Product Details

What you need to know before you take Valdoxan

Do not take Valdoxan – if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 6). – if your liver does not work properly (hepatic impairment). – if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic). Warnings and precautions There could be some reasons why Valdoxan may not be suitable for you: – If you are taking medicines known to affect the liver. Ask your doctor for advice on which medicine that is. – If you are obese or overweight, ask your doctor for advice. – If you are diabetic, ask your doctor for advice. – If you have increased levels of liver enzymes before treatment, your doctor will decide if Valdoxan is right for you. – If you have bipolar disorder, have experienced or if you develop manic symptoms (a period of abnormally high excitability and emotions) talk to your doctor before you start taking this medicine or before you continue with this medicine (see also under “Possible side effects” in section 4). – If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Valdoxan. During your treatment with Valdoxan : What to do to avoid potential serious liver problems – Your doctor should have checked that your liver is working properly before starting the treatment. Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan. Therefore follow-up tests should take place at the following time points: before initiation or dose increase around 3 weeks around 6 weeks around 12 weeks around 24 weeks Blood tests Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Valdoxan (see also under “How to take Valdoxan” in section 3). Be vigilant about signs and symptoms that your liver may not be working properly – If you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking Valdoxan. Effect of Valdoxan is not documented in patients aged 75 years and older. Valdoxan should therefore not be used in these patients. Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: – if you have previously had thoughts about killing or harming yourself. – if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. 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. Children and adolescents Valdoxan should not be used in children and adolescents (under 18 years old). Other medicines and Valdoxan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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) can modify the expected dose of agomelatine in your blood. Make sure to tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used in the treatment of hypertension), enoxacin (antibiotic) Make sure to tell your doctor if you are smoking more than15 cigarettes/day. Valdoxan with alcohol It is not advisable to drink alcohol while you are being treated with Valdoxan. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Breastfeeding should be discontinued if you take Valdoxan. Driving and using machines You might experience dizziness or sleepiness which could affect your ability to drive or operate machines. Make sure that your reactions are normal before driving or operating machines. Valdoxan contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Valdoxan contains sodium Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.