Mircera 50micrograms/0.3ml solution for injection pre-filled syringes

Mircera is a form of a hormone called erythropoietin. Erythropoietin is a hormone which is produced in the kidneys that is involved in the production of red blood cells. People who have kidney problems often become anaemic because as the condition of their kidneys worsens they produce less erythropoietin.

Mircera is used to treat anaemia, which is causing symptoms, in people who have kidney problems.

Other information about Mircera:

Mircera needs to be injected. Your prescriber will show you how to inject this medicine yourself.

There should also be instructions on how to inject this medicine in the Patient Information Leaflet that comes with this medicine or on the pharmacy label.

The pharmacy label on your medicine tells you how much medicine you should have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. You should not change the dose of your medicine unless you are told to do so by your prescriber.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

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

Some medicines work best if they are taken at a specific time of day. If someone is giving you this injection, the person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

If you are injecting this medicine yourself, make sure that you find out from your prescriber the best time to have Mircera.

In the case of Mircera:

This medicine needs to be injected. Your prescriber may give you your injections or you may be shown how to inject the medicine yourself. If you are injecting this medicine yourself, follow the instructions from your prescriber and the information on the pharmacy label. There should also be further information in the Patient Information Leaflet that comes with this medicine.

In the case of Mircera:

If you have any concerns about this medicine or about the process of having it you should talk to someone who is involved in your medical care.

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

The person who is responsible for giving you your medicine will make sure that you are given the correct dose of your medicine. If you inject the medicine yourself, make sure that you do not take any extra doses as this could cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

Suddenly stopping your medicine may cause your original condition to return. The person in charge of your care will make the decision about whether you should stop this medicine. If you experience any problems while having this medicine talk to someone who is involved in your care. If you are injecting this medicine yourself, and are not having any problems with the medicine, do not stop having it, even if you feel better, unless advised to do so by your prescriber.

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

If you are injecting this medicine yourself, read the pharmacy label to find out how you should look after your medicine. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions.

Do not use the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Specific information about how to look after Mircera can be found in the Patient Information Leaflet that comes with this medicine. Make sure that the medicine is out of the sight and reach of children.

In the case of Mircera:

Do not use the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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

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

• raised blood pressure

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

• headaches
• thrombosis

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

• brain or central nervous system problems caused by raised blood pressure
• hot flushes
• hypersensitivity reactions including anaphylactic reaction
• skin rash or rashes

The frequency of these side-effects is unknown:

• abnormal laboratory test results
• production of antibodies to erythropoietin
• thrombocytopenia

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

• cerebrovascular problems including stroke
• pulmonary embolism

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.

There are no known important interactions between Mircera and other medicines. If you experience any unusual symptoms while having Mircera and other medicines you should tell your prescriber.

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 Mircera.

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 Mircera:

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 Mircera:

Alcohol can interact with certain medicines.

In the case of Mircera:

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 Mircera:

Careful consideration needs to be given to the risks and the benefits of using this medicine during pregnancy.

You need to discuss your specific circumstances with your doctor to make a decision about whether you are going to take this medicine during pregnancy. You should only take this medicine during pregnancy if your doctor thinks you need to take it. If the decision is that you should not have Mircera, 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 Mircera:

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. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

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.

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