(℞) Prescription Required
Valdoxan (Agomelatina) Dosage and Side Effects
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.
Warnings and Precautions
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)
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 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
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 worse.
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.
Tell your doctor if you are taking propranolol (a medicine sometimes used to treat heart problems).
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.
If any of the signs below occur then tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
The possibility of a severe liver reaction exists, especially 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 which may cause difficulty in swallowing or breathing.
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.
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. This is why your doctor has asked you to have routine blood tests.
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:
Common side effects (may affect up to 1 in 10 people):
sleepiness (somnolence), difficulty in sleeping (insomnia)
migraine headache, dizziness abnormal dreams
feeling sick (nausea), diarrhoea, constipation, abdominal pain, vomiting
excessive sweating (hyperhidrosis),
increased levels of liver enzymes in your blood
Uncommon side effects (may affect up to 1 in 100 people):
mania/hypomania (see also under 'Before you start to take VALDOXAN'
suicidal thoughts or behaviour
pins and needles in the fingers and toes (paraesthesia), restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs)
ringing in the ears
eczema, pruritus, urticaria (hives)
agitation, irritability, restlessness, aggressive behaviour
muscle pain (myalgia).
Rare side effects (may affect up to 1 in 1,000 people):
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)
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)
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.
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.
Interactions with this medication
Proper Use of this medication
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 (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.
Other related products
The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.