Modafinil 100mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Modafinil

Saadav alates:

Morningside Healthcare Ltd

ATC kood:

N06BA07

INN (Rahvusvaheline Nimetus):

Modafinil

Annus:

100mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04040000; GTIN: 5055132712579

Infovoldik

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
•
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.
•
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.
What is in this leaflet
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
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.
2.
What you need to know before you take
Modafinil Tablets
Do not take Modafinil Tablets if you:
•
Are allergic to modafinil, or any of the other
ingredients of this medicine (listed in section 6)
•
Have an irregular heartbeat
•
Have uncontrolled, moderate to severe
high blood pressure (hypertension).
Warnings and precautions
•
Talk to your doctor or pharmacist before
taking Modafinil Tablets if you: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 (ove

Toote omadused

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, one in the morning and
one 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).
_Renal impairment _
There is inadequate information to determine safety and efficacy of
dosing in patients
with renal impairment (see section 5.2).
_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 modafi