STABLON Coated tablet (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Stablon 12.5 mg coated tablets.
2. Qualitative and quantitative composition
Tianeptine (INN), sodium salt 12.5 mg. <u>Excipient(s) with known effect:</u> 24 mg sucrose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White, oval coated tablets.
4.1. Therapeutic indications
Major depressive episodes (i.e. typical).
4.2. Posology and method of administration
Posology The recommended dosage is 1 tablet (12.5 mg) three times a day (morning, midday and evening) before the main meals of the days. Method of administration Oral use. Special populations Elderly ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under 15 years old.
4.4. Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harming and suicidality (suicidal behaviour). This risk persists until a significant ...
4.5. Interaction with other medicinal products and other forms of interaction
Unadvisable combinations With irreversible MAOIs inhibitors (ipronazide): risk of cardiovascular collapse or paroxysmal hypertension, hyperthermia, convulsions, death.
4.6. Pregnancy and lactation
Pregnancy In a peri- and postnatal study, increased post-implantation and postnatal losses were observed in rats at a maternotoxic dose (see section 5.3). There are no or limited data (less than 300 pregnancy ...
4.7. Effects on ability to drive and use machines
Some patients may experience diminished alertness. The attention of drivers and machine-operators should thus be drawn to the risk of somnolence with this product.
4.8. Undesirable effects
Summary of safety profile Side effects reported with tianeptine in clinical trials are of mild intensity. They consist mainly in nausea, constipation, abdominal pain, somnolence, headaches, dry mouth and ...
4.9. Overdose
Symptoms Experience with tianeptine in overdose (the maximum amount was 2250 mg in a single intake) has indicated signs and symptoms including: confusional state, convulsion, somnolence, dry mouth and ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other antidepressant <b>ATC code:</b> N06AX14 Mechanism of action Tianeptine is an antidepressant. In animals, Tianeptine has the following properties: Tianeptine increases ...
5.2. Pharmacokinetic properties
Absorption Gastrointestinal absorption is rapid and complete with negligible influence of food. Distribution Distribution is rapid, and is associated with a high level of protein binding (approximately ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenicity. In a conventional fertility study, an increase in pre-implantation losses was observed ...
6.1. List of excipients
<u>Tablet:</u> Maize starch Mannitol Magnesium stearate Talc <U>Coating:</u> Sodium bicarbonate Sodium carboxymethylcellulose White beeswax Titanium dioxide (E171) Ethylcellulose Glycerol 80 Polysorbate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
30 tablets in heat-sealed blister packs (PVC/aluminium).
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 August 2005 Date of latest renewal: 06 September 2010
10. Date of revision of the text
February 2022
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
