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Active substance(s): DIAZEPAM

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What is in Diazepam tablets?
The active ingredient of this medicine is Diazepam BP.
Diazepam tablets come in three strengths:
Diazepam 2 mg tablets which contains 2mg Diazepam,
together with the ingredients Lactose, Maize starch,
Pregelatinised maize starch and Magnesium stearate
Diazepam 5 mg tablets which contains 5mg Diazepam,
together with the ingredients Lactose, Maize starch,
Pregelatinised maize starch, Magnesium stearate (E572)
and Quinoline yellow (E104).
Diazepam 10 mg tablets which contains 10mg Diazepam,
together with the ingredients Lactose, Maize starch,
Magnesium stearate (E572) and Indigo carmine DFC blue 2
Diazepam 2mg is a round, flat, white tablet with bevelled
edges and embossed 2mg/DDSA.
Diazepam 5mg is a round, flat, pale yellow tablet with
bevelled edges and embossed 5mg/DDSA.
Diazepam 10mg is a round flat, pale blue tablet with bevelled
edges and a scoreline, and is embossed Tensium.
All three strengths are available in containers of 50, 100, 500
and 1,000 tablets.
Diazepam belongs to a group of medicines, the
benzodiazepines that slow down the nervous system and
are known as Central Nervous System (CNS) depressants.
The name and address of the Product Licence holder of
Diazepam is:
Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor,
Nicosia, P. C. 1060, Cyprus
The name and address of the manufacturer of Diazepam is:
Meridian Healthcare (UK) Ltd., 208-214 York Road,
Battersea, London SW11 3SD
Why have you been prescribed Diazepam?
In adults Diazepam is used for the short-term relief (2 - 4
weeks only) of nervousness or tension which is disabling or
which can cause unacceptable distress either on its own or

together with trouble in falling asleep or in sleeping, known
as insomnia.
Diazepam is also used to help relax muscles or relieve
muscle spasm which may occur with conditions such as
fibrositis and arthritis, bursitis and cervical spondylosis, and
to treat certain types of seizure such as those of epilepsy
and tetanus.
Diazepam is used for the treatment of the symptoms of
alcohol withdrawal.
Diazepam is also used for premedication for dental and
surgical procedures.
In children Diazepam is used for the treatment of
sleepwalking (somnambulism) and nightmares (night
terrors). It is also used in certain conditions to help relax
muscles and relieve muscle spasm.
Diazepam is also used for premedication for dental and
surgical procedures.
Before taking this medicine tell your doctor if you have ever
had any unusual or allergic reactions to diazepam or other
benzodiazepines. Also tell your doctor or pharmacist if you
are allergic to any other substances, such as foods,
preservatives or dyes.
The presence of other medical problems
The presence of other medical problems may affect the use
of this medicine. Make sure, therefore, to tell your doctor if
you have any other medical problems, especially:
• Any condition that affects your breathing, such as
asthma, emphysema.
• Any liver or kidney problems for which you have or are
receiving treatment.
• Raised eyeball pressure (Glaucoma)
• Depression
The effect of taking Diazepam with other medicines
This medicine will add to the effects of alcohol and other
medicines that slow down the Central Nervous System
(CNS), possibly causing drowsiness. Some examples of
CNS depressants are antihistamines (medicines for hayfever
and other allergies); sedatives; tranquillisers, sleeping
medicines; pain relieving medicines; barbiturates; medicines
for seizures; muscle relaxants; anaesthetics including some
dental anaesthetics.
Make sure you doctor is informed of any medication you are
taking, whether it has been prescribed or bought without a
prescription. It is particularly important that your doctor is
aware of any medicines you are taking which have been
mentioned in the paragraph above.
If you go to a doctor, dentist or hospital for any reason, tell
them you are taking Diazepam.
Driving and using machines

When Diazepam has been combined during treatment with
CNS depressants, sedative effects of these are likely to be
intensified, and may last for a few days after you have
stopped taking this medicine.
Diazepam can affect your ability to drive and use machines
as it may make you feel sleepy and dizzy.
Do not drive or operate dangerous machinery 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:
- Diazepam 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.
Please remember that alcohol may intensify these effects
and should be avoided during treatment.
Use in Pregnancy
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, and breathing and feeding
difficulties. If this medicine is taken regularly in late
pregnancy, your baby may develop withdrawal symptoms.
Take this medicine by mouth and only in the doses
prescribed by your doctor. Do not take more of it and do not
take it more often or for a longer time than your doctor
ordered. If you are taking this medicine for nervousness or
confusion or insomnia (trouble in sleeping), check with your
doctor at four-weekly intervals to make sure you need to
continue taking this medicine.
If your doctor decides that treatment should be stopped, then
Diazepam will be withdrawn gradually; even then symptoms
such as depression, nervousness, insomnia, irritability,
sweating and diarrhoea may occur.
If you are taking this medicine for epilepsy or other seizure
disorders, it must be taken every day in regularly spaced
doses as ordered by your doctor. This is necessary to keep
a constant amount of the medicine in the blood. To keep this
amount constant it is best not to miss any doses.
Stopping Diazepam after a long period of treatment may
cause seizures (convulsions).
If you feel this medicine is not working as well after you have
taken it for a short time (1-2 weeks) do not increase the
dose, instead check with your doctor.

If you miss a dose, skip the missed dose and go back to
your regular dosing schedule. Do not double the dose.
Common dosages:
For anxiety states:
The lowest dose should be used that can control symptoms.
Treatment will not normally be continued beyond 4 weeks.
Mild anxiety states: 2 mg (one Diazepam 2 mg tablet) three
times daily.
Severe anxiety states: 15 mg to 30 mg (three Diazepam 5
mg tablets to three Diazepam 10 mg tablets) daily in divided
Symptomatic relief of acute alcohol withdrawal: 5 mg to 20
mg (one Diazepam 5 mg tablet to two Diazepam 10 mg
tablets) repeated if necessary in 2 to 4 hours.
Insomnia associated with anxiety: 5 mg to 15 mg (one
Diazepam 5 mg tablet to three Diazepam 5 mg tablets)
before retiring. This treatment should not be used on a
routine basis but intermittently as directed by your doctor.
Conditions associated with muscle spasm:
The selected dose should relate to the severity of the case
which your doctor will judge of.
Muscle spasm: 2 to 15 mg (one Diazepam 2 mg tablets to
three Diazepam 5 mg tablets) daily in divided doses.
Management of muscle spasm of brain origin: 2 to 60 mg
(one Diazepam 2 mg tablet to six Diazepam 10 mg tablets)
daily in divided doses.
As an aid to the control of muscle spasm in tetanus: 3 to 10
mg/kg bodyweight daily.
As an aid to the management of some types of epilepsy: 2 to
60mg (one Diazepam 2 mg tablet to six Diazepam 10 mg
tablets) daily in divided doses.
Premedication: 5 to 20 mg (one Diazepam 5 mg tablet to two
Diazepam 10 mg tablets).
Treatment should always be tapered off gradually.
Dosages for sleepwalking (somnambulism): 1 to 5 mg (1/2
Diazepam 2 mg tablet to one Diazepam 5 mg tablet) at
Conditions associated with muscle spasm:
Control of tension and irritability in muscle spasm of brain
origin: 2 to 40 mg (one Diazepam 2 mg tablet to four
Diazepam 10 mg tablet) daily in divided doses.

As an aid to control the muscle spasm in tetanus: 3 to 10 mg
per kg bodyweight.
Premedication: 2 to 10 mg (one Diazepam 2 mg tablet to
one Diazepam 10 mg tablet).
Elderly and debilitated patients:
Doses should not exceed half those normally
What to do if too many tablets are taken at the same
If you think you may have taken an overdose of this
medicine obtain emergency help at your nearest hospital
casualty department or doctor. Some signs of an overdose
are continuing slurred speech or confusion, severe
drowsiness, severe weakness and staggering. Tell the
doctor in charge, or the nurse, or pharmacist that you are
taking this medicine and take any remaining tablets in their
original container with you.
Children and the elderly are usually more sensitive to the
effects of Diazepam and most of the side effects of this
medicine are more likely to occur in these patients.
Along with its needed effects, the medicine may cause some
unwanted effects, which may persist into the next day.
Common amongst these include drowsiness, sedation,
unsteadiness and difficulty with balance when walking. Loss
of memory may also occur.
Other adverse effects are rare and include headache,
dizziness, lowering of blood pressure, stomach upsets, skin
rashes, visual disturbances, changes in sexual desire,
difficulty in urinating, jaundice (yellow discolouration of eyes
and skin), and anaemic conditions causing unusual bruising
or bleeding.
If any of the above effects become troublesome check with
your doctor as soon as possible.
These side effects will become more noticeable if you are
taking anti-epileptic drugs.
When taken for trouble in sleeping (insomnia) by the elderly
more daytime drowsiness may be experienced than in
younger adults. In elderly patients falls and related injuries
may be more likely to occur.
Rarely, aggressive outbursts of anger, excitement and
confusion may be experienced. If this occurs check with your
doctor at once as they may wish you to discontinue using the
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow
Card Scheme at By reporting

side effects you can help provide more information on the
safety of this medicine.
Storing your medicine
Keep of the sight and reach of children.
Keep your medicine in a dry place, below 25°C. Protect from
light. Keep the tablets/capsules in the container in which
they were given to you.
If your doctor tells you to stop the treatment, return any
remaining tablets/capsules to the pharmacist.
On the container you will find the words “expiry date”
followed by numbers indicating the day, month and year.
This is the date after which the medicine is no longer fit for
use. Do not use the medicine after this date but return it to
your doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as
This leaflet does not contain the complete information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist who have
access to additional information.
PL 33414/0035, PL 33414/0036, PL 33414/0037
This leaflet was last revised in July 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.