Noctamid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lormetazepam 1mg;  

Available from:

Bayer New Zealand Limited

INN (International Name):

Lormetazepam 1 mg

Dosage:

1 mg

Pharmaceutical form:

Tablet

Composition:

Active: Lormetazepam 1mg   Excipient: Lactose monohydrate Magnesium stearate Povidone Starch

Units in package:

Blister pack, 30 tablets

Class:

Class C5 Controlled Drug

Prescription type:

Class C5 Controlled Drug

Manufactured by:

Bayer AG

Therapeutic indications:

Short-term treatment of insomnia (characterised by difficulty in falling asleep and frequent nocturnal awakenings). Noctamid is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1982-07-07

Patient Information leaflet

NOCTAMID
®
 CMI 

   1 

CONSUMER MEDICINE INFORMATION 
NOCTAMID
® 

(NOC·TA·MID) 
_lormetazepam _
1 mg tablet 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common
questions about Noctamid. It does not contain all 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 
Noctamid 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 IS NOCTAMID USED FOR 

Noctamid is used to
treat sleeping problems; this includes difficulty in
falling asleep.  

Noctamid should only be used for short periods.  

Noctamid is only indicated when the sleep disorder is severe
or causing extreme distress. 

Noctamid contains the active
ingredient lormetazepam, and belongs to the group of 
medicines called benzodiazepines. Benzodiazepines increase the
action of GABA (a 
chemical messenger), which helps calm the brain
down. This results in promotion of sleep. 
Benzodiazepines such as Noctamid should be taken
for short periods only. If you take 
Noctamid for too long it may become
habit-forming. Benzodiazepines may lead to physical 
or mental dependence (addiction). If you have any concerns, you
should discuss this with 
your doctor. 

ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN 
PRESCRIBED FOR YOU. Your doctor may have prescribed
it for another reason.

_ _
BEFORE YOU TAKE NOCTAMID  
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NOCTAMID IF: 
•  you have an allergy to lormetazepam, the active
ingredient in Noctamid; or any other 
benzodiazepines 
•  you have an

Summary of Product characteristics

190129 NOCTAMID
Page 1 of 11
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
NOCTAMID® lormetazepam 1.0 mg tablet.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NOCTAMID® lormetazepam 1.0 mg tablet.
For the full list of Excipients, see List of excipients.
3
PHARMACEUTICAL FORM
Each round, biconvex, white tablet, diameter 7 mm, with a score on one
side and “CF” in a hexagon
on the other, contains 1.0 mg lormetazepam.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Short-term treatment of insomnia (characterised by difficulty in
falling asleep and frequent nocturnal
awakenings).
Noctamid is only indicated when the disorder is severe, disabling or
subjecting the individual to
extreme distress.
4.2
Dose and method of administration
In adults, treatment should be started with 1 mg lormetazepam as a
single dose. Patients of advanced
age should take 0.5 mg lormetazepam as a single dose. For patients
with chronic respiratory
insufficiency or hepatic insufficiency, a dose reduction should be
considered.
It is possible to double the dose in individual cases.
The duration of treatment should be as short as possible. Generally it
varies from a few days to two
weeks with a maximum of four weeks, including gradual reduction of
dose.
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 situation (see
Special warnings and precautions
for use, Duration of Treatment).
Noctamid is to be taken with some liquid shortly before going to bed.
Noctamid should not be given to patients under 18 years of age for
insomnia without careful
assessment of the need to do so. The single dose for patients under 18
years of age depends on the
age, weight and general condition of the patient. The duration of
treatment must be kept to a
minimum
4.3
Contraindications
Myasthenia gravis, hypersensitivity to benzodiazepines or to any of
the excipients of Noctamid, severe
respiratory insufficiency (e.g. severe chronic obstructive pulmonary
disease) and sleep apn