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NITRAZEPAM TABLETS 5MG

Active substance(s): NITRAZEPAM

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NITRAZEPAM PIL:NITRAZEPAM PIL

6/21/13

3:22 PM

Page 1

Patient Information Leaflet

NITRAZEPAM 5MG TABLETS

Read all of this leaflet carefully before you start
to take your 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 or nurse. This includes any possible
side effects not listed in this leaflet.
In this leaflet
1. What Nitrazepam is and what it is used for
2. What you need to know before you take
Nitrazepam
3. How to take Nitrazepam Tablets
4. Possible side effects
5. How to store Nitrazepam Tablets
6. Contents of the pack and other information
1. What Nitrazepam is and what it is used for
• Nitrazepam belongs to the group of medicines
called benzodiazepines.
• Nitrazepam may be used for the short term
treatment of insomnia.
• Nitrazepam shortens the time taken to fall asleep
and lengthen the duration of sleep,
• It can help overcome any difficulties in getting to
sleep, but does not cure underlying cause of
insomnia.

2. What you need to know before you take
Nitrazepam
Do not take Nitrazepam and tell your doctor
if you
• are allergic to the group of medicine called
benzodiazepines, or you are allergic to any of the
ingredient (listed in section 6)
• are suffer from breathing problems,
• are suffering from phobia ( fear of particular
object or situation), obsession or psychiatric
illness
• suffer from a condition known as sleep apnoea
syndrome (where you stop breathing whilst
asleep)
• have severe liver or kidney disorder
• have myasthenia gravis ( a condition which
causes muscles to weaken and tire easily)
• have porphyria ( an inherited condition causing
skin blisters, abdominal pain or nervous
disorder)
Warnings and precautions
Talk to your doctor or pharmacist before taking
these tablets if you:
• have depression and anxiety
• have a history of alcoholism or drug abuse
• have problems with your heart, lungs, kidney or
liver
• have personality disorder
• have low blood level, a poor blood supply to the
brain
• have an illness/disorder which affects your
mental state
• are taking any other medicines, including those
not prescribed by your doctor like tranquillisers,
sleep inducing drugs and other such medicines
Other considerations
• Dependence - there is a risk of dependence when
taking these tablets, which increases with the
duration of treatment and also in patients with a
history of alcoholism and drug abuse.
• Tolerance - Speak to your doctor, if you notice
tablets are not working as well as they did when
first starting the treatment.

• Withdrawal - Treatment should be gradually




















withdrawn. Withdrawal symptoms occur with
Nitrazepam tablets even when normal doses are
given for short periods of time, see section 3, ‘If
you stop taking Nitrazepam tablets’.
Taking other medicines
Tell your doctor or pharmacist if you are
taking or have recently taken or might take any
other medicine, including medicines obtained
without prescription, especially if you are
already taking:
medicine to treat ulcer (e.g. cimetidine)
anaesthetics (to help relieve symptoms when you
stop taking opioids)
antidepressant (to treat mental problems)
alpha blockers or moxonidine (to lower high
blood pressure)
muscle relaxant (e.g. baclofen, tizanidine)
lofexidine (to help relieve symptoms when you
stop taking opioids)
nabilone (to treat nausea and vomiting)
strong pain killer may give you a heightened
sense of well being when taken with Nitrazepam,
which can increase your desire to continue taking
these medicines
caffeine and theophylline may reduce the
sedative effects of Nitrazepam
antihistamines ( to treat allergies)
certain antibiotics (e.g.rifampicin)
oestrogen containing contraceptives
disulfiram (to treat alcohol addiction)
antiviral or isoniazid (to treat tuberculosis)
levodopa (to treat Parkinson’s Disease)
medicines to treat epilepsy (e.g. phenytoin)
alcohol regularly or use recreational drugs
Taking Nitrazepam with food and drink
Do not drink alcohol while you are taking
Nitrazepam tablets. Alcohol may increase the
sedative effects of Nitrazepam tablets and make
you very sleepy.
Effect on drive and operating machinery
Nitrazepam may make you sleepy or affect your
concentration. This may affect your performance
at skilled tasks e.g. driving and operating
machinery. Alcohol will increase the sedative
effects of Nitrazepam and should therefore be
avoided. Do not drive or use any tools or
machines if you are affected.
Pregnancy and breast feeding
Do not take this medicine if you are pregnant,
might become pregnant, or are breast feeding, 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, breathing and feeding
difficulties.
If this medicine is taken regularly in late
pregnancy your baby may develop withdrawal
symptoms. Ask your doctor or pharmacist for
advice before taking any medicine.
Nitrazepam tablet contains lactose
Nitrazepam tablets contain lactose, if you have
been told that you have intolerance to lactose tell
your doctor before taking this medicine.

3. How to take Nitrazepam
Always take this medicine exactly as your doctor
has told you. The pharmacist’s label should tell you
how much to take and how often. If it does not or
you are not sure ask your doctor or pharmacist.
Doses:
• Adults - The usual dose is 5mg before retiring;
this dose may if necessary be increased to 10 mg.
• Children - Not recommended for use in children
under 12 years of age. Product is not
recommended for children use.

NITRAZEPAM PIL:NITRAZEPAM PIL

6/21/13

3:22 PM

• Elderly and debilitated patients - The usual

dose is 2.5 – 5mg before retiring it is important
to take this medicine as directed by your doctor.

The lowest dose, which can control symptoms,
should be used; it should not be continued beyond
four weeks. Long-term Chronic use is not
recommended. Treatment should always be ended
by reducing dosage gradually, patients who have
taken Nitrazepam for a long time may require a
longer period during which dosage are reduced.
Treatment if possible should be intermittent.
If you take more Nitrazepam than you should
If you or anyone else has swallowed a lot of the
tablets all together contact your nearest hospital
casualty department or doctor immediately.
Signs of an overdose include slowing down of
the nervous system ranging from tiredness to
coma such as confusion, drowsiness, lack of
coordination, reduced muscle tension, low blood
pressure, slow heart beat, breathing difficulties,
in rare cases overdose may lead to coma
(unrousable unconsciousness) and in very rare
cases may lead to death.
If you forget to take a dose
If you forget to take a tablet, leave it until the
next dose is due. Do not take two doses together.
If you stop taking Nitrazepam tablets
• Do not stop taking your medicine without telling
your doctor as he may wish to gradually reduce
the number of tablets you take before stopping
them completely.
• If you stop taking Nitrazepam tablets suddenly,
you may experience unpleasant side effects
including depression, nervousness, irritability,
sweating or diarrhoea.
• If you have been taking a high dose, you may
occasionally experience confusion, convulsions
or unusual behaviour.
• Treatment should be gradually withdrawn
otherwise the symptoms you are being treated for
may return more intense than before
(reboundinsomnia and anxiety). The risk of this
happening is greater when you stop taking
Nitrazepam suddenly. You may also experience
mood changes, anxiety, restlessness or changes
in sleep patterns.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nitrazepam tablets can cause
side effects in some people.
Contact your doctor immediately if you notice
the following:
• Allergic reaction (hypersensitivity) – swelling
of the face, lips, tongue or throat or difficulty
breathing or swallowing.
• Rash and other allergic skin reactions
including skin that is red or itchy, pale or red
irregular raised patches with severe itching
(hives), circular irregular red patches on the skin
of the hands and arms (Erythema Multiforme)
and severe form of skin rash with flushing, fever,
blisters or ulcers (Stevens-Johnson syndrome).
Tell your doctor if you notice any of the
following side effects:
• Common (occurs in less than 1 in 10 users)
Dizziness, drowsiness, unsteadiness, loss of coordination.
• Uncommon (occurs in less than 1 in 100 users)
Confusion, sleeping problems including
difficulty sleeping, reduced ability to concentrate, involuntary shakiness, muscle weakness.
• Rare (occurs in less than 1 in 1,000 users)
Changes in the numbers and types of your blood
cells, muscle cramps, changes in sex drive,
muscle spasm of neck shoulders and body,
headache, disturbed vision, a spinning sensation

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(vertigo), low blood pressure, breathing
problems, feeling sick, upset stomach, disease of
the liver causing yellowing of the skin or whites
of the eyes, difficulty in passing water, changes
in behaviour such as excitement, irritability,
aggressiveness, believing something that is not
true (delusions), rage, nightmares, seeing hearing
or feeling things that are not there (hallucinations), disturbances in thinking (depression,
mood swings, hallucinations, paranoia).
• Unknown frequency
Dependence, total or partial memory loss,
depression with or without suicidal tendencies,
speech problems, double vision.
You may become dependent on the tablets and
find it difficult to stop taking them or feel you
need to take them more often than necessary (see
Section 2 ‘Other Considerations’). If you stop
taking the tablets suddenly you may suffer from
withdrawal reactions (see Section 3 ‘If you stop
taking Nitrazepam tablets’ for withdrawal
symptoms).
Benzodiazepines are not recommended for the
primary treatment of psychotic illness.
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.

5. How to store Nitrazepam
Keep all medicines out of the sight and reach of
children
• Do not use this medicine after the expiry date
stated on the pack after Exp. The expiry date
refers to the last day of that month.
• Keep the container tightly closed.
• Store in the original container.
• Store in a cool and dry place away from bright
light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Nitrazepam Tablets contain
• The active substance is Nitrazepam BP. Each
tablet contains 5 mg of the active ingredient.
• The other ingredients are: lactose, maize
starch, pregelatinised maize starch, colloidal
silicon dioxide, stearic acid and magnesium
stearate. See end of section 2 for further
information on lactose.
What Nitrazepam Tablets look like and
contents of pack
• Creamy white tablets with bevel edge, embossed
‘N/5’on one face and ‘PV’ on the other.
• Pack sizes of Nitrazepam Tablets are: “28, 56,
500 & 1000” tablets. Not all pack sizes may be
marketed.

Marketing Authorization holder and
Manufacture:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or
audio format or additional copies, please contact the
licence holder at the address (or telephone, fax)
above.
PL 04556 / 0001

Reference: 00010613/01

Date leaflet last revised: June 2013

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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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