Normison

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Temazepam 10mg; Temazepam 10mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Temazepam 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Temazepam 10mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Active: Temazepam 10mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Sunset yellow aluminium lake

Units in package:

Blister pack, PVC/PVDC/Aluminium foil, 25 tablets

Class:

Class C5 Controlled Drug

Prescription type:

Class C5 Controlled Drug

Manufactured by:

Cambrex Profarmaco Milano Srl

Therapeutic indications:

NORMISON is indicated for use as a hypnotic or night-time sedative. As a hypnotic, NORMISON is indicated for severe or disabling insomnia characterised by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakening. NORMISON is indicated for use as a premedicant taken 30-60 minutes prior to surgical or other procedures.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Aluminium foil - 25 tablets - 18 months from date of manufacture stored at or below 30°C protect from moisture

Authorization date:

2005-03-29

Patient Information leaflet

NORMISON- Consumer Medicine Information
Page 1 of 4
NORMISON
temazepam
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NORMISON. It
does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking NORMISON
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT NORMISON IS
USED FOR
NORMISON is used to treat sleeping
problems, also called insomnia. It
contains the active ingredient
temazepam, a benzodiazepine. It is
thought to work by acting on the
brain chemicals.
In general, benzodiazepines such as
NORMISON should be taken for
short periods only (for example 2 to
4 weeks). Continuous long term use
is not recommended unless advised
by your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
NORMISON HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
this medicine for another reason.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE NORMISON IF YOU
ARE ALLERGIC TO:
•
Temazepam or any other
benzodiazepine medicines
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.
DO NOT TAKE NORMISON IF YOU
HAVE:
•
severe and chronic lung disease
or breathing difficulties
•
sleep apnoea
•
depression with or without
anxiety problems. Temazepam
can increase thoughts of death
or suicide.
DO NOT TAKE NORMISON IF THE
PACKAGING SHOWS SIGNS OF
TAMPERING OR THE TABLETS DO NOT
LOOK QUITE RIGHT.
DO NOT TAKE TH

Summary of Product characteristics

NORMISON (temazepam) 10 mg tablet – Data Sheet
Page 1 of 13
NEW ZEALAND DATA SHEET
1. NORMISON (TEMAZEPAM) 10 MG TABLET
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of temazepam.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
NORMISON 10 mg are white, round, biconvex tablets with a stylised "S"
on
one side and plain on the other side.
Do not halve the tablet. Dose equivalence when the tablet is divided
has not
been established.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NORMISON is indicated for use as a hypnotic or night-time sedative. As
a
hypnotic, NORMISON is indicated for severe or disabling insomnia
characterised by difficulty in falling asleep, frequent nocturnal
awakenings
and/or early morning awakening.
NORMISON is indicated for use as a premedicant taken 30-60 minutes
prior
to surgical or other procedures.
4.2
DOSE AND METHOD OF ADMINISTRATION
For use as a hypnotic, the usual adult dose is 20 mg taken one-half
hour
before retiring. In elderly or debilitated patients, 10 mg NORMISON is
the
initial recommended dosage.
The recommended dosage range in adults is 10 to 30 mg but dosage
should
be individualised to the lowest effective dose.
For use as a premedicant, the recommended adult dose is 20-30 mg taken
30-60 minutes prior to surgical or other procedures.
Since insomnia is often transient and intermittent, the prolonged
administration of NORMISON is generally not necessary or recommended.
In
general, hypnotics should be prescribed for short periods only (not
more than
2-4 weeks) unless the patient is already reliant on regular hypnotic
use.
Continuous long term use of NORMISON is not recommended, but
intermittent use may be appropriate.
NORMISON (temazepam) 10 mg tablet – Data Sheet
Page 2 of 13
For patients already receiving long-term NORMISON, it is recommended
that
the need for continued therapy be reviewed periodically.
Do not halve tablet. Dose equivalence when the tablet is divided has
not been
established.
NORMISON is not recommende