Diazepam 5mg Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Diazepam

Disponible desde:

Accord Healthcare Ireland Ltd.

Código ATC:

N05BA; N05BA01

Designación común internacional (DCI):

Diazepam

Dosis:

5 milligram(s)

formulario farmacéutico:

Tablet

Área terapéutica:

Benzodiazepine derivatives; diazepam

Estado de Autorización:

Not marketed

Fecha de autorización:

2018-03-29

Información para el usuario

1
IE/H/0744/001-002/IA/017, ver 01, 12/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
Diazepam 5 mg tablets
Diazepam 10 mg tablets
diazepam
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 Diazepam Tablets are and what they are used for
2.
What you need to know before you take Diazepam Tablets
3.
How to take Diazepam Tablets
4.
Possible side effects
5.
How to store Diazepam Tablets
6.
Contents of the pack and other information
1.
WHAT DIAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR
Diazepam Tablets contain the active substance diazepam which belongs
to a group of medicines called
benzodiazepines. Diazepam has anxiolytic, sedative and muscle relaxant
effect.
Diazepam Tablets are used:
In adults
­
short-term (2-4 weeks) symptomatic treatment of anxiety that is
severe, disabling or subjecting
the individual to extreme distress
­
Symptomatic treatment of acute alcohol withdrawal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM TABLETS
DO NOT TAKE DIAZEPAM TABLETS IF YOU:
­
are
ALLERGIC
(hypersensitive) to diazepam or to other benzodiazepine medicines or
to any of the
other ingredients of this medicine (see section 6).
­
have a condition called
MYASTHENIA GRAVIS
which causes muscles to weaken and tire easily.
­
suffer from
SLEEP APNOEA
(a sleep disorder where you have abnormal pauses in breathing during
sleep).
­
have
SEVERE LIVER
disorders.
­
have
ACUTE RESPIRATORY DEPRESSION
(slow and/or shallow breathing).
­
have
ACUTE INTOXICATION WITH OTHER CNS ACTIVE SUBSTANCES
(e.g. hypnotics, a

Ficha técnica

Health Products Regulatory Authority
26 September 2022
CRN00CT1X
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diazepam 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg diazepam.
Excipient:
Each diazepam 5 mg tablet contains 122 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pale yellow mottled, round, approximately 8.0 mm in diameter, flat,
bevel edged tablets, debossed with ‘CY’ on one side and
plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adult
- Short-term (2-4 weeks) symptomatic treatment of anxiety that is
severe, disabling or subjecting the individual to extreme
distress
- Symptomatic treatment of acute alcohol withdrawal.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Standard dosage
For optimal effect, the dosage should be carefully individualised.
Treatment should begin at the lowest effective dose
appropriate to the particular condition.
In order to obtain suitable doses of less than 5mg diazepam
alternative products have to be used.
Duration of treatment
The duration of treatment should be as short as possible. In general,
treatment should not last longer than 4 weeks including
tapering off process. Extension beyond this period should not take
place without re-evaluation of the patient’s status.
The patient must be re-evaluated after a period of no more than 4
weeks and then regularly thereafter in order to assess the
need for continued treatment.
- Long-term chronic use is not recommended. 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 with special expertise.
_Tapering off _
Treatment should always be tapered off gradually. Patients who have
taken benzodiazepines for a prolonged time may require
a longer period during which doses are reduced.
Adults:
_Anxiety _
- Usual dose: 2 mg to 5 mg diazepam two to three times daily.
Health Products Regulatory Auth