Agomelatina Egis

Package Leaflet: Information for the Patient

Agomelatyna Egis, 25 mg, Coated Tablets

Agomelatinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Agomelatyna Egis and what is it used for
• 2. Important information before taking Agomelatyna Egis
• 3. How to take Agomelatyna Egis
• 4. Possible side effects
• 5. How to store Agomelatyna Egis
• 6. Contents of the pack and other information

1. What is Agomelatyna Egis and what is it used for

Agomelatyna Egis contains the active substance agomelatine. It belongs to a group of antidepressant medicines. The medicine has been prescribed to treat depression. Agomelatyna Egis is used in adults. Depression is a long-term mood disorder that affects daily life. The symptoms of depression are different in different people, but often include deep sadness, feelings of worthlessness, loss of interest in favorite activities, sleep disturbances, feelings of slowing down, anxiety, changes in body weight. The expected benefits of using Agomelatyna Egis are a reduction in the severity and gradual disappearance of symptoms associated with depression.

2. Important information before taking Agomelatyna Egis

When not to take Agomelatyna Egis:

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor.

Taking Agomelatyna Egis may be inappropriate for several reasons:

"Possible side effects");

During treatment with Agomelatyna Egis:
What to do to avoid serious liver function disorders

• Before starting treatmentyour doctor should check if your liver is working properly. In some patients, during treatment with Agomelatyna Egis, liver enzyme activity in the blood may increase. For this reason, control tests should be performed according to the following schedule:

Based on these tests, your doctor will decide whether you should receive the medicine or continue taking Agomelatyna Egis (see also "How to take Agomelatyna Egis"in section 3).
Be aware of symptoms of abnormal liver function

• If you noticeany of the following symptoms of liver function disorder: unusually dark urine, pale stools, yellowing of the skin or eyes, pain in the upper right part of the abdomen, unusual fatigue (especially associated with other symptoms listed above),you should immediately consult your doctor, who may recommend stopping treatment with Agomelatyna Egis.

The action of Agomelatyna Egis has not been documented in patients over 75 years of age. Therefore, Agomelatyna Egis should not be used in these patients.
Suicidal thoughts and worsening of depression
If you have depression, you may sometimes have thoughts of self-harm or suicide. They may worsen at the beginning of treatment with antidepressants, as all these medicines start working only after some time, usually after about two weeks, and sometimes later.
It is more likely that you have such thoughts:

It may be helpful to tell a relative or friend that you are suffering from depression 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

Due to the lack of information, it is not recommended to use Agomelatyna Egis in children under 7 years of age. There are no available data. Agomelatyna Egis should not be used in children and adolescents from 7 to 17 years of age, as the safety and efficacy of its use have not been established.

Agomelatyna Egis and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take.
You should not take Agomelatyna Egis with some medicines (see also "When not to take Agomelatyna Egis"in section 2): fluvoxamine (another antidepressant), ciprofloxacin (an antibiotic) may change the amount of agomelatine in your blood.
Remember 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).
Remember to tell your doctor if you smoke more than 15 cigarettes a day.

Agomelatyna Egis with alcohol

It is not recommended to drink alcohol during treatment with Agomelatyna Egis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Breastfeeding should be stopped when taking Agomelatyna Egis.

Driving and using machines

You may experience dizziness or drowsiness, which may affect your ability to drive or operate machines. Before driving or operating machines, make sure your reactions are normal.

Agomelatyna Egis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Agomelatyna Egis contains sodium

Agomelatyna Egis contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Agomelatyna Egis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Agomelatyna Egis is one tablet (25 mg) in the evening before bedtime.
In some cases, your doctor may prescribe a higher dose (50 mg), which is two tablets taken at the same time, before bedtime.
Method of administration
Agomelatyna Egis is intended for oral use. Swallow the tablet with water. Agomelatyna Egis can be taken with or without food.
Duration of treatment
Agomelatyna Egis starts working on the symptoms of depression in most patients with depression within two weeks of starting treatment.
Depression should be treated for a sufficient period of time, at least six months, to ensure that the symptoms have disappeared. Your doctor may recommend continuing treatment with Agomelatyna Egis, even if you feel better, to prevent a relapse of depression.
If you have kidney problems, your doctor will individually assess whether taking Agomelatyna Egis is safe for you.
Monitoring liver function (see also section 2)
To check if your liver is working properly, your doctor will recommend laboratory tests before starting treatment, and then from time to time during therapy, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. If your doctor increases the dose to 50 mg, laboratory tests should be performed at the beginning of treatment with this dose, and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. If your doctor considers it necessary, they will also recommend later tests. You should not take Agomelatyna Egis if your liver is not working properly.
How to switch from an SSRI/SNRI antidepressant to Agomelatyna Egis?
If your doctor switches you from an SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin Norepinephrine Reuptake Inhibitor) antidepressant to Agomelatyna Egis, they will advise you on how to stop taking the previous medicine when you start taking Agomelatyna Egis.
For several weeks, you may experience withdrawal symptoms related to stopping the previous medicine, even if the dose is gradually reduced.
Withdrawal symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors. These symptoms are usually mild or moderate and disappear on their own within a few days.
If you reduce the dose of the previously taken medicine when you start taking Agomelatyna Egis, do not confuse possible withdrawal symptoms with the lack of early effect of Agomelatyna Egis.
Discuss with your doctor the best way to stop taking the previous antidepressant when starting treatment with Agomelatyna Egis.

Taking a higher dose of Agomelatyna Egis than recommended

If you have taken more Agomelatyna Egis than you should, or if, for example, a child has taken the medicine by mistake, contact your doctor immediately.
Experience with overdose of Agomelatyna Egis is limited. The reported symptoms include stomach pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or malaise.

Missing a dose of Agomelatyna Egis

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
The calendar printed on the blister pack containing the tablets will help you remember when you last took a tablet of Agomelatyna Egis.

Stopping treatment with Agomelatyna Egis

Do not stop taking Agomelatyna Egis without your doctor's advice, even if you feel better.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Agomelatyna Egis can cause side effects, although not everybody gets them.
Most side effects are mild or moderate. Side effects usually occur within the first two weeks of treatment and are usually transient.
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, unusual dreams, increased liver enzyme activity in the blood, vomiting, weight gain.
• uncommon side effects (may affect up to 1 in 100 people): migraine, feeling of tingling and numbness in the fingers of the hands and feet (paresthesia), blurred vision, restless legs syndrome (uncontrolled urge to move the legs), ringing in the ears, excessive sweating, rash, itching, hives, agitation, irritability, restlessness, aggressive behavior, nightmares, mania or hypomania (see also "Warnings and precautions"in section 2), suicidal thoughts or behaviors, confusion (disorientation), weight loss.
• rare side effects (may affect up to 1 in 1,000 people): severe skin rashes (rash), swelling of the face (edema) 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), liver failure*, hallucinations, inability to remain still (due to physical and mental restlessness), inability to completely empty the bladder. * A few cases have been reported, resulting in liver transplantation or death.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Agomelatyna Egis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. 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

What Agomelatyna Egis contains

• The active substance is agomelatine. Each coated tablet contains 25 mg of agomelatine.
• The other ingredients are:
• lactose monohydrate, corn starch, povidone K 30, sodium carboxymethylcellulose (type A), stearic acid, magnesium stearate, silica colloidal anhydrous; hypromellose, glycerol, macrogol 6000, yellow iron oxide (E 172) and titanium dioxide (E 171).
• ink: shellac, propylene glycol, concentrated ammonia solution, and indigo carmine, lacquer (E 132).

What Agomelatyna Egis looks like and contents of the pack

The 25 mg Agomelatyna Egis coated tablets (tablets) are oval in shape,

orange-yellow with blue company logo on one side.
The 25 mg Agomelatyna Egis coated tablets are available in calendar packs (blisters). The calendar packs contain 28, 56, 84, 98, or 100 tablets.

Marketing authorization holder

Egis Pharmaceuticals PLC, Keresztúri út 30-38, 1106 Budapest, Hungary

Manufacturer

Les Laboratoires Servier Industrie, 905, route de Saran, 45520 Gidy, France, SERVIER (IRELAND) INDUSTRIES LTD., Gorey Road, Arklow, Co. Wicklow, Y14 E284, Ireland, ANPHARM Pharmaceutical Company S.A., Annopol 6B, 03-236 Warsaw, Laboratorios Servier, S.L., Avda. de los Madroños, 33, 28043 Madrid, Spain. For detailed information, please contact the representative of the marketing authorization holder: EGIS Polska Sp. z o.o., ul. Komitetu Obrony Robotników 45D, 02-146 Warsaw, Tel: +48 22 417 92 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland: Agomelatine Anpharm 25 mg, France: Agomelatine Biogaran 25 mg comprimé pelliculé, Germany: Agomelatin Anpharm 25 mg Filmtabletten, Hungary: Agomelatin Anpharm 25 mg filmtabletta, Lithuania: Agomelatine Anpharm 25 mg plėvele dengtos tabletės, Poland: Agomelatyna Egis, Date of last revision of the leaflet:6.11.2024

Other sources of information

Detailed information about this medicinal product can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, http://www.urpl.gov.pl/pl