Edluar 10 mg sublingual tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

ZOLPIDEM TARTRATE

Disponible des:

Meda Health Sales Ireland Limited

Codi ATC:

N05CF; N05CF02

Designació comuna internacional (DCI):

ZOLPIDEM TARTRATE

Dosis:

10 milligram(s)

formulario farmacéutico:

Sublingual tablet

tipo de receta:

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

Área terapéutica:

Benzodiazepine related drugs; zolpidem

Estat d'Autorització:

Not marketed

Data d'autorització:

2012-09-24

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EDLUAR 5 MG SUBLINGUAL TABLETS
EDLUAR 10 MG SUBLINGUAL 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 Edluar is and what it is used for
2.
What you need to know before you take Edluar
3.
How to take Edluar
4.
Possible side effects
5.
How to store Edluar
6.
Contents of the pack and other information
1.
WHAT EDLUAR IS AND WHAT IT IS USED FOR
Edluar Tablets are sleeping pills (hypnotics) which work by acting on
the brain to cause sleepiness. It
may be used for short-term treatment of insomnia in adults 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 EDLUAR
DO NOT TAKE EDLUAR 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 acute and severe breathing problems
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Edluar if you:

are elderly or frail. If you get up at night, take care. Edluar may
relax your muscles. This
and the sedative effect increases your risk of falling and
consequently of hip fractures.

Fitxa tècnica

Health Products Regulatory Authority
18 January 2019
CRN008L5P
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Edluar 10 mg sublingual tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains 10 mg zolpidem tartrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual tablet.
White, round, flat-faced, bevel-edged tablet approximately 7.5 mm in
diameter with
X debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term treatment of insomnia in adults.
Hypnotic/ sedative drugs 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.
Posology
_Adults_
Health Products Regulatory Authority
18 January 2019
CRN008L5P
Page 2 of 15
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.
The total dose of Zolpidem should not exceed 10 mg in any patient.
_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 doses should
not be
exceeded.
_Hepatic impairment_
Patients with hepatic insufficiency do not clear the drug as rapidly
as patients with
normal