Epirubicin 10mg/5ml solution for injection vials

Epirubicin hydrochloride is used to treat many types of cancers.

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

Epirubicin hydrochloride works by damaging cancer cells in the body. Epirubicin hydrochloride also affects healthy cells and treatment with Epirubicin hydrochloride may damage your immune system or heart. Your medical team may arrange for you to have some tests to check how well your immune system and heart are working.

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

Epirubicin hydrochloride 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:

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

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

• blood and bone marrow problems - these may lead to bleeding problems, hypoxia or death
• hair loss
• red coloured urine

Common: More than 1 in 100 people who have Epirubicin hydrochloride

• dehydration
• diarrhoea
• hot flushes
• infections
• inflammation of the mouth
• injection site problems such as redness - these problems may lead to necrosis if Epirubicin hydrochloride is injected incorrectly
• loss of appetite
• mucous membrane problems
• nausea
• oesophagitis
• vomiting

Uncommon: More than 1 in 1000 people who have Epirubicin hydrochloride

• phlebitis
• thrombophlebitis

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

• abnormal laboratory test results
• amenorrhoea
• anaphylactic reactions
• ascites
• breathing difficulties
• chills
• ECG changes
• faster heart rate
• feeling dizzy
• fever
• general feeling of being unwell
• heart problems
• leukaemia
• liver problems
• lung problems
• metabolic problems
• oedema
• pulmonary oedema
• slower heart rate
• sperm problems
• urticaria
• weakness

The frequency of these side-effects is unknown

• breathing problems
• eye or eyesight problems
• hypersensitivity or allergic reactions
• itching
• menopausal symptoms
• nail problems
• photosensitivity
• pneumonia
• recall phenomenon
• redness of the skin
• sepsis
• septic shock
• shock
• skin colour changes
• skin problems
• skin rash or rashes
• thromboembolism such as pulmonary embolism - this may be fatal

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 Epirubicin hydrochloride:

The following types of medicine may interact with Epirubicin hydrochloride:

If you are taking Epirubicin hydrochloride 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 Epirubicin hydrochloride.

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 Epirubicin hydrochloride 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 Epirubicin hydrochloride:

Alcohol can interact with certain medicines.

In the case of Epirubicin hydrochloride:

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 Epirubicin hydrochloride:

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 Epirubicin hydrochloride, 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 Epirubicin hydrochloride:

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 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 epirubicin hydrochloride.

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 Epirubicin hydrochloride before, do not take Epirubicin hydrochloride. Talk to your prescriber, pharmacist or nurse as soon as possible.