Zolpidem 5mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Zolpidem tartrate

थमां उपलब्ध:

Bristol Laboratories Ltd

ए.टी.सी कोड:

N05CF02

INN (इंटरनेशनल नाम):

Zolpidem tartrate

डोज़:

5mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

Schedule 4 (CD Benz)

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 04010100; GTIN: 5060013942730

सूचना पत्रक

SAME SIZE ARTWORK
480 x 150 mm
Front
480 mm
150 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zolpidem tartrate 5 mg and 10 mg Film-coated 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. 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 Zolpidem tablets are and what they are used for
2.
What you need to know before you take Zolpidem tablets
3.
How to take Zolpidem tablets
4.
Possible side effects
5.
How to store Zolpidem tablets
6.
Contents of the pack and other information
1. What Zolpidem tablets are and what they are used for
The name of your medicine is Zolpidem tartrate 5mg and 10mg
Film-coated Tablets. This 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 every day 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
the risk of
dependence increases with the duration of treatment. Ask your doc

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zolpidem Tartrate 5 mg Tablets
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each tablet contains 5 mg zolpidem tartrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round, white, film-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zolpidem is indicated for the short-term treatment of insomnia in
adults in situations
where the insomnia is debilitating or is causing severe distress for
the patient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should be taken in a single intake and not be
re-administered during the
same night.
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.
Treatment should be as short as possible. It should not exceed four
weeks including
the period of tapering off. In certain cases extension beyond the
maximum treatment
period may be necessary; if so, extension beyond the maximum treatment
period
should not take place without re-evaluation of the patient’s status,
since the risk of
abuse and dependence increases with the duration of treatment (see
section 4.4).
Special populations
_Paediatric population _
Zolpidem is not recommended for use in children and adolescents below
18 years of
age, due to a lack of data to support use in this age group. The
available evidence
from placebo-controlled clinical trials is presented in section 5.1.
_Elderly _
Elderly or debilitated patients may be especially sensitive to the
effects of zolpidem
therefore a 5 mg dose is recommended. These recommended doses should
not be
exceeded.
_Hepatic impairment _
As clearance and metabolism of zolpidem is reduced in hepatic
impairment, dosage
should begin at 5 mg in these patients with particular caution being
exercised in
elderly patients. In adults (under 65 years) dosage may be increased
to 10 mg only
where the clinical response is inadequate and t