Lamegom

Package Leaflet: Information for the Patient

Lamegom, 25 mg, Coated Tablets

Agomelatine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Lamegom and What is it Used For

Lamegom contains the active substance agomelatine. It belongs to a group of antidepressant medications.
Lamegom has been prescribed for the treatment of depression.
Lamegom is used in adults.
Depression is a chronic mood disorder that affects daily life. The symptoms of depression
are different in different people, but often include deep sadness, feelings of worthlessness, loss of interest in favorite activities, sleep disturbances, feelings of slowing down, anxiety, weight changes.
The expected benefits of taking Lamegom include a reduction in the severity and gradual disappearance of symptoms associated with depression.

2. Important Information Before Taking Lamegom

When Not to Take Lamegom

• 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

Taking Lamegom may be inappropriate for the patient for several reasons:

• 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;
• if the patient has diabetes, they should consult their doctor;
• if the patient has increased liver enzyme activity before treatment, the doctor will decide whether Lamegom is suitable for them;
• if the patient has bipolar affective disorder, and symptoms of mania (excessive excitement and emotional arousal) occur or develop, the patient should discuss this with their doctor before starting or continuing treatment with this medication (see also section 4 "Possible Side Effects");

manic episodes (excessive excitement and emotional arousal), the patient should discuss this with their doctor before starting or continuing treatment with this medication (see also section 4 "Possible Side Effects");

• if the patient shows signs of dementia, the doctor will individually assess whether Lamegom is suitable for the patient.

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

• Before starting treatment, the doctor should check if the patient's liver is working properly. In some patients, during treatment with Lamegom, 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, the doctor will decide whether the patient should receive the medication or continue taking Lamegom (see also "How to Take Lamegom"in section 3).
Be Aware of Symptoms of Abnormal Liver Function

• If the patient observesany of the following 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), they should immediately consult their doctor, who may advise stopping Lamegom.

The effect of Lamegom has not been documented in patients over 75 years of age. Therefore, Lamegom should not be used in these 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 antidepressant medications, because all these medications start working only after some time, usually after about two weeks, and sometimes later.
It is more likely that the patient has such thoughts:

• if they have had suicidal thoughts or self-harm before;
• if the patient is a young adult. Clinical studies have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with mental disorders who were treated with an antidepressant medication.
• If the patient has thoughts of self-harm or suicide, they should immediately contact their doctor or go to the hospital.

It may be helpful to tell a relative or friend that the patient is suffering from depression and ask them to read this package leaflet. The patient may ask them to inform them if they notice that the depression is worsening or if they are concerned about changes in the patient's behavior.

Children and Adolescents

Due to the lack of information, it is not recommended to use Lamegom in children under 7 years of age.
There are no available data. Lamegom should not be used in children and adolescents from 7 to 17 years of age, as the safety and efficacy have not been established.

Lamegom and Other Medications

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

Taking Lamegom with Alcohol

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

Pregnancy and Breastfeeding

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 should be stopped when taking Lamegom.

Driving and Operating Machines

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

Lamegom 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 Lamegom

This medication should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Lamegom is one tablet (25 mg) in the evening before bedtime. In some cases, the doctor may prescribe a higher dose (50 mg), which is two tablets taken at the same time, before bedtime.
Method of administration
Lamegom is intended for oral use. The patient should swallow the tablet with water.
Lamegom can be taken with or without food.
Duration of treatment
Lamegom starts working on the symptoms of depression in most patients with depression within two weeks of starting treatment. Depression should be treated for a sufficient period, at least six months, to ensure that the symptoms have disappeared.
The doctor may recommend continuing treatment with Lamegom, even if the patient feels better, to prevent the recurrence of depression.
If the patient has kidney problems, the doctor will individually assess whether taking Lamegom is safe for them.
Monitoring Liver Function (see also section 2)
To check if the patient's liver is working properly, the doctor will recommend laboratory tests before starting treatment, and then at regular intervals during therapy, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks.
If the doctor decides to increase the dose to 50 mg, laboratory 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 the doctor considers it necessary, they will also recommend later tests.
Lamegom should not be taken if the patient's liver does not work properly.
How to Switch from an SSRI/SNRI Antidepressant to Lamegom
If the doctor switches the patient from an SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin Norepinephrine Reuptake Inhibitor) antidepressant to Lamegom, they will advise the patient on how to stop taking the previous medication when starting Lamegom.
For several weeks, the patient may experience withdrawal symptoms related to stopping the previous 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 the patient is reducing the dose of the previously taken medication when starting Lamegom, they should not confuse possible withdrawal symptoms with the lack of early effect of Lamegom.
The patient should discuss with their doctor the best way to stop taking the previous antidepressant medication when starting treatment with Lamegom.

Taking a Higher Than Recommended Dose of Lamegom

If the patient has taken more Lamegom than they should or if, for example, a child has accidentally taken the medication, they should immediately contact their doctor.
Experience with Lamegom overdose is limited. Reported symptoms include stomach pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, fainting, or malaise.

Missing a Dose of Lamegom

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 Lamegom

The patient should not stop taking Lamegom without their doctor's recommendation, even if they feel better.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Lamegom 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 patients): headache.
• Common side effects (may affect up to 1 in 10 patients): 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 patients):

migraine, feeling of tingling and 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 patients): severe skin reactions (rash), 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 the patient experiences any side effects, including any side effects not listed in the package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 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, more information can be collected on the safety of the medication.

5. How to Store Lamegom

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month.
Store in the original package to protect from moisture.
There are no special requirements for storing the medication at a certain temperature.
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 Package and Other Information

What Lamegom Contains

• The active substance of Lamegom is agomelatine in the form of agomelatine citrate. Each coated tablet contains 25 mg of agomelatine. The other ingredients of the tablet core are: microcrystalline cellulose (microcrystalline cellulose and silicon dioxide), mannitol, povidone 30, silicon dioxide, crospovidone (type A), sodium stearyl fumarate, magnesium stearate, stearic acid. See section 2 "Lamegom contains sodium".
• The other ingredients of the coating are: hypromellose, macrogol, titanium dioxide (E 171), talc, and yellow iron oxide (E 172).

What Lamegom Looks Like and What the Package Contains

The coated tablets (tablets) of 25 mg Lamegom are yellow, oblong, and biconvex, 9 mm long and 4.5 mm wide.
Packages contain 28, 30, 56, 84, or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia

Manufacturer

MEDIS International a.s., výrobní závod Bolatice Průmyslová 961/16 747 23 Bolatice Czech Republic Date of last revision of the package leaflet:14.01.2025