Refludan 50mg powder for solution for injection vials

Refludan helps prevent the formation of clots in people with heparin induced thrombocytopenia (HIT) and thromboembolic disease. In heparin induced thrombocytopenia there is an increased risk of clot formation. Refludan works by inhibiting the action of an enzyme that is involved in the clotting process and prevents the formation of clots. Refludan may cause serious allergic reactions including anaphylaxis and shock. The chances of anaphylactic reactions happening increase with subsequent treatment courses. These reactions could be fatal and it is very important that you tell your prescriber or medical team if you have had treatment with Refludan before.

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

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

• anaemia
• bleeding from various sites such as gastrointestinal, vaginal, rectal, nose, pulmonary, bleeding into the chest space and around the heart following surgery, bleeding into the brain or from punctured sites - bleeding could be fatal
• production of antibodies to hirudin

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

• allergic skin reactions including rash
• anaphylactic reactions including anaphylactic shock - this could be fatal
• angioedema including oedema of the face, tongue, or laryngeal oedema
• breathing difficulties
• chills
• cough
• fever
• hot flushes
• injection site reactions including pain
• itching
• stridor
• urticaria

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 Refludan:

The following types of medicine may interact with Refludan:

If you are taking Refludan 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 Refludan.

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 Refludan:

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 Refludan:

Alcohol can interact with certain medicines.

In the case of Refludan:

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 Refludan:

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 Refludan:

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 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.

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