Temazepam 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Temazepam

Available from:

Genus Pharmaceuticals Ltd

ATC code:

N05CD07

INN (International Name):

Temazepam

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 3 (CD No Register)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010100

Patient Information leaflet

TEMAZEPAM 10MG AND 20MG TABLETS
_Continued over page_
_Continued top of next column _
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Temazepam Tablets 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Temazepam BP.
Excipient with known effect: Lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Temazepam Tablets 10mg are round, white to pale yellow tablets with
TEM
10 on one side and plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short-term treatment of insomnia in cases where it is severe,
disabling
or subjecting the individual to extreme distress, especially for those
patients in
whom the persistence of a hypnotic effect would be undesirable.
Temazepam is also indicated for pre-operative medication prior to
minor
surgery or other similar 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 _
10-20 mg 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.
Preme