Agomelatine Aurovitas Spain 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Agomelatina Aurovitas Spain 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 could 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 Agomelatina Aurovitas Spain is and what it is used for
2. What you need to know before taking Agomelatina Aurovitas Spain
3. How to take Agomelatina Aurovitas Spain
4. Possible side effects
5. How to store Agomelatina Aurovitas Spain
6. Contents of the pack and other information

1. What Agomelatina Aurovitas Spain 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 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 profound 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 Agomelatina Aurovitas Spain

Do not take Agomelatina Aurovitas Spain

• 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 working properly (hepatic insufficiency).
• if you are taking fluvoxamine (another medicine used to treat 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. Please seek advice from your doctor 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 agomelatine is appropriate for you.
• If you have bipolar disorder, or have experienced or develop manic symptoms (periods of marked excitement and abnormal emotional elation), inform your doctor before starting or continuing 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.
• If you are taking medicines containing buprenorphine. Using these medicines together with Agomelatina Aurovitas Spain may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Agomelatina Aurovitas Spain”).

During 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 assessment of these tests, your doctor will decide whether you should start or continue taking Agomelatine Aurovitas Spain (see also section 3 “How to take Agomelatine Aurovitas Spain”).

Be alert for signs and symptoms indicating that your liver may not be functioning properly.

• If you notice any of the following signs and 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 if associated with other symptoms mentioned above), seek urgent medical advice, which may lead your doctor to recommend discontinuation of agomelatine treatment.

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 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 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 or go directly to the hospital immediately if you have any thoughts of self-harm or suicide.

It may be helpful to inform a close relative or friend about your depression 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 intended for use in children and adolescents (under 18 years of age).

Other medicines and Agomelatine Aurovitas Spain

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

You must not take Agomelatine Aurovitas Spain together with certain medicines (see also “Do not take Agomelatine Aurovitas Spain” 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 hypertension), enoxacin (an antibiotic), if you smoke more than 15 cigarettes/day, or medicines containing buprenorphine. These medicines may interact with Agomelatine Aurovitas Spain and you may experience symptoms such as involuntary rhythmic muscle contractions, including in the muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Taking Agomelatine Aurovitas Spain with alcohol

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

Pregnancy

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.

Breast-feeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Agomelatine Aurovitas Spain contains sodium

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

3. How to take Agomelatine Aurovitas Spain

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.

Duration of treatment

In most people with depression, agomelatine begins to act on depressive symptoms within two weeks of starting treatment. Your doctor may continue prescribing this medicine after you start feeling better, to prevent depression from returning.

Your depression should be treated for a sufficiently long period of at least 6 months to ensure that symptoms have resolved.

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

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.

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

If your doctor is switching your previous antidepressant (SSRI or SNRI) to agomelatine, they will advise you on how to discontinue your previous medicine when starting agomelatine.

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 off the previous medicine, possible withdrawal symptoms should not be mistaken for 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 agomelatine.

Liver function monitoring (see also section 2):

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

You must not use this medicine if your liver is not functioning properly.

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

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

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

If you forget to take Agomelatine Aurovitas Spain

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

If you stop taking Agomelatine Aurovitas Spain

You should ask your doctor before stopping treatment with this medicine.

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

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 experiences 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 via the national reporting system: Spanish System of Pharmacovigilance 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 Aurovitas Spain

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. The expiry date is 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 temperature.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Agomelatine Aurovitas Spain

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

Appearance of the medicinal product and pack contents

Agomelatine Aurovitas Spain 25 mg are film-coated tablets, yellow in colour, oblong, biconvex.

Agomelatine Aurovitas Spain 25 mg film-coated tablets are available in packs 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

Tel.: 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 most recent review of this leaflet: September 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/