Agomelatine Neuropharma

Patient Information Leaflet: Information for the Patient

Agomelatine NeuroPharma, 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 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 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 NeuroPharma and What is it Used For
• 2. Important Information Before Taking Agomelatine NeuroPharma
• 3. How to Take Agomelatine NeuroPharma
• 4. Possible Side Effects
• 5. How to Store Agomelatine NeuroPharma
• 6. Contents of the Pack and Other Information

1. What is Agomelatine NeuroPharma and What is it Used For

Agomelatine NeuroPharma contains the active substance agomelatine. It belongs to a group of antidepressant medications and has been prescribed to treat depression. Agomelatine NeuroPharma is used in adults. 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, anxiety, and changes in weight. The expected benefits of taking Agomelatine NeuroPharma include a reduction in the severity and gradual disappearance of symptoms associated with depression.

2. Important Information Before Taking Agomelatine NeuroPharma

When Not to Take Agomelatine NeuroPharma

Warnings and Precautions

Before Starting Treatment with this Medication, Discuss it with Your Doctor.

Taking Agomelatine NeuroPharma may be inappropriate for several reasons:

“Possible Side Effects”);

During treatment with Agomelatine NeuroPharma:
What to Do to Avoid Potential Serious Liver Function Disorders

• Before Starting Treatmentyour doctor should check if your liver is working properly. In some patients, during treatment with Agomelatine NeuroPharma, 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 medication or continue taking Agomelatine NeuroPharma (see also “How to Take Agomelatine NeuroPharma”in section 3).
Warning Signs 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 abdomen, unusual fatigue (especially associated with other symptoms mentioned above),you should immediately consult your doctor, who may advise you to stop taking Agomelatine NeuroPharma.

The action of Agomelatine NeuroPharma has not been documented in patients aged 75 and older. Therefore, Agomelatine NeuroPharma should not be used in these patients.
Suicidal Thoughts and Depression Worsening
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 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 tell you if they notice that your depression has worsened or if they are concerned about changes in your behavior.

Children and Adolescents

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

Agomelatine NeuroPharma 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 NeuroPharma with certain medications (see also “When Not to Take Agomelatine NeuroPharma”in section 2): fluvoxamine (another antidepressant medication), 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 medications: propranolol (a beta-blocker used to treat high blood pressure), enoxacin (an antibiotic), and if you smoke more than 15 cigarettes a day.

Taking Agomelatine NeuroPharma with Alcohol

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

Pregnancy

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

Inform your doctor if you are breastfeeding or plan to breastfeed, as breastfeeding should be stopped when taking Agomelatine NeuroPharma.
Before taking any medication, consult your doctor or pharmacist.

Driving and Operating 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 NeuroPharma Contains Sodium

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

3. How to Take Agomelatine NeuroPharma

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Agomelatine NeuroPharma 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.
In most patients with depression, Agomelatine NeuroPharma starts working on depressive symptoms within two weeks of starting treatment. Your doctor may advise you to continue taking Agomelatine NeuroPharma even if you feel better, to prevent the recurrence of depression.
Depression should be treated for a sufficient period, at least six months, to ensure that symptoms have disappeared.
Do not stop taking Agomelatine NeuroPharma without your doctor's advice, even if you feel better.
Agomelatine NeuroPharma is intended for oral use. Swallow the tablet with water. Agomelatine NeuroPharma can be taken with or without food.
How to Switch from an SSRI/SNRI Antidepressant to Agomelatine NeuroPharma?
If your doctor switches your antidepressant medication from an SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) to Agomelatine NeuroPharma, they will advise you on how to stop taking the previous medication when you start taking Agomelatine NeuroPharma.
For several weeks, you may experience withdrawal symptoms related to stopping the previous antidepressant medication, even if the dose is gradually reduced.
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 reduce the dose of the previously taken medication and start taking Agomelatine NeuroPharma, do not confuse possible withdrawal symptoms with the lack of early effect of Agomelatine NeuroPharma.
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Liver Function Monitoring (see also section 2):
To check if your liver is working properly, your doctor will recommend laboratory tests before starting treatment and then at certain 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.
You must not take Agomelatine NeuroPharma if your liver is not working properly.
If you have kidney problems, your doctor will individually assess whether taking Agomelatine NeuroPharma is safe for you.

Taking a Higher Dose of Agomelatine NeuroPharma than Recommended

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

Missing a Dose of Agomelatine NeuroPharma

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 NeuroPharma

Before stopping treatment with this medication, discuss it with your doctor.
If you think that the effect of Agomelatine NeuroPharma is too strong or too weak, talk to your doctor or pharmacist. If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Agomelatine NeuroPharma 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 generally 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, 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 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.
• rare side effects (may affect up to 1 in 1,000 people): severe skin rash (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 fully 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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products, 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,
e-mail: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of this medication.
Side effects can also be reported to the marketing authorization holder.

5. How to Store Agomelatine NeuroPharma

Keep this medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
The batch number is printed on the label and carton after (Lot).
Store in the original package to protect from moisture. There are no special storage temperature recommendations for this medication.
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 NeuroPharma Contains

• The active substance is agomelatine. Each coated tablet contains agomelatine citrate equivalent to 25 mg of agomelatine.
• The other ingredients of the tablet core are: microcrystalline cellulose (microcrystalline cellulose, silicon dioxide), mannitol, povidone 30, 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 NeuroPharma Looks Like and Contents of the Pack

Agomelatine NeuroPharma 25 mg coated tablets are yellow, oblong, biconvex, and measure 9x4.5 mm.
Agomelatine NeuroPharma 25 mg coated tablets are available in blisters. The packs contain 7, 14, 28, 42, 56, 84, 98, or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str.23
40764 Langenfeld
Germany

Manufacturer

MEDIS International a.s., výrobní závod Bolatice, Průmyslová 961/16, 74723 Bolatice, Czech Republic
neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764 Langenfeld, Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
info-poland@neuraxpharm.com

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Netherlands: Agomelatine-neuraxpharm 25 mg filmomhulde tabletten
Germany:
Agomelatin-neuraxpharm 25 mg Filmtabletten
Spain:
Agomelan 25 mg comprimidos recubiertos con pelícu-la EFG
United Kingdom:
Agomelatine-neuraxpharm 25 mg film-coated tablets
Portugal:
Agomelatina-neuraxpharm 25 mg comprimidos revestidos por película
France:
Agomélatine-neuraxpharm 25 mg comprimé pelliculé
Poland:
Agomelatine NeuroPharma

Date of Last Revision of the Leaflet: