Agomelatine adamed

Package leaflet: Information for the patient

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

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

Table of contents of the leaflet:

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

1. What Agomelatine Adamed is and what it is used for

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

2. Important information before using Agomelatine Adamed

When not to use Agomelatine Adamed:

• 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 to treat depression) or ciprofloxacin (an antibiotic).

Warnings and precautions
Before starting treatment with this medicine, discuss it with your doctor.
Treatment with Agomelatine Adamed may be inappropriate for several reasons:

• if the patient is taking medicines known to affect liver function. Consult your doctor about which medicines are concerned;
• 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 elevated liver enzyme activity before treatment, the doctor will decide whether Agomelatine Adamed is suitable for the patient;
• if the patient has bipolar affective disorder, or if symptoms of mania (excessive excitement and emotional arousal) have occurred or are developing, the patient should speak with their doctor before starting treatment with this medicine or before continuing treatment (see also section 4 “Possible adverse reactions” );
• if the patient shows signs of dementia, the doctor will individually assess whether Agomelatine Adamed is suitable for the patient.

During treatment with Agomelatine Adamed:
What should be done to avoid potentially serious liver function disorders

• - Before starting treatment, the doctor should check whether the patient's liver is functioning properly. In some patients, liver enzyme activity in the blood may increase during treatment with Agomelatine Adamed. 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 Agomelatine Adamed (see also section 3. "How to take Agomelatine Adamed").

Watch for symptoms of impaired liver function

• If the patient experiences any of the following objective or subjective 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 fatigue (especially when associated with other symptoms listed above), the patient should immediately consult a doctor, who may advise discontinuing treatment with Agomelatine Adamed.

The efficacy of Agomelatine Adamed has not been demonstrated in patients aged 75 years and older. For this reason, Agomelatine Adamed should not be used in these patients.

Thoughts of suicide and worsening depression
If the patient has depression, they may sometimes experience thoughts of self-harm or suicide. These may worsen at the beginning of treatment with antidepressant medicines, as all such medicines take some time to work—usually about two weeks, sometimes longer.

The patient is more likely to have such thoughts:

• if they have previously had thoughts of suicide or self-harm;
• if they are 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 antidepressant medicines.

If the patient has thoughts of self-harm or suicide, they should immediately contact their doctor or go to hospital.

It may be helpful to inform a relative or friend that the patient suffers from depression and ask that person to read this leaflet. The patient may also ask them to inform the patient if they notice worsening depression or changes in behaviour that concern them.

Children and adolescents
Agomelatine Adamed is not intended for use in children and adolescents (under 18 years of age).

Agomelatine Adamed and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

The patient should not take Agomelatine Adamed together with certain medicines (see also section 2 "When not to take Agomelatine Adamed"): fluvoxamine (another medicine used to treat depression), ciprofloxacin (an antibiotic), as they may alter the blood levels of agomelatine.

Remember to inform the doctor if the patient is taking any of the following medicines: propranolol (a beta-blocker used to treat high blood pressure), enoxacin (an antibiotic).

Remember to inform the doctor if the patient smokes more than 15 cigarettes per day.

Taking Agomelatine Adamed with alcohol
Drinking alcohol is not recommended during treatment with Agomelatine Adamed.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, planning to become pregnant, or breastfeeding, she should consult a doctor or pharmacist before taking this medicine.

Breastfeeding must be discontinued during treatment with Agomelatine Adamed.

Driving and operating machinery
The patient may experience dizziness or drowsiness, which could affect their ability to drive or operate machinery. The patient should ensure their reactions are adequate before driving or operating machinery.

Agomelatine Adamed contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Agomelatine Adamed

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.
The recommended dose of Agomelatine Adamed 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
at bedtime.
Method of administration
Agomelatine Adamed is intended for oral use. Swallow the tablet with water.
Agomelatine Adamed may be taken with or without food.
Duration of treatment
In most patients with depression, Agomelatine Adamed begins to relieve depressive symptoms
within two weeks of starting treatment. Depression should be treated for an adequate duration,
at least 6 months, to ensure that symptoms have fully resolved.
Your doctor may recommend continuing treatment with Agomelatine Adamed even after you start
feeling better, in order to prevent relapse of depression.
If you have kidney problems, your doctor will individually assess whether taking Agomelatine Adamed
is safe for you.
Monitoring of liver function (see also section 2)
To check whether your liver is functioning properly, your doctor will recommend blood tests before
starting treatment, and then periodically during therapy, usually after 3 weeks, 6 weeks, 12 weeks, and
24 weeks.
If your doctor decides to increase your dose to 50 mg, blood tests should be performed when starting
this dose, and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks.
Your doctor may also recommend further tests if considered necessary.
Do not take Agomelatine Adamed if your liver is not functioning properly.
How to switch from an SSRI/SNRI antidepressant to Agomelatine Adamed?
If your doctor is switching your antidepressant treatment from an SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) to Agomelatine Adamed, they will advise you on how to discontinue the previous medication while starting Agomelatine Adamed.
For several weeks, you may experience withdrawal symptoms related to stopping the previous medication, even if the dose is gradually reduced. Withdrawal symptoms may 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.
When starting Agomelatine Adamed while tapering off the previous antidepressant, do not confuse possible withdrawal symptoms with lack of early response to Agomelatine Adamed. When initiating therapy with Agomelatine Adamed, you should discuss with your doctor the best way to discontinue the previous antidepressant.

Taking more Agomelatine Adamed than recommended
If you take more Agomelatine Adamed than you should, or if, for example, a child accidentally takes the
medicine, contact your doctor immediately.
Experience with overdose of Agomelatine Adamed is limited. Reported symptoms include upper
abdominal pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or general malaise.
If you miss a dose of Agomelatine Adamed
Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.
Stopping Agomelatine Adamed
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, please 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 enzyme activity in blood, vomiting, weight gain.
• uncommon adverse reactions (may occur in up to 1 in 100 patients): migraine, prickling and tingling sensations in fingers and toes (paraesthesiae), blurred vision, restless legs syndrome (an 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, muscle pain.
• rare adverse reactions (may occur in up to 1 in 1,000 patients): severe skin reactions (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, 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 urinary bladder. * A few cases have been reported which resulted 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
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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Agomelatine Adamed

Keep this 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.
Keep in the original packaging in order to protect from moisture. No special storage temperature requirements.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Agomelatine Adamed contains

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

What Agomelatine Adamed looks like and contents of the pack
Agomelatine Adamed 25 mg coated tablets are yellow, elongated, biconvex coated tablets, measuring 9 x 4.5 mm.
Agomelatine Adamed 25 mg coated tablets are packed in blisters.
The pack contains 28 tablets.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

MEDIS International a.s., vyrobni zavod Bolatice
Prumyslova 961/16
74723 Bolatice
Czech Republic