Stablon Tablets Uses, Dosage, Side Effects, Reviews

Important to know about Stablon Tablets ?

This drug is recommended in depressive states of mild, moderate or severe intensity.

Stablon Tablets Uses, Dosage, Side Effects, Reviews

Stablon Tablets Uses, Dosage, Side Effects, Reviews

Stablon Tablets indication and Uses :

Major depressive episodes (ie characterized).

Stablon Tablets Dosage :

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.

How it works Stablon Tablets :

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)

Stablon Tablets Side Effects :

Summary of the security profile:

Stablon Tablets Side Effects

Stablon Tablets Side Effects

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)

Frequency

Side effects

Metabolism and nutrition disorders

Frequent

Anorexia

indeterminate *

hyponatremia

Psychiatric disorders

Frequent

nightmares

Rare

Abuse, addiction, especially in subjects under 50 years of age with a history of drug dependence or alcohol dependence

indeterminate *

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

Frequent

Insomnia

Drowsiness

Dizzying sensations

headaches

presyncope

tremors

indeterminate *

Extrapyramidal disorders

dyskinesia

Heart conditions

Frequent

tachycardia

premature

Chest pain

Vascular disorders

Frequent

Hot flashes

Respiratory, thoracic and mediastinal disorders

Frequent

Dyspnea

Gastrointestinal disorders

Frequent

Gastralgias

Abdominal pain

Dry mouth

nausea

vomiting

Constipation

flatulence

Skin and subcutaneous tissue disorders

Rare

Maculopapular or erythematous rash

itching

Urticaria

indeterminate *

Acne

Exceptional bullous reactions

Musculoskeletal and systemic disorders

Frequent

myalgia

Low back pain

General disorders and administration site abnormalities

Frequent

Asthenia

Sensation of discomfort in the throat

Hepatobiliary disorders

indeterminate *

Increased liver enzymes

Hepatitis can be exceptionally severe

* Post-market data

Stablon Tablets Interactions :

Associations advised against

+ Irreversible MAOIs (iproniazid): because of the risk of collapse or paroxysmal hypertension, hyperthermia, convulsions, death.

Stablon Tablets Warnings and Precautions :

Special warnings

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.

Drive and use machines:

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.

Stablon Tablets Warnings and Precautions

Stablon Tablets Warnings and Precautions

Stablon Tablets and PREGNANCY / BREAST FEEDING / FERTILITY:

Pregnancy :

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.

Breastfeeding:

Tricyclic antidepressants are excreted in breast milk, so breastfeeding is not recommended for the duration of treatment.

Fertility:

In rats, one study showed a decrease in reproductive performance in females (increased preimplantation losses) at maternotoxic dose. The clinical impact is not known.

What happens if I overdose from Stablon Tablets ?

sYMPTOMS

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.

To behave

Tianeptine has no known specific antidote. In cases of acute intoxication, symptomatic treatment and routine surveillance should be established. Specialized medical monitoring is recommended.

What is  Forms and Composition Stablon Tablets?

FORMS and PRESENTATIONS

12.5 mg coated tablet (white):   Box of 28, in blister packs.

Hospital model: Box of 100, in blister packs.

COMPOSITION
  p cp
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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