LUSTRAL Film-coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
LUSTRAL 50 mg film coated tablets.
2. Qualitative and quantitative composition
Each 50 mg film-coated tablet contains sertraline hydrochloride equivalent to 50 mg sertraline. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. Sertraline 50 mg film-coated tablets are white, capsular shaped (10.3 4.2 mm), film-coated scored tablets marked ZLT 50 on one side and PFIZER on the other. The tablet can be divided ...
4.1. Therapeutic indications
Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of recurrence of major depressive episodes. Panic disorder, with or without agoraphobia. Obsessive compulsive disorder ...
4.2. Posology and method of administration
Posology Initial treatment Depression and OCD Sertraline treatment should be started at a dose of 50 mg/day. Panic Disorder, PTSD, and Social Anxiety Disorder Therapy should be initiated at 25 mg/day. ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk ...
4.4. Special warnings and precautions for use
Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) The development of potentially life-threatening syndromes like serotonin syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) has been reported ...
4.5. Interaction with other medicinal products and other forms of interaction
Contraindicated Monoamine Oxidase Inhibitors <u>Irreversible MAOIs (e.g. selegiline)</u> Sertraline must not be used in combination with irreversible MAOIs such as selegiline. Sertraline must not be initiated ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no well controlled studies in pregnant women. However, a substantial amount of data did not reveal evidence of induction of congenital malformations by sertraline. Animal studies showed ...
4.7. Effects on ability to drive and use machines
Clinical pharmacology studies have shown that sertraline has no effect on psychomotor performance. However, as psychotropic drugs may impair the mental or physical abilities required for the performance ...
4.8. Undesirable effects
Nausea is the most common undesirable effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo. These undesirable ...
4.9. Overdose
Toxicity Sertraline has a margin of safety dependent on patient population and/or concomitant medication. Deaths have been reported involving overdoses of sertraline, alone or in combination with other ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Selective serotonin reuptake inhibitors (SSRI) <b>ATC code:</b> N06AB06 Mechanism of action Sertraline is a potent and specific inhibitor of neuronal serotonin (5 HT) ...
5.2. Pharmacokinetic properties
Absorption In man, following an oral once-daily dosage of 50 to 200 mg for 14 days, peak plasma concentrations of sertraline occur at 4.5 to 8.4 hours after the daily administration of the drug. Food does ...
5.3. Preclinical safety data
Preclinical data does not indicate any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenesis. Reproduction toxicity studies ...
6.1. List of excipients
Sertraline film-coated tablets <u>Tablet cores:</u> calcium hydrogen phosphate dihydrate (E341) microcrystalline cellulose (E460) hydroxypropylcellulose (E463) sodium starch glycollate (Type A) magnesium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Tablets are packed in Aluminium/PVC blisters of 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, or 500 tablets. Tablets are packed in Aluminium/PVC blister strips containing 30x1. Not all ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Upjohn UK Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
8. Marketing authorization number(s)
PL 50622/0045
9. Date of first authorization / renewal of the authorization
23/06/2009
10. Date of revision of the text
03/2021
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