InfoCons Consumer Protection informs you – Valdoxan – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only . Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects ,talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Valdoxan is and what it is used for

Valdoxan contains the active ingredient agomelatine . It belongs to a group of medicines called antidepressants. Y ou have been given Valdoxan to treat your depression.

Valdoxan is used in adults.

Depression is a continuing disturbance of mood that interferes with everyday life. The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep distur bances, feeling of being slowed down, feelings of anxiety, changes in weight.

The expected benefits of Valdoxan are to reduce and gradually remove the symptoms related to your depression.

⚠️ 2. 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:

26 – 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 pla ce 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 s igns 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 advi se 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.

27 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 is not recommended in children below 7 years due to lack of information. No data is available.

Valdoxan should not be used in children and adolescents aged 7 to 17 years because safety and efficacy have not been established.

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 modif y 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 than 15 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 machine s.

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 c ontains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium -free’.

💊 3. How to take V aldoxan

Always take this medicine exactly as your doctor or pharmacist has told you. 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.

28 Method of administration Valdoxan is for oral use. You should swallow your tablet with a drink of water. Valdoxan can be taken with or without food.

Duration of treatment Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.

Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms.

Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression from returning.

If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Valdoxan.

Surveillance of the liver function (see also section 2) :

Your doctor will run laboratory tests to check that your liver is working properly before starting treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.

If your doctor increase the dose to 50mg, laboratory tests should be performed at this initiation and then periodically during treatment, usually after 3 weeks, 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.

How to switch from an antidepressant medicine (SSRI/SNRI) to Valdoxan?

If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Valdoxan, he/she will advise you on how you should discontinue your previous medicine when starting Valdoxan.

You may experience discontinuation symptoms related to stopping of your previous medicine for a few weeks, even if the dose of your previous antidepressant medicine is decreased gradually.

Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking. These effects are usually mild to moderate and disappear spontaneously within a few days.

If Valdoxan is initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of Valdoxan.

You should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting Valdoxan.

If you take more Valdoxan than you should

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, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise.

If you forget to take Valdoxan

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 stop taking Valdoxan

Do not stop taking your medicine without the advice of your doctor even if you feel better.

If you have any further questions on the use of this product, please ask your doctor or pharmacist.

❗ 4. Possible side effects

Like all medicines, this medicine 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 treat ment and are usually temporary.

These side effects include:

• Very common side effects (may affect more than 1 in 10 people ) : headache
• Common side effects ( may affect up to 1 in 10 people ): dizziness, sleepiness (somnolence), difficulty in sleeping (insomnia), feeling sick (nausea), diarrhoea, constipation, abdominal pain, back pain, tiredness, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight increased .
• Uncommon side effects (may affect up to 1 in 100 people) : migraine, pins and needles in the fi ngers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs), ringing in the ears , excessive sweating (hyperhidrosis), eczema , pruritus, urticaria (hives) , agitation , irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour,confusion, weight decreased , muscle pain .
• 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 *, hallucinations, inability to remain still (due to physical and mental unrest) , inability to completely empty the bladder .
• Few cases resulting in liver transplantation or death have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Valdoxan

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What Valdoxan contains

• The active substance is agomelatine. Each film-coated tablet contains 25 mg of agomelatine.
• The other ingredients are: lactose monohydrate, maize starch, povidone (K30) , sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica ,hypromellose, glycerol, macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171).

What Valdoxan looks like and contents of the pack

Valdoxan 25 mg film- coated tablets (tablet) are oblong, orange-yellow.

Valdoxan 25 mg film-coated tablets are available in calendar blisters. Packs contain 14, 28, 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 50, rue Carnot 92284 Suresnes cedex – France

Manufacturer

Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy France Servier (Ireland) Industries Ltd Gorey road Arklow – Co. Wicklow – Ireland Anpharm Przedsiebiorstwo Farmaceutyczne S.A.

03-236 Warszawa ul. Annopol 6B Poland Laboratorios Servier, S.L.

Avda. de los Madroños, 33 28043 Madrid Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien S.A. Servier Benelux N.V. Tél/Tel: +32 (0)2 529 43 11 Lietuva UAB “SERVIER PHARMA” Tel: +370 (5) 2 63 86 28 България Сервие Медикал ЕООД Luxembourg/Luxemburg S.A. Servier Benelux N.V.

31 Тел.: +359 2 921 57 00 Tél/Tel: +32 (0)2 529 43 11 Česká republika Servier s.r.o.

Tel: +420 222 118 111 Magyarorsz ág Servier Hungaria Kft.

Tel.: +36 1 238 7799 Danmark Servier Danmark A/S Tlf.: +45 36 44 22 60 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Deutschland Servier Deutschland GmbH Tel: +49 (0)89 57095 01 Nederland Servier Nederland Farma B.V.

Tel: +31 (0)71 5246700 Eesti Servier Laboratories OÜ Tel:+ 372 664 5040 Norge Servier Danmark A/S Tlf: +45 36 44 22 60 Eλλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000 Österreich Servier Austria GmbH Tel: +43 (1) 524 39 99 España Laboratorios Servier S.L.

Tel: +34 91 748 96 30 Polska Servier Polska Sp. z o.o.

Tel.: +48 (0) 22 594 90 00 France Les Laboratoires Servier Tél: +33 (0)1 55 72 60 00 Portugal Servier Portugal, Lda Tel: +351 21 312 20 00 Hrvatska Servier Pharma, d. o. o.

Tel: +385 (0)1 3016 222 România Servier Pharma SRL Tel: +4 021 528 52 80 Ireland Servier Laboratories (Ireland) Ltd.

Tel: +353 (0)1 663 8110 Slovenija Servier Pharma d. o. o.

Tel: +386 (0)1 563 48 11 Ísland Servier Laboratories c/o Icepharma hf Sími: +354 540 8000 Slovenská republika Servier Slovensko spol. s r.o.

Tel:+421 (0) 2 5920 41 11 Italia Servier Italia S.p.A.

Tel: +39 06 669081 Suomi/Finland Servier Finland Oy Puh /Tel: +358 (0)9 279 80 80 Κύπρος C.A. Papaellinas Ltd.

Sverige Servier Sverige AB 32 Τηλ: +357 22741741 Tel: +46 (0)8 522 508 00 Latvija SIA Servier Latvia Tel: +371 67502039

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site : https://www.ema. europa .eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Valdoxan (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/08/499).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.