Mogadon 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NITRAZEPAM

Available from:

Meda Pharmaceuticals Limited

ATC code:

N05CD02

INN (International Name):

NITRAZEPAM

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. Do not pass it on
to 
others. It may harm them, even if their symptoms are the same as 
yours.
 • If you experience any side effect and this becomes serious,
tell 
your doctor or pharmacist.
IN THIS LEAFLET: 
1. What Mogadon is and what it is used for
2. 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 IS AND WHAT IT IS 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 UNDE

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�