Noctamid 1mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lormetazepam

Available from:

Imbat 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:

Authorised

Authorization date:

2013-04-05

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOCTAMID
® 1MG TABLETS (lormetazepam)
Your medicine is available using the name Noctamid 1mg
Tablets but will be referred to as Noctamid throughout this
leaflet.
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 d

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noctamid 1mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg lormetazepam.
Excipient(s) with known effect: lactose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Spain_
Round, white tablet with ‘CF’ imprinted in a hexagon on one face
and a breakline on the reverse.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA1410/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose
Magnesium stearate
Maize starch
Povidone 25000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blisters and outer carton of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
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6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium blisters, 3 blisters strips, each containing 10 tablets in a
cardboard outer carton.
Pack size: 30 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limite