Provigil 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Modafinil

Available from:

Sigma Pharmaceuticals 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

Adobe InDesign CC
JB V 10.InD
Cutterguide
Black
Provigil 100/200mg tabs ALL
SpUK Macors (A) V4
60026
Leaflet
157x420mm
N/A
Font NewsGoth BT
Body Size 10pt
MW
21-6-19
3.0
DS
2-7-19
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROVIGIL
® 100 MG TABLETS
PROVIGIL
® 200 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 PROVIGIL is and what it is
used for
2. What you need to know before you
take PROVIGIL
3. How to take PROVIGIL
4. Possible side effects
5. How to store PROVIGIL
6. Contents of the pack and other
information
1. WHAT PROVIGIL 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 PROVIGIL
DO NOT TAKE PROVIGIL:
• if you are ALLERGIC to modafinil or 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).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking PROVIGIL if you:
• Have any HEART PROBLEMS or HIGH BLOOD

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
100 mg tablets
200 mg tablets>
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of modafinil.

Excipient(s) with known effect:
Each tablet contains 68 mg of anhydrous lactose.

For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
The tablets are white to off-white, 13 x 6 mm, capsule-shaped and
debossed with ‘100’ on one
side.

4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
< Invented name> 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
3
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 400 mg in one or two divided doses can be used in
patients with insufficient
response to the initial 200 mg 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 week