This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Find out more here.

Continue >
The eMC  

Last Updated 04 Jul 2014

You are viewing:

Combodart 0.5mg/0.4mg capsules

Combodart (Com-boh-dart) is a medicine which is used in benign prostatic hyperplasia. Combodart contains tamsulosin hydrochloride/dutasteride. It is supplied by GlaxoSmithKline UK.

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

Combodart 0.5mg/0.4mg capsules

Information specific to Combodart 0.5mg/0.4mg capsules when used in benign prostatic hyperplasia

Print this medicine guide

Can't read the PDF? Download Adobe Reader at adobe.com.

Your medicine

Combodart is used in the treatment of moderate to severe benign prostatic hyperplasia in males. It also helps to reduce the risk of acute urinary retention and the need for surgery. Combodart contains two medicines - dutasteride and tamsulosin hydrochloride.

Dutasteride works by blocking 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. Dutasteride can help to reduce the swelling of the prostate gland and make it easier to pass urine.

Tamsulosin hydrochloride relaxes the muscles surrounding the prostate gland and helps males who have an enlarged prostate to pass urine more easily.

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

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

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

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

Back to top

When to take your medicine

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.

In the case of Combodart:

  • this medicine should be taken about 30 minutes after a meal, at the same time each day
Back to top

How to take your 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.

In the case of Combodart:

  • swallow the capsule whole. You must not chew or crush it as it may irritate your mouth and throat
  • it is important to avoid contact with a leaking capsule because dutasteride, one of the medicines in Combodart, can be absorbed through the skin. If contact is made with a leaking capsule, wash the affected area immediately with soap and water

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.

Back to top

Taking too much of your medicine

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 so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or call 111 for advice.

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

Back to top

Stopping your medicine

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 call 111.

Back to top

Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should 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 Combodart:

  • do not store in temperatures above 30°C

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.

Back to top

Whether this medicine is suitable for you

Combodart 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:

Combodart is not used in women, children or adolescents.

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

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects
  • to check that this medicine is having the desired effect

Over time it is possible that Combodart can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Combodart has become unsuitable, it is important that the prescriber is contacted immediately.

Back to top

Side-effects

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 take Combodart:

  • breast problems such as breast enlargement or tenderness
  • changes in libido
  • ejaculation problems
  • feeling dizzy - if you feel dizzy, sit or lie down until you feel better
  • impotence

Uncommon: More than 1 in 1000 people who take Combodart:

  • heart problems
  • shock caused by heart problems

The frequency of these side-effects is unknown :

These side-effects have been reported when people have taken dutasteride which is one of the ingredients in Combodart. The frequency of these side-effects in people who take Combodart is not known :

  • breast cancer - seek immediate medical advice if you have changes in the breast area such as lumps or discharge from the nipple
  • depression
  • excessive hair growth
  • hair loss
  • hypersensitivity reactions such as rashes, itching, urticaria, oedema, and angioedema
  • increased risk of prostate cancer
  • testicular pain or swelling

These side-effects have been reported when people have taken tamsulosin hydrochloride which is one of the ingredients in Combodart. The frequency of these side-effects in people who take Combodart is not known :

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 111.

Back to top

Taking other medicines

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 Combodart:

The following types of medicine may interact with Combodart:

If you are taking Combodart and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Back to top

Complementary preparations and vitamins

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 Combodart.

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.

Back to top

Driving and operating machinery

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 Combodart:

  • this medicine could affect your ability to drive or operate machinery

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.

Back to top

Diet

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 Combodart:

  • there are no specific foods that you must exclude from your diet when taking Combodart
Back to top

Alcohol

Alcohol can interact with certain medicines.

In the case of Combodart:

  • there are no known interactions between alcohol and Combodart
Back to top

Family planning and pregnancy

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 has been reached when the medicine comes into contact with the developing baby.

In the case of Combodart:

  • Combodart must not be taken by women. It is a medicine which has implications for pregnancy
  • if you are pregnant or think you may be pregnant, you must take care not to come into contact with leaking capsules of Combodart. This is because Combodart may be absorbed through the skin and it may cause your baby some problems
  • this medicine may decrease male fertility because it affects sperm production
  • this medicine may be present in small amounts in semen and may cause harm if it comes into contact with an existing pregnancy. If you are taking Combodart and are sexually active you must use a condom when having penetrative sex

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.

Back to top

Breast-feeding

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

Back to top

Ingredients of your medicine

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.

Combodart contains:

  • black iron oxide (E172)
  • butylhydroxytoluene (E321)
  • carnauba wax
  • carrageenan (E407)
  • glycerol
  • hypromellose
  • lecithin (may contain soya oil)
  • maize starch
  • medium chain triglycerides
  • methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent (also contains polysorbate 80 and sodium lauril sulfate)
  • microcrystalline cellulose
  • mono-di-glycerides of caprylic/capric acid
  • potassium chloride
  • potassium hydroxide
  • propylene glycol
  • red iron oxide (E172)
  • shellac
  • sunset yellow (E110)
  • talc
  • titanium dioxide (E171)
  • triethyl citrate
  • yellow iron oxide (E172)

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

Back to top

Combodart, Version 6, last updated 04 Jul 2014