PROVIGIL Tablet (2021)
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Περιεχόμενα
Name of the medicinal product
PROVIGIL 100 mg tablets.
Qualitative and quantitative composition
Each tablet contains 100 mg of modafinil.
Excipient(s) with known effect:
Each tablet contains 68mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet.
The tablets are white to off-white, 13 x 6 mm, capsule-shaped and debossed with '100' on one side.
Therapeutic indications
Provigil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy.
Excessive sleepiness is defined as difficulty maintaining wakefulness...
Posology and method of administration
Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders (see section 4.1).
A diagnosis of narcolepsy should be made according to t...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Uncontrolled moderate to severe hypertension.
Cardiac arrhythmias.
Special warnings and precautions for use
Diagnosis of sleep disorders
Modafinil should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of narcolepsy, has been made in acco...
Interaction with other medicinal products and other forms of interaction
Modafinil may increase its own metabolism via induction of CYP3A4/5 activity but the effect is modest and unlikely to have significant clinical consequences.
Anticonvulsants
Co-administration of po...
Fertility, pregnancy and lactation
Pregnancy
There is limited amount of data from the use of modafinil in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3).
Modafinil is not recommended for use du...
Effects on ability to drive and use machines
Patients with abnormal levels of sleepiness who take modafinil should be advised that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking...
Undesirable effects
The following adverse reactions have been reported in clinical trials and/or post-marketing experience. The frequency of adverse reactions considered at least possibly related to treatment, in clin...
Overdose
Symptoms
Death has occurred with modafinil overdose alone or in combination with other drugs. Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have incl...
Pharmacodynamic properties
Pharmacotherapeutic group:
Psychoanaleptics, centrally acting sympathomimetics
ATC code:
N06BA07
Mechanism of action
Modafinil promotes wakefulness in a variety of species, including man. The pr...
Pharmacokinetic properties
Modafinil is a racemic compound, and the enantiomers have different pharmacokinetics where the elimination t
½
of the R-isomer is three times that of the S-isomer in adult humans.
Absorption
Modaf...
Preclinical safety data
Toxicology studies by single and repeated dosing have revealed no particular toxic action in animals.
Modafinil is not considered to be mutagenic or carcinogenic.
Reproductive toxicity studies cond...
List of excipients
Lactose monohydrate
Pregelatinised starch (maize)
Microcrystalline cellulose
Croscarmellose sodium
Povidone K29/32
Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Opaque PVC/PVDC/aluminium blisters.
Packs of 10, 20, 30, 50, 60, 90, 100 or 120 tablets.
Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Marketing authorization number(s)
PL 14776/0098
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 October 1997
Date of latest renewal: 24 June 2017
Date of revision of the text
25/05/2021
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