Temazepam 20mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Temazepam

Предлага се от:

Genus Pharmaceuticals Ltd

АТС код:

N05CD07

INN (Международно Name):

Temazepam

дозиране:

20mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

Schedule 3 (CD No Register)

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04010100

Листовка

TEMAZEPAM 10MG AND 20MG TABLETS
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BBBA7399
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 TEMAZEPAM TABLETS ARE AND WHAT
THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TEMAZEPAM TABLETS
3 HOW TO TAKE TEMAZEPAM TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE TEMAZEPAM TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT TEMAZEPAM TABLETS ARE AND WHAT
THEY ARE USED FOR
Temazepam tablets are sedatives which may be used:
•
for the short-term treatment of insomnia (difficulty
sleeping), which is severe, disabling or distressing
•
as a pre-medication before minor surgery or
investigative procedures, especially when hospital
admission is not required.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TEMAZEPAM TABLETS
DO NOT TAKE TEMAZEPAM TABLETS IF YOU:
•
are ALLERGIC to temazepam or any of the ingredients of this
medicine (listed in section 6). An allergic reaction may include
a rash, itching, difficulty breathing or swallowing or swelling
of the face, lips, throat or tongue (see section 6 for list of
ingredients)
•
are UNDER 18 YEARS OF AGE
•
have any LONG-TERM MENTAL ILLNESS including obsessions or
phobias (irrational fears)
•
suffer from ANXIETY with depression or as the only treatment
for depression (as treatment with temazepam may unmask
depression or worsen existing depression, or suicidal
thoughts)
•
suffer from sudden or severe BREATHING PROBLEMS
•
have SEVERE LIVER

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Temazepam Tablets 20mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg Temazepam PhEur
Excipient with known effect
Each 20mg tablet contains 282.20mg lactose PhEur.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white uncoated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for:
1) The short-term treatment of insomnia only when it is severe,
disabling, or
subjecting the individual to extreme stress, especially for those
patients in
whom the persistence of a hypnotic effect would be undesirable.
2) The premedication before minor surgical and investigative
procedures
particularly when hospital admission is not essential.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Treatment to be given
•
under close medical supervision
•
at the lowest effective dose
•
for the shortest possible duration (not exceeding 4 weeks).
Treatment should be tapered off gradually (see section 4.4). Extension
of use
should not take place without further clinical evaluation.
Chronic use not recommended (little is known of the long-term safety
and
efficacy: potential for dependence- see section 4.4).
When treatment is started the patient should be informed that
•
treatment will be of limited duration
•
the dosage will be progressively decreased
•
there is the possibility of rebound phenomena.
Patients who have received benzodiazepines for a long time may require
an
extended withdrawal period.
The recommended doses are as follows:
_Insomnia_
_Adults_
10-20mg at bedtime. A dose of 20mg will be found satisfactory for most
patients. In extreme cases this may be increased to 30-40mg in
patients who do
not respond to the lower dose.
_Elderly or debilitated or those with cerebrovascular disease or
hepatic or renal _
_impairment _
5mg at bedtime. This may be increased to 10mg or to 20mg in extreme
cases.
_Premedication_
_Adults _
The normal dose is 20-40mg, half an hour to one hour befor