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NITRAZEPAM TABLETS BP 5MG

Active substance(s): NITRAZEPAM

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Nitrazepam 5mg Tablets
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 any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
Nitrazepam tablets are and
1 What

what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
Nitrazepam tablets are and what they
1 What

are used for
Nitrazepam belongs to a group of medicines called
benzodiazepines. Nitrazepam tablets may be used for the
short term treatment of sleeplessness, which is severe,
disabling or distressing, and when sleepiness during the day
is acceptable.

2 Before you take
Do not take Nitrazepam tablets and tell your doctor
if you

• are allergic (hypersensitive) to Nitrazepam or to other
benzodiazepine medicines or to any of the other ingredients
in your tablets (see section 6)
• are breathless or have difficulty breathing
• have a phobia (a fear of a particular object or situation),
obsession or other mental illness
• have myasthenia gravis (a condition which causes muscles
to weaken and tire easily)
• suffer from sleep apnoea ( a condition where you stop
breathing whilst asleep)
• have severe liver disorders
• have porphyria (an inherited condition causing skin blisters,
abdominal pain and brain or nervous system disorders).

Check with your doctor or pharmacist before taking
Nitrazepam tablets if you have
• depression (with or without anxiety)
• a history of alcoholism or drug abuse
• problems with your heart and lungs, kidney or liver
• someone close to you who has recently died
• low blood levels of a protein called albumin
• a personality disorder
• a poor blood supply to the brain (arteriosclerosis).

• the patient is a child
• are elderly
• epilepsy
• an illness/disorder which affects your mental state

Other considerations

• Dependence - when taking this medicine there is a risk of
dependence, which increases with the dose and duration of
treatment and also in patients with a history of alcoholism
and drug abuse.
• Tolerance – if after a few weeks you notice that the tablets
are not working as well as they did when first starting
treatment, you should speak to your doctor.
• 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

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription. Especially:
• antidepressants, antipsychotics (to treat mental
problems), antihistamines (to treat allergies), anaesthetics,
lofexidine (to help relieve symptoms when you stop taking
opioids), nabilone (to treat nausea and vomiting), hypnotics
(to help you sleep), alpha blockers or moxonidine (to
lower high blood pressure), muscle relaxants (eg baclofen,
tizanidine) or probenecid (used to treat gout). Taking these
medicines with Nitrazepam could make you very sleepy.
• some strong pain killers may give you a heightened sense
of well being when taken with Nitrazepam, which can
increase your desire to continue taking these medicines
(dependency) or can make you very sleepy.
• caffeine and theophylline may reduce the sedative effects
of Nitrazepam.
• medicines for epilepsy eg hydantoins, in particular
phenytoin, or barbiturates (Nitrazepam can affect the blood
levels of these medicines).
• cimetidine (for ulcers), oestrogen-containing
contraceptives, disulfiram (to treat alcohol addiction),
ritonavir (antiviral) or isoniazid (to treat tuberculosis) as
these can cause Nitrazepam to be removed from the body
more slowly than usual.
• rifampicin (an antibiotic) as this can cause Nitrazepam to be
removed from the body more quickly than usual.
• levodopa (to treat Parkinson’s Disease) as Nitrazepam may
cause levodopa to not work so well.

Taking Nitrazepam tablets 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.

Pregnancy and breast-feeding

You should not take Nitrazepam tablets if you are pregnant,
planning to become pregnant or are breast feeding. If you
take Nitrazepam tablets late in your pregnancy or during
labour your baby might have a low body temperature,
floppiness, and breathing difficulties. If taken regularly
during late pregnancy, your baby may develop withdrawal
symptoms. Ask your doctor or pharmacist for advice before
taking any medicine.

Continued top of next column
AAAG9620 50809730

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Nitrazepam 5mg Tablets PIL - UK
item no: AAAG9620

dimensions: 148 x 210 Reel Fed

print proof no: 1

pharmacode:

origination date: 13.06.14

min pt size: 7

originated by: S.Anson
approved for print/date

revision date:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date:

colours/plates:

Nitrazepam Tablets
5mg x 28’s (UK)

1. Black

JDE No.:

2.
3.
4.

50809730

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 12311

6.

Date Sent:
30/05/14
Technologist: R.Wrey

Non Printing Colours
1.
2.
3.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Driving and using machines

· 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).

The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
• Do not drive while taking this medicine until you know how it
affects you.
• It is an offence to drive if this medicine affects your ability to drive
• 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.

Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:

Nitrazepam tablets may affect how your muscles work or may
make you feel sleepy or forgetful. It may also impair your alertness
(especially if you don’t have 7-8 hours uninterrupted sleep). Do not
drive or use any tools or machines if you are affected in this way.

Important information about some of the ingredients
of Nitrazepam tablets
Nitrazepam tablets contain lactose (a type of sugar). If you have
been told that you have intolerance to some sugars contact your
doctor before taking this medicine.

3 How to take
Always take Nitrazepam tablets exactly as your doctor has told
you. You should not take Nitrazepam tablets for longer than
4 weeks. You should check with your doctor or pharmacist if you
are not sure.
Swallow the tablets whole, with a glass of water.
Doses
Adults: 5mg before going to bed, your doctor may increase this
up to 10mg.
Elderly and debilitated patients: 2.5-5mg before going to bed. It
is particularly important to take this medicine exactly as directed
by the doctor.
Children under 12 years: Not recommended.

If you take more Nitrazepam tablets than you should

If you (or someone else) swallow a lot of tablets at the same time,
or you think a child may have swallowed any, contact your nearest
hospital casualty department or tell your doctor immediately.
Signs of an overdose include slowing down of the nervous system
ranging from tiredness to coma such as confusion, drowsiness, lack
of co-ordination, 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 Nitrazepam tablets

Do not take a double dose to make up for a forgotten dose. If you
forget to take a dose take it as soon as you remember it and then
take the next dose at the right time.

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 difficulty sleeping, depression, nervousness, irritability,
sweating, diarrhoea, confusion, unusual behaviour or seizures.
• Treatment should be gradually withdrawn otherwise the
symptoms you are being treated for may return more intense
than before (rebound insomnia 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

Common (occurs in less than 1 in 10 users)
Dizziness, drowsiness, unsteadiness, loss of co-ordination.
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 (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).
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
Keep out of the reach and sight of children.
Store below 25°C in a dry place protected from light.
Do not use Nitrazepam tablets after the expiry date
stated on the label/carton/bottle. 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 Nitrazepam tablets contain:

• The active substance (the ingredient that makes the
tablet work) is Nitrazepam. Each tablet contains 5mg
of the active ingredient.
• The other ingredients are lactose, magnesium stearate,
maize starch and stearic acid.

What Nitrazepam tables look like and
contents of the pack

Nitrazepam tablets are white, circular uncoated tablets
Pack size is 28 tablets.

Like all medicines, Nitrazepam tablets can cause side-effects,
although not everybody gets them.

Marketing Authorisation Holder and Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK.

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.

Date of Revision: June 2014
Actavis, Barnstaple, EX32 8NS, UK
AAAG9620 50809730

Continued top of next column

148x210 Leaflet Reel Fed Profile (BST)

Nitrazepam 5mg Tablets PIL - UK
item no: AAAG9620

dimensions: 148 x 210 Reel Fed

print proof no: 1

pharmacode:

origination date: 13.06.14

min pt size: 7

originated by: S.Anson
approved for print/date

revision date:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date:

colours/plates:

Nitrazepam Tablets
5mg x 28’s (UK)

1. Black

JDE No.:

2.
3.
4.

50809730

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 12311

6.

Date Sent:
30/05/14
Technologist: R.Wrey

Non Printing Colours
1.
2.
3.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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