- 1 [highlight]Important to know about Stablon Tablets ?[/highlight]
- 2 [highlight]Stablon Tablets indication and Uses[/highlight]
- 3 [highlight]Stablon Tablets Dosage[/highlight]
- 4 [highlight]How it works Stablon Tablets[/highlight]
- 5 [highlight]Stablon Tablets Side Effects[/highlight]
- 6 [highlight]Stablon Tablets Interactions[/highlight]
- 7 [highlight]Stablon Tablets Warnings and Precautions[/highlight]
- 8 [highlight]Drive and use machines[/highlight]
- 9 [highlight]Stablon Tablets and PREGNANCY / BREAST FEEDING / FERTILITY:[/highlight]
- 10 [highlight]What happens if I overdose from Stablon Tablets ?[/highlight]
- 11 [highlight]What is Forms and Composition Stablon Tablets?[/highlight]
[highlight]Important to know about Stablon Tablets ?[/highlight]
This drug is recommended in depressive states of mild, moderate or severe intensity.
[highlight]Stablon Tablets indication and Uses[/highlight]
Major depressive episodes (ie characterized).
[highlight]Stablon Tablets Dosage[/highlight]
The recommended dosage is 1 tablet at 12.5 mg three times a day, morning, noon and night, at the beginning of the main meals.
In chronic alcoholic, cirrhotic or non-cirrhotic, no dosage modification is necessary.
In patients over 70 years of age and in case of renal insufficiency, limit the dosage to 2 tablets per day.
[highlight]How it works Stablon Tablets[/highlight]
Pharmacotherapeutic group: OTHER ANTIDEPRESSANTS.
ATC Code: N06AX14.
Tianeptine is an antidepressant:
In animals, tianeptine has the following characteristics:
- Tianeptine increases the spontaneous activity of pyramidal cells of the hippocampus and accelerates their recovery after functional inhibition,
- Tianeptine increases serotonin reuptake speed by neurons of the cortex and hippocampus.
In humans, tianeptine is characterized by:
- A clear activity on somatic complaints, in particular digestive complaints related to anxiety and mood disorders.
Tianeptine also has no effect:
- On sleep and vigilance,
- On the cholinergic system (absence of anticholinergic manifestation)
[highlight]Stablon Tablets Side Effects[/highlight]
Summary of the security profile:
The adverse effects seen with tianeptine in clinical trials are of moderate intensity. They consist mainly of nausea, constipation, abdominal pain, drowsiness, headache, dry mouth and dizziness.
Table of adverse effects
The following adverse reactions have been observed in clinical trials and / or the post-marketing use of tianeptine and are classified according to their frequency:
Very common ( ³ 1/10); frequent ( ³ 1/100, <1/10); uncommon ( ³ 1/1000, <1/100); rare ( ³ 1/10000, <1/1000); very rare (<1/10000), undetermined (can not be estimated from the available data).
Organ-Class System (SOC)
Metabolism and nutrition disorders
Abuse, addiction, especially in subjects under 50 years of age with a history of drug dependence or alcohol dependence
Idiosyncratic cases and suicidal behavior have been reported during treatment with tianeptine or shortly after discontinuation (see section 4.4).
Confusional state, hallucinations
Nervous system disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Maculopapular or erythematous rash
Exceptional bullous reactions
Musculoskeletal and systemic disorders
Low back pain
General disorders and administration site abnormalities
Sensation of discomfort in the throat
Increased liver enzymes
Hepatitis can be exceptionally severe
* Post-market data
[highlight]Stablon Tablets Interactions[/highlight]
+ Irreversible MAOIs (iproniazid): because of the risk of collapse or paroxysmal hypertension, hyperthermia, convulsions, death.
[highlight]Stablon Tablets Warnings and Precautions[/highlight]
Prolonged use and high doses can lead to a state of dependence.
Do not exceed the recommended dosage.
Suicidal ideation and worsening of your depression or anxiety disorder
If you suffer from depression and / or anxiety disorders, you may sometimes have ideas of self-aggression (aggression towards yourself) or suicide. These events may be increased at the beginning of antidepressant treatment, as this type of medication does not act immediately but only after 2 weeks or more of treatment.
You are more likely to exhibit such events in the following cases:
- if you have ever had suicidal thoughts or self-aggression in the past.
- if you are a young adult. Clinical studies have shown that the risk of suicidal behavior is increased in adults under 25 with psychiatric illness and treated with antidepressants.
If you have suicidal thoughts or self-aggression, contact your doctor immediately or go directly to the hospital.
You can get help from a friend or relative, tell them you’re depressed or have an anxiety disorder, and ask them to read this leaflet. You can ask him to tell you if he thinks your depression or anxiety is getting worse, or if he’s worried about a change in your behavior.
Due to the presence of sucrose, this drug should not be used in cases of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
Precautions for use
Do not stop treatment abruptly, but decrease dosage for 7 to 14 days.
If you have to have a general anesthesia, you should tell the resuscitator anesthesiologist who will be able to stop the treatment 24 or 48 hours before the procedure.
Tell your doctor in case of kidney failure.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
[highlight]Drive and use machines[/highlight]
In some patients, a decrease in alertness is likely to occur. Attention is therefore drawn to the risk of drowsiness associated with the use of this drug, especially for vehicle drivers and machine users.
[highlight]Stablon Tablets and PREGNANCY / BREAST FEEDING / FERTILITY:[/highlight]
Maintaining a good maternal psychic balance is desirable throughout pregnancy. If medication management is necessary to ensure this balance, it should be instituted or continued in an effective dose throughout pregnancy and if possible in monotherapy.The animal data are reassuring, but the clinical data are still insufficient.
Given these data, it is best to avoid using tianeptine during pregnancy, regardless of the term. If it is essential to initiate or maintain treatment with tianeptine during pregnancy, consider the pharmacological profile of the drug for monitoring the newborn.
In rats, one study showed a decrease in reproductive performance in females (increased preimplantation losses) at maternotoxic dose. The clinical impact is not known.
[highlight]What happens if I overdose from Stablon Tablets ?[/highlight]
Experience with cases of acute tianeptine intoxication (maximum quantity: 2250mg, ingested in a single dose) mainly highlights vigilance disorders that can go as far as coma, particularly in cases of multiple intoxications.
Tianeptine has no known specific antidote. In cases of acute intoxication, symptomatic treatment and routine surveillance should be established. Specialized medical monitoring is recommended.
[highlight]What is Forms and Composition Stablon Tablets?[/highlight]
|FORMS and PRESENTATIONS|
12.5 mg coated tablet (white): Box of 28, in blister packs.
Hospital model: Box of 100, in blister packs.
|Tianeptine (INN) sodium salt||12.5 mg|
Excipients: D-mannitol, corn starch, talc, magnesium stearate. Coating:ethylcellulose, glycerol oleate, Sepifilm SE 700 white (povidone, carmellose sodium, anhydrous colloidal silica, talc, sucrose, polysorbate 80, titanium dioxide, sodium bicarbonate), white beeswax.
Excipient with known effect: sucrose.
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- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
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- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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