Stilnoct 10mg 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:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Benzodiazepine related drugs; zolpidem

Authorization status:

Authorised

Authorization date:

2007-05-04

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
STILNOCT
® 10MG 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
10mg Film-Coated Tablets
Reference No:
PPA1151/030/001
Your medicine is imported from the UK under the name of
‘Zolpidem Tartrate 10mg Tablets’ but is marketed as
‘Stilnoct 10mg 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

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 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Zolpidem tartrate 10mg
Excipient(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK_
Oblong, white, scored tablet engraved ‘SN10’ on one side and plain
on the other.
4 CLINICAL PARTICULARS
As per PA0540/160/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/160/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core
Lactose Monohydrate
Microcrystalline cellulose
Hypromellose
Sodium starch glycollate
Magnesium stearate
Film coating
Macrogol 400
Titanium dioxide (E171)
Hypromellose
Health Products Regulatory Authority
25 January 2019
CRN008QF8
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container
and outer package of the product on the market in the country of
origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in a dry place in the original packaging. Do not store above
30ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/foil blister strips in a cardboard outer carton. 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
PPA1151/030/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 04 May 2007
Date of last renewal: 04 May 2012
10 DATE OF REVISION OF THE TEXT
April 2018