Zoldem 10 mg film coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

ZOLPIDEM TARTRATE

Tilgjengelig fra:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-kode:

N05CF; N05CF02

INN (International Name):

ZOLPIDEM TARTRATE

Dosering :

10 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

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

Terapeutisk område:

Benzodiazepine related drugs; zolpidem

Autorisasjon status:

Not marketed

Autorisasjon dato:

2003-06-30

Informasjon til brukeren

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOLDEM 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.
IN THIS LEAFLET:
1.
What Zoldem is and what it is used for
2.
What you need to know before you take Zoldem
3.
How to take Zoldem
4.
Possible side effects
5.
How to store Zoldem
6.
Contents of the pack and other information
1.
WHAT ZOLDEM IS AND WHAT IT IS USED FOR
Zoldem contains zolpidem, which belongs to a group of medicines called
hypnotics. Zoldem Tablets
are sleeping pills, which work by acting on the brain to cause
sleepiness.
This medicine may be used in adults for short-term treatment of
insomnia which is severe, disabling or
causing great distress. Insomnia is a difficulty in falling asleep or
sleeping properly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOLDEM
DO NOT TAKE ZOLDEM IF YOU

are allergic to zolpidem tartrate or any of the other ingredients of
this medicine (listed in
section 6). An allergic reaction may include a rash, itching,
difficulty breathing or swelling of
the face, lips, throat or tongue.

have severe liver problems

suffer from sleep apnoea (a condition where you stop breathing for
very short periods whilst
sleeping)

suffer from severe muscle weakness (myasthenia gravis)

have ever experienced sleep walking or behaviours that are unusual
during sleep and that you
performed without being fully awake (such as driving, eating, making a
phone call, or having
sex, etc.) after taking Zoldem or other medicines containing zolpidem


Preparatomtale

Health Products Regulatory Authority
24 September 2021
CRN00CFWM
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoldem 10 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg zolpidem tartrate.
Excipients with known effect: Each film-coated tablet contains 47 mg
lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white capsule shaped tablet approximately 9.6mm x 3.9mm,
marked “ZM breakline 10” on one side and “G” on the
other.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
Duration of treatment
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.
As with all hypnotics, long-term use is not recommended and a course
of treatment should not exceed four weeks. 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 product acts rapidly and therefore should be taken with fluid just
before going to bed, or in bed.
Posology
_Adults_
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.
_Elderly (over 65 years) or debilitated patients_
Elderly or debilitated patients may be especially sensitive to the
effects of Zolpidem therefore a 5 mg dose is recommended.
These recommended dose