MabThera 100mg/10ml concentrate for solution for infusion vials

MabThera is used to treat certain types of non-Hodgkin's lymphoma. It is also used as a further treatment for people with non-Hodgkin's lymphoma which has responded well to previous treatment. MabThera may be used alone or with other medicines to treat cancer. Non-Hodgkin's lymphoma affects white blood cells. MabThera works by destroying certain white blood cells which can help in the treatment of non-Hodgkin's lymphoma.

Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered. How well you feel and how you are likely to cope with treatment is also important.

Your cancer treatment will usually consist of a treatment session with MabThera followed by a break of a number of days before the next treatment session with MabThera. This cycle may be repeated many times as part of your cancer treatment.

MabThera works by damaging white blood cells in the body. As well as the white blood cells affected by non-Hodgkin's lymphoma, MabThera also affects healthy cells and treatment with MabThera may damage your immune system. You may be at more risk of getting infections while you are having MabThera. Your medical team may arrange for you to have some blood tests to check how well your immune system is working.

When MabThera is given for the first time it may cause a reaction which may be fatal. These reactions usually occur during treatment or within two hours of having MabThera. To prevent these reactions you may be given some other medicines. Your medical team will monitor you for any reactions and advise you of the signs and symptoms to look out for. If you develop any of these symptoms, immediately tell the person who is looking after you. They may need to change your dose or stop the treatment until the reaction has stopped. In some cases the reaction needs to be treated before treatment with MabThera can be continued.

Other information about MabThera:

MabThera 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.

The person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

This medicine will be given to you as an infusion. 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 MabThera, 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.

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

MabThera 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 a child.

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

Over time it is possible that MabThera can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that MabThera 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 may be more information about the side-effects caused by the combination of this medicine with other medicines in the Patient Information Leaflet or Summary of Product Characteristics for MabThera.

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

• abnormal laboratory test results
• blood and bone marrow problems
• hair loss
• infections - some of these infections could be new, worsen or return and may be fatal. Seek immediate medical advice if you have any signs and symptoms of an infection during or six months after stopping treatment with MabThera
• infusion reactions including changes in blood pressure, pulmonary oedema, kidney or lung problems, heart or worsening of heart problems or multi-organ failure - some infusion reactions may be fatal. Seek immediate medical advice if you get symptoms such as bronchospasm, breathing difficulties, fever, chills, rigors, flushing, itching, angioedema, nausea, indigestion, urticaria, rashes, headache, throat irritation, rhinitis, vomiting, tiredness, indigestion, weakness, faster heart rate or pain

Common: More than 1 in 100 people who have MabThera

• a drop in blood pressure on standing or sitting up
• constipation
• cough
• diarrhoea
• difficulty sleeping
• eye or eyesight problems
• eye watering
• facial oedema
• feeling agitated
• feeling anxious
• feeling dizzy
• flu or flu-like symptoms
• general feeling of being unwell
• heart attack
• hypersensitivity reactions
• hypoaesthesia
• increased blood sugar levels
• increased muscle tone
• inflammation of the mouth
• irregular heart rate
• loss of appetite
• metabolic problems
• night sweats
• oedema of the extremities
• pain including pain in the back, chest, ear, neck, stomach, joints or muscles
• paraesthesiae
• reactivation or worsening of hepatitis B - this may be fatal
• sepsis
• shivering
• sinusitis
• skin problems
• swallowing difficulties
• sweating
• tinnitus
• vasodilatation
• weight loss

Uncommon: More than 1 in 1000 people who have MabThera

• angina
• asthma
• blood clotting problems
• depression
• distension of the stomach
• feeling nervous
• hypoxia
• lymphadenopathy
• pain at the site of infusion
• slower heart rate
• taste changes

Rare: More than 1 in 10,000 people who have MabThera

• anaphylactic reactions

Very rare: Fewer than 1 in 10,000 people who have MabThera

• brain or central nervous system problems - seek medical advice if you get symptoms such as eye or eyesight problems, headache, seizures or changes in mental status
• cytokine release syndrome
• gastrointestinal problems - some of these problems may be fatal
• loss of vision
• neuropathies
• paralysis of the face
• serum sickness
• toxic epidermal necrolysis - this may be fatal
• tumour lysis syndrome
• vasculitis

The frequency of these side-effects is unknown

• immune problems - these may occur in children
• loss of other senses including loss of hearing

If you feel unwell or if you have concerns about a side-effect, tell the person looking after you immediately.

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 types of medicine may interact with MabThera:

If you are taking MabThera and one of the above 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 MabThera.

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.

Like all medicines MabThera can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, 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 MabThera:

Alcohol can interact with certain medicines.

In the case of MabThera:

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 MabThera:

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 MabThera, 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 MabThera:

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.

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