Modafinil 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Modafinil

Available from:

Torrent Pharma (UK) Ltd

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; GTIN: 5060623371470

Patient Information leaflet

Modafinil 100 mg tablets – DE/H/2481/001/DC
ukl pil
DCP/p/033/18/2
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MODAFINIL 100 MG TABLETS
Modafinil
_ _
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 side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Modafinil 100 mg tablets is and what it is used for
2. What you need to know before you take Modafinil 100 mg tablets
3. How to take Modafinil 100 mg tablets
4. Possible side effects
5. How to store Modafinil 100 mg tablets
6. Contents of the pack and other information
1. WHAT MODAFINIL 100 MG TABLETS IS AND WHAT IT IS USED FOR
_ _
The active ingredient in the tablets is modafinil.
Modafinil 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 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 100 MG TABLETS
DO NOT TAKE MODAFINIL 100 MG TABLETS
:
•
if you a
re allergic to modafinil, or to any of the other ingredients of this
medicine (listed in
Section 6).
•
If you have an irregular heartbeat.
•
If you have uncontrolled, moderate to severe high blood pressure
(hypertension).
WARNING AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING MODAFINIL 100 MG
TABLETS IF YOU:
•
Have any
HEART PROBLEMS
or
HIGH BL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Modafinil 100 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg modafinil.
Excipient with known effect:
Each tablet contains 46.9 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, circular and biconvex tablets; diameter: 9 mm.
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 da