Mogadon 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NITRAZEPAM

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

N05CD02

INN (International Name):

NITRAZEPAM 5 mg

Pharmaceutical form:

TABLET

Composition:

NITRAZEPAM 5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2007-06-04

Patient Information leaflet

PATIENT INFORMATION LEAFLET
MOGADON 5 MG TABLETS
Nitrazepam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
-
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 experience any side effect and this becomes serious, tell your
doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1.
What Mogadon tablets are and what they are used for
2.
What you need to know before you take Mogadon tablets
3.
How to take Mogadon tablets
4.
Possible side effects
5.
How to store Mogadon tablets
6.
Further information
1. WHAT MOGADON TABLETS ARE AND WHAT THEY ARE USED FOR
Mogadon belongs to a group of medicines known as benzodiazepines,
which are tranquillisers
(medicines that have a calming effect). Mogadon shortens the time
taken to fall asleep and
lengthens the duration of sleep.
Mogadon Tablets are used for the short term treatment of sleeplessness
(also known as insomnia)
when it is severe.
Mogadon Tablets help you to sleep but do not cure the underlying cause
of your insomnia, which
you should discuss with your doctor
2. BEFORE YOU TAKE MOGADON TABLETS
DO NOT TAKE MOGADON TABLETS IF YOU:
• are allergic (hypersensitive) to nitrazepam or any of the other
ingredients of Mogadon Tablets
(these are listed in section 6, ˝Further Information˝).
• are allergic (hypersensitive) to any medicine known as a
benzodiazepine (e.g. flurazepam,
diazepam, chlordiazepoxide or temazepam).
• suffer from lung disease.
• suffer from difficulty breathing while awake or asleep.
• suffer from myasthenia gravis (a condition in which the muscles
become weak and tire easily).
• are suffering from a psychiatric illness or a personality disorder
(severe mental problems).
• have a severe liver condition.
Mogadon Tablets are not for use in anyone under 18 years of age.
Take special care with Mogadon Ta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mogadon 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of nitrazepam.
There is 301 mg lactose per tablet.
For the full list of excipients, See section 6.1
3
PHARMACEUTICAL FORM
Tablets
Round, white tablets with “ V ” MOG 5
imprinted on one face with a single break bar on the other.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of insomnia when it is severe, disabling or
subjecting the
individual to unacceptable distress, where daytime sedation is
acceptable.
An underlying cause for insomnia should be sought before deciding upon
the use of
benzodiazepines for symptomatic relief.
Benzodiazepines are not recommended for the primary treatment of
psychotic illness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: _
ADULTS
5 mg before retiring. This dose may, if necessary, be increased to 10
mg.
ELDERLY
_Elderly or debilitated patients_
: the elderly or patients with impaired renal and/or
hepatic function will be particularly susceptible to the adverse
effects of Mogadon.
Doses should not exceed half those normally recommended.
If organic brain changes are present, the dosage of Mogadon should not
exceed 5mg
in these patients.
OTHER POPULATIONS
In patients with chronic pulmonary insufficiency and in patients with
chronic renal or
hepatic disease, the dosage may need to be reduced.
PAEDIATRIC POPULATION
Mogadon tablets are contraindicated for use in children.
Dosage should be adjusted on an individual basis. Treatment should, if
possible, be
on an intermittent basis.
Treatment should be as short as possible and should be started with
the lowest
recommended dose. The maximum dose should not be exceeded. Generally
the
duration of treatment varies from a few days to two weeks with a
maximum of four
weeks; including the tapering off process. Patients who have taken
benzodiazepines
for a prolonged time may require a longer period during which doses