team.

RoActemra 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 someone under the age of two years.

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

Over time it is possible that RoActemra can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that RoActemra has become unsuitable, it is important that the prescriber is contacted immediately.

RoActemra 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 someone under the age of 18 years.

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

Over time it is possible that RoActemra can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that RoActemra 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.

As part of treatment, this medicine may be used in combination with other medicines. There is no information available about the side-effects of RoActemra when it is taken on its own. The information included here relates to the side-effects caused by the combination of this medicine with other medicines that it is usually given with. There may be more information on the side-effects of RoActemra in the Patient Information Leaflet for RoActemra.

Very common: More than 1 in 10 people who have RoActemra

• diarrhoea
• high levels of cholesterol or other lipids in the blood
• infections - your medical team will tell you how to recognise symptoms of infection. You must seek immediate medical advice if you develop any signs of infection while being treated with RoActemra. Some serious infections may be fatal
• joint pain
• stomach discomfort

Common: More than 1 in 100 people who have RoActemra

• abnormal laboratory test results
• blood problems
• breathing difficulties
• cough
• eye or eyesight problems
• feeling dizzy
• gastritis
• headaches
• hypersensitivity reactions including anaphylaxis - some of these reactions may be fatal
• itching
• mouth ulcers
• oedema of the extremities
• production of antibodies to RoActemra
• raised blood pressure
• skin rash or rashes
• stomach pain - seek immediate medical advice if you get stomach pains
• urticaria
• weight gain

Uncommon: More than 1 in 1000 people who have RoActemra

• gastrointestinal infections - some of these infections may be fatal. Seek immediate medical advice if you get stomach pain or an unexplained change in bowel habits as well as a fever or if you have rectal bleeding
• inflammation of the mouth
• kidney stones
• stomach ulcers
• thyroid problems

The frequency of these side-effects is unknown

• angioedema

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.

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.

As part of treatment, this medicine may be used in combination with other medicines. There is no information available about the side-effects of RoActemra when it is taken on its own. The information included here relates to the side-effects caused by the combination of this medicine with other medicines that it is usually given with. There may be more information on the side-effects of RoActemra in the Patient Information Leaflet for RoActemra.

Very common: More than 1 in 10 people who have RoActemra

• high levels of cholesterol or other lipids in the blood
• infections - your medical team will tell you how to recognise symptoms of infection. You must seek immediate medical advice if you develop any signs of infection while being treated with RoActemra. Some serious infections may be fatal

Common: More than 1 in 100 people who have RoActemra

• abnormal laboratory test results
• blood problems
• breathing difficulties
• cough
• eye or eyesight problems
• feeling dizzy
• gastritis
• headaches
• hypersensitivity reactions including anaphylaxis - some of these reactions may be fatal
• itching
• mouth ulcers
• oedema of the extremities
• production of antibodies to RoActemra
• raised blood pressure
• skin rash or rashes
• stomach pain - seek immediate medical advice if you get stomach pains
• urticaria
• weight gain

Uncommon: More than 1 in 1000 people who have RoActemra

• gastrointestinal infections - some of these infections may be fatal. Seek immediate medical advice if you get stomach pain or an unexplained change in bowel habits as well as a fever or if you have rectal bleeding
• inflammation of the mouth
• kidney stones
• stomach ulcers
• thyroid 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 RoActemra:

The following types of medicine may interact with RoActemra:

If you are taking RoActemra 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. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with RoActemra.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

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 RoActemra:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

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 RoActemra:

Alcohol can interact with certain medicines.

In the case of RoActemra:

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 RoActemra:

It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

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

In the case of RoActemra:

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. Some may be used to prolong the life of the medicine.

RoActemra contains:

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 RoActemra before, do not have RoActemra. Talk to your prescriber, pharmacist or nurse as soon as possible.