Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - valdoxan

Document Subject

Generated Narrative: MedicinalProductDefinition mp79d322f9708e44619600f26fcf371238

identifier: http://ema.europa.eu/identifier/EU/1/08/499/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Valdoxan 25 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-79d322f9708e44619600f26fcf371238

identifier: http://ema.europa.eu/identifier/EU/1/08/499/002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - valdoxan

Attesters

What is in this leaflet:

1. What Valdoxan is and what it is used for
2. What you need to know before you take Valdoxan
3. How to take Valdoxan
4. Possible side effects
5. How to store Valdoxan
6. Contents of the pack and other information

Valdoxan contains the active ingredient agomelatine. It belongs to a group of medicines called antidepressants. You 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 disturbances, 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.

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 .

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.

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.

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 treatment 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 fingers 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.

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.

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).
• printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132)

What Valdoxan looks like and contents of the pack Valdoxan 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of company logo
on one side. Valdoxan 25 mg film-coated tablets are available in calendar blisters. Packs contain 14, 28, 56, 84 or 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 Madro os, 28043 Madrid Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 Lietuva UAB SERVIER PHARMA
Tel: +370 (5) 2 63 86

.: +359 2 921 57 Luxembourg/Luxemburg S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 esk republika Servier s.r.o. Tel: +420 222 118 Magyarorsz g Servier Hungaria Kft. Tel: +36 1 238 7Danmark Servier Danmark A/S Tlf: +45 36 44 22 Malta V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 Deutschland Servier Deutschland GmbH Tel: +49 (0)89 57095 Nederland Servier Nederland Farma B.V. Tel: +31 (0)71 5246Eesti Servier Laboratories O
Tel:+ 372 664 5Norge Servier Danmark A/S Tlf: +45 36 44 22 E

: +30 210 939 1 sterreich Servier Austria GmbH Tel: +43 (1) 524 39 Espa a Laboratorios Servier S.L. Tel: +34 91 748 96 Polska Servier Polska Sp. z o.o. Tel: +48 (0) 22 594 90 France Les Laboratoires Servier Tel: +33 (0)1 55 72 60 Portugal Servier Portugal, Lda Tel.: +351 21 312 20 Hrvatska Servier Pharma, d. o. o. Tel.: +385 (0)1 3016 Rom nia Servier Pharma SRL Tel: +4 021 528 52 Ireland Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8Slovenija Servier Pharma d. o. o.
Tel.: +386 (0)1 563 48 sland Servier Laboratories c/o Icepharma hf S mi: +354 540 8Slovensk republika Servier Slovensko spol. s r.o. Tel.:+421 (0) 2 5920 41 Italia Servier Italia S.p.A. Tel: +39 06 669Suomi/Finland Servier Finland Oy P. /Tel: +358 (0)9 279 80
C.A. Papaellinas Ltd. : +357 22741Sverige Servier Sverige AB Tel : +46 (0)8 522 508 Latvija SIA Servier Latvia United Kingdom (Northern Ireland) Servier Laboratories (Ireland) Ltd

Tel: +371 67502Tel: +44 (0)1753 666This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: