Diazepam 10 mg Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Diazepam

Доступна с:

Actavis Group PTC ehf

код АТС:

N05BA; N05BA01

ИНН (Международная Имя):

Diazepam

дозировка:

10 milligram(s)

Фармацевтическая форма:

Tablet

Тип рецепта:

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

Терапевтические области:

Benzodiazepine derivatives; diazepam

Статус Авторизация:

Marketed

Дата Авторизация:

2012-02-24

тонкая брошюра

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FMD info
NA (not a carton)

No

Yes

Details
PRODUCT STRENGTH FORM PACK SIZE COMPONENT - MARKET
Black
BBBA2716
D Braund
10.08.18
13.08.18
D. Braund
150 x 440
7.3pt
Actavis Jakarta
n/a
n/a
2
Version 2
01.11.2017
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, tell 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 IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE DIAZEPAM
3
HOW TO TAKE DIAZEPAM
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE DIAZEPAM
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT DIAZEPAM IS AND WHAT IT IS USED FOR
Diazepam contains the active substance diazepam
which belongs to a group of medicines called
benzodiazepines. Diazepam has anxiolytic, sedative
and muscle relaxant effect.
Diazepam is used:
• in the treatment of anxiety.
• in the treatment of muscle spasms, including those
caused by cerebral spasticity (originates in the brain).
• for symptoms of alcohol withdrawal.
• to provide sedation before operations
(premedication).
Your doctor may prescribe Diazepam for other uses.
Please follow your doctor’s ins

Характеристики продукта

Health Products Regulatory Authority
26 November 2018
CRN008JM3
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diazepam 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg diazepam.
Excipient(s) with known effect:
Each Diazepam 10 mg tablet contains 320.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round, flat and bevelled tablets, 11.0 mm in diameter, with a
scoreline on one
side and ‘D10’ engraved on the other. The tablet can be divided
into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Anxiety.
- Adjunct in the control of skeletal muscle spasm, including
spasticity caused by
upper motor neuron disorders (such as cerebral palsy).
- Alcohol withdrawal symptoms.
- Premedication before general anaesthesia or for sedation during
minor surgical or
investigative procedures.
Benzodiazepines are only indicated when the disorder is severe,
disabling or
subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard dosage
For optimal effect, the dosage should be carefully individualised.
Treatment should
begin at the lowest effective dose appropriate to the particular
condition.
Duration of treatment
The duration of treatment should be as short as possible (see section
4.4). The
patient should be re‑evaluated after a period of no more than 4
weeks and then
Health Products Regulatory Authority
26 November 2018
CRN008JM3
Page 2 of 19
regularly thereafter in order to assess the need for continued
treatment, especially in
case the patient is symptom free. In general, treatment must not last
longer than 8 to
12 weeks, including tapering off process.
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
benzodi