Modafinil 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Modafinil

Available from:

Waymade Healthcare Plc

ATC code:

N06BA07

INN (International Name):

Modafinil

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04040000

Patient Information leaflet

180 x 295 mm
9 pt
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT
INFORMATION FOR YOU.
!
If you get any of the side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
1.
What Modafinil Tablets are and what they are used for
2.
What you need to know before you take Modafinil
Tablets
3.
How to take Modafinil Tablets
4.
Possible side effects
5.
How to store Modafinil Tablets
6.
Contents of the pack and other information
1.
WHAT MODAFINIL TABLETS ARE AND WHAT THEY ARE
USED FOR
!
Keep this leaflet. You may need to read it again.
!
If you have any further questions, ask your doctor or
pharmacist.
!
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
The active ingredient in the tablets is modafinil.
Modafinil Tablets can be taken by adults who suffer from
narcolepsy to help them to stay awake. Narcolepsy is a
condition that causes excessive daytime sleepiness and
a
tendency
to
fall
asleep
suddenly
in
inappropriate
situations (sleep attacks). Modafinil Tablets may improve
your narcolepsy and reduce the likelihood that you will
have sleep attacks but there may still be other ways that
you can improve your condition and your doctor will
advise you.
WHAT IS IN THIS LEAFLET
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODAFINIL
TABLETS
DO NOT TAKE MODAFINIL TABLETS IF YOU:
WARNINGS AND PRECAUTIONS
!
Have KIDNEY OR LIVER PROBLEMS (because you will
need to take a lower dose).
!
Are
ALLERGIC
to
modafinil,
or
any
of
the
other
ingredients of this medicine (listed in section 6).
!
Have UNCONTROLLED, MODERATE TO SEVERE HIGH BLOOD
PRESSURE (hypertension).
!
Have any HEART PROBLEMS or HIGH BLOOD PRESSURE.
Your doctor will need to check these regularly while
you are taking Modafinil Tablets.
!
Have ever had DEPRESSION, LOW MOOD, ANXIETY,
PSYCHOSIS (loss of contact with reality) or MANIA
(over-excitement or feeling

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Modafinil 100mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Modafinil 100mg.
Excipient: Each tablet contains 84.0 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round, biconvex, tablet
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 in the morning or as two doses in the morning and at
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 200mg 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 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