Noctamid Tablets 1 mg
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
16-08-2019
Summary of Product characteristics
(SPC)
15-11-2019
Active ingredient:
Lormetazepam
Available from:
Bayer Limited
ATC code:
N05CD; N05CD06
INN (International Name):
Lormetazepam
Dosage:
1 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Benzodiazepine derivatives; lormetazepam
Authorization status:
Marketed
Authorization date:
1982-11-01
Patient Information leaflet
Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Telephone:
+353 1 2999313
Fax:
+353 1 2061456
www.bayer.ie
Bayer Limited
19006
NOCTAMID TABLETS 1MG
LORMETAZEPAM
READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START
USING 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 NOCTAMID IS AND WHAT IT
IS USED FOR
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE NOCTAMID
3.
HOW TO TAKE NOCTAMID
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NOCTAMID
6.
CONTENTS OF THE PACK AND
OTHER INFORMATION
1.
WHAT NOCTAMID IS AND WHAT
IT IS USED FOR
Noctamid contains lormetazepam,
which belongs to the group of
medicines called benzodiazepines.
Noctamid helps to
- shorten the time it takes for you to
fall asleep
- reduce the frequency of
awakening in the night
- prolong your sleep time without
making you feel tired or drowsy
the next day.
Your doctor will prescribe Noctamid
for a short time only when your
sleep problems are severe,
disabling or causing extreme
distress
.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE NOCTAMID
DO NOT TAKE NOCTAMID:
if you have a particular
condition in which the MUSCLES
BECOME WEAK and tire easily
(myasthenia gravis)
if you have severe BREATHING
DIFFICULTY (respiratory
insufficiency e.g. severe
chronic obstructive disease)
if your BREATHING SOMETIMES
STOPS when you are asleep
(sleep apnoea syndrome)
if you have taken an excessive
amount of alcohol or other
drugs (e.g. sleeping tablets,
painkillers or drugs used to
treat psychiatric illness)
if you are ALLERGIC to this type
of drug or any of the other
ingredients of this medicine
(list
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
14 November 2019
CRN009G7Z
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noctamid Tablets 1 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lormetazepam 1mg
Excipient: Contains 70.3mg lactose (as monohydrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round, white, flat tablets with a beveled edge, imprinted ‘CF’ in
a regular hexagon on one face and a breakline on the reverse.
The tablet can be divided into equal halves.
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 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In adults, treatment should be started with 1 mg lormetazepam as a
single dose.
Patients of advanced age should get 0.5 mg lormetazepam as a single
dose.
For patients with mild to moderate chronic respiratory insufficiency
or hepatic insufficiency a dose reduction should be
considered.
The dose may be doubled 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 section 4.4 ‘Special warnings and
precautions for use’).
Paediatric population
Noctamid should not be given to patients under 18 years of age 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.
Method of administration
Noctamid is to be taken with some liquid shortly before going to bed.
4.3 CONTRAINDICATIONS
Myas
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