Agomelatine +pharma

Package Leaflet: Information for the Patient

Agomelatine +pharma, 25 mg, Coated Tablets

Agomelatine

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Agomelatine +pharma and what is it used for

Agomelatine +pharma contains the active substance agomelatine. It belongs to a group of antidepressant medications and has been prescribed to treat depression.
Agomelatine +pharma is used in adults.
Depression is a chronic mood disorder that affects daily life. The symptoms of depression are different for different people, but often include deep sadness, feeling worthless, loss of interest in favorite activities, sleep disturbances, feeling slowed down, anxiety, weight changes.
The expected benefits of taking Agomelatine +pharma include a reduction in the severity and gradual disappearance of symptoms associated with depression.

2. Important information before taking Agomelatine +pharma

When not to take Agomelatine +pharma

Warnings and precautions

Taking Agomelatine +pharma may be inappropriate for several reasons:

During treatment with Agomelatine +pharma:
What to do to avoid serious liver function disorders
Before starting treatment, your doctor should check if your liver is working properly.
In some patients, treatment with Agomelatine +pharma may increase liver enzyme activity in the blood. For this reason, control blood tests should be performed before starting treatment or after increasing the dose, and periodically after about 3 weeks, 6 weeks, 12 weeks, and 24 weeks of treatment.
Based on these tests, your doctor will decide whether you should receive the medication or continue taking Agomelatine +pharma (see also "How to take Agomelatine +pharma" in section 3).
Be aware of symptoms of abnormal liver function
If you noticeany of the following symptoms of liver function disorders:
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 Agomelatine +pharma.
The action of agomelatine is not documented in patients over 75 years of age. 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 worsen at the beginning of treatment with antidepressant medications, as all these medications start working only after some time, usually after about two weeks, and sometimes later.
It is more likely that you will 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 inform you if they notice that your depression is worsening or if they are concerned about changes in your behavior.

Children and adolescents

Due to the lack of information, it is not appropriate to use Agomelatine +pharma in children under 7 years of age. There is no available data.
Agomelatine +pharma should not be used in children and adolescents between 7 and 17 years of age, as the safety and efficacy have not been established.

Agomelatine +pharma and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
You should not take Agomelatine +pharma with certain medications (see also "When not to take Agomelatine +pharma" in section 2): fluvoxamine (another medication used to treat depression), ciprofloxacin (an antibiotic), which may change the amount of agomelatine in your blood.
Remember to tell your doctor if you are taking any of the following medications:

• propranolol (a beta-blocker used to treat high blood pressure)
• enoxacin (an antibiotic)

Make sure your doctor is informed if you smoke more than 15 cigarettes a day.

Taking Agomelatine +pharma with alcohol

It is not recommended to drink alcohol during treatment with Agomelatine +pharma.

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 medication.
Breastfeeding should be discontinued when 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 medication contains less than 1 mmol of sodium (23 mg) per coated tablet, which means it is considered "sodium-free".

3. How to take Agomelatine +pharma

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Agomelatine +pharma is one coated tablet (25 mg) in the evening before bedtime.
In some cases, your doctor may prescribe a higher dose (50 mg), which is two coated tablets taken at the same time, before bedtime.
Method of administration
Agomelatine +pharma is intended for oral use. Swallow the tablet with water. Agomelatine +pharma can be taken with or without food.
Duration of treatment
In most patients with depression, Agomelatine +pharma starts to work on depressive symptoms within two weeks of starting treatment.
Depression should be treated for a sufficient period, at least six months, to ensure that symptoms have disappeared.
Your doctor may recommend continuing treatment with Agomelatine +pharma even if you feel better, to prevent a relapse of depression.
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 if your liver is working properly, your doctor will recommend laboratory tests before starting treatment, and then at regular intervals 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 start of 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.
Do not take Agomelatine +pharma if your liver is not working properly.
How to switch from an SSRI/SNRI antidepressant to Agomelatine +pharma?
If your doctor switches your antidepressant medication from an SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin Norepinephrine Reuptake Inhibitor) to Agomelatine +pharma, they will advise you on how to stop taking the previous medication when starting Agomelatine +pharma.
For several weeks, you may experience withdrawal symptoms related to stopping the previous medication, even if the dose is gradually decreased.
Withdrawal symptoms include: dizziness, feeling numb, 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 are reducing the dose of the previously taken medication when starting Agomelatine +pharma, do not confuse possible withdrawal symptoms with the lack of early effect of Agomelatine +pharma.
Discuss with your doctor the best way to stop taking the previous antidepressant medication when starting treatment with Agomelatine +pharma.

Taking a higher dose of Agomelatine +pharma than recommended

If you have taken more Agomelatine +pharma than you should, or if, for example, a child has taken the medication by mistake, contact your doctor immediately.
Experience with overdose of agomelatine is limited. Reported symptoms include stomach pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, discoloration, 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 the usual time.

Stopping treatment with Agomelatine +pharma

Do not stop taking Agomelatine +pharma without your doctor's advice, even if you feel better. Before stopping treatment, you should discuss it with your doctor.

4. Possible side effects

Like all medications, Agomelatine +pharma 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 enzymes in the blood, vomiting, weight gain

Uncommon side effects(may affect up to 1 in 100 people)

• migraine, feeling of tingling and numbness in fingers and toes (paresthesia), blurred vision, restless legs syndrome (uncontrolled urge to move 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, muscle pain Rare side effects(may affect up to 1 in 1,000 people)
• severe skin rashes (erythema), facial swelling (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 any not listed in this leaflet, please 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, phone: +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 local representative of the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Agomelatine +pharma

Keep the medication out of sight and reach of children.
Store in the original packaging to protect from moisture.
There are no special storage temperature recommendations for this medication.
Do not use this medication after the expiration date stated on the blister pack and carton after "EXP". The expiration date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Agomelatine +pharma contains

• The active substance of Agomelatine +pharma is agomelatine. Each coated tablet contains agomelatine citrate, equivalent to 25 mg of agomelatine.
• Other ingredients are:
• tablet core: microcrystalline cellulose (microcrystalline cellulose, silicon dioxide), mannitol, povidone 30, silicon dioxide, crospovidone (type A), sodium stearyl fumarate, magnesium stearate, stearic acid 50
• tablet coating: hypromellose 2910/5, macrogol 6000, titanium dioxide (E 171), talc, yellow iron oxide (E 172)

What Agomelatine +pharma looks like and contents of the pack

Agomelatine +pharma coated tablets are yellow, oblong, biconvex, film-coated tablets, 9 x 4.5 mm in size.
The medication is available in blisters. The packs contain 28, 30, 56, 60, 84, 90 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer

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 medication is authorized 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
To obtain more detailed information on this medication, contact the local representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
Podgórska 34
31-536 Kraków, Poland
phone: +48 12 262 32 36
e-mail: [email protected]

Date of last revision of the leaflet: