DIAZEPAM 5 MG TABLETS

Active substance: DIAZEPAM

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DIAZEPAM 2 mg, 5 mg
and 10 mg TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

IN THIS LEAFLET:
1. What Diazepam is and what it is used
for
2. Before you take Diazepam
3. How to take Diazepam
4. Possible side effects
5. How to store Diazepam
6. Further information

1

WHAT DIAZEPAM IS AND WHAT
IT IS USED FOR

Diazepam Tablets belong to a group of
drugs called benzodiazepines which
promote sleep and relieves anxiety by
altering brain activity concerned with
emotion.
Diazepam is used:
• for the short term (2 – 4 weeks) relief of
severe anxiety
• to relax muscles
• for the short term relief of difficulty in
sleeping (when it is severe and causing
distress)
• to relax or sedate people undergoing
certain uncomfortable medical
procedures.

2

BEFORE YOU TAKE DIAZEPAM

DO NOT take Diazepam if you:
• are allergic (hypersensitive) to
diazepam or benzodiazipines, or any of
the other ingredients of this medicine
• have long-term or severe liver problems
• suffer from severe breathing problems
• suffer from sleep apnoea (difficulty
breathing while asleep)
• suffer from myasthenia gravis (a
disorder where muscles become weak
and tire easily)
• suffer from mental illness, such as
phobias, or obsessions.
Diazepam should NOT be taken on its own
to treat depression or anxiety associated
with depression.
Take special care with Diazepam
Tell your doctor before you start to take
this medicine if you:
• have suffered a loss or bereavement
• have lung problems
• have liver problems
• suffer from personality disorders
• have had problems with alcohol or drug
abuse.

Taking other medicines
Talk to your doctor if you are taking any of
the following:
• anxiolytics/sedatives e.g. lorazepam,
buspirone
• hypnotics e.g. temazepam, zopiclone
• anti-epileptic drugs e.g. phenytoin or
phenobarbital
• anti-depressants e.g. amitriptyline,
fluvoxamine or fluoxetine
• antipsychotics (used for mental
disorders) e.g. chlorpromazine,
haloperidol
• antihistamines with a sedative effect
(for allergies) e.g. chlorphenamine,
promethazine
• strong painkillers e.g. codeine,
co-proxamol
• drugs which affect the way Diazepam is
broken down by the liver e.g.
cimetidine, omeprazole or rifampicin
(for tuberculosis)
• cisapride (used to treat gastric reflux).
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Taking Diazepam with food and drink
• DO NOT drink alcohol while taking
these tablets, as it may increase the
sedative effect of the drug.
Pregnancy and breast-feeding
• If you are pregnant, planning to become
pregnant or breast-feeding ask your
doctor or pharmacist for advice before
taking this medicine.
• 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.
Driving and using machines
• Your tablets may make you confused,
forgetful, drowsy, unsteady or affect
your co-ordination. These effects may
be increased if you have not had
enough sleep. DO NOT drive or operate
machinery if you are affected.
Important information about some of the
ingredients of Diazepam Tablets
• Patients who are intolerant to lactose
should note that Diazepam Tablets
contain a small amount of lactose. If
your doctor has told you that you have
an intolerance to some sugars, contact
your doctor before taking this medicine.
• The 5 mg tablet contains E110 (sunset
yellow), which may cause allergic
reactions.

3

HOW TO TAKE DIAZEPAM

Always take Diazepam Tablets exactly as
your doctor has told you. You should check
with your doctor or pharmacist if you are
not sure. You should continue to take
these tablets for as long as your doctor
tells you to. The tablets should be
swallowed with a drink of water.

Your doctor will decide on the correct
dosage; the usual dose is:
Anxiety:
Other important things to remember
• Adults: 2 mg three times daily. If your
when taking Diazepam:
symptoms are severe you may be given
• When taking this medicine there is a
15 – 30 mg daily taken in divided doses.
risk of dependence (a need to keep
Muscle spasm:
taking the medicine). The risk increases • Adults: 2 – 60 mg daily taken in
with the dose and length of treatment
divided doses.
period. The risk is greater if you have
• Children: 2 – 40 mg daily taken in
ever had a history of alcohol or drug
divided doses.
abuse, or suffer from a personality
For both adults and children the dose is
disorder.
dependent on the symptoms, your
• When stopping this medicine you may
doctor will decide on the correct
experience withdrawal effects (see
dosage.
section 3, If you stop taking Diazepam) Trouble in sleeping associated with
• Behavioural effects may occur while
anxiety:
taking Diazepam (see section 4, Possible • Adults: 5 – 15 mg before going to bed.
Side Effects)
Do not take more than the maximum
• To reduce the risk of amnesia (loss of
dose.
memory), you should make sure that
Pre-medication:
you are able to have an uninterrupted
• Adults: 5 – 20 mg
sleep of at least 7 hours
• Children: 2 – 10 mg
• Tell the hospital or dentist you are
Children:
taking Diazepam if you are to have an
Your doctor will want to carefully assess
operation requiring an anaesthetic.
children given Diazepam and keep length
of treatment as short as possible.

Elderly and Debilitated (very frail)
patients:
Normally the starting dose is half of the
ordinary adult dose.
Patients with liver problems:
Your doctor may prescribe a lower dose.
Long-term use of Diazepam is not
recommended. Treatment should not
normally last more than 4 weeks for
sleeping problems or 2 – 3 months for
anxiety.
You may become tolerant to the effects of
Diazepam after you have been taking it for
a few weeks. If you notice that the tablets
are not working as well as they did when
you first started taking them, you should
go and see your doctor as an adjustment
to your dosage may be required.
If you take more Diazepam than you
should
If you (or someone else) swallow a lot of
the tablets all together, or if you think a
child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause drowsiness,
difficulty in controlling movements,
slurred speech and involuntary eye
movements. Coma, low blood pressure
and breathing problems can also occur.

Other side effects are:
• loss of memory, difficulty sleeping,
anxiety, confusion (particularly in the
elderly), depression
• difficulty in controlling movements,
shaking
• dizziness, blurred or double vision,
slurred speech
• nausea, vomiting, stomach problems,
diarrhoea, constipation, the production
of too much or too little saliva
• headache
• low blood pressure
• changes in sexual desire
• skin reactions
• incontinence or problems passing
urine.
Very rarely, jaundice (characterised by the
yellowing of the skin or the whites of the
eyes) and increased levels of liver enzymes
in the blood may occur.
Withdrawal effects are known to occur
(see section 3, If you stop taking
Diazepam).
If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

5

HOW TO STORE DIAZEPAM

Keep out of the reach and sight of
children.
These tablets should be stored at or below
25°C and protected from moisture and
light in the package or container supplied.
If you forget to take Diazepam
Do not transfer them to another container.
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly Do not use Diazepam after the expiry date
that is stated on the outer packaging. The
time to take the next one. DO NOT take a
expiry date refers to the last day of that
double dose to make up for a forgotten
month.
tablet.
Medicines should not be disposed of via
If you stop taking Diazepam
wastewater or household waste. Ask your
DO NOT stop taking your tablets suddenly, pharmacist how to dispose of medicines
or without your doctor telling you, as you no longer required. These measures will
may suffer from withdrawal effects.
help to protect the environment.
If your doctor decides to stop your tablets,
they will reduce the dose gradually to
6 FURTHER INFORMATION
minimise any withdrawal effects, which
What Diazepam Tablets contain:
may include:
• The active ingredient is diazepam,
• headache, muscle pain, tension
2 mg, 5 mg, or 10 mg.
• severe anxiety, confusion, restlessness
• The other ingredients are lactose
and irritability
monohydrate, powdered cellulose,
• in severe cases of withdrawal you may
maize starch and magnesium stearate
experience a feeling of things being
(E572). The 5 mg tablet also contains the
unreal, a feeling of detachment from
colours quinoline yellow (E104) and
your surroundings, numbness and
sunset yellow (E110). The 10 mg tablet
tingling in the hands and feet, sounds
contains the colour indigo carmine
seeming to be louder than usual and
(E132).
which can sometimes be painful if the
sound is loud, sensitivity to light or
What Diazepam Tablets look like and
touch, hallucinations and fits.
contents of the pack:
• Diazepam Tablets 2 mg are white, flat,
Even when you stop taking Diazepam
bevel edged tablets. They are engraved
gradually, you may feel anxious,
“Berk 2” with a breakline on reverse or
depressed and restless and have difficulty
“2” with a breakline on reverse.
sleeping. You may also experience
sweating and diarrhoea. If this happens go • Diazepam Tablets 5 mg are yellow, flat,
bevel edged tablets. They are engraved
to your doctor for advice.
“Berk 5” with a breakline on reverse or
If you have any further questions on the
“5” with a breakline on reverse.
use of this product, ask your doctor or
• Diazepam Tablets 10 mg are blue, flat,
pharmacist.
bevel edged tablets. They are engraved
“Berk 10” with a breakline on reverse or
4 POSSIBLE SIDE EFFECTS
“10” with a breakine on reverse.
Like all medicines, Diazepam can cause side The 2 mg and 5 mg tablets are available in
effects, although not everybody gets them. pack sizes of 7, 10, 14, 21, 28, 30, 50, 56, 60,
84, 90, 100, 110, 112, 120, 150, 160, 168,
Stop taking the tablets and tell your
250, 1000, 5000, 20000 or 10 x 50.
doctor immediately or go to the casualty
department at your nearest hospital if the The 10 mg tablets are available in pack
sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90,
following happens:
• an allergic reaction (swelling of the lips, 100, 110, 112, 120, 150, 160, 168, 200, 500,
face or neck leading to severe difficulty 1000 or 20000.
Not all pack sizes may be marketed.
in breathing; skin rash or hives).
This is a very serious but rare side effect.
Marketing Authorisation Holder and
You may need urgent medical attention or Manufacturer
hospitalisation.
Marketing Authorisation holder and
Tell your doctor immediately if you suffer company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
from:
• behavioural changes such as
This leaflet was last revised: May 2008
restlessness, agitation, irritability,
aggressiveness, delusions, rages,
PL 00289/0164-0166
nightmares, hallucinations, psychiatric
disorders and inappropriate behaviour,
as your treatment may be stopped.
Please take this leaflet, any remaining
tablets, and the container with you to the
hospital or doctor so that they know which
tablets were consumed.

The most common side effects are:
• tiredness
• drowsiness
• reduced alertness
• muscle weakness.
These effects are usually more common at
the start of therapy but decrease on
continuing treatment.

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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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