Package leaflet: information for the patient

Agomelatine +pharma, 25 mg, film-coated tablets
Agomelatinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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 a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Agomelatine +pharma is and what it is used for
Important information before taking Agomelatine +pharma
How to take Agomelatine +pharma
Possible side effects
How to store Agomelatine +pharma
Contents of the pack and other information

1. What Agomelatine +pharma is and what it is used for
Agomelatine +pharma contains the active substance agomelatine. It belongs to a group of medicines
called antidepressants and has been prescribed to treat depression.
Agomelatine +pharma is used in adults.
Depression is a chronic mood disorder that affects daily life. Symptoms of depression vary between individuals, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feelings of slowing down, anxiety, and changes in body weight.
The expected benefits of taking Agomelatine +pharma are a reduction in the severity and gradual disappearance of symptoms related to depression.

2. Important information before taking Agomelatine +pharma

When not to take Agomelatine +pharma

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 function disorders)
if you are taking fluvoxamine (another medicine used to treat depression) or ciprofloxacin (an antibiotic)

Warnings and precautions
Taking Agomelatine +pharma may not be suitable for several reasons:

if you are taking medicines known to affect the liver. Ask your doctor which medicines these are.
if you are obese or overweight, you should consult your doctor
if you have diabetes, you should consult your doctor
if you had increased liver enzyme activity before treatment, your doctor will decide whether Agomelatine +pharma is suitable for you
if you have bipolar affective disorder and have experienced or are developing symptoms of mania (excessive excitement and emotional agitation), talk to your doctor before starting or continuing treatment with this medicine (see also section 4 "Possible side effects")
if you have dementia, your doctor will individually assess whether Agomelatine +pharma is suitable for you

During treatment with Agomelatine +pharma:
What to do to avoid serious liver function disorders
Before starting treatment, your doctor should check whether your liver is working properly.
In some patients, liver enzyme activity in the blood may increase during treatment with Agomelatine +pharma. For this reason, blood tests should be performed before starting treatment or after increasing the dose, and periodically at approximately 3 weeks, 6 weeks, 12 weeks, and 24 weeks of treatment.
Based on these tests, your doctor will decide whether you should receive Agomelatine +pharma or continue taking it (see also "How to take Agomelatine +pharma" in section 3).
Be aware of symptoms indicating abnormal liver function
If you notice any of the following symptoms of liver dysfunction:
unusually dark urine, pale-coloured stools, yellowing of the skin or eyes, pain in the upper right part of the
abdomen, unusual tiredness (especially when associated with other symptoms listed above),
seek immediate medical advice, as your doctor may recommend stopping Agomelatine +pharma.
The effect of agomelatine has not been documented in patients aged 75 years and older. Therefore, Agomelatine +pharma 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. These may increase at the beginning of treatment with antidepressants, as all such medicines take some time to work, usually about two weeks, and sometimes longer.
You are more likely to have such thoughts:

if you have previously had thoughts of suicide or self-harm
if you are a young adult. Clinical trials have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders who were treated with an antidepressant. If you have thoughts of self-harm or suicide, contact your doctor immediately or go to hospital.

It may be helpful to tell a relative or friend that you suffer from 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
Due to lack of information, it is not appropriate to use Agomelatine +pharma in children under 7 years of age. No data are available.
Agomelatine +pharma should not be used in children and adolescents aged 7 to 17 years, as safety and efficacy have not been established.
Agomelatine +pharma and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
You should not take Agomelatine +pharma together with certain medicines (see also "When not to take Agomelatine +pharma" in section 2): fluvoxamine (another medicine used to treat depression) or ciprofloxacin (an antibiotic), as they may alter the amount of agomelatine in the 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)

Ensure your doctor is informed if you smoke more than 15 cigarettes per day.
Taking Agomelatine +pharma with alcohol
Drinking alcohol is not recommended during treatment with Agomelatine +pharma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Breastfeeding must be discontinued while taking Agomelatine +pharma.
Driving and using machines
You may experience dizziness or drowsiness, which may affect your ability to drive or operate machinery. Before driving or operating machinery, make sure your reactions are normal.
Agomelatine +pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Agomelatine +pharma

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your
doctor or pharmacist.
The recommended dose of Agomelatine +pharma is one 25 mg coated tablet taken in the evening before bedtime.
In some cases, your doctor may prescribe a higher dose (50 mg), which is two coated tablets taken together before bedtime.
Method of administration
Agomelatine +pharma is intended for oral use. Swallow the tablet with water. Agomelatine +pharma may be taken with or without food.
Duration of treatment
In most patients with depression, Agomelatine +pharma begins to relieve depressive symptoms within
two weeks of starting treatment.
Depression should be treated for a sufficient length of time—at least 6 months—to ensure symptoms have resolved.
Your doctor may recommend continuing treatment with Agomelatine +pharma even after you start feeling better to prevent depression from returning.
If you have kidney problems, your doctor will individually assess whether taking Agomelatine +pharma is safe for you.

Monitoring liver function (see also section 2 “Important information before taking Agomelatine +pharma”)
To check whether your liver is functioning properly, your doctor will recommend laboratory tests before starting treatment and periodically during therapy, usually at 3 weeks, 6 weeks, 12 weeks, and 24 weeks.
If your doctor increases your dose to 50 mg, laboratory tests should be performed at the beginning of treatment with this dose and then periodically during therapy, usually at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Your doctor may also recommend further tests if considered necessary.
Do not take Agomelatine +pharma if your liver is not functioning properly.

How to switch from an SSRI/SNRI antidepressant to Agomelatine +pharma?
If your doctor is switching your antidepressant from an SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) to Agomelatine +pharma, they will advise you on how to discontinue the previous medication when starting Agomelatine +pharma.
For several weeks, you may experience withdrawal symptoms related to stopping the previous medication, 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 Agomelatine +pharma is started while tapering off the previous antidepressant, do not confuse possible withdrawal symptoms with a lack of early response to Agomelatine +pharma.
Discuss with your doctor the best way to discontinue the previous antidepressant when starting treatment with Agomelatine +pharma.

Taking more Agomelatine +pharma than prescribed
If you take more Agomelatine +pharma than you should, or if, for example, a child accidentally takes the medicine, contact your doctor immediately.
Experience with agomelatine overdose is limited. Reported symptoms include upper abdominal pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or malaise.

Missing a dose of Agomelatine +pharma
Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.

Stopping Agomelatine +pharma
Do not stop taking this medicine without consulting your doctor, even if you start to feel better.
Before stopping treatment with this medicine, discuss it with your doctor.

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 generally 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 enzyme activity 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, nightmares, mania or hypomania (see also “Warnings and precautions” in section 2), suicidal thoughts or suicidal behaviour, confusion (disorientation), weight loss, muscle pain

Rare adverse reactions (may occur in up to 1 in 1,000 patients)

severe skin reactions (rash with erythema), 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), liver failure*, hallucinations, inability to remain still (due to physical and mental restlessness), inability to completely empty the bladder

* Several cases have been reported resulting in liver transplantation or death.

Reporting of adverse reactions
If any adverse reactions occur, including any 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, phone: +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 local representative of the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Agomelatine +pharma

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from moisture.
No special temperature storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the blister and the outer carton following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Agomelatine +pharma contains

The active substance is agomelatine. Each coated tablet contains agomelatine with citric acid, equivalent to 25 mg of agomelatine.
The other ingredients are:
- tablet core: microcrystalline cellulose siliconed (microcrystalline cellulose, colloidal anhydrous silica), mannitol, povidone 30, colloidal anhydrous silica, crospovidone (type A), sodium stearyl fumarate, magnesium stearate, stearic acid 50
- tablet coating: hypromellose 2910/5, macrogol 6000, titanium dioxide (E 171), talc, iron oxide yellow (E 172)

What Agomelatine +pharma looks like and contents of the pack
Agomelatine +pharma coated tablets are yellow, elongated, biconvex coated tablets with dimensions of 9 x 4.5 mm.
The medicine is available in blister packs. Pack sizes contain 28, 30, 56, 60, 84, or 90 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturers
MEDIS International a.s., vyrobni zavod Bolatice
Prumyslova 961/16
74723 Bolatice
Czech Republic
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Agomelatin Genericon 25 mg Filmtabletten
Czech Republic Agomelatin +pharma
Poland Agomelatine +pharma

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36
e-mail: [email protected]