DIAZEPAM 10MG

Active substance: DIAZEPAM

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PATIENT INFORMATION LEAFLET

TENSIUM TABLETS
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL
THE PRESCRIBED COURSE OF TENSIUM.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR
MORE INFORMATION.
What is in Tensium tablets?
The active ingredient of Tensium is Diazepam BP.
Tensium tablets come in three strengths:
Tensium 2 mg tablets which contains 2mg Diazepam,
together with the ingredients Lactose, Maize starch,
Pregelatinised maize starch and Magnesium stearate
(E572).
Tensium 5 mg tablets which contains 5mg Diazepam,
together with the ingredients Lactose, Maize starch,
Pregelatinised maize starch, Magnesium stearate (E572)
and Quinoline yellow (E104).
Tensium 10 mg tablets which contains 10mg Diazepam,
together with the ingredients Lactose, Maize starch,
Magnesium stearate (E572) and Indigo carmine DFC blue 2
(E132).
Tensium 2mg is a round, flat, white tablet with bevelled
edges and embossed 2mg/DDSA.
Tensium 5mg is a round, flat, pale yellow tablet with bevelled
edges and embossed 5mg/DDSA.
Tensium 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.
Tensium 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
Tensium is:
Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor,
Nicosia, P. C. 1060, Cyprus
The name and address of the manufacturer of Tensium is:
Meridian Healthcare (UK) Ltd., 208-214 York Road,
Battersea, London SW11 3SD
Why have you been prescribed Tensium?
In adults Tensium 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.
Tensium 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.
Tensium is used for the treatment of the symptoms of
alcohol withdrawal.
Tensium is also used for premedication for dental and
surgical procedures.
In children Tensium 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.
Tensium is also used for premedication for dental and
surgical procedures.
BEFORE TAKING THIS MEDICINE
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 Tensium 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 Tensium.
PRECAUTIONS WHILE USING THIS MEDICINE
Use whilst driving or operating machinery

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.
This medicine may cause some people, especially elderly
persons, to become drowsy, dizzy, lightheaded, clumsy or
unsteady, or less alert than normal. Even if taken at bedtime
it may cause some people to feel drowsy or less alert on
rising.
You should not attempt to drive or operate dangerous
machinery when taking Tensium. Your ability to perform
such tasks will be affected, especially after altering the
doses you are taking. 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.
PROPER USE OF THIS MEDICINE
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 Tensium 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 Tensium 2 mg tablet) three
times daily.
Severe anxiety states: 15 mg to 30 mg (three Tensium 5 mg
tablets to three Tensium 10 mg tablets) daily in divided
doses.
Symptomatic relief of acute alcohol withdrawal: 5 mg to 20
mg (one Tensium 5 mg tablet to two Tensium 10 mg tablets)
repeated if necessary in 2 to 4 hours.
Insomnia associated with anxiety: 5 mg to 15 mg (one
Tensium 5 mg tablet to three Tensium 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 Tensium 2 mg tablets to
three Tensium 5 mg tablets) daily in divided doses.
Management of muscle spasm of brain origin: 2 to 60 mg
(one Tensium 2 mg tablet to six Tensium 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 Tensium 2 mg tablet to six Tensium 10 mg
tablets) daily in divided doses.
Premedication: 5 to 20 mg (one Tensium 5 mg tablet to two
Tensium 10 mg tablets).
Treatment should always be tapered off gradually.
Children:
Dosages for sleepwalking (somnambulism): 1 to 5 mg (1/2
Tensium 2 mg tablet to one Tensium 5 mg tablet) at
bedtime.
Conditions associated with muscle spasm:
Control of tension and irritability in muscle spasm of brain
origin: 2 to 40 mg (one Tensium 2 mg tablet to four Tensium
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 Tensium 2 mg tablet to one
Tensium 10 mg tablet).
Elderly and debilitated patients:
Doses should not exceed half those normally
recommended.

What to do if too many tablets are taken at the same
time.
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.

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.

WHAT SIDE EFFECTS CAN TENSIUM HAVE?
Children and the elderly are usually more sensitive to the
effects of Tensium 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.

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.

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
drug.
Other side effects not listed above may also occur in some
people. If you notice any other side effects check with your
doctor.
Storing your medicine
You must keep this medicine in a safe place where children
cannot get at it. Your medicine could harm them.
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.

A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as
yours.

PLs 33414/0035, 33414/0036, 33414/0037
This leaflet was revised February 2009.

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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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