Clomethiazole 192mg capsules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Clomethiazole

Доступна с:

Neon Healthcare Ltd

код АТС:

N05CM02

ИНН (Международная Имя):

Clomethiazole

дозировка:

192mg

Фармацевтическая форма:

Oral capsule

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 04010100; GTIN: 4260095682246

тонкая брошюра

KOEPCKE.PUBLISHING
stand (datum): 17.06.2021 [08:00 uhr] (1)
format: 420 x 120 mm
farben: 1/1-farbig schwarz
mat.-nr.: 9000528/19 intrapharm
schriftgröße: 9 pt
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOMETHIAZOLE 192 MG CAPSULES
CLOMETHIAZOLE
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 Clomethiazole Capsules are and what they are used for
2. What you need to know before you take Clomethiazole Capsules
3. How to take Clomethiazole Capsules
4. Possible side effects
5. How to store Clomethiazole Capsules
6. Contents of the pack and other information 1. WHAT CLOMETHIAZOLE CAPSULES ARE AND WHAT THEY
ARE USED FOR
Clomethiazole Capsules contain a medicine called clomethiazole.
This belongs to a group of medicines called hypnotics and sedatives.
It has a calming (sedative) effect on your nervous system.
Clomethiazole Capsules are used to:
• Treat feelings of restlessness and agitation.
• Help you if you are unable to sleep (short-term treatment).
• Relieve the symptoms of alcohol withdrawal. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CLOMETHIAZOLE CAPSULES
DO NOT TAKE CLOMETHIAZOLE CAPSULES:
• if you are allergic to clomethiazole or any of the other
ingredients of
this medicine (listed in section 6).
•
if you have lung or breathing problems which have recently got worse.
Do not take Clomethiazole Capsules if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking
Clomethiazole Capsules.
WARNING AND PRECAUTIONS
Talk to your doctor or ph

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Heminevrin 192 mg Capsules
Clomethiazole 192 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clomethiazole 192 mg (base) per capsule.
Excipients with known effect: 7 mg Sorbitol (E420) per capsule. For a
full list of
excipients, see 6.1.
3
PHARMACEUTICAL FORM
Soft Capsules
Greyish-brown, soft gelatin capsules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clomethiazole is a short acting hypnotic and sedative with
anticonvulsant
effect. It is used for the: management of restlessness and agitation
in the
elderly, short term treatment of severe insomnia in the elderly and
treatment of
alcohol
withdrawal
symptoms
where
close
hospital
supervision
is
also
provided.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Management of restlessness and agitation in the elderly: one capsule
three
times daily.
Severe insomnia in the elderly: 1 - 2 capsules before going to bed.
The lower
dose should be tried first. As with all psychotropic drugs, treatment
should be
kept to a minimum, reviewed regularly and discontinued as soon as
possible.
Alcohol withdrawal states: Clomethiazole is not a specific 'cure' for
alcoholism. Alcohol withdrawal should be treated in hospital or, in
exceptional
circumstances, on an outpatient basis by specialist units when the
daily dosage
of clomethiazole must be monitored closely by community health staff.
The
dosage should be adjusted to patient response. The patient should be
sedated
but rousable. A suggested regimen is:
Initial dose:
2 to 4 capsules, if necessary repeated after some hours.
Day 1, first 24 hours:
9 to 12 capsules, divided into 3 or 4 doses.
Day 2:
6 to 8 capsules, divided into 3 or 4 doses.
Day 3:
4 to 6 capsules, divided into 3or 4 doses.
Days 4 to 6:
A gradual reduction in dosage until the final dose.
Administration for more than nine (9) days is not recommended.
_Paediatric population _
The safety and efficacy of Clomethiazole in children and adolescents
under 18
years of age has not been established.