Mogadon 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nitrazepam

Available from:

Mylan IRE Healthcare Limited

ATC code:

N05CD; N05CD02

INN (International Name):

Nitrazepam

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Benzodiazepine derivatives; nitrazepam

Authorization status:

Not marketed

Authorization date:

1977-04-01

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOGADON
5 MG TABLETS
Nitrazepam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 effect not listed in this leaflet.
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.
Contents of the pack and other information
1. WHAT MOGADON TABLETS ARE AND WHAT THEY ARE USED FOR
Mogadon tablets contain the active ingredient nitrazepam, which
belongs to a group of medicines
called benzodiazepines. Mogadon tablets are used for severe insomnia
(sleeplessness).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOGADON TABLETS
DO NOT TAKE MOGADON TABLETS:
–
If you are allergic (hypersensitive) to nitrazepam,
–
If you are allergic to other similar drugs (benzodiazepines),
–
If you are allergic to any of the other ingredients of Mogadon tablets
(listed in section 6).
An allergic reaction may include rash, itching, difficulty breathing
or swelling of the face,
lips, throat or tongue.
–
If you have a condition called myasthenia gravis
–
If you have severe breathing difficulties
–
If you have sleep apnoea syndrome (breathing problems when asleep)
–
If you have severe liver disease
–
If you suffer from acute pulmonary insufficiency
–
If you have a mental illness
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mogadon tablets:
–
If you have a history of alcohol or drug abuse
–
If you intend to stop taking Mogadon tablets – you

Summary of Product characteristics

Health Products Regulatory Authority
24 November 2020
CRN00C1SJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mogadon 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mogadon tablet contains 5 mg of Nitrazepam.
Excipients: also includes lactose monohydrate 301mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round, white tablets with “V” over “MOG5” marked on one side
and with a single break-line on the other. The tablet can be
divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Insomnia
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Insomnia_
_Adults:_
The usual total daily dosage is 5 to 10 mg before retiring. In
hospitalised patients a single dose of 20mg may be given.
_Elderly or debilitated patients:_
The elderly or patients with impaired renal and/or hepatic function
will be particularly susceptible to 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.
_Children:_
Not recommended.
_Other populations:_
In patients with chronic pulmonary insufficiency and in patients with
chronic renal or hepatic disease, dosage may need to be
reduced.
Treatment should be as short as possible and should be started with
the lowest possible 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 are reduced. Specialist help may be appropriate.
Little is known regarding the efficacy or safety of
benzodiazepines in long-term use.
In certain cases, extension beyond the maximum treatment period may be
necessary; if so, it should