Avodart (Ay-voh-dart) is a medicine which is used in benign prostatic hyperplasia. Avodart contains dutasteride. It is made by GlaxoSmithKline UK.

The information in this Medicine Guide for Avodart varies according to the condition being treated and the particular preparation used.

We have information for a single preparation used in the treatment of prostatic hyperplasia (benign). The preparation name is shown in red below.

Avodart 500microgram soft capsules

Form: Capsule

Regulated Information Patient Information Leaflet Summary of Product Characteristics

 

To get the most benefit from your medicine, take it exactly as prescribed. You should also take care to look after your medicine.

Medicines are used to treat, control or prevent a condition. Some medicines will give you immediate relief from your symptoms while others take much longer to work.

Avodart has been prescribed for your current medical problems and should not be used for other medical problems. Do not share your medicine with other people as it may not be suitable for them and could cause them harm. In the same way, you should not use medicines that belong to other people.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often to take your medicine. This is the dose that you and your prescriber have agreed you should take. Depending on your response to the medicine, how the medicine works and the goals of your treatment, your prescriber may vary your dose. You should not change the dose of your medicine unless you are told to do so by your prescriber.

Avodart is used to block the effects of a hormone in the body which causes swelling of the prostate gland in men. An enlarged prostate gland can make it difficult to pass urine. Avodart can help to reduce the swelling of the prostate gland and make it easier to pass urine.

This medicine should only be taken by men and should not be taken or handled by women, children or adolescents. Avodart may be absorbed through the skin. Women, children or adolescents who come into contact with leaking capsules of Avodart must immediately wash it off their skin with soap and water.

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. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Avodart:

If you are having problems taking this medicine, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other medicines that are easier for you to take.

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can 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 and it is therefore essential 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. This is why you must speak to your prescriber if you are having any problems taking your medicine.

If you are not having any problems taking this medicine then do not stop taking 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.

The instructions on how you should keep your medicine are on the pharmacy label. 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 take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Avodart:

You must not take 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.

Your prescriber will not give you this medicine if they know of any reasons why you must not take it. Sometimes it is necessary to prescribe this medicine with extra caution. For more information see the ‘Whether this medicine is suitable for you’ section.

If you have been prescribed this medicine you need to be aware of the side-effects that you could develop while taking this medicine. For more information see the 'Side-effects' section.

Avodart 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 or an adolescent.

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

Over time it is possible that Avodart can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Avodart 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. Very occasionally, certain side-effects can be beneficial.

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.

Between 1% and 10% of people who take Avodart

• impotence
• decreased libido
• ejaculation problems
• breast enlargement or tenderness

Less than 0.01% of people who take Avodart

• allergic reactions including rash, itching, urticaria and angioedema

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 have been prescribed this medicine you and your prescriber may need to think about whether you need to change any of your everyday activities. You must also discuss with your prescriber any other medicines and any complementary preparations you are taking.

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 Avodart:

The following types of medicine may interact with Avodart:

If you are taking Avodart 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 Avodart.

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 Avodart 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 Avodart:

Alcohol can interact with certain medicines.

In the case of Avodart:

Taking this medicine could have an impact on your decisions relating to family planning, pregnancy and breast-feeding.

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 Avodart:

This medicine must not be taken by women. There is a risk that it may harm the baby if taken by women who are pregnant. If you take this medicine during pregnancy or if you come into contact with the ingredients, you must immediately contact your prescriber. For more information, talk to someone who is involved in your medical care.

This medicine must not be taken by women so its effects on breast-feeding are not known.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

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