Javlor 250 mg/10ml concentrate for solution for infusion

Javlor is used in the treatment of advanced or metastatic cancer of the bladder or urinary tract when other therapies containing the medicine platinum have failed.

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

Javlor works by preventing cancer cells from growing and multiplying. This leads to death of cancer cells. Javlor also affects healthy cells and treatment with Javlor may affect your blood cell count and your heart function. Your medical team may arrange for you to have some tests to monitor your blood counts and side-effects of your treatment while you are having Javlor.

Other information about Javlor:

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

Javlor 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 Javlor can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Javlor 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 Javlor:

• blood and bone marrow problems
• constipation
• diarrhoea
• fever
• hair loss
• inflammation of the mouth
• injection site problems
• loss of appetite
• muscle pain or tenderness
• nausea
• neuropathy of the extremities
• stomach pain
• tiredness
• vomiting
• weakness
• weight loss

Common: More than 1 in 100 people who have Javlor:

• blood pressure changes
• bowel problems
• breathing difficulties
• chest pain
• chills
• cough
• dehydration
• difficulty sleeping
• ear pain
• fainting or brief loss of consciousness
• faster heart rate
• feeling dizzy
• headaches
• hypersensitivity reactions
• increased sweating
• indigestion
• infections - some infections have been reported to be fatal
• itching
• mouth problems
• muscle weakness
• neuralgia
• neuropathies
• oedema
• pain
• pain in the jaw, back, joints, muscles and bones
• painful extremities
• skin rash or rashes
• swallowing difficulties
• taste changes
• thrombosis of the veins
• urticaria

Uncommon: More than 1 in 1000 people who have Javlor:

• abnormal laboratory test results
• dry skin
• eye or eyesight problems
• gastrointestinal problems
• gum problems
• heart attack - this may be fatal
• heart or circulation problems
• kidney problems
• leakage of Javlor out of the vein
• neuropathy of the extremities
• oesophagitis
• pain on swallowing
• redness of the skin
• respiratory distress
• sepsis
• throat pain
• tinnitus
• vertigo
• weight gain

The following side effects have been reported in people who have had medicines similar to Javlor. The frequency of these side-effects in people who have Javlor is not known:

• bronchospasm
• cardiac arrest - this may be fatal
• endocrine problems

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 medicines may interact with Javlor:

The following types of medicine may interact with Javlor:

If you are taking Javlor 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 Javlor:

If you have been prescribed Javlor 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 Javlor:

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 Javlor:

If your diet includes any of the above, speak to your prescriber or pharmacist for further advice.

Alcohol can interact with certain medicines.

In the case of Javlor:

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 Javlor:

You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant. This is so that together you can make a decision about what treatment you may need during your pregnancy.

You should discuss whether there are any other medicines which you could take during pregnancy which would treat your condition.

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

In the case of Javlor:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could have which would also allow you to breast-feed.

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.

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