AGOMELATINE QUALIGEN 25 mg FILM-COATED TABLETS

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

This medicine contains the active substance agomelatine. Agomelatine belongs to a group of medicines called antidepressants and has been prescribed for you to treat your depression.

Agomelatina is used in adults.

Depression is a long-lasting change in mood that interferes with daily life. The symptoms of depression vary from person to person, but usually consist of 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.

2. Before taking Agomelatina Qualigen

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 is not working properly (liver failure).
• if you are taking fluvoxamine (another medicine 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 medicines that are known to affect the liver. Ask your doctor for advice on these medicines.
• 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 enzymes before treatment, your doctor will decide if this medicine is suitable for you.
• If you have bipolar disorder, have experienced or developed manic symptoms (periods of great 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).

During your treatment with agomelatina:

What to do to avoid potentially serious liver problems:

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

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 agomelatina”).

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

• If you notice any of these signs and symptoms of liver problems: unusual darkening of the urine, light-colored stools, yellowing of the 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 stopping treatment with agomelatine.

The effect of agomelatine has not been documented in patients over 75 years of age. 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 medicines take time to work, usually a couple of weeks but sometimes longer.

You are more likely to have these thoughts:

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 relative or close 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 worried about changes in your behavior.

Children and adolescents

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

Using agomelatina with other medicines

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

Do not take agomelatine with certain medicines (see also “Do not take agomelatine” in section 2): fluvoxamine (another medicine used to treat depression) and ciprofloxacin (an antibiotic), as they may change the expected dose of agomelatine in your blood.

Make sure to tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used to treat high blood pressure), enoxacin (an antibiotic), and if you smoke more than 15 cigarettes/day.

Taking agomelatina with alcohol

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

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding

Ask your doctor if you are breastfeeding or planning to breastfeed, as you should stop breastfeeding if you take agomelatine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy or drowsy that could affect your ability to drive or use machines. You should make sure your reaction is normal before driving or using machines.

Sodium

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

3. How to take Agomelatina Qualigen

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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.

In most people with depression, agomelatine starts to work on the symptoms of depression within two weeks of starting treatment. Your doctor may continue to prescribe this medicine 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 medicine without consulting your doctor, even if you feel better.

This medicine 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 switches your previous antidepressant medication from an SSRI or SNRI to agomelatine, they will advise you on how to stop your previous treatment 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 is gradually reduced.

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

If treatment with agomelatine is started while the dose of the previous medicine is being gradually reduced, 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 you start treatment with agomelatine.

Liver function monitoring (see also section 2):

Your doctor will ask for tests to check that your liver is working properly before starting treatment and, after that, 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 the dose increase and, after that, periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. After that, tests will be performed if the doctor considers it necessary.

Do not use this medicine if your liver is not working properly.

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

If you take more Agomelatina Qualigen than 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 medicine and the amount taken.

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

If you forget to take Agomelatina Qualigen

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

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

If you stop taking Agomelatina Qualigen

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

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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 enzymes in the blood, vomiting, weight gain.
• Uncommon side effects (may affect up to 1 in 100 people): migraine, tingling in the fingers and toes (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, agitation, irritability, restlessness, aggressive behavior, nightmares, mania/hypomania (see also “Warnings and precautions” in section 2), suicidal thoughts or behavior, confusion, weight loss.
• Rare side effects (may affect up to 1 in 1,000 people): severe skin rash, facial swelling (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 have been reported that resulted in liver transplantation or death.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Agomelatina 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 carton and blister after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Agomelatina Qualigen

• The active substance is: agomelatine

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

• The other ingredients are:
• • Core of the tablet: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 the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the following countries:

Date of last revision of this leaflet: July 2018