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The eMC  

Last Updated 24 Jan 2014

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Valdoxan 25mg tablets

Valdoxan (val-dox-an) is a medicine which is used in depression. Valdoxan contains agomelatine. It is supplied by Servier Laboratories Limited.

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

Valdoxan 25mg tablets

Information specific to Valdoxan 25mg tablets when used in depression

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Your medicine

Valdoxan belongs to a class of medicines called antidepressants. It is used to treat depression. Depression is believed to be caused by an imbalance of chemicals in the brain. Valdoxan helps restore this chemical imbalance which can help improve symptoms of depression.

Some people who take an antidepressant may find that it intensifies depression and suicidal feelings in the early stages of treatment. These people have an increased risk of self-harm or suicide when they first start taking an antidepressant. As the medicine starts to work these risks decrease.

If you are taking Valdoxan, or you care for someone who is taking Valdoxan, you need to look out for changes in thoughts or behaviour that could be linked to self-harm or suicide. If you notice any of these changes or are worried about how Valdoxan is affecting you or someone you care for, you should contact your prescriber, a mental health professional or NHS Direct as soon as possible. Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.

Other information about Valdoxan:

  • your doctor may start you on a low dose of this medicine and then increase the dose depending on how you respond to treatment

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.

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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. 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 Valdoxan:

  • you should take Valdoxan just before you go to bed
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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 Valdoxan:

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.

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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 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.

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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.

In the case of Valdoxan:

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

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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 Valdoxan:

  • there are no special instructions on how to look after your medicine

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.

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Whether this medicine is suitable for you

Valdoxan 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 who is under 18 years of age.

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 confirm that this is the right dose

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

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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 Valdoxan:

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

Rare: More than 1 in 10,000 people who take Valdoxan:

  • angioedema
  • facial oedema
  • hallucinations
  • liver problems - some of these liver problems may be fatal. Seek immediate medical advice if you develop jaundice, dark urine, light coloured stools, pain in the right side of the stomach or unexplained or unexpected tiredness
  • mania or mania-like behaviour - seek immediate medical advice if you develop mania or mania-like symptoms
  • skin rash or rashes
  • weight gain
  • weight loss

The frequency of these side-effects is unknown:

  • suicide attempt or thoughts of committing suicide - you or your carer must seek immediate medical advice if: you have thoughts of committing suicide, you attempt to commit suicide, your symptoms worsen or your behaviour is unusual

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.

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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 Valdoxan:

The following types of medicine may interact with Valdoxan:

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

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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 Valdoxan.

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.

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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 Valdoxan:

  • 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.

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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 Valdoxan:

  • there are no specific foods that you must exclude from your diet when taking Valdoxan
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Alcohol

Alcohol can interact with certain medicines.

In the case of Valdoxan:

It is not advisable to drink alcohol while you are taking this medicine.

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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 you have reached when you take the medicine.

In the case of Valdoxan:

  • you should only take this medicine during pregnancy if your doctor thinks that you need it

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 Valdoxan, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Valdoxan:

  • women who are taking Valdoxan should not breast-feed

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 take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

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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.

Valdoxan contains:

  • aluminium lake
  • glycerol
  • hypromellose
  • indigotine E132
  • lactose monohydrate
  • macrogol
  • magnesium stearate
  • maize starch
  • povidone
  • propylene glycol
  • shellac
  • silica colloidal anhydrous
  • sodium starch glycollate (type A)
  • stearic acid
  • titanium dioxide (E171)
  • 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 Valdoxan before, do not take Valdoxan. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Valdoxan, Version 10, last updated 24 Jan 2014