Valdoxan 25 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Valdoxan 25 mg film-coated tablets

agomelatine

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Valdoxan is and what it is 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. Contents of the pack and other information

1. What Valdoxan is and what it is used for

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

Depression is a persistent disturbance of mood that interferes with daily life. Symptoms of depression vary from person to person, but usually include deep sadness, feelings of worthlessness, loss of interest in hobbies, sleep disturbances, a sense of slowness, feelings 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 starting Valdoxan

Do not take Valdoxan

• if you are allergic to agomelatine or to any of the other ingredients of this medicine (listed in section 6).

• if your liver is not working properly (hepatic insufficiency).

• if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).

Warnings and precautions

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

• If you are taking medicines known to affect the liver. Please seek advice from your doctor regarding these medicines.

• If you have obesity or are overweight, please seek advice from your doctor.

• If you are diabetic, please seek advice from your doctor.

• If you have elevated liver enzyme levels before treatment, your doctor will decide whether Valdoxan is appropriate for you.

• If you have bipolar disorder, or have experienced or develop manic symptoms (periods of abnormal excitement and emotional elation), inform your doctor before starting or continuing this medicine (see also “Possible side effects” in section 4).

• If you suffer from dementia, your doctor will perform an individual assessment to determine whether taking Valdoxan is appropriate for you.

During your treatment with Valdoxan:

What to do to avoid potentially serious liver problems:

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

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

Be alert for signs and symptoms indicating that your liver is not functioning properly.

• If you notice any of the following signs or symptoms of liver problems: unusual darkening of the urine, light-coloured stools, yellowing of the skin or eyes, pain in the upper right part of the abdomen, unusual fatigue (especially when associated with other symptoms mentioned above), seek urgent medical advice, which may lead your doctor to recommend discontinuing treatment with Valdoxan.

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

Suicidal thoughts and worsening of depression

If you are depressed, you may occasionally have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as all these medicines take some time to become effective, usually about two weeks but sometimes longer.

You are more likely to have such thoughts:

• if you have previously had thoughts of self-harm or suicide.
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders who are being treated with antidepressants.

Contact your doctor or go directly to the hospital immediately if you experience any thoughts of self-harm or suicide.

It may be helpful to inform a close family member or friend that you are depressed and ask them to read this leaflet. You may wish to ask them to inform you if they notice your depression worsening or if they are concerned about changes in your behaviour.

Children and adolescents

Valdoxan is not recommended for children under 7 years of age due to lack of information. No data are available.

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

Other medicines and Valdoxan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You must not take Valdoxan together 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 alter the intended blood levels of agomelatine.

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

Taking Valdoxan with alcohol

It is not advisable 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding must be discontinued if you are taking Valdoxan.

Driving and use of machines

You may experience dizziness or drowsiness, which could affect your ability to drive or operate machinery. You should ensure that your reaction is normal before driving or operating machinery.

Valdoxan contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Valdoxan contains sodium

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

3. How to take Valdoxan

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Method of administration

Valdoxan is for oral use. You must swallow your tablet with a glass of water.

You may take Valdoxan with or without food.

Duration of treatment

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

Your depression should be treated for a sufficient period of at least 6 months to ensure that your symptoms have resolved.

Your doctor may continue prescribing Valdoxan after you start feeling better to prevent depression from returning.

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 request blood tests to check that your liver is functioning properly before starting treatment, and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. If your doctor increases your dose to 50 mg, blood tests should be performed at the time of dose increase and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Afterwards, blood tests will be performed if your doctor considers them necessary.

You must not use Valdoxan if your liver is not functioning properly.

Switching from an antidepressant (SSRI/SNRI) to Valdoxan:

If your doctor switches your previous antidepressant medication from an SSRI or SNRI to Valdoxan, your doctor will advise you on how to discontinue your previous medication when starting Valdoxan.

You may experience withdrawal symptoms related to discontinuation of the previous treatment for several weeks, even if the dose of your previous antidepressant medication is gradually reduced.

Withdrawal symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors. These effects are generally mild to moderate and resolve spontaneously within a few days.

If treatment with Valdoxan is started while gradually tapering off the previous medication, possible withdrawal symptoms should not be mistaken for lack of efficacy of Valdoxan at the beginning of treatment.

You should consult your doctor about the best way to discontinue your previous antidepressant treatment when starting 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 accidentally taken the medicine, contact your doctor immediately.

Experience with overdose of Valdoxan is limited, but reported symptoms include upper abdominal pain, somnolence, 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 missed doses. Simply take the next dose at your usual time.

The calendar printed 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 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 everyone experiences them.

Most side effects are mild or moderate. They usually occur during the first two weeks of treatment and are generally 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, somnolence, difficulty sleeping (insomnia), nausea, diarrhoea, constipation, abdominal pain, back pain, 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 irresistible urge to move the legs), tinnitus, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also “Warnings and precautions” in section 2), suicidal thoughts or behaviour, confusion, weight loss, muscle pain.
• Rare side effects (may affect up to 1 in 1,000 people): severe skin rash (erythematous rash), facial oedema (swelling) and angioedema (swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing), hepatitis, yellowing of the skin or whites of the eyes (jaundice), liver failure*, hallucinations, inability to stay still (due to physical and mental restlessness), inability to completely empty the bladder.

* A small number of cases have been reported which led to liver transplantation or death.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valdoxan

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

Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valdoxan

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

Appearance of Valdoxan and contents of the pack

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

Valdoxan 25 mg film-coated tablets are available in calendar blisters. Packs containing 14, 28, 56, 84 or 98 tablets. A pack containing 100 film-coated tablets is also available for hospital use.

Only certain pack sizes may be marketed.

Marketing Authorization 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 Authorization Holder:

Date of the most recent review of this leaflet: 04/2025

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