Agomelatine Adamed

Package Leaflet: Information for the Patient

Agomelatine Adamed, 25 mg, Coated Tablets

Agomelatine

Read the 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 medicine has been prescribed for you. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Agomelatine Adamed and what is it 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 is Agomelatine Adamed and what is it 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. 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, restlessness, and changes in body weight. The expected benefits of taking Agomelatine Adamed are a reduction in the severity and gradual disappearance of symptoms associated with depression.

2. Important information before taking Agomelatine Adamed

When not to take Agomelatine Adamed:

• 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 antidepressant) or ciprofloxacin (an antibiotic).

Warnings and precautions

Before starting treatment with this medicine, discuss it with your doctor.

Taking Agomelatine Adamed may be inappropriate for several reasons:

• if you are taking medicines known to affect liver function. You should consult your doctor about which medicines this applies to;
• if you are obese or overweight, you should consult your doctor;
• if you have diabetes, you should consult your doctor;
• if you have elevated liver enzyme activity before treatment, your doctor will decide whether Agomelatine Adamed is suitable for you;
• if you have bipolar affective disorder, if manic symptoms (excessive excitement and emotional arousal) occur or develop in you, you should discuss this with your doctor before starting treatment with this medicine or continuing treatment (see also section 4 “Possible side effects”);
• if you have dementia, your doctor will individually assess whether Agomelatine Adamed is suitable for you.

During treatment with Agomelatine Adamed:
What to do to avoid potentially serious liver function disorders

• - Before starting treatmentyour doctor should check if your liver is working properly. In some patients, during treatment with Agomelatine Adamed, liver enzyme activity in the blood may increase. For this reason, control tests should be performed according to the following schedule:

Based on these tests, your doctor will decide whether you should receive the medicine or continue taking Agomelatine Adamed (see also section 3 “How to take Agomelatine Adamed”).
Be aware of symptoms of abnormal liver function

• - If you noticeany of the following subjective or objective 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 the medication.

Agomelatine Adamed.

The effect of Agomelatine Adamed has not been documented in patients aged 75 and older. For this reason, Agomelatine Adamed 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. They may worsen at the beginning of treatment with antidepressants, because all these medicines start working only after some time, usually after about two weeks, and sometimes later.
It is more likely that you have such thoughts:

• if you have had suicidal thoughts or self-harm before;
• if you are a young adult. Clinical trials have shown an increased risk of suicidal behavior in young adults (under 25 years old) with mental disorders who were treated with an antidepressant. If you have thoughts of self-harm or suicide, you should immediately contact your doctor or go to the hospital.

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 keep an eye on you and inform you if they notice that your depression is getting worse or if they are concerned about changes in your behavior.

Children and adolescents

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

Agomelatine Adamed and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You should not take Agomelatine Adamed with certain medicines (see also section 2 “When not to take Agomelatine Adamed”): fluvoxamine (another antidepressant), ciprofloxacin (an antibiotic) may change the amount of agomelatine in your 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).
Remember to tell your doctor if you smoke more than 15 cigarettes a day.

Taking Agomelatine Adamed with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding should be stopped if you are taking Agomelatine Adamed.

Driving and using machines

You may experience dizziness or drowsiness, which may affect your ability to drive or use machines. Before driving or using machines, make sure your reactions are normal.

Agomelatine Adamed contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially ‘sodium-free’.

3. How to take Agomelatine Adamed

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Agomelatine Adamed is one tablet (25 mg) 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
Agomelatine Adamed is for oral use. Swallow the tablet with water.
Agomelatine Adamed can be taken with or without food.
Duration of treatment
In most patients with depression, Agomelatine Adamed starts working on symptoms of depression within two weeks of starting treatment. Depression should be treated for a sufficient period of time, at least 6 months, to ensure that symptoms have disappeared.
Your doctor may recommend continuing treatment with Agomelatine Adamed, even if you feel better, to prevent a relapse of depression.
If you have kidney problems, your doctor will individually assess whether taking Agomelatine Adamed is safe for you.
Monitoring liver function (see also section 2)
To check if your liver is working properly, your doctor will recommend blood 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 decides to increase the dose to 50 mg, blood tests should be performed when introducing 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 Adamed if your liver is not working properly.
  How to switch from an SSRI/SNRI antidepressant to Agomelatine Adamed?

If your doctor switches you from an SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin Norepinephrine Reuptake Inhibitor) antidepressant to Agomelatine Adamed, they will advise you on how to stop taking the previous medicine and start taking Agomelatine Adamed. For several weeks, you may experience withdrawal symptoms related to stopping the previous medicine, even if it is done gradually by reducing the dose. Withdrawal symptoms include: dizziness, numbness, 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 start taking Agomelatine Adamed while reducing the dose of the previously taken medicine, do not confuse possible withdrawal symptoms with the lack of early effect of Agomelatine Adamed. When starting treatment with Agomelatine Adamed, you should discuss with your doctor the best way to stop taking the previous antidepressant.

Taking a higher dose of Agomelatine Adamed than recommended

If you have taken more Agomelatine Adamed than you should or if, for example, a child has accidentally taken the medicine, contact your doctor immediately.
Experience with overdose of Agomelatine Adamed is limited. Reported symptoms include stomach pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, discoloration, or malaise.

Missing a dose of Agomelatine Adamed

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

Stopping treatment with Agomelatine Adamed

Do not stop taking Agomelatine Adamed without your doctor's advice, even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Agomelatine Adamed 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 enzyme activity in the blood, vomiting, weight gain.
• uncommon side effects (may affect up to 1 in 100 people): migraine, tingling or numbness in the fingers and toes (paresthesia), blurred vision, restless legs syndrome (uncontrolled urge to move the 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): serious skin rashes (rash with redness), swelling of the face (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, which ended with liver transplantation or death.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products
National Institute of Pharmacy and Medicinal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +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 marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the carton and blister. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture. There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Agomelatine Adamed contains

• The active substance of Agomelatine Adamed is agomelatine. Each coated tablet contains 25 mg of agomelatine in the form of agomelatine citrate. The other ingredients of the tablet core are: microcrystalline cellulose silanized (microcrystalline cellulose, colloidal silicon dioxide), mannitol, povidone 30, colloidal silicon dioxide, crospovidone (type A), sodium stearyl fumarate, magnesium stearate, stearic acid 50. The other ingredients 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, film-coated tablets, 9 x 4.5 mm in size.
Agomelatine Adamed 25 mg tablets are packaged in blisters.
The pack contains 28 tablets.

Marketing authorization holder:

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

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
MEDIS International a.s., výrobní závod Bolatice
Průmyslová 961/16
74723 Bolatice
Czech Republic
Date of last revision of the leaflet: March 2021