Expiration date: 02/2027
Method of administration and dosage
Always take the drug in full accordance with the recommendations of your doctor or pharmacy employee. If in doubt, consult your doctor or a pharmacy employee.
Recommended dose:
The recommended dose of Agomelatin Canon is 1 tablet (25 mg) before bedtime. In some cases, the attending physician may prescribe a higher dose (50 mg), that is, taking 2 tablets at the same time, before bedtime.
If you have impaired kidney function, your doctor will conduct an individual assessment of whether it is safe to take Agomelatin Canon in your case.
Liver function monitoring (see also section 2 of the leaflet):
Your doctor will order laboratory tests to evaluate liver function before starting therapy, and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.
If your doctor increases the dose of the drug to 50 mg, laboratory tests will be prescribed immediately before increasing the dose, and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks. After that, tests will be performed if the attending physician deems it necessary.
You should not take Agomelatin Canon if you have liver dysfunction.
How to switch from treatment with other antidepressants (SSRIs (selective serotonin reuptake inhibitors)/SSRIs (selective serotonin and norepinephrine reuptake inhibitors)) Agomelatin Canon therapy?
If your doctor decides to replace therapy with SSRI or SSRI-related antidepressants with Agomelatin Canon therapy, your doctor should explain to you how to stop using previously prescribed therapy when you start taking Agomelatin Canon.
For several weeks, you may experience symptoms associated with stopping previously taken antidepressants, even if you have gradually reduced their dose.
Withdrawal symptoms include dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and trembling.
These phenomena are usually mild or moderate and resolve on their own within a few days.
If the start of therapy with Agomelatin Canon coincides with the period of dose reduction of the previously taken drug, the possible appearance of withdrawal symptoms should not be considered as the absence of an early effect of Agomelatin Canon.
You should consult with your doctor about the most appropriate way to stop taking a previously prescribed antidepressant when you start taking Agomelatin Canon.
Route and (or) method of administration
The drug Agomelatin Canon is intended for oral administration.
The tablet should be swallowed whole, washed down with water.
The drug Agomelatin Canon can be taken regardless of food intake.
Duration of therapy
In most people with depression, the drug Agomelatin Canon begins to act on the symptoms of depression within two weeks after the start of therapy.
Drug therapy for depression should be carried out for at least 6 months, until the symptoms disappear completely. Your doctor may continue to prescribe Agomelatin Canon until you feel better to avoid a return of depression.
If you forgot to take the drug Agomelatin Canon
If you forgot to take a pill, take the next dose at the usual time. Do not take a double dose, trying to compensate for the missed dose.
If you have stopped taking Agomelatin Canon
Do not stop taking the drug without consulting your doctor, even if you feel better.
If you have any questions about the use of the drug, contact your doctor or a pharmacy employee.
Indications
The drug Agomelatin Canon is used in adults over the age of 18 for the treatment of major depressive disorder.
Composition
The active ingredient is agomelatine.
Each film-coated tablet contains 25 mg of agomelatine.
Other ingredients (excipients) are: sodium carboxymethyl starch, corn starch, colloidal silicon dioxide, magnesium stearate, mannitol, povidone K-30.
The composition of the film shell is Opadray 20A220084 yellow: hypromellose (hydroxypropylmethylcellulose), hyprolose (hydroxypropylcellulose), talc, titanium dioxide, iron oxide red dye, iron oxide yellow dye.
Contraindications
Do not take Agomelatin Canon:
- if you are allergic to agomelatin or any other components of the drug (listed in section 6 of the leaflet);
- if you have impaired liver function (impaired liver function);
- If you are taking fluvoxamine (another medication for depression) or ciprofloxacin (an antibiotic);
- if you are under 18 years old.
With caution:
Consult your doctor before taking Agomelatin Canon.
Tell your doctor if any of the following applies to you:
- if you are taking medications that may impair liver function. Consult your doctor about these medications.;
- If you are obese or overweight, consult your doctor.;
- If you have diabetes, consult your doctor.;
- If you have elevated liver enzymes before starting treatment, your doctor will decide whether Agomelatin Canon is suitable for you.;
- if you suffer from bipolar disorder, if you have experienced symptoms of mania in the past or present (a period of abnormally high excitability and emotionality), consult your doctor before starting or continuing to take this medication (see section 4 of the leaflet);
- if you suffer from dementia. The attending physician will conduct an individual assessment in order to understand whether it is possible to take the drug Agomelatin Canon in your case.
If you have any of the above conditions, contact your doctor before or during treatment with Agomelatin Canon.
Use during pregnancy and lactation:
If you are pregnant or breastfeeding, think you are pregnant, or plan to become pregnant, consult your doctor before using the drug.
There is no or limited data on the use of agomelatine during pregnancy. As a precautionary measure, it is recommended to avoid prescribing Agomelatin Canon during pregnancy.
It is necessary to evaluate the importance of breastfeeding for the child and therapy for the mother, and decide whether to stop breastfeeding or to stop taking the drug.
Special instructions
During therapy with Agomelatin Canon:
Actions aimed at avoiding serious liver dysfunction:
- Before starting therapy, your doctor should check your liver function. In some patients, the content of liver enzymes in the blood may increase during treatment with Agomelatin Canon. Therefore, it is necessary to carry out control analyses in accordance with the following scheme:
Before starting therapy or increasing the dose About 3 weeks About 6 weeks About 12 weeks About 24 weeks
Blood Tests ✓ ✓ ✓ ✓ ✓
Based on the results of these tests, your doctor will decide whether you should start or continue taking Agomelatin Canon (see section 3 of the leaflet).
Carefully monitor for possible signs and symptoms of liver dysfunction.:
- If you notice signs or symptoms of liver disorders: unusual darkening of urine, light stools, yellowing of the skin/eyes, pain in the right upper abdomen, unusual fatigue (especially in combination with other symptoms listed above) - contact your doctor immediately, who may advise you to stop taking Agomelatin The canon.
The effect of Agomelatin Canon in patients aged 75 years and older has not been confirmed, therefore Agomelatin Canon should not be taken in patients of this age group.
Kidney failure
If you have kidney disease, consult your doctor before taking the drug.
Suicidal thoughts and worsening depression
If you are experiencing depression, you may sometimes have thoughts of self-harm or suicide. This may increase with the first intake of antidepressants, as these medications do not begin to take effect immediately, usually after about two weeks, and sometimes even later.
Most likely, these thoughts may come to you:
- if you have previously had thoughts of self-harm or suicide.;
- if you are a young person. Clinical research data show that the risk of suicidal behavior increased in young people (younger than 25 years old) with mental disorders who took an antidepressant.
If you have thoughts of self-harm or suicide, consult your doctor immediately or go to the hospital.
It may be helpful if you tell someone in your family or close friends that you have depression and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse or if they're concerned about changes in your behavior.
Children
Do not give the drug to children aged 0 to 18 years, as efficacy and safety have not been established.
The drug Agomelatin Canon with food, drinks and alcohol
Food intake does not affect the effectiveness of the drug. Alcohol consumption is not recommended during therapy with Agomelatin Canon.
Effects on the ability to drive vehicles and other mechanisms:
This medication may cause dizziness or drowsiness, which may affect the ability to drive vehicles and work with mechanisms. Before starting to drive vehicles or work with mechanisms, make sure that your reactions are consistent with the norm.
Packaging and release form
Film-coated tablets, 25 mg - 28 pcs per pack, together with a leaflet in a pack of cardboard.
Side effects
Like all medications, the drug can cause undesirable reactions, but they do not occur in everyone.
Most adverse reactions are mild or moderate. They usually occur within the first two weeks of treatment and are transient.
Stop taking Agomelatin Canon and seek medical help immediately if one of the following signs of an allergic reaction (Quincke's edema) occurs, which has been observed rarely (may occur in no more than 1 person out of 1000):
- difficulty breathing or swallowing;
- Swelling of the face, lips, tongue, or throat.
Other possible adverse reactions that may occur when taking Agomelatin Canon.
Very common (may occur in more than 1 person out of 10):
- headache.
Common (may occur in no more than 1 person out of 10):
- anxiety;
- unusual dreams;
- dizziness;
- drowsiness;
- insomnia;
- nausea;
- diarrhea (diarrhea);
- constipation;
- abdominal pain;
- vomiting;
- a change in the biochemical analysis of blood (increased activity of ALT and/or ACT);
- back pain;
- fatigue;
- weight gain.
Infrequently (may occur in no more than 1 person out of 100):
- suicidal thoughts or suicidal behavior;
- motor restlessness with emotional arousal, irritability (agitation);
- aggressiveness
- nightmares;
- mental disorders (mania/hypomania);
- confusion;
- severe headache (migraine);
- burning, tingling, or a feeling of "crawling" on the skin (paresthesia);
- Restless legs syndrome;
- pathological restlessness (akathisia);
- blurred vision;
- tinnitus;
- a change in the biochemical analysis of blood (increased activity of γ-glutamyltransferase);
- sweating;
- eczema;
- itchy skin;
- hives;
- muscle pain (myalgia);
- weight loss.
Rarely (may occur in no more than 1 person out of 1000):
- hallucinations;
- inflammation of the liver (hepatitis);
- a change in the biochemical analysis of blood (increased activity of alkaline phosphatase);
- liver failure;
- jaundice;
- intense redness of skin areas (erythematous rash);
- problems with emptying a full bladder (urinary retention).
Reporting of adverse reactions
If you experience any adverse reactions, consult your doctor. These also include any adverse reactions not listed in the leaflet. You can also report the adverse reactions directly (see below). By reporting adverse reactions, you are helping to gain more information about the safety of the drug.
Pharmacotherapeutic group
psychoanalytics; antidepressants; other antidepressants
Interaction with other medicinal products
Tell your doctor or pharmacy employee that you are taking, have recently taken, or may start taking any other medications.
You should not take Agomelatin Canon with the following medications: fluvoxamine (a drug for the treatment of depression) or ciprofloxacin (an antibiotic), as this may change the agomelatin content in the blood.
Be sure to tell your doctor if you are taking the following medications: propranolol (a beta-blocker prescribed for the treatment of hypertension), enoxacin (an antibiotic).
Pharmacodynamics
Characteristics of the drug:
The drug Agomelatin Canon contains the active ingredient agomelatin, which belongs to a group of drugs called antidepressants.
Mechanism of action:
Depression is a persistent mood disorder that interferes with a person's daily activities. Symptoms of depression vary from person to person, but their usual components are deep sadness, a sense of inadequacy, loss of interest in favorite activities, sleep disorders, a feeling of lethargy, anxiety, and changes in body weight.
The expected benefit of Agomelatin Canon is the reduction and gradual disappearance of symptoms associated with depression.
If there is no improvement or you feel worse, you should consult a doctor.
Storage temperature
from 2℃ to 25℃
The dosage form
of the tablet is round biconvex, film-coated yellow. In the cross-section, the core is white or almost white.
Overdose
If you have taken more of Agomelatin Canon than you should have, or, for example, if a child has accidentally taken the drug, consult a doctor immediately.
The experience of overdose with Agomelatin Canon is very limited, but the symptoms include pain in the upper abdomen, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis of the skin and mucous membranes (cyanosis) or malaise.
