VALDOXAN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valdoxan 25 mg Film-Coated Tablets

agomelatine

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.

Contents of the pack and other information

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

1. What is Valdoxan and what is it used for

Valdoxan contains the active substance agomelatine. Agomelatine belongs to a group of medicines called antidepressants. Valdoxan has been prescribed for you to treat your depression. Valdoxan is used in adults.

Depression is a long-lasting alteration of mood that interferes with daily life. The symptoms of depression vary from person to person, but they usually consist of deep sadness, feelings of uselessness, loss of interest in hobbies, sleep disturbances, feeling of slowness, feeling of anxiety, and weight changes.

The expected benefits of Valdoxan are to gradually reduce and eliminate 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 is not working properly (liver insufficiency).
• if you are taking fluvoxamine (another medicine used to treat depression) or ciprofloxacin (an antibiotic).

Warnings and precautions

There may be reasons why Valdoxan is not suitable for you:

• If you are taking medicines that are known to affect the liver. Ask your doctor for advice about these medicines.
• If you have obesity or are overweight, ask your doctor for advice.

• If you are diabetic, ask your doctor for advice.
• If you have elevated liver enzyme levels before treatment, your doctor will decide whether Valdoxan is suitable for you.
• If you have bipolar disorder, have experienced or developed manic symptoms (a period of great excitement and abnormal elation of emotions) inform your doctor before starting to take this medicine or before continuing to take it (see also “Possible side effects” in section 4).

• If you suffer from dementia, your doctor will perform an individual assessment to decide whether it is suitable for you to take Valdoxan.

During your treatment with Valdoxan:

What to do to avoid potentially serious liver problems:

• Your doctor must check that your liver is working properly before starting treatment.Some patients may experience increases in blood liver enzyme levels during treatment with Valdoxan. Therefore, follow-up tests should be performed at the following frequency:

Based on the assessment of these tests, your doctor will decide whether you should receive or continue using Valdoxan (see also section 3 “How to take Valdoxan”).

Be aware of the signs and symptoms that may indicate that your liver is not working properly.

• If you noticeany of these signs and symptoms of liver problems: unusual darkening of the urine, light-colored stools, yellowing of the skin/eyes, pain in the upper right part of the abdomen, unusual fatigue (especially associated with other symptoms mentioned above), seek urgent advice from a doctor, who may recommend that you stop treatment with Valdoxan.

The effect of Valdoxan has not been documented in patients over 75 years of age. Valdoxan should therefore not be used in these patients.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of self-harm or suicide. These thoughts may be increased at the beginning of treatment with antidepressants, as all these medicines take time to work, usually a couple of weeks but sometimes longer.

You are more likely to have these thoughts:

Contact your doctor or go directly to the hospital as soon as you have any thoughts of self-harm or suicide.

It may be helpful for you to tell a relative or close friend that you are depressed and ask them to read this leaflet. You can ask them to tell you if they notice that 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 from 7 to 17 years because its safety and efficacy have not been established.

Other medicines and Valdoxan

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Do not take Valdoxan with certain medicines (see also “Do not take Valdoxan” in section 2): fluvoxamine (another medicine used to treat depression) and ciprofloxacin (an antibiotic) as they may change 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 to treat hypertension), enoxacin (an antibiotic).

Make sure to tell your doctor if you smoke more than 15 cigarettes/day.

Taking Valdoxan with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 may feel dizziness or drowsiness that could affect your ability to drive or use machines. You should make sure your reaction is normal before driving or using machinery.

Valdoxan contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Valdoxan contains sodium

Valdoxan contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Valdoxan

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Valdoxan is one tablet (25 mg) before bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), i.e., two tablets that should be taken together before bedtime.

Method of administration

Valdoxan is for oral use. You should swallow your tablet with the help of a glass of water.

You can take Valdoxan with or without food.

Duration of treatment

In most people with depression, Valdoxan starts to work on the symptoms of depression within two weeks of starting treatment.

Your depression should be treated for a sufficient period of at least 6 months to ensure that you no longer have symptoms.

Your doctor may continue to prescribe Valdoxan when you feel better to prevent depression from coming back.

If you have kidney problems, your doctor will perform an individual assessment to decide whether it is safe for you to take Valdoxan.

Liver function monitoring (see also section 2):

Your doctor will ask you for tests to check that your liver is working properly before starting treatment and, afterwards, periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. If your doctor increases the dose to 50 mg, tests should be performed at the time of dose increase and, afterwards, periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. After that, tests will be performed if the doctor considers it necessary.

You should not use Valdoxan if your liver is not working properly.

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

If your doctor switches your previous antidepressant medicine from an SSRI or SNRI to Valdoxan, they will warn you about how to stop treatment with your previous medicine when you start taking Valdoxan.

You may experience withdrawal symptoms related to the interruption of your previous treatment for a few weeks, even if the dose of your previous antidepressant medicine is gradually reduced.

Withdrawal symptoms include: dizziness, numbness, sleep disturbance, agitation or anxiety, headache, nausea, vomiting, and tremors. These effects are usually mild to moderate and disappear on their own within a few days.

If treatment with Valdoxan is started while gradually reducing the dose of the previous medicine, possible withdrawal symptoms should not be confused with a lack of effect of Valdoxan at the beginning of treatment.

You should consult your doctor about the best way to stop your previous antidepressant treatment when you start treatment with Valdoxan.

If you take more Valdoxan than you should

If you have taken more Valdoxan tablets than you should, or if, for example, a child has taken the medicine by accident, contact your doctor immediately.

Experience with Valdoxan overdose is limited, but reported symptoms include upper stomach pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or general malaise.

If you forget to take Valdoxan

Do not take a double dose to make up for forgotten doses. Simply take the next dose at the usual time.

The printed calendar on the blister pack containing the tablets will help you remember when you last took a Valdoxan tablet.

If you stop taking Valdoxan

Do not stop taking your medicine without consulting your doctor, even if you feel better.

If you have any further questions on the use of this product, 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 appear in the first two weeks of treatment and are normally transient.

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, drowsiness, difficulty sleeping (insomnia), nausea, diarrhea, constipation, abdominal pain, back pain, fatigue, anxiety, abnormal dreams, increased 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 (paresthesia), blurred vision, restless legs syndrome (a disorder characterized by an irresistible urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, itching, hives (urticaria), agitation, irritability, restlessness, aggressive behavior, nightmares, mania/hypomania (see also “Warnings and precautions” in section 2), suicidal thoughts or behavior, confusion, weight loss, muscle pain.
• Rare side effects (may affect up to 1 in 1,000 people): severe skin rash (erythematous rash), facial swelling (swelling) and angioedema (swelling of the face, lips, tongue, and/or throat that 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 restlessness), inability to empty the bladder completely.

• A small number of cases resulting in liver transplant or death have been reported. Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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. Storing 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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Valdoxan

• The active substance is agomelatine. Each film-coated tablet contains 25 mg of agomelatine.
• The other ingredients are:

Appearance of Valdoxan and pack contents

Valdoxan 25 mg film-coated tablets are oblong,

yellow-orange, with the company logo engraved in blue on one side. Valdoxan 25 mg film-coated tablets are available in calendar blisters. Packs containing 14, 28, 56, 84 or 98 tablets. A pack of 100 film-coated tablets is also available for hospital use.

Only some 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of last revision of this prospectus:

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu/.