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MOGADON 5MG TABLETS

Active substance(s): NITRAZEPAM

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PATIENT INFORMATION LEAFLET



Mogadon 5 mg Tablets
Nitrazepam
Read all of this leaflet carefully before you start taking this
medicine.

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˝).

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription. This is extremely important, as using more than one
medicine at the same time can strengthen or weaken the effect of the
medicines involved. In particular, tell your doctor if you are taking
any of the following medicines:

 • Keep this leaflet. You may need to read it again.

 • are allergic (hypersensitive) to any medicine known as
a benzodiazepine (e.g. flurazepam, diazepam, chlordiazepoxide
or temazepam).

 • If you have any further questions, ask your doctor or pharmacist.

 • suffer from lung disease.

 • Medicines used to relieve pain or anaesthetics.

 • 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.

 • suffer from difficulty breathing while awake or asleep.

 • Antihistamines (used for treating allergies) that cause drowsiness
(e.g. chlorphenamine).

 • 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.

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 • 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 Tablets
Tell your doctor before you take these tablets if you:
 • have a long-term lung, liver or kidney disease.
 • suffer from depression or have recently suffered the death of a close
friend or relative.
 • are suffering or have suffered from a mental illness.
 • have abused alcohol or drugs. You must not drink alcohol or use
drugs while taking Mogadon.
• are pregnant or breast-feeding.
Because Mogadon Tablets relax the muscles, elderly patients should
take extra care when they get up at night as there is a risk of falls and
consequently of injuries including hip fractures.

 • Antidepressants, other tranquillisers or sleeping pills, or other such
medicines that act on the brain and nerves.

 • Medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
 • Medicines that affect the liver (e.g. the antibiotic rifampicin).
Taking Mogadon Tablets with food and drink
Do not drink alcohol for as long as you are taking Mogadon Tablets.
Alcohol will increase the effects of the tablets and this can be
dangerous.
Pregnancy and breast-feeding
Tell your doctor before taking Mogadon Tablets if you are pregnant,
think that you are pregnant or intend to become pregnant during
treatment. Your doctor will then decide whether you should take this
medicine.
Tell your doctor before taking Mogadon Tablets if you are breastfeeding. Avoid taking Mogadon Tablets if you are breast-feeding as
Mogadon passes into breast-milk.
If your doctor has decided that you should receive this medicine
during late pregnancy or during labour, your baby might have a low
body temperature, floppiness and breathing and feeding difficulties.
Also, your unborn baby may be at risk of developing dependency
to this medicine and after birth may be at some risk of developing
withdrawal symptoms.

Driving and using machines
Mogadon Tablets may cause side effects such as reduced alertness,
confusion, tiredness, dizziness, poor muscle co-ordination and
double vision. This may affect your ability to drive and operate
machinery. Do not drive or operate machinery if you experience any
of these side effects.
The medicine can affect your ability to drive. Do not drive while
taking this medicine until you know how it affects you.
It may be an offence to drive if your ability to drive safely is affected.
However, you would not be committing an offence if:
The medicine has been prescribed to treat a medical or dental
problem and
• You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.
There is further information for patients who are intending to drive in
Great Britain – go to https://www.gov.uk/drug-driving-law
Important information about some of the ingredients of Mogadon
Tablets
Lactose: Mogadon tablets contain lactose. Therefore, if you have
been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

3.  HOW TO TAKE MOGADON TABLETS
Your doctor will find the lowest dose to control your symptoms.
The dose that your doctor prescribes will depend on the nature of your
illness, your reaction to the medicine, your age and bodyweight.
Always take Mogadon exactly as your doctor has told you. Do not
change the prescribed dose yourself. You should check with your
doctor or pharmacist if you are not sure how to take this medicine.
If you think that the effect of your medicine is too weak or too strong,
talk to your doctor.

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5.  HOW TO STORE MOGADON TABLETS

Mogadon is not for use in children.

Withdrawal symptoms may include:

Common side effects:

The usual starting dose is 5 mg (one tablet). However, if you are
elderly or suffer from a lung, liver or kidney condition, or are
generally unwell, your starting dose will not usually be more than
2.5 mg (half a tablet).

 • a recurrence of sleep problems  • mood changes

 • drowsiness during the day

 •  headache

Store Mogadon Tablets out of the sight and reach of children.

 •  depression

 •  irritability

 • a feeling of emptiness

 •  dizziness

 •  nervousness

 •  sweating

 • reduced alertness

 • muscle weakness

Store the bottle or blister in the original outer carton in order
to protect from light.

You may not need to take this medicine every night.

 • extreme anxiety

 •  diarrhoea

 •  confusion

 • poor muscle co-ordination

Swallow the tablet(s) whole with water or another non-alcoholic
drink.

 •  tension

 •  headaches

 •  tiredness

 • double vision

 •  restlessness

 • muscle weakness

Rare side effects:

Take the medicine just before going to bed. Make sure that you can
sleep without interruptions for 7 to 8 hours after taking the tablets.
Treatment will not normally be continued for more than four weeks.
Mogadon Tablets may become less effective if you take them for more
than four weeks. If you think that your medicine is no longer working
or your insomnia does not improve, you should consult your doctor.
Also, you may become dependent on the tablets if you use them at
high doses and for long periods. Therefore, Mogadon Tablets are not
suitable for long-term use and after a few weeks it is worth trying to
get by without these tablets. This will help to prevent you becoming
used to Mogadon and reduce the risk of dependence.
Withdrawal symptoms may occur when you stop taking Mogadon
Tablets (see section below When you stop taking Mogadon Tablets).
Do not stop taking Mogadon Tablets without speaking to your doctor.

 •  confusion

 •  giddiness

 • inability to pass urine

In severe cases the following symptoms may occur:

 • reduced blood pressure

 • changes in behaviour

 • stomach upsets 

 • yellowing of the eyes and skin
(jaundice)

 • numbness and tingling of
the extremities

 • over-sensitivity to light,
noise and touch
 •  hallucinations

 •  fits
If you have taken benzodiazepines for a long time, the reduction in
your dosage will be over a longer period of time than would normally
be required when you stop taking this medicine. You may need
additional help. Your doctor will be able to discuss this with you.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

If you take more Mogadon Tablets than you should
If you take too many tablets or someone else accidentally takes your
medicine, contact your doctor, pharmacist or nearest hospital straight
away.

4.  POSSIBLE SIDE EFFECTS

If you forget to take Mogadon
Do not take a double dose to make up for a forgotten dose. Instead
you should simply continue with the next dose when it is due.

Changes in behaviour may occur rarely. These changes may include
aggression, excitement, confusion, restlessness, agitation, irritability,
rages, hallucinations, nightmares and depression.
If these behavioural symptoms occur, you must inform your doctor.
He/she may want you to stop taking this medicine.

When you stop taking Mogadon Tablets
Your doctor will advise you when to stop taking the tablets.
Do not stop taking Mogadon tablets abruptly. You may experience
withdrawal effects if your treatment is stopped suddenly. This is
less likely if your dose is gradually reduced towards the end of your
treatment.

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Like all medicines, Mogadon Tablets can cause side effects, although
not everybody gets them.

• skin rashes
• changes in your vision other
than double vision

• an abnormality of the blood
(blood dyscrasias)

 • changes in the level of sexual
desire
If you are woken up soon after taking the medicine your memory may
be temporarily affected.
If you are an elderly patient, you may be more susceptible to side
effects. If this happens, tell your doctor and he/she may decide
to change your dose.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

Store Mogadon Tablets in a dry place below 25°C.
Do not use Mogadon Tablets after the expiry date which is stated on
the bottle or blister and the outer carton after ˝EXP˝. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6.  FURTHER INFORMATION
What Mogadon Tablets contain
Active substance:
Other ingredients:

Nitrazepam. Each tablet contains 5 mg
of nitrazepam.
Lactose, maize starch and magnesium
stearate.

What Mogadon Tablets look like and contents of the pack
V
˝ marked on one side and a line
The white tablets are round with ˝ MOG5
across the other so that they can be broken in half easily.
Mogadon Tablets come in packs of 30 tablets.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd., Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK
Manufacturer
ICN Polfa Rzeszów S.A., ul. Przemyslowa 2, 35-959 Rzeszów
Poland
For any information about this medicine, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 03/2014.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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