Zolpidem 5mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Zolpidem tartrate

제공처:

Teva UK Ltd

ATC 코드:

N05CF02

INN (국제 이름):

Zolpidem tartrate

복용량:

5mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

Schedule 4 (CD Benz)

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04010100; GTIN: 5017007023715

환자 정보 전단

PATIENT INFORMATION LEAFLET
ZOLPIDEM 5MG OR 10MG TABLETS
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 of the side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
•
Your doctor may have given you this medicine before from another
company. It may
have looked slightly different. However, either brand will have the
same effect.
WHAT IS IN THIS LEAFLET:
1.
What zolpidem is and what it is used for
2.
What you need to know before you take zolpidem
3.
How to take zolpidem
4.
Possible side effects
5.
How to store zolpidem
6.
Contents of the pack and other information
1. WHAT ZOLPIDEM IS AND WHAT IT IS USED FOR
The name of your medicine is Zolpidem 5mg or 10mg Tablets (called
zolpidem throughout
this leaflet). Zolpidem contains a medicine called zolpidem tartrate.
This belongs to a group
of medicines called hypnotics. It works by acting on your brain to
help you sleep.
Zolpidem is used for temporary sleep problems in adults that are
causing you severe distress
or that are affecting your everyday life. This includes sleep problems
in adults such as:
•
Difficulty falling asleep
•
Waking in the middle of the night
•
Waking too early
Your doctor will identify your sleep problem wherever possible and the
underlying factors
before prescribing this medicine for you. The failure of your sleep
problems to stop after a 7-
14 day course of treatment may indicate you have an underlying
disorder, your doctor will
assess you at regular intervals.
Zolpidem is used for short-term treatment of insomnia in adults. Do
not use long-term.
Treatment should be as short as possible, because th

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zolpidem tartrate 5mg, film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains: 5 mg zolpidem tartrate.
Excipient with known effect
: 45.20 mg lactose monohydrate/film-coated tablet
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets.
The tablet is white, oval, biconvex, film-coated and embossed with
"ZIM" on one side and
"5" on the other side_. _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zolpidem is indicated for short-term treatment of insomnia in adults.
Benzodiazepines or benzodiazepine-like agents are only indicated when
the disorder is severe,
disabling or subjecting the individual to extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be as short as possible. Generally the duration of
treatment varies from a
few days to two weeks with a maximum, including the tapering off
process, of four weeks.
The tapering off process should be tailored to the individual.
In certain cases extension beyond the maximum treatment period may be
necessary; if so, it
should not take place without re-evaluation of the patient's status.
The treatment should be taken in a single intake and not be
re-administered during the same
night.
Adults:
The recommended daily dose for adults is 10 mg to be taken immediately
at bedtime. The
lowest effective daily dose of zolpidem should be used and must not
exceed 10 mg.
Elderly:
In elderly or debilitated patients who may be especially sensitive to
the effects of zolpidem a
dose of 5 mg is recommended. This dose should only be increased to 10
mg where the clinical
response is inadequate and the drug is well tolerated.
Patients with hepatic insufficiency
Patients with hepatic insufficiency who do not clear the drug as
rapidly as normal individuals,
a dose of 5 mg is recommended. This dose should only be increased to
10 mg where the
clinical response is inadequate and the drug is well tolerated.
Paediatric po