VALDOXAN 25 mg Tabletki Powlekane

Treść ulotki

1. Valdoxan 25 mg film-coated tablets
   1. What is Valdoxan and what is it used for
   2. What you need to know before taking Valdoxan
   3. How to take Valdoxan
   4. Possible side effects
   5. How to store Valdoxan
   6. Package contents and other information

Valdoxan 25 mg film-coated tablets

agomelatine

Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their
symptoms are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

1. What is Valdoxan and what is it used for

Valdoxan contains the active ingredient agomelatine. It belongs to a group of medicines called
antidepressants. Valdoxan has been prescribed to treat depression.
Valdoxan is used in adults.
Depression is a persistent mood disorder that interferes with everyday life. The
symptoms of depression vary from person to person, but often include deep
sadness, feelings of self-worthlessness, loss of interest in favorite activities, sleep disturbances,
a feeling of slowing down, feelings of anxiety, weight changes.
The expected benefits of Valdoxan are the gradual reduction and elimination of symptoms related to your
depression.

2. What you need to know before taking 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 is not working properly (liver impairment),
• if you are taking fluvoxamine (another medicine used to treat depression) or ciprofloxacin (an antibiotic).

Warnings and precautions
Valdoxan may not be suitable for you for some reason

• If you are taking medicines that affect liver function. Ask your doctor which medicines these are.
• If you are obese or overweight, ask your doctor.
• If you are diabetic, ask your doctor.
• If you have an increase in liver enzyme levels before treatment, your doctor will decide if Valdoxan is suitable for you.
• If you suffer from bipolar disorder, if you have had or are experiencing manic symptoms (a period of excitement and abnormally intense emotions), talk to your doctor before starting to

take the medicine or before continuing with taking it (see also “ Possible side effects

” in section 4).

• If you suffer from dementia, your doctor will perform a subjective assessment to determine if taking Valdoxan is safe for you.

During treatment with Valdoxan:

What to do to avoid the onset of potentially serious liver problems:

• Your doctor must ensure that your liver is working properly before starting treatment. Some patients may have an increase in liver enzyme levels in the blood during treatment with Valdoxan. Therefore, constant monitoring must be performed according to the following schedule:

Based on the evaluation of these tests, your doctor will decide if you can take or continue to
use Valdoxan (see also “How to take Valdoxan”in section 3).

Be careful of signs and symptoms that may indicate that your liver is not working properly

• If you noticeany of these signs and symptoms of liver problems: abnormally dark urine, pale stools, yellowing of the skin/eyes, pain in the upper right abdomen, unusual fatigue (especially when associated with the other symptoms listed above),urgently contact a doctor who can advise you to stop treatment with Valdoxan.

The effect of Valdoxan has not been documented in patients aged 75 years or older. Therefore,
Valdoxan should not be used in these patients.

Thoughts of suicide and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of killing yourself. These thoughts may
be increased when you first start taking antidepressants, as these
medicines take time to work, usually about two weeks, but
sometimes even longer.
You may be more likely to have these thoughts:

• if you have had thoughts of killing yourself or harming yourself in the past,
• if you are a young adult. Data from clinical studies have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric disorders who have been treated with an antidepressant. At any time you have thoughts of harming yourself or of killing yourself, contact your doctor or go to hospital immediately.

It may be helpful to tell a relative or close friend that you are depressed and ask them to read
this leaflet. You may ask them to tell you if they think your depression is getting worse
or if they are worried about changes in your behavior.

Children and adolescents
Valdoxan is not recommended in children under 7 years of age due to lack of
information. No data are available.
Valdoxan should not be used in children and adolescents between 7 and 17 years of age
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 must not take Valdoxan with certain medicines (see also “ Do not take Valdoxan”
in section 2): fluvoxamine (another medicine used to treat depression)
ciprofloxacin (an antibiotic) can change the expected dose of agomelatine in the blood.
Tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used
to treat high blood pressure), enoxacin (an antibiotic).
Make sure to tell your doctor if you smoke more than 15 cigarettes a day.

Valdoxan with alcohol
It is not advisable to drink alcohol while being treated with Valdoxan.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding must be stopped if you take Valdoxan.

Driving and using machines
You may feel dizzy or sleepy, which can affect your ability to drive or operate
machinery. Make sure your reactions are normal before driving or operating machinery.

Valdoxan contains lactose.
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

Valdoxan contains sodium
Valdoxan contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Valdoxan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose of Valdoxan is one tablet (25 mg) before bedtime. In some cases, your
doctor may prescribe a higher dose (50 mg), that is two tablets to be taken together
before bedtime.
Method of administration
Valdoxan is for oral use. You must swallow the tablet with a sip of water. Valdoxan can be
taken with or without food.
Duration of treatment
In most depressed patients, Valdoxan begins to act on the symptoms of depression within
two weeks from the start of treatment.
Depression must be treated for a sufficient period of at least 6 months to ensure you
get rid of the symptoms.
The doctor may continue to prescribe Valdoxan when you feel better to prevent the
depression from returning.
If you suffer from kidney disorders, your doctor will perform an individual assessment to establish whether
taking Valdoxan is safe for you.

Monitoring of liver function (see also paragraph 2):
Your doctor may prescribe laboratory tests to check the correct functioning of the liver
before the start of treatment and then periodically during treatment, generally after 3
weeks, 6 weeks, 12 weeks and 24 weeks.
If your doctor increases the dose you are taking to 50 mg, laboratory tests must be
performed at the start of the new dosage and then periodically during treatment,
usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks. Afterwards the tests will be
performed if your doctor deems it necessary.
If the liver is not functioning correctly, you should not use Valdoxan.

How to switch from an antidepressant medicine (SSRI/SNRI) to Valdoxan?
If your doctor changes your previous antidepressant therapy with an SSRI or SNRI and prescribes
Valdoxan for you, they will advise you on how to stop the previous treatment when you start therapy with
Valdoxan.
Even if the dose of the previous antidepressant medicine is gradually reduced, you may experience for
some weeks withdrawal symptoms related to the interruption of the previous medicine.
Withdrawal symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety,
headache, nausea, malaise and tremor. These effects are generally mild to moderate and
disappear spontaneously within a few days.
If you start taking Valdoxan while reducing the dosage of the previous medicine, the possible
withdrawal symptoms should not be confused with a lack of early benefits of
Valdoxan.
When you start Valdoxan, you should discuss with your doctor the best way to stop your
previous antidepressant therapy.

If you take more Valdoxan than you should
If you have taken a quantity of Valdoxan greater than that prescribed, or if for example a child has
taken the medicine by mistake, contact your doctor immediately.
Experience of overdose with Valdoxan is limited, but the reported symptoms include pain in the
upper part of the stomach, drowsiness, 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 missed dose. Take the next dose
at the usual time.
The calendar printed on the blister pack containing the tablets will help you remember when you took
your last Valdoxan tablet.

If you stop taking Valdoxan
Do not stop taking the medicine without your doctor's advice, even if you feel better.
If you have any doubts about the use of this medicine, 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 treatment and are generally transient.
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, drowsiness, difficulty sleeping (insomnia), nausea, diarrhoea, constipation, abdominal pain, pain in the

back, fatigue, anxiety, abnormal dreams, increased levels of liver enzymes in the blood,
vomiting, weight gain.

• Uncommon side effects (may affect up to 1 in 100 people): migraine, tingling in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder characterised by an uncontrollable need to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, itching, urticaria, agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also “Warnings and precautions” in paragraph 2), suicidal thoughts or behaviours, confusion, weight loss, muscle pain.
• Rare side effects (may affect up to 1 in 1,000 people): severe skin rashes (erythematous rash), facial swelling (oedema) and angioedema (swelling of the face, lips, tongue and/or throat which can cause difficulty breathing or swallowing), hepatitis, yellowing of the skin or the whites of the eyes (jaundice), liver failure*, hallucinations, inability to remain still (due to physical and mental agitation), inability to completely empty the bladder.

* Some cases have been reported that ended with a liver transplant or with a fatal outcome

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in
Appendix V.
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Valdoxan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and blister. The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valdoxan contains

• The active ingredient is agomelatine. Each film-coated tablet contains 25 mg of agomelatine.
• The other ingredients are: lactose monohydrate, corn starch, povidone (K30), sodium glycolate starch type A, stearic acid, magnesium stearate, anhydrous colloidal silica, hypromellose, glycerol, macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171). printing ink: shellac, propylene glycol and aluminum lake containing indigo carmine (E132).

Description of the appearance of Valdoxan and package contents
The film-coated tablets (tablet) of Valdoxan 25 mg are oblong, yellow-orange, with the

company logo printed in blue on one side.
Valdoxan 25 mg tablets are available in blister packs with a calendar. The 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 further information on this medicinal product, 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
Тел.: +359 2 921 57 00

Luxembourg/Luxemburg
S.A. Servier Benelux N.V.
Tél/Tel: +32 (0)2 529 43 11

Česká republika
Servier s.r.o.
Tel: +420 222 118 111

Magyarország
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

Norge
Servier Danmark A/S
Tel:+ 372 664 5040 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

Suomi/Finland
Servier Finland Oy
Puh /Tel: +358 (0)9 279 80 80

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22741741

Italia
Servier Italia S.p.A.
Tel: +39 06 669081

Sverige
Servier Sverige AB
Tel: +46 (0)8 522 508 00

Latvija
SIA Servier Latvia
Tel: +371 67502039
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu

Annex IV
Scientific conclusions and justification for the variation of the terms
of the marketing authorisation(s)
Scientific conclusions
Considering the assessment of the Pharmacovigilance and Risk Assessment Committee
( Pharmacovigilance and Risk Assessment Committee, PRAC) of the Periodic Safety Update Report
( Periodic Safety Update, PSUR) for agomelatine, the scientific conclusions are as
follows:
Based on the measures to avoid hepatotoxicity reported in guidelines/clinical practice and
contraindication in decrease, the PRAC agreed that the additional risk minimisation
measures can be removed from Annex II.D and the RMP.
Having examined the PRAC recommendation, the CHMP agrees with the related overall conclusions
and justification of the PRAC recommendation.

Justification for the variation of the terms of the marketing authorisation(s)
Based on the scientific conclusions relating to agomelatine, the CHMP considers that the benefit/risk
ratio of the medicinal product containing/medicinal products containing agomelatine is unchanged
save for the proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation(s).