Agomelatine (pronounced a-go-mel-a-tin)
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What VALDOXAN is used for
VALDOXAN is used in the treatment of depression or to help prevent depression returning, and is only available with a doctor's prescription. The symptoms of depression vary from one person to another, but commonly include persistent sadness, loss of interest in favourite activities, feelings of worthlessness, sleep problems, feeling of being slowed down, feelings of anxiety or changes in appetite and weight. Changes in your daily sleep and appetite patterns are examples of disturbances of your 'body clock' that occur commonly in depression.
VALDOXAN can help regulate your 'body clock' (circadian rhythm) with positive benefits on mood and sleep in depression.
VALDOXAN is not addictive.
VALDOXAN is not recommended for children or adolescents (under 18 years old).
Your doctor may prescribe VALDOXAN for another purpose. Ask your doctor if you have any questions about why VALDOXAN has been prescribed for you.
Before you take VALDOXAN
There are some people who shouldn't take VALDOXAN. Please read the list below. If you think any of these situations apply to you or you have any questions, please see your doctor.
When you must not take VALDOXAN
Do not take VALDOXAN if:
you suffer from liver disease or you know your liver does not work properly (hepatic impairment).
you are currently taking fluvoxamine (a drug used in the treatment of depression) or ciprofloxacin (an antibiotic used to treat infections).
you have an allergy to VALDOXAN or any of the ingredients (including lactose) listed at the end of this leaflet.
the packaging is torn or shows signs of tampering.
the expiry date (EXP) printed on the pack has passed.
Before you start to take VALDOXAN
Tell your doctor if you have ever experienced or develop an episode of bipolar disorder, mania or hypomania (extreme upward mood swings or irritable mood).
Your doctor should be made aware if you have a history of dementia.
Tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding.
Talk to your doctor about how much alcohol you drink. People who drink excessive quantities of alcohol should not take VALDOXAN. Excessive alcohol may cause liver problems and may make depression worse. You may also be at risk of liver problems if you are obese.
If you have any doubts or questions about taking VALDOXAN consult your doctor.
Taking other medications
Tell your doctor if you are taking any other medications, including medications you buy without a prescription from a pharmacy, supermarket, health food shop or naturopath/herbalist.
How to take VALDOXAN
Always take VALDOXAN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow VALDOXAN tablets whole with some water in the evening at bedtime.
VALDOXAN can be taken with or without food.
How much to take
The usual dose of VALDOXAN is one tablet in the evening at bedtime. In some cases your doctor may prescribe two tablets (50 mg) to be taken together in the evening at bedtime. You should not take more than the maximum recommended dose of 50 mg daily.
Do not change your dose without the advice of your doctor even if you feel better.
How long to take it
Current experience with medications to treat depression shows that treatment for six months or longer provides the best opportunity of long-term recovery from a first episode of depression. For those who have previously had depression, a longer period of treatment will usually be recommended.
With VALDOXAN, some people experience improvements in mood and sleep within two weeks of starting treatment. As people respond differently to medications, do not become discouraged if you do not notice a difference right away.
Continue taking VALDOXAN until your doctor advises you to stop. Even when you are feeling better, your doctor would usually continue to give you VALDOXAN for some time to help to prevent your depression from returning.
If you forget to take it
If you forget to take your VALDOXAN skip the dose you missed, take your next planned dose at the usual time and continue as normal.
To avoid confusion, it is recommended that you leave the tablet you missed in the tablet strip and continue on with the next day's tablet as indicated on the tablet strip calendar.
Do not try to make up for missed doses. Simply take one dose per day.
The calendar printed on the tablet strip should help you remember when you last took a VALDOXAN tablet. It is also a good reminder of how much VALDOXAN you have left so you can get your prescription refilled if you need to.
If you take too much (overdose)
It is important that you do not take more VALDOXAN tablets than your doctor has prescribed. The experience of overdoses with VALDOXAN is limited but reported symptoms include stomach pain, drowsiness tiredness, agitation, anxiety, dizziness, blue-ish discolouration of the skin or mucous membranes and/or a general feeling of being unwell. If you do take more than you have been prescribed, contact your doctor immediately for advice.
If anyone accidentally swallows any of your VALDOXAN tablets, call your nearest Poisons Information Centre for advice (telephone: 13 11 26), or go to Accident and Emergency at your nearest hospital. Keep the telephone number for these places handy whilst taking any medications.
While you are taking VALDOXAN
VALDOXAN is processed by the liver. To check how your liver is functioning before and during treatment, routine blood tests are usually performed at the start of treatment and then periodically during the first months of treatment (usually after 6 weeks, 12 weeks and 24 weeks). VALDOXAN may sometimes affect the results of these blood tests. If you have increased levels of liver enzymes before treatment with VALDOXAN, additional blood tests may be required.
You may also have tests to check that your liver is working properly if you start to take medicines that interfere with how the body processes VALDOXAN.
Talk to your doctor about how much alcohol you drink.
Things you must do
To make sure you have the best opportunity of long-term recovery from your depression, continue to take VALDOXAN as long as your doctor recommends you to.
Tell your doctor if you have experienced or develop an episode of bipolar disorder, mania or hypomania (extreme upward mood swings or irritable mood).
Tell your doctor immediately if you become pregnant while taking VALDOXAN.
Tell all doctors, dentists and healthcare professionals who are treating you that you are taking VALDOXAN.
Do not take any other medications, whether they require a prescription or not, without first telling your doctor that you are taking VALDOXAN as sometimes the action of one medicine may interfere with another.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Tell your doctor if you feel the tablets are not helping your condition.
Keep all of your doctor's appointments so that your progress can be checked.
If you are being treated for depression, be sure to discuss with your doctor any problems you may have and how you feel, especially any feelings of severe sadness or bursts of unusual energy or anger.
If you have any thoughts about suicide or doing harm to yourself call your doctor immediately and also contact someone you trust.
All thoughts or talk about suicide or violence towards others or yourself are serious. Such thoughts may even occur after commencing antidepressant treatment, particularly before the full antidepressant effect is seen. Such thoughts are more likely to occur in young adults under 25 years of age.
If you or someone you know is showing any of the following common warning signs, either contact your doctor or healthcare professional or go to the nearest hospital for treatment:
worsening of your depression,
thoughts or talk about death or suicide,
thoughts or talk about self-harm or doing harm to others,
any recent attempts of self-harm,
an increase in aggressive behaviour, irritability or agitation.
In addition to talking to your doctor, confidential support and counselling services are available from LifeLine by calling 13 11 14.
You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Things you must not do
You should not take VALDOXAN together with certain medications (see also under "When you must not take VALDOXAN") such as: fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).
Do not give this medicine to anyone else even if their symptoms seem similar to yours or if they have the same condition as you.
Things to be careful of
As with all medications used to treat depression, you should make sure that you know how you react to VALDOXAN before you drive or operate machinery. Speak to your doctor if you have any concerns.
It is recommended to avoid drinking alcohol while taking any antidepressant including VALDOXAN.
Unwanted effects potentially due to treatment and/or your depression
Tell your doctor or pharmacist or go to the nearest Accident and Emergency at the nearest hospital as soon as possible if you do not feel well while you are taking VALDOXAN.
VALDOXAN has been developed to treat people with depression and is usually well tolerated, however all medications may have unwanted effects in some people.
Increases in liver enzymes, and rarely inflammation of the liver, have been observed in some patients treated with VALDOXAN. When VALDOXAN was discontinued in these patients, the increases in liver enzymes usually returned to normal levels.
Some people taking VALDOXAN for depression have reported the following adverse reactions, which may relate to their depression, general health or any of their treatments:
headache, dizziness, migraine, pins and needles in the fingers and toes or blurred vision
nausea, diarrhoea, constipation, stomach pain
sleepiness or difficulty in sleeping, fatigue
anxiety or agitation
abnormal dreams, including nightmares
aggressive behaviour
excessive sweating or skin rash
back pain
suicidal thoughts or behaviour.
Do not be alarmed, you may not experience any of these. Other unwanted effects have been uncommonly reported and you should ask your doctor or pharmacist if you want to know more.
The possibility of a severe liver reaction exists with excessive alcohol consumption and/or with any other medication processed by the liver, e.g. VALDOXAN. Symptoms of severe liver reactions may include:
yellow colouring of the skin or whites of the eyes (jaundice)
abnormal bleeding or bruising
confusion, loss of consciousness or hallucinations.
The possibility of a severe allergic reaction exists with any medication. The following are general signs and symptoms of an allergic reaction:
itching, skin rash or hives
shortness of breath, wheezing or trouble breathing
swelling of the face, lips, tongue or other parts of the body.
Severe liver reactions and severe allergic reactions are very serious. Medical attention or hospitalisation may be required and should be sought urgently from a doctor or Accident and Emergency at the nearest hospital.
See your doctor if you experience any of these or notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you don't understand something in this list.
After taking VALDOXAN
Storage
Keep your tablets in the pack until it is time to take them. Keep them in a cool, dry place where it stays below 30°C. Keep them where children cannot reach them.
Disposal
If your doctor tells you to stop taking VALDOXAN, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.
Product description
VALDOXAN is registered on the Australian register of Therapeutic Goods and has the Australian Register Number: AUST R 159712.
What it looks like
VALDOXAN 25mg film-coated tablets are oblong, orange-yellow with blue imprint of the company logo on one side.
VALDOXAN 25mg tablets are contained in a foil blister strip with a calendar printed on the blister to help you remember when you last took a tablet of VALDOXAN.
Ingredients
Each tablet of VALDOXAN contains 25mg of agomelatine as the active ingredient and the following inactive ingredients: lactose, starch - maize, povidone, sodium starch glycollate, stearic acid, magnesium stearate, silica - colloidal anhydrous, hypromellose, iron oxide yellow (CI77492), glycerol, macrogol 6000 and titanium dioxide (CI77891), shellac, indigo carmine (CI73015) and propylene glycol.
VALDOXAN contains lactose.
Manufacturer/Sponsor
VALDOXAN is a product discovered by Servier Research International.
It is distributed in Australia by:
SERVIER LABORATORIES (AUST) PTY LTD
8 Cato Street
Hawthorn Victoria 3122
ABN: 54 004 838 500
Telephone: 1800 153 590
Internet: www.servier.com.au
This document was last revised in July 2011
