Stilnoct 5 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZOLPIDEM TARTRATE

Available from:

Imbat Limited

ATC code:

N05CF; N05CF02

INN (International Name):

ZOLPIDEM TARTRATE

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Benzodiazepine related drugs; zolpidem

Authorization status:

Authorised

Authorization date:

2009-03-13

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
STILNOCT
® 5MG FILM-COATED TABLETS
(zolpidem tartrate)
Blind or partially sighted?
Is this leaflet hard to see or
read?
Call [phone]
(Regulatory)
Please be ready to give the
following information:
Product name: Stilnoct 5mg
Film-Coated Tablets
Reference: PPA1151/030/002
Your medicine is imported from the UK under the name of
‘Zolpidem Tartrate 5mg Tablets’ but is marketed as ‘Stilnoct
5mg Film-Coated Tablets’ in Ireland.
Your medicine is available using the above name but will be
referred to as Stilnoct throughout this leaflet.
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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1.
What Stilnoct is and what it is used for
2.
What you need to know before you take Stilnoct
3.
How to take Stilnoct
4.
Possible side effects
5.
How to store Stilnoct
6.
Contents of the pack and other information
1.
WHAT STILNOCT IS AND WHAT IT IS USED FOR
The name of your medicine is Stilnoct. The tablets come in
two strengths: Stilnoct 5mg Tablets and Stilnoct 10mg
Tablets.
Zolpidem tartrate belongs to a group of medicines called
hypnotics. It works by acting on your brain to help you sleep.
Stilnoct is used for temporary sleep problems in adults that
are causing severe distress or that are affecting everyday life.
This includes sleep problems such as:

Difficulty falling asleep

Waking in the middle of the night

Waking too early
Stilnoct is not meant to be used every day for long periods of
time. Ask your doctor for advice if you are

Summary of Product characteristics

Health Products Regulatory Authority
25 January 2019
CRN008QF8
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stilnoct 5 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg zolpidem tartrate
Excipients include: lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK:_
Round, white, film-coated tablet with no markings.
4 CLINICAL PARTICULARS
As per PA0540/160/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/160/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Hypromellose
Sodium starch glycollate
Magnesium stearate
Macrogol 400
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
25 January 2019
CRN008QF8
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
carton and
blister-foil.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package in order to protect from light and
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pack size: 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE
MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF
THE
PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/030/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13th March 2009
10 DATE OF REVISION OF THE TEXT
January 2019