Label: information for the user

Agomelatine Qualigen 25mg film-coated tablets

Read this label carefully before starting to use this medication, as it contains important information for you

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 not listed in this label. See section 4.

This medicationcontains the active ingredient agomelatine. Agomelatine belongs to a group of medicines called antidepressants and has been prescribed to treat your depression.

Agomelatineis used in adults.

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

The expected benefits ofagomelatineare to gradually reduce and eliminate the symptoms related to your depression.

Do not take agomelatine

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

- if your liver does not function properly (liver insufficiency).

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

Warnings and precautions

You may have reasons why agomelatine is not suitable for you:

- If you are taking medicines that are known to affect the liver. Ask your doctor for advice on these medicines.

- If you have obesity or 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 if this medicine is appropriate for you.

- If you have bipolar disorder, have experienced or develop manic symptoms (period of excessive excitement and abnormal elevation 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 have dementia, your doctor will perform an individual assessment to decide if it is appropriate for you to take agomelatine.

During your treatment with agomelatine:

What to do to avoid potentially serious liver problems:

- Your doctor must check that your liver is functioning correctlybefore starting treatment.Some patients may experience increases in blood levels of liver enzymes during treatment with this medicine. Therefore, follow-up blood tests should be performed with the following frequency:

Based on the evaluation of these tests, your doctor will decide if you should receive or continue using this medicine (see also section 3 “How to take agomelatine”).

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

-If you observeany of these signs and symptoms of liver problems:unusual darkening of urine, pale stools, yellowing of the skin/eyes, upper right abdominal pain, unusual fatigue (especially associated with other previously mentioned symptoms), seek urgent advice from a doctor, who may recommend stopping treatment with agomelatine.

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

Thoughts of suicide and worsening of depression

If you are depressed, you may occasionally 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 take effect, usually two weeks but sometimes longer.

You are more likely to have these thoughts:

- if you have previously had thoughts of self-harm or suicide.

- if you are a young adult. There is information from clinical trials that has shown an increased risk of suicidal behavior in young adults (under 25 years) who have a psychiatric disorder and are being treated with antidepressants.

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 to tell a close relative or friend that you are depressed and ask them to read this leaflet. You may ask them to tell you if they notice that your depression is worsening, or if they are concerned about changes in your behavior.

Children and adolescents

This medicine is not intended for use in children and adolescents (under 18 years).

Use of agomelatine with other medicines

Inform your doctor or pharmacist if you are using or have recently used or may need to take any other medicine.

You should not take agomelatine with certain medicines (see also “Do not take agomelatine” in section 2): fluvoxamine (another medicine used in the treatment of depression) and ciprofloxacin (an antibiotic) as they may modify the planned dose of agomelatine in your blood.

Make sure to inform your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used in the treatment of hypertension), enoxacine (an antibiotic), and if you smoke more than 15 cigarettes per day.

Agomelatine and alcohol

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

Pregnancy

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Lactation

Consult your doctor if you are breastfeeding your child or intend to do so, as you should stop breastfeeding if you take agomelatine.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

You may feel dizziness or drowsiness that may affect your ability to drive or operate machinery. Make sure you are sure of your reaction before driving or operating machinery.

Sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose ofagomelatineis 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.

In most people with depressionagomelatinestarts to act on the symptoms of depression within a period of two weeks from the start of treatment. Your doctor may continue prescribing this medication when you feel better to prevent depression from coming back.

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

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

This medicationis for oral administration. You should swallow your tablet with the help of a glass of water. You can takeagomelatinewith or without food.

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

If your doctor changes your previous antidepressant medication from an SSRI or SNRI toagomelatine, they will advise you on how to discontinue treatment with your previous medication when you start takingagomelatine.

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

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

If treatment withagomelatinebegins while the dose of the previous medication is gradually reduced, possible withdrawal symptoms should not be confused with a lack of effect ofagomelatineat the beginning of treatment.

You should consult your doctor about the best way to discontinue your previous antidepressant treatment when you start treatment withagomelatine.

Liver function control (see also section 2):

Your doctor will ask for tests to check that your liver is functioning properly before starting treatment and, subsequently, periodically during treatment, normally 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, subsequently, periodically during treatment, normally after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Subsequently, tests will be performed if the doctor considers it necessary.

You should not use this medicationif your liver does not function properly.

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

If you take moreagomelatinethan you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The experience of overdose withagomelatineis limited, but the symptoms reported include upper stomach pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or general discomfort.

If you forgot to take agomelatine

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

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

If you interrupt treatment withagomelatine

You should ask your doctor before interrupting treatment with this medication.

If you think the effect ofagomelatineis too strong or too weak, consult your doctor or pharmacist.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The majority of adverse effects are mild or moderate. They usually appear in the first two weeks of treatment and are normally transient.

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, drowsiness, insomnia (difficulty sleeping), nausea, diarrhea, constipation, abdominal pain, back pain, fatigue, anxiety, abnormal dreams, elevated liver enzyme levels in the blood, vomiting, weight gain.

-Uncommon Adverse Effects(may affect up to 1 in 100 people): migraine, tingling in the fingers of the hands and feet (paresthesia), 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 behavior, nightmares, mania/hypomania (see also "Warnings and Precautions" in section 2), suicidal thoughts or behavior, confusion, weight loss.

-Rare Adverse Effects(may affect up to 1 in 1,000 people): severe skin rash (erythematous rash), facial edema (swelling) and angioedema (swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing), hepatitis, yellowing of the skin or white of the eyes (jaundice), liver insufficiency*, hallucinations, inability to remain still (due to physical and mental restlessness), inability to completely empty the bladder.

* A reduced number of cases led to liver transplant or death.

Reporting 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 prospectus. You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAgomelatina Qualigen

• The active ingredient is: agomelatina

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

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U..

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible manufacturer:

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Medis International AS., výrobní závod Bolatice

Prumyslova 961/16

74723 Bolatice

Czech Republic

This medicine is authorized in:

Last reviewed date of this leaflet: July 2018