Agomelatine egis

Package leaflet: Information for the patient

Agomelatyna Egis, 25 mg, film-coated tablets
Agomelatinum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Agomelatyna Egis contains the active substance agomelatine. It belongs to a group of medicines
called antidepressants. This medicine has been prescribed to treat depression.
Agomelatyna Egis is used in adults.
Depression is a chronic mood disorder that affects daily life. Symptoms of depression
may vary among individuals, but often include profound sadness, feelings of worthlessness, loss of
interest in favourite activities, sleep disturbances, sensations of slowing down, anxiety, and changes in body weight.
The expected benefits of treatment with Agomelatyna Egis are a reduction in the severity and gradual resolution of symptoms associated with depression.

2. Important information before using Agomelatyna Egis

When not to use Agomelatyna Egis:

• if the patient is allergic to agomelatine or to any of the other ingredients of this medicine (listed in section 6);
• if the patient's liver is not functioning properly (liver function disorders);
• if the patient is taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).

Warnings and precautions
Before starting to take this medicine, you should discuss it with your doctor.
Treatment with Agomelatyna Egis may be inappropriate for several reasons:

• if the patient is taking medicines known to affect the liver. Please consult your doctor about which medicines are involved;
• if the patient is obese or overweight, the patient should consult their doctor;
• if the patient has diabetes, the patient should consult their doctor;
• if the patient had increased liver enzyme activity before starting treatment, the doctor will decide whether Agomelatyna Egis is suitable;
• if the patient has bipolar affective disorder and has experienced or is experiencing symptoms of mania (excessive excitement and emotional arousal), the patient should talk to their doctor before starting or continuing treatment with this medicine (see also section 4 “Possible side effects”);
• if the patient has dementia, the doctor will individually assess whether Agomelatyna Egis is appropriate.

During treatment with Agomelatyna Egis:
What should be done to avoid serious liver function disorders

• Before starting treatment, the doctor should check whether the patient's liver is functioning properly. In some patients, treatment with Agomelatyna Egis may increase liver enzyme activity in the blood. For this reason, monitoring tests should be performed according to the following schedule:

Based on these tests, the doctor will decide whether the patient should receive the medicine or
continue treatment with Agomelatyna Egis (see also "How to take Agomelatyna Egis" in section 3).
Be aware of symptoms indicating impaired liver function

• If the patient experiences any of the following signs of liver dysfunction: unusually dark urine, pale stools, yellowing of the skin or eyes, pain in the upper right part of the abdomen, unusual fatigue (especially when associated with other symptoms listed above), the patient should immediately consult a doctor, who may recommend discontinuing Agomelatyna Egis.

The efficacy of Agomelatyna Egis has not been demonstrated in patients aged 75 years and older.
Therefore, Agomelatyna Egis should not be used in these patients.
Suicidal thoughts and worsening of depression
If the patient suffers from depression, they may sometimes have thoughts of self-harm or suicide.
These thoughts may increase at the beginning of treatment with antidepressant medicines, as all such medicines take some time to become effective, usually about two weeks, and sometimes longer.
The risk of such thoughts is higher if:

• the patient has previously had thoughts of suicide or self-harm;
• the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants. If the patient has thoughts of self-harm or suicide, they should immediately contact their doctor or go to a hospital.

It may be helpful to inform a relative or friend that the patient suffers from depression and ask them to read this leaflet. The patient may ask them to inform the patient if they notice worsening of depression or are concerned about changes in the patient's behaviour.
Children and adolescents
Due to lack of information, use of Agomelatyna Egis is not recommended in children under 7 years of age. There are no available data. Agomelatyna Egis should not be used in children and adolescents aged 7 to 17 years, as safety and efficacy have not been established.
Agomelatyna Egis with other medicines
The patient should inform their doctor or pharmacist about any medicines they are currently taking, have recently taken, or plan to take.
The patient should not take Agomelatyna Egis together with certain medicines (see also "When not to use Agomelatyna Egis" in section 2): fluvoxamine (another medicine used to treat depression), ciprofloxacin (an antibiotic) may alter the blood levels of agomelatine.
The patient should remember to inform their doctor if they are taking any of the following medicines:
propranolol (a beta-blocker used to treat high blood pressure), enoxacin (an antibiotic).
The patient should remember to inform their doctor if they smoke more than 15 cigarettes per day.
Agomelatyna Egis and alcohol
Drinking alcohol during treatment with Agomelatyna Egis is not recommended.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Breastfeeding must be discontinued during treatment with Agomelatyna Egis.
Driving and using machines
The patient may experience dizziness or drowsiness, which could affect their ability to drive or operate machinery. Before driving or operating machinery, the patient should ensure their reactions are normal.
Agomelatyna Egis contains lactose
If the patient has been informed by their doctor that they have an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Agomelatyna Egis contains sodium
Agomelatyna Egis contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Agomelatyna Egis

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose of Agomelatyna Egis is one tablet (25 mg) taken in the evening before bedtime.
In some cases, your doctor may prescribe a higher dose (50 mg), which is two tablets taken together
before bedtime.
Method of administration
Agomelatyna Egis is intended for oral use. Swallow the tablet with water. Agomelatyna Egis may be
taken with or without food.
Duration of treatment
Agomelatyna Egis begins to act on depressive symptoms in most patients with depression within
two weeks of starting treatment.
Depression should be treated for a sufficient length of time, at least 6 months, to ensure that symptoms
have resolved. Your doctor may recommend continuing treatment with Agomelatyna Egis even after
you start feeling better, to prevent depression from returning.
If you have kidney problems, your doctor will individually assess whether taking Agomelatyna Egis
is safe for you.
Monitoring of liver function (see also section 2)
To check whether your liver is functioning properly, your doctor will recommend laboratory tests
before starting treatment, and then periodically 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, followed by periodic monitoring during
therapy, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. If your doctor considers it necessary,
further tests may be recommended later. Agomelatyna Egis must not be used if your liver is not
functioning properly.
How to switch from an SSRI/SNRI antidepressant to Agomelatyna Egis?
If your doctor is switching your antidepressant from an SSRI (Selective Serotonin Reuptake
Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) to Agomelatyna Egis, they will
advise you on how to discontinue the previous medicine when starting Agomelatyna Egis.
For several weeks, you may experience withdrawal symptoms related to stopping the previous
medicine, even if its dose is gradually reduced.
Withdrawal symptoms include: dizziness, numbness or tingling sensations, sleep disturbances,
agitation or anxiety, headache, nausea, vomiting, and tremor. These symptoms are usually mild or
moderate and resolve spontaneously within a few days.
If Agomelatyna Egis is started while tapering off the previous antidepressant, possible withdrawal
symptoms should not be mistaken for a lack of early efficacy of Agomelatyna Egis.
You should discuss with your doctor the best way to discontinue the previous antidepressant when
starting treatment with Agomelatyna Egis.
Taking more Agomelatyna Egis than prescribed
If you have taken more Agomelatyna Egis than you should have, or if, for example, a child has
accidentally taken the medicine, contact your doctor immediately.
Experience with overdose of Agomelatyna Egis is limited. Reported symptoms include upper abdominal
pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or general 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 Agomelatyna Egis
Do not stop taking this medicine without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Most adverse reactions are mild or moderate. Adverse reactions usually occur during the first two weeks of treatment and are usually transient.
Adverse reactions include:

• very common adverse reactions (may occur in more than 1 in 10 patients): headache.
• common adverse reactions (may occur in up to 1 in 10 patients): dizziness, somnolence, difficulty sleeping (insomnia), nausea, diarrhoea, constipation, abdominal pain, back pain, fatigue, anxiety, unusual dreams, increased liver enzymes in blood, vomiting, weight gain.
• uncommon adverse reactions (may occur in up to 1 in 100 patients): migraine, sensation of pricking and tingling in fingers and toes (paraesthesia), blurred vision, restless legs syndrome (uncontrollable urge to move the legs), tinnitus, excessive sweating, rash, itching, urticaria, restlessness, irritability, agitation, aggressive behaviour, nightmares, mania or hypomania (see also "Warnings and precautions" in section 2), suicidal thoughts or suicidal behaviour, confusion (disorientation), weight loss.
• rare adverse reactions (may occur in up to 1 in 1,000 patients): severe skin eruptions (rash with erythematous characteristics), facial swelling (oedema), and angioedema (swelling of the face, lips, tongue, and (or) throat, which may cause difficulty in breathing or swallowing), hepatitis, jaundice (yellowing of the skin or whites of the eyes), 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Agomelatyna Egis

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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: monohydrate lactose, maize starch, povidone K 30, sodium carboxymethyl starch (type A), stearic acid, magnesium stearate, anhydrous colloidal silicon dioxide; hypromellose, glycerol, macrogol 6000, yellow iron oxide (E 172) and titanium dioxide (E 171).

What Agomelatyna Egis looks like and contents of the pack
The 25 mg film-coated tablets of Agomelatyna Egis are oval-shaped and orange-yellow in colour.
The 25 mg film-coated tablets of Agomelatyna Egis are available in calendar packs (blisters). The calendar packs contain 28, 56, 84, 98 or 100 tablets.
Marketing Authorisation 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
Poland
Laboratorios Servier, S.L.
Avda. de los Madroños, 33
28043 Madrid
Spain
For detailed information, please contact the representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Poland
Tel: +48 22 417 92 00
This medicinal product is authorised in the European Economic Area countries 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
Further information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
http://www.urpl.gov.pl/pl