Provigil 100 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Modafinil

Available from:

Lexon (UK) Ltd

ATC code:

N06BA; N06BA07

INN (International Name):

Modafinil

Dosage:

100 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Centrally acting sympathomimetics; modafinil

Authorization status:

Authorised

Authorization date:

2017-07-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROVIGIL 100MG 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:
What Provigil is and what it is used for
What you need to know before you take Provigil
How to take Provigil
Possible side effects
How to store Provigil
Contents of the pack and other information
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.
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 PRESSURE. Your doctor will need
to check these regularly while you are taking Provigil.
*
Have ever had DEPRESSION, LOW MOOD, ANXIETY, PSYCHOSIS (loss of
contact with reality) or MANIA (over-excitement or feeling of extreme
happiness) or BI

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Provigil 100 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of modafinil.
Excipient(s) with known effects:
Each tablet contains 68 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from the UK_
The tablets are white to off-white, 13 x 6 mm, capsule-shaped and
debossed with “100” on one side.
4 CLINICAL PARTICULARS
As per PA0749/198/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/198/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
lactose monohydrate
pregelatinised starch (maize)
microcrystalline cellulose
croscarmellose sodium
povidone K29/32
magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PVDC/aluminium blisters.
Pack of 30 tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused product or waste material should be disposed of in
accorda