Lamegom

Patient Information Leaflet

Lamegom, 25 mg, film-coated tablets
agomelatine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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.

Leaflet Contents

1. What Lamegom is and what it is 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 pack and other information

1. What Lamegom is and what it is used for

Lamegom contains the active substance agomelatine. It belongs to a group of medicines called antidepressants.
Lamegom has been prescribed to treat depression.
Lamegom 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, anxiety, and changes in body weight.
The expected benefits of taking Lamegom are a reduction in the severity and gradual disappearance of symptoms related to depression.

2. Important information before using Lamegom

When not to use Lamegom

• 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
The use of Lamegom may be inappropriate for several reasons:

• if the patient is taking medicines known to affect the liver. The patient should consult a doctor to determine which medicines are concerned;

• if the patient is obese or overweight, the patient should consult a doctor;

• if the patient has diabetes, the patient should consult a doctor;

• if the patient had increased liver enzyme activity before treatment, the doctor will decide whether Lamegom is suitable;

• if the patient has bipolar affective disorder and has experienced or is developing symptoms of mania (excessive excitement and emotional agitation), the patient should talk to the doctor before starting or continuing treatment with this medicine (see also section 4 “Possible side effects”);

• if the patient has dementia, the doctor will individually assess whether Lamegom is appropriate for the patient.

During treatment with Lamegom:
What should be done to avoid potential serious liver function disorders

• Before starting treatment, the doctor should check whether the patient's liver is functioning properly. In some patients, treatment with Lamegom may lead to increased liver enzyme activity in the blood. For this reason, regular 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
taking Lamegom (see also “How to take Lamegom” in section 3).
Be aware of symptoms indicating liver dysfunction

• If the patient experiences any of the following signs of liver problems: unusually dark urine, pale 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 Lamegom.

The efficacy of Lamegom has not been documented in patients aged 75 years and older.
Therefore, Lamegom should not be used in these patients.
Suicidal thoughts and worsening of depression
If the patient suffers from depression, they may sometimes have 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, and sometimes longer.
It is more likely that the patient will have such thoughts:

• if they have previously had thoughts of suicide or self-harm;
• if the patient is 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 a hospital.

It may be helpful to inform a relative or friend that the patient suffers from depression and ask them to read this leaflet. The patient may ask them to inform the patient if they notice worsening of depression or if they are concerned about changes in the patient's behaviour.
Children and adolescents
Due to lack of data, the use of Lamegom is not recommended in children under 7 years of age.
No data are available. Lamegom should not be used in children and adolescents aged 7 to 17 years, as safety and efficacy have not been established.
Lamegom and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The patient should not take Lamegom together with certain medicines (see also “When not to take Lamegom” in section 2): fluvoxamine (another medicine used to treat depression), ciprofloxacin (an antibiotic) may alter the amount of agomelatine in the blood.
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 Lamegom with alcohol
Drinking alcohol is not recommended during treatment with Lamegom.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Breastfeeding must be discontinued during treatment with Lamegom.
Driving and operating machinery
The patient may experience dizziness or drowsiness, which may affect the ability to drive or operate machinery. Before driving or operating machinery, ensure that reactions are normal.
Lamegom 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 Lamegom

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Lamegom is one tablet (25 mg) taken in the evening before bedtime. In some
cases, the doctor may prescribe a higher dose (50 mg), which is two tablets taken together
before bedtime.
Method of administration
Lamegom is intended for oral use. The tablet should be swallowed with water.
Lamegom may be taken with or without food.
Duration of treatment
Lamegom begins to act on symptoms of depression in most patients within two
weeks after starting treatment. Depression should be treated for a sufficient duration, at least
6 months, to ensure that symptoms have resolved.
The doctor may recommend continuing treatment with Lamegom even when the patient feels better,
to prevent recurrence of depression.
If the patient has kidney problems, the doctor will individually assess whether taking Lamegom
is safe for the patient.
Monitoring liver function (see also section 2)
To check whether the patient's liver is functioning properly, the doctor will recommend laboratory
tests before starting treatment, and then periodically 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 deemed necessary by the doctor, further tests may also be recommended.
Lamegom must not be used if the patient's liver is not functioning properly.
How to switch from an SSRI/SNRI antidepressant to Lamegom?
If the doctor is switching an antidepressant from the SSRI (Selective Serotonin Reuptake
Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) group to Lamegom, the doctor
will advise the patient on how to discontinue the previous medicine when starting
Lamegom.
For several weeks, the patient may experience withdrawal symptoms related to stopping the
previous medicine, even if its dose is gradually reduced.
Withdrawal symptoms 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 Lamegom while tapering off the previously used medicine, possible withdrawal symptoms should not be mistaken for lack of early effect of Lamegom.
Discuss with the doctor the best way to discontinue the previous antidepressant when initiating therapy with Lamegom.
Taking more Lamegom than recommended
If the patient has taken more Lamegom than prescribed, or if, for example, a child
accidentally ingested the medicine, contact a doctor immediately.
Experience with overdose of Lamegom is limited. Reported symptoms include upper abdominal pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or malaise.
Missing a dose of Lamegom
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Lamegom
Do not stop taking Lamegom without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most adverse reactions are mild or moderate. Adverse reactions usually occur during the first two weeks of treatment and are generally 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, tingling and numbness in fingers of hands and feet (paraesthesia), blurred vision, restless legs syndrome (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 bladder. * Several 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lamegom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
There are no special requirements regarding the storage temperature of this medicine.
Medicines must not be disposed of via wastewater 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 Lamegom contains

• The active substance is agomelatine in the form of agomelatine with citric acid. Each coated tablet contains 25 mg of agomelatine. The other ingredients of the tablet core are: microcrystalline cellulose with silica (microcrystalline cellulose and colloidal anhydrous silica), mannitol, povidone 30, colloidal anhydrous silica, 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 contents of the pack
Coated tablets (tablets), 25 mg Lamegom, are yellow, oblong, biconvex, 9 mm in length and 4.5 mm in width.
Packs contain 28, 30, 56, 84 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Manufacturer
MEDIS International a.s., vyrobni zavod Bolatice
Prumyslova 961/16
747 23 Bolatice
Czech Republic