Brand Name: Valdoxan
Drug Name: Agomelatine
Form: Film coated Tablets
Packaging Type: Box containing 28 25 mg tablets
Country of Origin: Germany
Valdoxan, (active ingredient agomelatine), is the first in a new class of antidepressants called melatonergic agonists. This novel approach to treating depression has many advantages over current treatments. Valdoxan not only works effectively as an antidepressant, it has been shown to improve sleep/wake cycles without causing daytime sleepiness. Additionally, it doesn’t appear to have the side effect of loss of sexual desire or problems with stopping the drug (discontinuation symptoms) that other antidepressants do.
Clinical studies have shown that a dose of 25 mg of Valdoxan once daily in the hours before bed effectively treats major depressive disorders. Further studies showed that it works in adults of all ages and in elderly people. Another clinical trial showed that Valdoxan has a similar effectiveness to venlafaxine, which is commonly known as Effexor.
Valdoxan interacts with receptors for melatonin and with melatonin antagonist receptors. Scientists believe that the dual action may be responsible for the re-regulation of the sleep/wake cycle.
One common problem with traditional treatment of sleep problems that so often go with depression is that treatments left patients somewhat sedated during the daytime. But Valdoxan specifically acts on the wake/sleep cycle, balancing them without making patients sleepy during the daytime.
One of the most exciting properties of Valdoxan is that it relieves depression as well as drugs like Effexor and Paxil, but it does not cause loss of sexual function or the discontinuation symptoms that are often associated with SSRI (serotonin specific reuptake inhibitors) antidepressants.
A double-blind study of 492 patients with recurring major depressive disorders measured time until relapse and withdrawal due to lack of effectiveness. Valdoxan resulted in a lower relapse rate compared to patients taking a placebo over a six month period. In the placebo group, 46.6% of the patients relapsed over a six month period, whereas in the Valdoxan group, only 21.7% relapsed over the same time period. This pattern held up even in the subpopulation of the study group which had the most severe depression. In a trial comparing Valdoxan with the SSRI sertraline (trade name Zoloft), Valdoxan was found to work better and have a lower rate of discontinuation than sertraline.
Valdoxan has also been shown to have anxiolytic, or anxiety-relieving properties, which could make it a useful drug for treatment of anxiety disorders.
The most common side effects associated with Valdoxan, seen in between 1% and 10% of patients, are headache, dizziness, sleepiness, insomnia, migraine, nausea, diarrhea, excessive sweating, and increases in anxiety. In some patients, liver enzymes were increased.
Most reported side effects were minor and came and went within the first two weeks of treatment. It is possible that some of the reported side effects were linked to depression rather than the drug.
Valdoxan should not be used in patients who have liver problems like cirrhosis or active liver disease. It should not be taken by patients who are taking medicines that would slow down the breakdown of Valdoxan such as fluvoxamine (trade name Luvox) and the antibiotic ciprofloxacin (trade name Cipro). It should also not be taken by patients with age related dementia.
In January 2009 Valdoxan was granted marketing approval in the European Union for treatment of adult patients with major depression. The drug has not yet attained approval from the U.S. Food and Drug Administration as of mid-2009.
Valdoxan was developed by French pharmaceutical company Servier. In the United States, Novartis has exclusive rights to develop and market the drug.
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Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should not take Valdoxan together with certain medicines (see also under ‘Do not take Valdoxan’ in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic).
Valdoxan can be taken with or without food. It is not advisable to drink alcohol while you are being treated with Valdoxan.
Talk to your doctor if you become pregnant (or plan to become pregnant) while you are taking Valdoxan. Ask your doctor or pharmacist for advice before taking any medicine.
Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Valdoxan.
Ask your doctor or pharmacist for advice before taking any medicine.
You might experience dizziness or sleepiness which could affect your ability to drive or operate machinery. Make sure that your reactions are normal before driving or operating machines.
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Valdoxan.
Always take Valdoxan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose of Valdoxan is one tablet (25 mg) at bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime. Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment. Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression from returning.
Do not stop taking your medicine without the advice of your doctor even if you feel better.
Valdoxan is for oral use. You should swallow your tablet with a drink of water. Valdoxan can be taken with or without food. Your doctor will run laboratory tests to check that your liver is working properly at the initiation of treatment and then periodically during treatment, usually after 6 weeks, 12 weeks and 24 weeks. Thereafter tests will be taken if the doctor finds it necessary.
You must not use Valdoxan if your liver does not work properly. If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Valdoxan.
If you have taken more Valdoxan than you should, or if for example a child has taken medicine by accident, contact your doctor immediately.
The experience of overdoses with Valdoxan is limited but reported symptoms include pain in the upper part of the stomach and drowsiness.
Do not take a double dose to make up for a forgotten dose. Just carry on with the next dose at the usual time.
The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Valdoxan. If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Like all medicines, Valdoxan can cause side effects, although not everybody gets them.
Most side effects are mild or moderate. They usually occur within the first two weeks of the treatment and are usually temporary.
The frequency of possible side effects listed below is defined using the following system:
These side effects include:
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Valdoxan after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substance is agomelatine. Each tablet contains 25 mg of agomelatine.
The other ingredients are:
Valdoxan 25 mg film-coated tablets are oblong, orange-yellow with a blue imprint of ‘company logo’ on one side. Valdoxan 25 mg film-coated tablets are available in calendar blisters. Packs contain 7, 14, 28, 42, 56, 84 or 98 tablets. Packs of 100 film-coated tablets are also available for hospital use. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Les Laboratoires Servier
22, rue Garnier
Servier (Ireland) Industries Ltd
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site http://www.emea.europa.eu
The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.