How does it work?

Valdoxan tablets contain the active ingredient agomelatine,which is a type of medicine called an antidepressant. It is used to treatdepression.

Agomelatine acts on the melatonin and serotonin receptors in thebrain.

Melatonin is a hormone made by the pineal gland, a structure inthe brain. It is normally released soon after it starts to get dark. The amountproduced then increases until about four am, before dropping off again.Melatonin is linked with the control of circadian rhythms and promoting sleep.It works by acting on melatonin receptors in the brain.

Agomelatine mimics the action of melatonin and helps tore-synchronise the body’s circadian rhythms. These include mood, anxiety,appetite, body temperature and sleep/wake cycles. These circadian rhythms,particularly sleep cycles, are severely disturbed in people with depression.Agomelatine’s main action is to improve the onset and quality of sleep and thisin turn has an antidepressant effect.

Agomelatine also helps to improve mood in depression byincreasing noradrenaline and dopamine release in the brain. These are naturalchemicals called neurotransmitters that are involved, amongst other things, inregulating mood.

What is it used for?

• Major episodes of depression.

Warning!

• Depression and other psychiatric illnesses are associated with an increased risk of suicidal thoughts, self-harm, and suicide. You should be aware that this medicine may not start to make you feel better for at least two to four weeks. However, it is important that you keep taking it in order for it to work properly and for you to feel better. If you feel your depression or anxiety has got worse, or if you have any distressing thoughts, or feelings about suicide or harming yourself in these first few weeks, or indeed at any point during treatment or after stopping treatment, then it is very important to talk to your doctor.
• It is recommended that you avoid drinking alcohol while taking this medicine.
• This medicine may cause sleepiness or dizziness and so could reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• You will need to have a blood test to check your liver function before you start treatment with this medicine. This should be repeated 6, 12 and 24 weeks after starting treatment, and then as your doctor feels necessary.

Use with caution in

• People with decreased kidney function.
• Elderly people over 65 years old.
• Young adults (aged under 25 years).
• People with history of attempted suicide or at risk of attempting suicide.
• History of mania or hypomania.
• People who are alcoholic or who consume large quantities of alcohol.

Not to be used in

• People with decreased liver function.
• Elderly people with dementia.
• People taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic).
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Valdoxan tablets contain lactose).
• This medicine is not recommended for children or adolescents under 18 years old, as its safety and effectiveness have not been established in this age group

This medicine should not be used if you are allergic to any ofits ingredients. Please inform your doctor or pharmacist if you have previouslyexperienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been investigated. If you do get pregnant while using this medicine you should consult your doctor straight away. This medicine should be used with caution during pregnancy and only if the benefits to the mother outweigh the potential risks to the foetus. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. It is not recommended for use by mothers who are breastfeeding. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Headache.
• Dizziness.
• Drowsiness.
• Migraine.
• Difficulty sleeping (insomnia).
• Disturbances of the gut, such as nausea, diarrhoea, constipation, upper abdominal pain.
• Excessive sweating.
• Back pain.
• Fatigue.
• Anxiety.
• Raised liver enzymes.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Blurred vision.
• Pins and needles (paraesthesia).
• Eczema.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Red rash.
• Inflammation of the liver (hepatitis).

Unknown frequency

• Suicidal thoughts or behaviour.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

Agomelatine should not be taken at the same time as theantidepressant fluvoxamine or the antibioticciprofloxacin. Fluvoxamine andciprofloxacin both increase the amount of agomelatine in thebody, by preventing its breakdown.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain agomelatine as the active ingredient.