Agomelatine G.l. Pharma

Leaflet accompanying the packaging: patient information

Agomelatine G.L. Pharma, 25 mg, coated tablets
Agomelatine

It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.

• The leaflet should be kept, so it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific individual. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Agomelatine G.L. Pharma and what is it used for

Agomelatine G.L. Pharma contains the active substance agomelatine. It belongs to a group of medications called antidepressants and has been prescribed to treat depression.
Agomelatine G.L. Pharma is used in adult patients.
Depression is a chronic mood disorder that affects daily life. The symptoms of depression vary from person to person but often include deep sadness, feelings of worthlessness, loss of interest in favorite activities, sleep disturbances, feelings of slowing down, restlessness, and changes in weight.
The expected effect of Agomelatine G.L. Pharma is to reduce and gradually eliminate the symptoms associated with depression.

2. Important information before taking Agomelatine G.L. Pharma

When not to take Agomelatine G.L. Pharma:

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

Warnings and precautions

There may be several reasons why taking Agomelatine G.L. Pharma may be inappropriate for the patient:

• If the patient is taking medications known to affect the liver. The patient should consult their doctor about which medications this applies to.
• If the patient is obese or overweight, they should consult their doctor.
• In case of diabetes, the patient should consult their doctor.
• If the patient had elevated liver enzyme activity before starting treatment, the doctor will decide whether Agomelatine G.L. Pharma is suitable for the patient.
• If the patient has bipolar affective disorder and develops symptoms of mania (periods of excessive excitement and emotion), they should consult their doctor before starting or continuing treatment (see also "Possible side effects" in section 4).
• If the patient has dementia, the doctor will conduct an individual assessment to determine whether Agomelatine G.L. Pharma is suitable for the patient.

During treatment with Agomelatine G.L. Pharma:
How to proceed to avoid potential liver function disorders

• The doctor should check if the patient's liver is working properly before starting treatment. In some patients, taking Agomelatine G.L. Pharma may increase liver enzyme activity in the blood. For this reason, tests should be performed with the following frequency:

Based on the results of these tests, the doctor will decide whether the patient can receive Agomelatine G.L. Pharma or continue its use (see also "How to take Agomelatine G.L. Pharma" in section 3).
Caution should be exercised regarding symptoms of abnormal liver function

• If the patient observes any of the following symptoms of liver function disorder: unusual dark urine, light-colored stools, yellowing of the skin or eyes, pain in the upper right abdomen, unusual fatigue (especially in combination with other symptoms listed above), they should immediately consult their doctor, who may recommend stopping the use of Agomelatine G.L. Pharma.

The effect of Agomelatine G.L. Pharma has not been documented in patients aged 75 and older. Therefore, Agomelatine G.L. Pharma should not be used in such patients.
Suicidal thoughts and depression worsening
If the patient has depression, they may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment with an antidepressant, as all such medications take time to start working, usually about two weeks, and sometimes longer.
The occurrence of such thoughts is more likely if:

• the patient has previously had thoughts of suicide or self-harm;
• the patient is a young adult. Clinical trial data show an increased risk of suicidal behavior in young adults (under 25 years old) with mental disorders who were treated with antidepressants. If the patient has ever had thoughts of suicide or self-harm, they should immediately consult their doctor or go to the hospital.

It may be helpful to inform a relative or close friend that the patient has depression and ask them to read this leaflet. The patient may ask them to inform them if they notice that the depression has worsened or if they notice changes in the patient's behavior.

Children and adolescents

Agomelatine G.L. Pharma is not intended for use in children and adolescents under 18 years of age.

Agomelatine G.L. Pharma and other medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Agomelatine G.L. Pharma should not be taken at the same time as certain medications (see also "When not to take Agomelatine G.L. Pharma" in section 2): fluvoxamine (another medication used to treat depression), ciprofloxacin (an antibiotic) may change the concentration of agomelatine in the blood.
The patient should remember to inform their doctor if they are taking any of the following medications: propranolol (a beta-blocker used to treat high blood pressure), enoxacin (an antibiotic), and if they smoke more than 15 cigarettes a day.

Using Agomelatine G.L. Pharma with alcohol

It is not recommended to drink alcohol while taking Agomelatine G.L. Pharma.

Pregnancy

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed, as breastfeeding should be discontinued when taking Agomelatine G.L. Pharma.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and operating machinery

The patient may experience dizziness or drowsiness, which may affect their ability to drive and operate machinery. The patient should make sure their reactions are normal before driving or operating machinery.

Agomelatine G.L. Pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Agomelatine G.L. Pharma

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Agomelatine G.L. Pharma is one tablet (25 mg) before bedtime. In some cases, the doctor may prescribe a higher dose (50 mg), i.e., two tablets taken together before bedtime.
In most patients with depression, Agomelatine G.L. Pharma starts to work on depressive symptoms within two weeks of starting treatment. The doctor may recommend continuing the use of Agomelatine G.L. Pharma even if the patient feels better, to prevent the recurrence of depression.
Depression should be treated for a sufficient period, at least six months, to ensure that the symptoms have disappeared.
The patient should not stop taking the medication without their doctor's advice, even if they feel better.
Agomelatine G.L. Pharma is intended for oral use. The tablet should be swallowed with water.
Agomelatine G.L. Pharma can be taken with or without food.
How to switch from an SSRI/SNRI antidepressant to Agomelatine G.L. Pharma?
If the doctor changes the antidepressant therapy from an SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) medication to Agomelatine G.L. Pharma, they will advise the patient on how to stop taking the previous medication when starting Agomelatine G.L. Pharma.
For several weeks, the patient may experience withdrawal symptoms related to stopping the previous medication, even if it is stopped gradually by reducing the dose.
Withdrawal symptoms include: dizziness, agitation, sleep disturbances, excitement or anxiety, headaches, nausea, vomiting, and diarrhea. These symptoms are usually mild or moderate and disappear on their own within a few days.
If the patient is reducing the dose of the previously taken medication and starts taking Agomelatine G.L. Pharma, they should not confuse possible withdrawal symptoms with the lack of early effect of Agomelatine G.L. Pharma.
When starting therapy with Agomelatine G.L. Pharma, the patient should discuss with their doctor the best way to stop taking the previous antidepressant medication.
Liver function monitoring (see also section 2)
Before starting treatment and periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks, the doctor will recommend performing tests to check if the patient's liver is working properly.
If the doctor decides to increase the dose to 50 mg, they will also recommend performing tests at the start of treatment and then periodically after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Further tests will be recommended if the doctor considers it necessary.
Agomelatine G.L. Pharma should not be used if the patient's liver does not work properly.
If the patient has kidney function disorders, the doctor will conduct an individual assessment of the patient's condition and decide whether the use of Agomelatine G.L. Pharma is safe for them.

Taking a higher dose of Agomelatine G.L. Pharma than recommended

If the patient has taken a higher dose of Agomelatine G.L. Pharma than recommended or if a child has accidentally taken the medication, they should immediately consult their doctor.
Information on overdose of Agomelatine G.L. Pharma is limited, but reported symptoms include stomach pain, drowsiness, fatigue, excitement, anxiety, tension, dizziness, cyanosis, or malaise.

Missing a dose of Agomelatine G.L. Pharma

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Agomelatine G.L. Pharma

Before stopping treatment with Agomelatine G.L. Pharma, the patient should discuss it with their doctor.
If the patient thinks that the effect of Agomelatine G.L. Pharma is too strong or too weak, they should consult their doctor or pharmacist.
In case of any further doubts related to the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Agomelatine G.L. 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 temporary.
Common side effects:

• Very common (may affect more than 1 in 10 people): headache.
• Common (may affect up to 1 in 10 people): dizziness, drowsiness, difficulty sleeping (insomnia), nausea, diarrhea, constipation, stomach pain, back pain, fatigue, anxiety, unusual dreams, increased liver enzyme activity in the blood, vomiting, weight gain.
• Uncommon (may affect up to 1 in 100 people): migraine, tingling or numbness in fingers and toes (paresthesia), blurred vision, restless legs syndrome (a disorder characterized by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating, rash, itching, hives, excitement, irritability, anxiety, aggressive behavior, nightmares, mania or hypomania (see also "Warnings and precautions" in section 2), suicidal thoughts or behaviors, confusion, weight loss.
• Rare (may affect up to 1 in 1,000 people): severe skin reactions (rash), facial and angioedema (swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing), liver inflammation, 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 the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medication.

5. How to store Agomelatine G.L. Pharma

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month stated.
The medication should be stored in its original packaging to protect it from moisture.
There are no special storage temperature recommendations for this medication.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Agomelatine G.L. Pharma contains

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

What Agomelatine G.L. Pharma looks like and contents of the packaging

Agomelatine G.L. Pharma is a yellow, elongated, biconvex, coated tablet, 9.00 mm long and 4.5 mm wide.
Agomelatine G.L. Pharma is available in blisters.
The packaging contains 28 tablets.

Marketing authorization holder

G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria
MEDIS International a.s., výrobní závod Bolatice
Průmyslová 961/16
74723 Bolatice
Czech Republic