Stilnoct 10mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZOLPIDEM TARTRATE

Available from:

PCO Manufacturing Ltd.

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:

2017-01-20

Patient Information leaflet

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_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STILNOCT
® 10 MG FILM-COATED TABLETS
ZOLPIDEM TARTRATE
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 every day 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 unsure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STILNOCT
DO NOT TAKE STILNOCT IF:

You are allergic (hypersensitive) to zolpidem tartrate or any of the
other
ingredients of this medicine (listed in section 6 below). Signs of an
allergic
reaction include: rash, swallowing or breathing problems, swelling of
your lips,
face, throat or tongue

Your lungs do not work properly (respiratory failure)

You have severe liver problems

You are under 18 years of age
Do not take this medicine if

Summary of Product characteristics

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’.
4 CLINICAL PARTICULARS
As per PA0540/160/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/160/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Microcrystalline cellulose
Hypromellose
Sodium starch glycolate
Magnesium stearate
Titanium dioxide (E171)
Macrogol 400
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 carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C in the original packaging.
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6.5 NATURE AND CONTENTS OF CONTAINER
Carton of 28 tablets in blister strips.
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
PCO Manufacturing
Unit 10, Ashbo