Agolek

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 Agolek, liver enzyme activity in the blood may increase. For this reason, tests should be performed with the following frequency:

Based on these tests, your doctor will decide whether you should receive the medicine or continue taking Agolek (see also "How to take Agolek" in section 3).
You should be alert for symptoms indicating abnormal liver function

• If you noticeany of the symptoms of liver function disorder: unusual 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 mentioned above), you should immediately consult your doctor, who may advise you to stop taking Agolek.The action of Agolek is not documented in patients over 75 years of age. Therefore, Agolek should not be used in these patients. Suicidal thoughts and worsening of depressionIf you have depression, you may sometimes have thoughts of self-harm or suicide. These may worsen at the beginning of treatment with antidepressants, as all these medicines start working only after some time, usually after about two weeks, and sometimes later. It is more likely that you will have such thoughts:

Children and adolescents

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

Agolek and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
You should not take Agolek with certain medicines (see also "When not to take Agolek" in section 2): 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), and if you smoke more than 15 cigarettes a day.

Taking Agolek with alcohol

It is not recommended to drink alcohol during treatment with Agolek.

Pregnancy

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

Tell your doctor if you are breastfeeding or plan to breastfeed, as breastfeeding should be stopped when taking Agolek.
Before taking any medicine, consult your doctor or pharmacist.

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.

Agolek contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Agolek

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 Agolek 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 at the same time, before bedtime.
Duration of treatment
For most patients with depression, Agolek starts to work on depressive symptoms within two weeks of starting treatment. Your doctor may advise you to continue taking Agolek, even if you feel better, to prevent the recurrence of depression.
Depression should be treated for a sufficient period of time, at least 6 months, to ensure that the symptoms have disappeared.
If you have kidney problems, your doctor will individually assess you and decide whether it is safe for you to take Agolek.
Method of administration
Agolek is intended for oral use. Swallow the tablet with water.
Agolek can be taken with or without food.
How to switch from an SSRI/SNRI antidepressant to Agolek?
If your doctor changes your antidepressant therapy from an SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin Norepinephrine Reuptake Inhibitor) to Agolek, they will advise you on how to stop taking the previous medicine when you start taking Agolek.
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, excitement 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 Agolek while reducing the dose of the previously taken medicine, do not confuse possible withdrawal symptoms with the lack of early effect of Agolek.
When starting treatment with Agolek, you should discuss with your doctor the best way to stop taking the previous antidepressant.
Monitoring liver function (see also section 2)
To check if your liver is working properly, your doctor will recommend that you have blood tests before starting treatment, and then from time to time during therapy, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks.
If your doctor increases the dose to 50 mg, you should have blood tests at the start of treatment with 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 Agolek if your liver is not working properly.

Taking a higher dose of Agolek than recommended

If you have taken more Agolek than you should or if, for example, a child has taken the medicine by mistake, contact your doctor immediately.
Experience with agomelatine overdose is limited. Reported symptoms include stomach pain, drowsiness, fatigue, excitement, anxiety, tension, dizziness, cyanosis, or malaise.

Missing a dose of Agolek

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

Stopping treatment with Agolek

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

4. Possible side effects

Like all medicines, Agolek 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, feeling of tingling and numbness in the 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 (disorientation), weight loss, muscle pain
• rare side effects (may affect up to 1 in 1,000 people): serious skin rashes (rash-like reactions), 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, resulting in liver transplantation or death.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal 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
You can also report side effects 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 Agolek

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 after EXP. 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. This will help protect the environment.

6. Contents of the pack and other information

What Agolek contains

• The active substance of Agolek is agomelatine. Each coated tablet contains agomelatine as agomelatine citrate, equivalent to 25 mg of agomelatine. The other ingredients of the medicine 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 Agolek looks like and contents of the pack

Agolek 25 mg coated tablets are yellow, oblong, biconvex, 9 x 4.5 mm in size.
Agolek 25 mg coated tablets are packaged in blisters and, together with the leaflet, in a cardboard box. The packs contain 14, 28, 30, 56, 60, 84, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14 A
05-170 Zakroczym
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Manufacturer

MEDIS International a.s.,
vyrobni zavod Bolatice
Prumyslova 961/16
747 23 Bolatice
Czech Republic

Date of last revision of the leaflet:

• 13.01.2023