AGOMELATINE AUROVITAS SPAIN 25 mg FILM-COATED TABLETS

2. What you need to know before taking Agomelatina Aurovitas Spain

Do not take Agomelatina Aurovitas Spain

• if you are allergic to agomelatine or any of the other components of this medication (listed in section 6).
• if your liver does not function properly (liver failure).
• if you are taking fluvoxamine (another medication used to treat 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 for advice on these medications.
• If you have obesity or are 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 agomelatine is suitable for you.
• If you have bipolar disorder, have experienced or developed manic symptoms (periods of great excitement and abnormal emotional elevation) 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 suffer from dementia, your doctor will perform an individual assessment to decide if it is suitable for you to take agomelatine.
• If you are taking medications containing 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 properly before starting treatment.Some patients may experience increases in blood levels of liver enzymes during treatment with agomelatine. Therefore, follow-up tests should be performed at the following frequency:

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

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

• If you notice any of these signs and symptoms of liver problems: unusual darkening of urine, light-colored stools, yellowish skin/eyes, pain in the upper right part of the abdomen, unusual fatigue (especially associated with other symptoms mentioned above), seek urgent advice from a doctor, who may recommend interrupting treatment with agomelatine.

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

Suicidal thoughts and worsening of your 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 take effect, usually a couple of weeks but sometimes longer.

It is more likely that you will have thoughts of this type:

• 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 old) who suffer from 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 discuss with a close relative or friend that you are depressed and ask them to read this package leaflet. You can 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

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

Other Medications and Agomelatina Aurovitas Spain

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

Do not take Agomelatina Aurovitas Spain with certain medications (see also "Do not take Agomelatina Aurovitas Spain" in section 2): fluvoxamine (another medication used to treat depression) and ciprofloxacin (an antibiotic), as they may alter the expected 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 to treat hypertension), enoxacin (an antibiotic), if you smoke more than 15 cigarettes/day, and medications containing buprenorphine. These medications may interact with Agomelatina Aurovitas Spain, and you may experience symptoms such as involuntary rhythmic muscle contractions, including the muscles 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.

Taking Agomelatina Aurovitas Spain with Alcohol

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

Pregnancy

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

Breastfeeding

Consult your doctor if you are breastfeeding or plan to breastfeed, as you should interrupt breastfeeding if you take agomelatine.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

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

3. How to take Agomelatina Aurovitas Spain

Follow the administration instructions of this medication exactly as 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), i.e., two tablets that should be taken together before bedtime.

Duration of Treatment

In most people with depression, agomelatine starts to act on the symptoms of depression within two weeks of starting treatment. Your doctor may continue to prescribe this medication when you feel better to prevent depression from returning.

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 should 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 advise you on how to stop treatment with your previous medication when you start taking agomelatine.

You may experience withdrawal symptoms related to the interruption of your previous treatment for a few 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, the 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 stop your previous antidepressant treatment when starting treatment with agomelatine.

Liver Function Monitoring (see also section 2):

Your doctor will ask you to perform tests to check that your liver is functioning properly before starting treatment and, afterwards, periodically during treatment, usually 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, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Later, tests will be performed if the doctor considers it necessary.

You should not use this medication if 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 more Agomelatina Aurovitas Spain than you should

If you have taken more tablets of agomelatine 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Agomelatina Aurovitas Spain

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

If you stop treatment with Agomelatina Aurovitas Spain

You should ask your doctor before stopping 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Most side effects are mild or moderate. They usually appear in the first two weeks of treatment and are usually transient.

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, drowsiness, difficulty sleeping (insomnia), nausea, diarrhea, constipation, abdominal pain, back pain, fatigue, anxiety, abnormal dreams, increased liver enzyme levels in the blood, vomiting, weight gain.
• Uncommon side 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), ringing in the ears, excessive sweating (hyperhidrosis), eczema, itching, hives (urticaria), 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 side 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 can cause difficulty breathing or swallowing), hepatitis, yellowing of the skin or the whites of the eyes (jaundice), liver failure*, hallucinations, inability to remain still (due to physical and mental restlessness), inability to empty the bladder completely.

• A small number of cases were reported that resulted in liver transplantation or death.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system: Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Agomelatina Aurovitas Spain

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

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in 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.

6. Package Contents and Additional Information

Composition of Agomelatina Aurovitas Spain

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

Appearance of the Product and Package Contents

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

MEDIS International a.s.

vyrobni zavod Bolatice

Prumyslova 961/16

747 23 Bolatice

Czech Republic

Date of the Last Revision of this Package Leaflet: September 2021

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