Description

Buy Modafinil 100mg tablets Online

1. Name of the medicinal product
Modafinil 100 mg tablets

2. Qualitative and quantitative composition
Each tablet contains 100 mg of modafinil.

Excipient with known effect: Each tablet contains 227.000 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Tablet

White to off-white, capsule shaped, uncoated tablets, debossed with ‘4’ & ‘2’ separated by score line on one side ‘J’ on other side.

The tablet can be divided into equal doses.

4. Clinical particulars
4.1 Therapeutic indications
Modafinil 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 and an increased likelihood of falling asleep in inappropriate situations.

4.2 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 the International Classification of Sleep Disorders (ICSD2) guideline.

Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis.

Posology

The recommended starting daily dose is 200 mg. The total daily dose may be taken as a single dose, one in the morning or as two doses in the morning and at one noon, according to physician assessment of the patient and the patient’s response.

Doses of up to 400mg in one or two divided doses can be used in patients with insufficient response to the initial 100mg modafinil dose.

Long-term use

Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks).

Patients with renal impairment

There is inadequate information to determine safety and efficacy of dosing in patients with renal impairment (see section 5.2).

Patients with hepatic impairment

The dose of Modafinil 100 mg tablets should be reduced by half in patients with severe hepatic impairment (see section 5.2).

Elderly

There are limited data available on the use of modafinil in elderly patients. In view of the potential for lower clearance and increased systemic exposure, it is recommended that patients over 65 years of age commence therapy at 100 mg daily.

Paediatric population

Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns (see section 4.4).

Method of administration

For oral use. Tablets should be swallowed whole.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Uncontrolled moderate to severe hypertension and in patients with cardiac arrhythmias.

4.4 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 accordance with ICSD diagnostic criteria. Such an evaluation usually consists, in addition to the patient’s history, sleep measurements testing in a laboratory setting and exclusion of other possible causes of the observed hypersomnia.

Serious rash, including Stevens – Johnson syndrome, Toxic Epidermal Necrolysis and Drug

Rash with Eosinophilia and Systemic Symptoms

Serious rash requiring hospitalisation and discontinuation of treatment has been reported with the use of modafinil, occurring within 1 to 5 weeks after treatment initiation. Isolated cases have also been reported after prolonged treatment (e.g., 3 months). In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in paediatric patients (age <17 years); this includes serious rash. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil. Modafinil should be discontinued at the first sign of rash and not restarted (see section 4.8).

Rare cases of serious or life-threatening rash, including Stevens – Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience.

Paediatric use

Because safety and effectiveness in controlled studies in children have not been established and because of the risk of serious cutaneous hypersensitivity and psychiatric adverse reactions, the use of modafinil is not recommended.

Multi-organ hypersensitivity reaction

Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil.

Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. There are no factors