LUDIOMIL Film coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Maprotiline hydrochloride 25 mg and 75 mg film coated tablets.
Qualitative and quantitative composition
Tablets contain 25 mg or 75 mg of maprotiline hydrochloride.
Pharmaceutical form
Ludiomil 25 mg are round, grey-orange tablets with a white core, diameter 6.1 mm, with slightly convex faces and slightly bevelled edges. The tablets are imprinted DP and a score on one side. Each tablet ...
Therapeutic indications
Depression Endogenous and late-onset (involutional) depression. Psychogenic, reactive, and neurotic depression, exhaustion depression. Somatogenic depression. Masked depression. Menopausal depression. ...
Posology and method of administration
During treatment with Ludiomil the patient should be kept under medical surveillance. The recommended dose range is between 75 and 150 mg daily. Depending on the severity of the symptoms, patient response ...
Contraindications
Hypersensitivity to maprotiline, any of the excipients (see section 6.1), or cross-sensitivity to tricyclic antidepressants. Convulsive disorder or a lowered convulsion threshold (e.g. brain damage of ...
Special warnings and precautions for use
Antiarrhythmics Antiarrhythmics that are potent inhibitors of CYP2D6, such as quinidine and propafenone, should not be used in combination with Ludiomil. The anticholinergic effects of quinidine may cause ...
Interaction with other medicinal products and other forms of interaction
CYP2D6 inhibitors Concomitant administration of CYP2D6 inhibitors may lead to an increase in concentration of maprotiline, up to ~3.5-fold in patients with a debrisoquine extensive metaboliser phenotype, ...
Fertility, pregnancy and lactation
Fertility No special recommendations. Women of child-bearing potential No special recommendations. Pregnancy Animal experiments showed no teratogenic or mutagenic effects and no evidence of impaired fertility ...
Effects on ability to drive and use machines
Patients receiving Ludiomil should be warned that blurred vision, dizziness, somnolence and other CNS symptoms (see section 4.8) may occur, in which case they should not drive, operate machinery, or engage ...
Undesirable effects
Adverse effects are usually mild and transient, disappearing with continued treatment or following a reduction in the dosage. They do not always correlate with plasma drug levels or with dose. It is often ...
Overdose
Symptoms The signs and symptoms of overdose with Ludiomil are similar to those reported with tricyclic antidepressants. Cardiac abnormalities and neurological disturbances are the main complications. In ...
Pharmacodynamic properties
ATC code: N06AA21 Maprotiline hydrochloride is a tetracyclic antidepressant, psychoanaleptics, non-selective mono-amine reuptake inhibitor, which shares a number of basic therapeutic properties with the ...
Pharmacokinetic properties
Absorption Following single oral administration of film-coated tablets, maprotiline hydrochloride is slowly but completely absorbed. The mean absolute bioavailability is approximately 66 to 70%. Within ...
Preclinical safety data
Preclinical data of Ludiomil, based on conventional studies on the toxicity of repeated administration, genotoxicity, mutagenicity, carcinogenic potential for teratogenicity and reproductive toxicity, ...
List of excipients
Silica Calcium phosphate Lactose Magnesium stearate Stearic acid Hydroxypropyl methylcellulose Yellow iron oxide (E172) Polysorbate 80 Titanium dioxide (E171) Talc Maize starch Red iron oxide (E172)
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Store below 30°C.
Nature and contents of container
25 mg: Blister packs of 30, 50 and 100 tablets. 75 mg: Blister packs of 20 and 30 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
AFT Pharmaceuticals Ltd., PO Box 33.203, Takapuna, Auckland Email:customer.service@aftpharm.com
Date of first authorization / renewal of the authorization
20/05/1982
Date of revision of the text
November 2018
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