Patient Information Leaflet: Package Insert

Agomelatine Aurovitas Spain 25 mg Film-Coated Tablets

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

5.Storage of Agomelatine Aurovitas Spain

6.Contents of the pack and additional information

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

Agomelatina is 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 of agomelatine are to reduce and gradually eliminate the symptoms related to your depression.

Do not take Agomelatina Aurovitas Spain

• if you are allergic to agomelatine or any of the other ingredients of this medication (listed in section 6).
• if your liver does not function properly (hepatic insufficiency).
• if you are taking fluvoxamine (another medication used in the treatment of depression) or ciprofloxacin (an antibiotic).

Warnings and precautions

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

• If you are taking medications that are known to affect the liver. Ask your doctor about these medications.
• If you have obesity or overweight, ask your doctor.
• If you are diabetic, ask your doctor.
• If you have elevated liver enzyme levels before treatment, your doctor will decide if agomelatine is appropriate for you.
• If you have bipolar disorder, have experienced or develop manic symptoms (a period of excessive excitement and abnormal elevation of emotions), inform your doctor before starting to take this medication or before continuing to take it (see also “Possible side effects” in section 4).
• If you have dementia, your doctor will perform an individual evaluation to decide if it is appropriate for you to take agomelatine.
• If you are taking medications that contain buprenorphine. The use of these medications with Agomelatina Aurovitas Spain may cause serotonin syndrome, a potentially fatal disease (see “Other medications and Agomelatina Aurovitas Spain”).

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 agomelatine. Therefore, follow-up analyses should be performed with the following frequency:

Based on the evaluation of these analyses, your doctor will decide if you should receive or continue to use Agomelatina Aurovitas Spain (see also section 3 “How to take Agomelatina Aurovitas Spain”).

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, pain in the upper right abdomen, unusual fatigue (especially associated with other symptoms mentioned earlier), 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 medications take time to exert their effect, usually two weeks but sometimes longer.

You are more likely to have these thoughts:

• if you have had previous 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 can ask them to tell you if they notice that your depression is getting worse, or if they are concerned about changes in your behavior.

Children and adolescents

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

Other medications and Agomelatina Aurovitas Spain

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

You should not take Agomelatina Aurovitas Spain with certain medications (see also “Do not take Agomelatina Aurovitas Spain” in section 2): fluvoxamine (another medication 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 medications: propranolol (a beta-blocker used in the treatment of hypertension), enoxacine (an antibiotic), if you smoke more than 15 cigarettes per dayand medications that contain buprenorphine. These medications may interact with Agomelatina Aurovitas Spain and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms.

Agomelatina Aurovitas Spain and alcohol

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

Pregnancy

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

Lactation

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

During treatment with agomelatine, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how agomelatine affects you.

Agomelatina Aurovitas Spain contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this 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 of agomelatine is one tablet (25 mg) before bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), that is, two tablets that must be taken together before bedtime.

Treatment duration

In most people with depression, agomelatine starts to act on depression symptoms within 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.

Method of administration

This medication is for oral administration. You must swallow your tablet with the help of a glass of water. You can take agomelatine with or without food.

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

If your doctor changes your previous antidepressant medication from an SSRI or SNRI to agomelatine, they will inform you about how to discontinue treatment with your previous medication when you start taking agomelatine.

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

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

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, afterwards, 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, afterwards, 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 medication if your liver is not functioning properly.

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

If you take more Agomelatine Aurovitas Spain than you should

If you have taken more agomelatine tablets than you should, or if, for example, a child has taken the medication by accident, contact your doctor immediately. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Agomelatina Aurovitas Spain

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

If you interrupt treatment with Agomelatina Aurovitas Spain

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

If you think the effect of agomelatine is too strong or too weak, consult your doctor or pharmacist.

If you have any other questions 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 Frequent Adverse Effects(may affect more than 1 in 10 people): headache.
• Frequent 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.
• Infrequent 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, muscle pain.
• 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, yellow discoloration 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. The expiration date is the last day of the month indicated.

Store in the original packagingto protect it from moisture. This medication does not require any special storage temperature.

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

Composition of Agomelatina Aurovitas Spain

• The active ingredient is agomelatine. Each film-coated tablet contains 25 mg of agomelatine.
• The other components are: microcrystalline cellulose, mannitol, povidone, anhydrous colloidal silica, crospovidone, stearate of stearic acid and sodium, magnesium stearate and stearic acid. Film-coating: hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide (E171), talc, and yellow iron oxide (E172).

Appearance of the product and content of the packaging

Agomelatina Aurovitas Spain 25 mg are film-coated tablets, yellow in color, oblong, biconvex.

Agomelatina Aurovitas Spain 25 mg film-coated tablets are available in packaging containing 28 or 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

MEDIS International a.s.

vyrobni zavod Bolatice

Prumyslova 961/16

747 23 Bolatice

Czech Republic

Last review date of this leaflet: September 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/