Agomelatine Qualigen 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Agomelatine Qualigen 25mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start using this medicine, as 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 it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine contains the active substance agomelatine. It belongs to a group of medicines called antidepressants. Agomelatina Qualigen has been prescribed to treat your depression.

Agomelatina Qualigen 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 eventually eliminate the symptoms related to your depression.

2. Before taking/using Agomelatina Qualigen

Do not take Agomelatina Qualigen

• if you are allergic to agomelatine or to any of the other components 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 Agomelatina Qualigen is not suitable for you:

• If you are taking medicines known to affect the liver. Ask your doctor for advice regarding 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 abnormal 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 Agomelatina Qualigen is appropriate for you.

During treatment with Agomelatina Qualigen:

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 this medicine. Therefore, follow-up blood tests must be carried out with the following frequency:

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 Agomelatina Qualigen").

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 discontinuation of treatment with Agomelatina Qualigen.

The effect of agomelatine has not been documented in patients aged 75 years and older. Therefore, Agomelatina Qualigen 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 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 immediately to the hospital if you experience any thoughts of self-harm or suicide.

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

Children and adolescents

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

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

Other medicines and Agomelatina Qualigen

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

You must not take Agomelatina Qualigen together with certain medicines (see also "Do not take Agomelatina Qualigen" 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 Agomelatina Qualigen with alcohol

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

Pregnancy and breastfeeding

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

Breastfeeding must be discontinued if you are taking Agomelatina Qualigen.

Driving and use of machines

You may experience dizziness or drowsiness, which could affect your ability to drive or operate machinery.

You should ensure your reaction time is normal before driving or operating machinery.

Agomelatina Qualigen contains sodium

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

3. How to take Agomelatina Qualigen

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 Agomelatina Qualigen 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

Agomelatina Qualigen is for oral use. Swallow the tablet with a glass of water.

You may take this medicine with or without food.

Duration of treatment

In most people with depression, Agomelatina Qualigen 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 this medicine after you feel better 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 Agomelatina Qualigen.

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.

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

You must not use Agomelatina Qualigen if your liver is not functioning properly.

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

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

You may experience withdrawal symptoms related to discontinuation of the 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 initiated while tapering the previous medication, potential withdrawal symptoms should not be mistaken for 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 Agomelatina Qualigen.

If you take more Agomelatina Qualigen than you should

If you have taken more tablets of Agomelatina Qualigen than prescribed, or if, for example, a child has accidentally ingested the medicine, contact your doctor immediately.

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

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

If you forget to take Agomelatina Qualigen

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

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

If you stop taking Agomelatina Qualigen

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 adverse effects

Like all medicines, this medicine can produce 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 they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Agomelatine Qualigen

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 outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store this medicine 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 packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Agomelatina Qualigen

• The active substance is: agomelatine

Each film-coated tablet contains 25 mg of agomelatine-citric acid co-crystal (equivalent to 25 mg of agomelatine).

• The other components are:
  • Tablet core: colloidal silicon dioxide, microcrystalline cellulose, mannitol, povidone, anhydrous colloidal silica, crospovidone, sodium stearyl fumarate, magnesium stearate, stearic acid.
  • Film coating: hypromellose, macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172).

Appearance of Agomelatina Qualigen and pack contents

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

Agomelatina Qualigen is available in blisters. Packs contain 7, 14, 28, 42, 56, 84, 98 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Medis International AS., vyrobni zavod Bolatice

Prumyslova 961/16

74723 Bolatice

Czech Republic

This medicinal product is authorized in:

Date of the most recent review of this leaflet: June 2025