Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you have any questions about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using VALDOXAN?
VALDOXAN contains the active ingredient agomelatine. VALDOXAN is used in the treatment
of depression and the prevention of relapse of depression. VALDOXAN is also used in
the treatment of anxiety. It is only available with a doctor's prescription. For more
information, see Section
1. Why am I using VALDOXAN? in the full CMI.
2. What should I know before I use VALDOXAN?
Do not use if you have ever had an allergic reaction to VALDOXAN or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. Do not use VALDOXAN if you suffer from liver disease or you know your liver does not
work properly (hepatic impairment). For more information, see Section
2. What should I know before I use VALDOXAN? in the full CMI.
3. What if I am taking other medicines?
4. How do I use VALDOXAN?
The usual dose of VALDOXAN is one tablet at bedtime. In some cases your doctor may
prescribe two tablets (50 mg) to be taken together at bedtime. You should not take
more than the maximum recommended dose of two tablets daily. Do not change your dose
without the advice of your doctor even if you feel better. VALDOXAN can be taken with
or without food. More instructions can be found in Section
4. How do I use VALDOXAN? in the full CMI.
5. What should I know while using VALDOXAN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using VALDOXAN.
Have blood tests to check your liver function before the start of treatment and before
a dose increase to 50mg (dose should only be increased by your doctor), and then around:
3, 6, 12 and 24 weeks.
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Things you should not do
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You should not take VALDOXAN together with certain medications such as: fluvoxamine
(another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).
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Driving or using machines
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As with all medications used to treat depression or anxiety, you should make sure
that you know how you react to VALDOXAN before you drive or operate machinery.
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Drinking alcohol
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It is recommended to avoid drinking alcohol while taking any antidepressant including
VALDOXAN.
People who drink excessive quantities of alcohol should not take VALDOXAN. Excessive
alcohol may cause liver problems and may make depression or anxiety worse.
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Looking after your medicine
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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.
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6. Are there any side effects?
VALDOXAN is usually well tolerated, however all medications may have unwanted effects
in some people. If you do experience any side effects, most of them are minor and
temporary. However, some side effects may need medical attention. Severe liver reactions
(especially with excessive alcohol consumption and/or with any other medication processed
by your liver) and severe allergic reactions have very rarely been reported. Medical
attention or hospitalisation may then be required and should be sought urgently from
a doctor or Accident and Emergency at the nearest hospital. For more information,
including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
Agomelatine (pronounced a-go-mel-a-tin)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VALDOXAN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using VALDOXAN.
Where to find information in this leaflet:
1. Why am I using VALDOXAN?
VALDOXAN contains the active ingredient agomelatine.
VALDOXAN is used in the treatment of depression and the prevention of relapse of depression.
VALDOXAN is also used in the treatment of generalised anxiety disorder.
The symptoms of depression vary from one person to another, but a depressive episode
commonly includes 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.
Generalised anxiety disorder is a chronic feeling of excessive worry or nervousness
and difficulties to control them. It is commonly associated with increased irritability,
sleep disturbances, concentration difficulties, and physical symptoms such as fatigue
or muscle tension.
VALDOXAN can help regulate your 'body clock' (circadian rhythm) with positive benefits
on mood and sleep in depression and/or anxiety.
Your doctor may prescribe VALDOXAN for another purpose other than the treatment of
your depression and/or anxiety.
Ask your doctor if you have any questions about why VALDOXAN has been prescribed for
you.
VALDOXAN is not addictive.
VALDOXAN does not cause discontinuation symptoms on stopping treatment and can be
stopped without the need to taper dose.
In clinical studies VALDOXAN had no effect on sexual function.
VALDOXAN is not recommended for children, adolescents (under 18 years old) or elderly
patients:
with major depression aged 75 or older
with generalised anxiety aged over 65.
2. What should I know before I use 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.
Warnings
Do not use VALDOXAN if:
you are allergic to agomelatine, or any of the ingredients listed at the end of this
leaflet.
always check the ingredients to make sure you can use this medicine.
you suffer from liver disease or you know your liver does not work properly (hepatic
impairment).
routine blood tests show levels of liver enzymes have increased to more than 3 times
the upper limit of normal.
you are currently taking fluvoxamine (a medicine 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 use VALDOXAN:
A routine blood test should be performed before treatment to check how your liver
is functioning. If you have increased levels of liver enzymes your doctor will decide
if VALDOXAN is right for you.
You may be at risk of liver problems if you are overweight, obese or have diabetes
or if you are taking medicines known to affect your liver (ask your doctor if you
are unsure which medicines these might be).
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 or anxiety worse.
Tell your doctor if you are smoking more than 15 cigarettes/day.
If you have any doubts or questions about taking VALDOXAN consult with your doctor
Check with your doctor if you:
have ever experienced or develop an episode of bipolar disorder, mania or hypomania
(extreme upward mood swings or irritable mood).
have a history of dementia.
are pregnant, plan to become pregnant or are breast-feeding.
drink alcohol. People who drink excessive quantities of alcohol should not take VALDOXAN.
Excessive alcohol may cause liver problems and may make depression or anxiety worse.
are smoking more than 15 cigarettes/day.
have any doubts or questions about taking VALDOXAN consult with your doctor.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with VALDOXAN and affect how it works. Medicines that
may increase the effect of VALDOXAN include:
fluvoxamine (a medicine used in the treatment of depression)
ciprofloxacin (an antibiotic used to treat infections)
propranolol (a medicine sometimes used to treat heart problems)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VALDOXAN.
4. How do I use VALDOXAN?
Always take VALDOXAN exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
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 two tablets, i.e. 50 mg daily.
Do not change your dose without the advice of your doctor even if you feel better.
Current experience with VALDOXAN to treat depression or anxiety shows that treatment
for at least six months or longer provides the best opportunity of long-term recovery.
When 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 long to take VALDOXAN
Current experience with VALDOXAN to treat depression or anxiety shows that treatment
for at least six months or longer provides the best opportunity of long-term recovery.
With VALDOXAN some people may experience improvements within two to four 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 or anxiety from returning.
When you and your doctor have decided to stop VALDOXAN, there is no need to taper
the dose as VALDOXAN does not cause discontinuation symptoms after stopping treatment.
If you forget to take VALDOXAN
VALDOXAN should be used regularly at the same time each day.
If you forget to take your VALDOXAN, skip the dose you missed, take your next planned
treatment at the usual dose and usual time, then continue as normal. Do not take a
double dose to make up for the dose you missed.
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.
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 use too much VALDOXAN
It is important that you do not take more VALDOXAN tablets than your doctor has prescribed.
If you think that you have used too much VALDOXAN, you may need urgent medical attention.
The experience of overdoses with VALDOXAN is limited but reported symptoms may 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.
You should immediately:
phone the Poisons Information Centre (by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
If anyone accidentally swallows any of your VALDOXAN tablets, call your nearest Poisons
Information Centre for advice (Australian 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.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using VALDOXAN?
Your liver function
VALDOXAN is processed by the liver. Before you started taking VALDOXAN a blood test
was required to check your liver function. While you are taking VALDOXAN you will
need further blood tests to check your liver continues to function properly. These
tests should be performed:
before the start of treatment and before a dose increase to 50mg (dose should only
be increased by your doctor).
and then around:
3 weeks,
6 weeks,
12 weeks and
24 weeks.
These blood test results will help your doctor decide whether VALDOXAN is suitable
for you. VALDOXAN may sometimes affect the results of these blood tests.
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 should do
To make sure you have the best opportunity of long-term recovery , continue to take
VALDOXAN as long as your doctor recommends you to.
Tell your doctor if you have previously experienced a bipolar disorder or develop
an episode of extreme upward mood swings or irritable mood.
Check with your doctor that your liver function tests are done as described in the
YOUR LIVER FUNCTION section above.
Seek advice from your doctor immediately if you develop signs or symptoms of potential
liver problems (such as dark urine, light coloured faeces, yellow skin or eyes, pain
in your upper right abdomen, new-onset and unexplained fatigue). Your doctor may advise
you to stop taking VALDOXAN.
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.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
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.
Call your doctor straight away:
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 symptoms of depression or anxiety
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.
If someone you know shows any of these symptoms, suggest they urgently contact a healthcare
professional.
In addition to talking to your doctor, confidential support and counselling services
are available (in Australia) from LifeLine by calling 13 11 14.
You may find it helpful to tell a relative or close friend that you are depressed
or anxious and ask them to read this leaflet. You might ask them to tell you if they
think your symptoms are getting worse, or if they are worried about changes in your
behaviour.
Things you should not do
Do not stop using this medicine suddenly.
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.
Driving or using machines
As with all medications used to treat depression or anxiety, 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.
Drinking alcohol
It is recommended to avoid drinking alcohol while taking any antidepressant including
VALDOXAN.
Tell your doctor if you drink alcohol. 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 or anxiety worse.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
When to discard your medicine
Discard the medicine when the expiry date (EXP) printed on the pack has passed.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
VALDOXAN 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. This is why your
doctor has asked you to have routine blood tests.
Some people taking VALDOXAN have reported the following side effects, which may relate
to VALDOXAN, their depression, anxiety, general health or to any of their other treatment(s).
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
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.
Less serious side effects
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Less serious side effects
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What to do
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Psychiatric disorders:
agitation, irritability, restlessness, aggressive behaviour
mania/hypomania (see also under 'Before you start to take VALDOXAN')
suicidal thoughts or behaviour
nightmares
confusion
hallucinations
anxiety
Nervous system disorders:
headache
migraine
dizziness, abnormal dreams
sleepiness (somnolence), difficulty in sleeping (insomnia)
pins and needles in the fingers and toes (paraesthesia), restless legs syndrome (a
disorder that is characterised by an uncontrollable urge to move the legs)
inability to remain still (due to physical and mental unrest)
Eye disorders:
blurred vision
Ear disorders:
ringing in the ears
Gastrointestinal Disorders:
feeling sick (nausea), diarrhoea, constipation, abdominal pain, vomiting
Liver disorders:
increased levels of liver enzymes in your blood
hepatitis, yellow coloration of the skin or the whites of the eyes (jaundice), hepatic
failure (isolated cases of death or liver transplantation have been reported in patients
with hepatic risk factors)
Skin and subcutaneous tissue disorders:
eczema, pruritus, urticaria (hives)
excessive sweating (hyperhidrosis
serious skin eruption (erythematous rash), face oedema (swelling) and angioedema (swelling
of the face, lips, tongue and/or throat that may cause difficulty in breathing or
swallowing)
Musculoskeletal and connective tissue disorders:
back pain, muscle pain.
Kidney and urinary disorders:
inability to completely empty the bladder.
General disorders:
weight increased.
weight decreased
tiredness.
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Ask your doctor or pharmacist if you don’t understand something in this list.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What VALDOXAN contains
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Active ingredient
(main ingredient)
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agomelatine
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Other ingredients
(inactive ingredients)
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lactose monohydrate, maize starch, povidone, sodium starch glycollate, stearic acid,
magnesium stearate, colloidal anhydrous silica, hypromellose, iron oxide yellow, glycerol,
macrogol 6000 and titanium dioxide, shellac, indigo carmine and propylene glycol
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Do not take this medicine if you are allergic to any of these ingredients.
What VALDOXAN looks like
VALDOXAN is registered on the Australian register of Therapeutic Goods and has the
Australian Register number: AUST R 159712.
VALDOXAN 25 mg film-coated tablets are oblong, orange-yellow with blue imprint of
the company logo on one side.
VALDOXAN 25 mg 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.
Who distributes VALDOXAN
VALDOXAN is a product discovered by Servier Research International. It is distributed
in Australia by:
Servier Laboratories (Aust.) Pty. Ltd.
Building 9, Level 4
588A Swan Street
Burnley, 3121, Victoria
Telephone: 1800 153 590
Internet: www.servier.com.au
This leaflet was prepared in May 2022