Agomelatine Stada 25 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Agomelatine Stada 25 mg film-coated tablets EFG

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

• Keep this leaflet as 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 may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Agomelatine Stada is and what it is used for
2. What you need to know before taking Agomelatine Stada
3. How to take Agomelatine Stada
4. Possible side effects

5 Storage of Agomelatine Stada

1. Contents of the pack and other information

1. What Agomelatina Stada is and what it is used for

This medicine contains the active substance agomelatine. Agomelatine belongs to a group of medicines called antidepressants and has been prescribed to you to treat your depression.

Agomelatine 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, feelings of sluggishness, anxiety, and weight changes.

The expected benefits of agomelatine are to gradually reduce and eliminate the symptoms related to your depression.

2. What you need to know before starting to take Agomelatine Stada

Do NOT take agomelatine

• 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 functioning 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 agomelatine may not be suitable for you:

• If you are taking medicines known to affect the liver. Consult your doctor about these medicines.
• If you have obesity or are overweight, consult your doctor.
• If you are diabetic, consult your doctor.
• If you have elevated liver enzyme levels before starting treatment, your doctor will decide whether this medicine is appropriate for you.
• If you have bipolar disorder, or have experienced or develop manic symptoms (periods of abnormally increased excitement and emotional elation), inform your doctor before starting or continuing to take 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 agomelatine is appropriate for you.

During your treatment with agomelatine:

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 increases in blood levels of liver enzymes during treatment with agomelatine. Therefore, follow-up blood tests should be performed according to the following schedule:

Based on the evaluation of these tests, your doctor will decide whether you should start or continue treatment with this medicine (see also section 3 "How to take agomelatine").

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

• If you notice any of the following signs or symptoms of liver problems: unusual darkening of the urine, pale 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 agomelatine.

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

Suicidal thoughts and worsening of your depression

If you are depressed, you may occasionally experience 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 being treated with antidepressants.

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

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

Children and adolescents

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

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

Other medicines and Agomelatine Stada

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

You must not take agomelatine together with certain medicines (see also "Do not take agomelatine" 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 you 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 you inform your doctor if you smoke more than 15 cigarettes per day.

Taking Agomelatine Stada with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding must be discontinued if you are taking agomelatine.

Driving and using machines

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

Agomelatine Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, it is "sodium-free".

3. How to take Agomelatina Stada

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

The recommended dose of agomelatine 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

This medicine is for oral use. You must swallow your tablet with a glass of water. You may take agomelatine with or without food.

Duration of treatment

In most people with depression, agomelatine begins to act 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 symptoms have completely resolved.

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

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

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, tests will be performed if your doctor considers it necessary.

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

Switching from an antidepressant (SSRI/SNRI) to agomelatine

If your doctor is switching your previous antidepressant medication from an SSRI or SNRI to agomelatine, they will advise you on how to discontinue your previous medication when starting agomelatine.

You may experience withdrawal symptoms related to stopping your previous treatment for several weeks, even if the dose of your previous antidepressant 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 agomelatine is started while gradually tapering off the previous medication, possible withdrawal symptoms should not be mistaken for a lack of efficacy of agomelatine at the beginning of treatment.

You should consult your doctor about the best way to discontinue your previous antidepressant treatment when starting agomelatine.

If you take more Agomelatina Stada than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount ingested.

Experience with agomelatine overdose is limited, but reported symptoms include upper abdominal pain, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or general malaise.

If you forget to take Agomelatina Stada

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 an agomelatine tablet.

If you stop taking Agomelatina Stada

Do not stop taking this 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Most adverse effects are mild or moderate. They usually occur during the first two weeks of treatment and are usually temporary.

These adverse effects include:

Very common adverse effects (may affect more than 1 in 10 people):

• headache.

Common adverse 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 adverse effects (may affect up to 1 in 100 people):

• migraine, tingling in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder characterized 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 adverse effects (may affect up to 1 in 1,000 people):

• severe skin rash (erythematous rash), facial swelling (oedema) 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), hepatic failure*, hallucinations, inability to remain 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Agomelatine Stada

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 pack, after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture. This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Agomelatina Stada

• The active substance is agomelatine. Each film-coated tablet contains agomelatine-citric acid co-crystals equivalent to 25 mg of agomelatine.
• The other components of the core are:
  • colloidal silicon dioxide, microcrystalline cellulose, mannitol, povidone, anhydrous colloidal silicon dioxide, crospovidone, sodium stearyl fumarate, magnesium stearate and stearic acid.
• The coating components are:
  • hypromellose, macrogol, titanium dioxide (E171), talc and yellow iron oxide (E172).

Appearance of Agomelatina Stada and contents of the pack

Agomelatina Stada 25 mg film-coated tablets are yellow, oblong, biconvex tablets measuring 9 mm x 4.5 mm.

Agomelatina Stada 25 mg film-coated tablets are available in blisters. Packs contain 7, 14, 28, 42, 56, 84, 98 or 100 (hospital pack) tablets or 7x1, 14x1, 28x1, 42x1, 56x1, 84x1, 98x1, 100 (hospital pack) x1 tablets (unit dose).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

MEDIS International a.s., vyrobni zavod Bolatice

Prumyslova 961/16

747 23 Bolatice

Czech Republic

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Agomelatin Stada

Finland: Agomelatine STADA 25 mg tabletti, kalvopäällysteinen

France: AGOMELATINE EG 25 mg comprimés pelliculés

Germany: Agomelatin AL 25 mg Filmtabletten

Hungary: Agomelatin STADA 25 mg filmtabletta

Iceland: Agomelatine 25 mg filmuhúðuð tafla

Netherlands: Agomelatine STADA 25 mg filmomhulde tabletten

Portugal: Agomelatina Ciclum

Slovakia: Agomelatín Stada

Spain: Agomelatina STADA 25 mg comprimidos recubiertos con película EFG

Sweden: Agomelatine STADA 25 mg filmdragerade tabletter

Date of the most recent revision of this leaflet: August 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).