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DIAZEPAM 10MG TABLETS

Active substance(s): DIAZEPAM

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GB 724-8115-APIL
Package leaflet: Information for the user

Diazepam can pass into br
pharmacist for advice befo

Diazepam 2 mg, 5 mg and 10 mg Tablets
Diazepam

Read all of this leaflet carefully before you start taking this
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. 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.
This includes any possible side effect not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Diazepam Tablets are and what they are used for
2. What you need to know before you take Diazepam Tablets
3. How to take Diazepam Tablets
4. Possible side effects
5. How to store Diazepam Tablets
6. Contents of the pack and other information

1. What Diazepam Tablets are and what they are
used for
The name of your medicine is Diazepam 2 mg, 5 mg or 10 mg
Tablets (referred to as Diazepam Tablets in this leaflet).
Diazepam Tablets contain the active ingredient diazepam, which
belongs to a group of medicines called benzodiazepines.
Diazepam Tablets help in the treatment of anxiety, muscle
spasms and convulsions (fits).
Diazepam Tablets are used to treat a number of conditions,
including:
In adults
• short term relief (2-4 weeks only) of severe anxiety, which is an
emotional state where you may sweat, tremble, feel anxious
and have a fast heart beat and may occur alone or with
insomnia (trouble sleeping) or mental health problems
• helping muscles relax and for muscle spasm and cerebral
palsy (a condition affecting the brain which causes movement
problems and rigidity or stiffness)
• epilepsy (when taken with other medicines)
• patients with the symptoms of alcohol withdrawal
• helping to relax nervous dental patients.
In children
• helping to treat tension and irritability caused by cerebral
spasticity (a condition associated with a disease or trauma
affecting the brain or spinal cord which causes weakness,
un-coordinated movements, rigidity and stiffness)
• helping to treat muscle spasm caused by tetanus (when taken
with other medicines).
Both adults and children can take Diazepam Tablets before an
operation to help with relaxation and to cause sleepiness.

2. What you need to know before you take
Diazepam Tablets
Do not take Diazepam Tablets
• if you are allergic to diazepam or any of the other ingredients
of this medicine (listed in section 6).
• if you have a phobia (a fear of a particular object or
situation) or other mental illness
• if you have breathing problems, which may be severe,
including slow and/or shallow breathing
• if you have myasthenia gravis (a condition which causes
muscles to weaken and tire easily)
• if you suffer from sleep apnoea (a sleep disorder where you
have abnormal pauses in breathing during sleep)
• if you have severe liver disorders
• if you have porphyria (an inherited condition causing skin
blisters, abdominal pain and brain or nervous system disorders)
• if you suffer from depression (with or without anxiety) or
hyperactivity
• if you are planning a pregnancy or are pregnant (see below
Pregnancy and breast-feeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking Diazepam
Tablets
• if you have long term kidney, liver, heart or respiratory
problems
• if you have a personality disorder
• if you have a history of alcoholism or drug abuse
• you have a history of seizures (fits)
• if someone close to you has recently died
• if you have low blood levels of a protein called albumin
• if you are elderly (risk of confusion or clumsiness, causing fall
or injury)
• if you have a poor blood supply to the brain (arteriosclerosis)
• If you have breathing difficulties
• If you smoke
• If you suffer from depression
• If you have suicidal thoughts
• If you have epilepsy or a history of seizures
Other considerations
• Mental side effects – contact your doctor if you experience
side effects such as agitation, hyperactivity, restlessness,
aggressiveness, nightmares or hallucinations. These side
effects are more likely to occur in children or the elderly.
• Amnesia (total or partial memory loss) – you could experience
amnesia when taking this medicine. To reduce the risk you
should ensure that you will be able to have uninterrupted sleep
of 7-8 hours. Amnesia is more likely to occur when taking high
doses of diazepam.
• 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. Therefore, you should take Diazepam Tablets for
a short a period of time as possible.
• 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 Diazepam Tablets even
when normal doses are given for short periods of time. See
Section 3, ‘If you stop taking Diazepam Tablets’.
Other medicines and Diazepam Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines, including medicines
obtained without prescription.
This is especially important if you are taking the following:
• antidepressants (e.g. fluvoxamine, fluoxetine)
• antipsychotics such as clozapine (to treat mental problems)
• antihistamines (to treat allergies)
• general anaesthetics
• sedatives (used to give calming effects)
• hypnotics (to help you sleep)
• erythromycin (an antibiotic)
• muscle relaxants (e.g. suxamethonium, tubocurarin)
• some strong pain killers such as morphine (opioids) may
give you a heightened sense of well being when taken with
diazepam, which can increase your desire to continue taking
these medicines (dependency) or can make you very sleepy.
• barbiturates such as phenobarbital (to treat epilepsy and
mental disorders)
• medicines to lower high blood pressure, diuretics (water
tablets), nitrates (for heart conditions) as these could lower
your blood pressure too much.
• antacids (reduces stomach acid) may slow down absorption
of diazepam in the body.
Taking these medicines with diazepam could affect your mental
status, make you very sleepy and suppress your breathing and
blood pressure.
• disulfiram (to treat alcohol addiction). Taking this medicine
with diazepam could make you very sleepy and can cause
diazepam to be removed from the body more slowly than
usual.
• medicines for epilepsy e.g. phenobarbital, phenytoin and
carbamazepine, sodium valproate, (diazepam can affect the
blood levels of these medicines). Diazepam can furthermore
affect how phenytoin works.
• theophylline (to treat asthma and other breathing disorders),
as it can weaken the effect of diazepam. As this can cause
diazepam to be removed from the body more quickly than
usual.
• cimetidine, omeprazole or esomeprazole (stomach acid
reducing medicines), as these can cause diazepam to be
removed from the body more slowly than usual.
• rifampicin, to treat infections (an antibiotic) as this can cause
diazepam to be removed from the body more quickly than
usual. The effect of diazepam can be weakened.
• amrenavir, atazanavir, ritonavir, delavirdine, efavirenz,
indinavir, nelfinavir or saquinavir (antivirals), fluconazole,
itraconazole, ketoconazole or voriconazole (anti-fungal
medicines) as these can cause diazepam to be removed from
the body more slowly than usual and therefore increase the
risk of side effects. As these can make you feel sleepy for
longer or cause difficulty breathing.
• isoniazid (used to treat tuberculosis), as it can cause
diazepam to be removed from the body more slowly than
usual.
• oral contraceptives, as they can slow down the removal of
diazepam from the body and increase its effect. Breakthrough
bleeding can occur when taking diazepam and oral
contraceptives together, but the contraceptive protection is
not reduced.
• cisapride (used to treat stomach problems), as it can cause
diazepam to be removed from the body more slowly than
usual.
• corticosteroids (medicines used to treat inflammation in the
body) as they can weaken the effect of diazepam.
• levodopa (used to treat Parkinson’s disease). Diazepam can
reduce the effect of levodopa.
• valproic acid (used to treat epilepsy and mental disorders) as
it can slow down the removal of diazepam from the body and
increase its effect.
• ketamine (an anaesthetic) as diazepam increases the effect of
ketamine.
• lofexidine (to help relieve symptoms when you stop taking
opioids)
• nabilone (to treat nausea and vomiting)
• alpha blockers or moxonidine (to lower high blood pressure)
Diazepam Tablets and food and drink
Do not drink alcohol while you are taking Diazepam Tablets.
Alcohol may increase the sedative effects of Diazepam Tablets
and make you very sleepy.
Grapefruit juice may increase the amount of diazepam in your
blood. If you are elderly, suffer from cirrhosis or any of the
conditions listed in section 2, this could possibly increase the
sedative effects of Diazepam Tablets and you should speak to
your doctor or pharmacist.
Drinks containing caffeine may reduce the effects of diazepam.
Other special warnings
- If you see another doctor or visit a hospital, remember to tell
them what medicines you are already taking.
- If you are going to have an operation please tell the
anaesthetist that you are taking Diazepam Tablets as this may
affect some of the drugs he/she may use.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
You should not take Diazepam Tablets if you are pregnant,
planning to become pregnant or are breast-feeding. If you take
Diazepam 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.

Received Date:
CDL JOB No. :
Required By :

22/07/2016
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62281
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27/07/2016

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DATE: 26/07/2016
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Adults

• Anxiety or mental healt
divided doses.
• To help you sleep: 5mg• To help cerebral palsy o
day, in divided doses.
• To help control muscle s
divided doses.
• To help epilepsy: 2mg-6
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may be repeated after 2
• Before dental treatment:
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• Before an operation: 5m

PAGE 1 OF 2

Elderly or frail
If you are elderly or frail you
effects of Diazepam Tablet
will give you much lower do
than half the adult dose.

Renal and/or hepatic imp
If you have liver or kidney p
lower dose.

Use in children
For tension and irritability in
day, in divided doses.

If your doctor has given you
before an operation, the us

If you take more Diazepam
If you (or someone else) sw
or you think a child may ha
nearest hospital casualty d
immediately. Signs of an ov
of coordination, feeling slee
irregular or slow heartbeat,
weakness or excitement. A
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difficulties.

If you forget to take Diaze
If you forget to take a dose
time. Do not take a double

If you stop taking Diazepa
• Do not stop taking your
as she/he may wish to g
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side effects including de
sweating or diarrhoea. If
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• Treatment should be gra
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restlessness or changes

If you have any further que
your doctor or pharmacist.

4. Possible side effec

Like all medicines this med
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Serious side effects
If you notice any of the follo
and contact your doctor im
Uncommon: may affect up
• Respiratory depression (

Rare: may affect up to 1 in
• Respiratory arrest (cessa
• Unconsciousness
• Jaundice (yellowing of y

Diazepam can pass into breast milk. Ask your doctor or
pharmacist for advice before taking any medicine.
Driving and using machines
Diazepam Tablets can make you sleepy, forgetful, have poor
co-ordination along with other side effects that can affect
everyday activities (see Possible side effects). You should not
drive, operate machinery or take part in such activities where, if
affected, you could put yourself or others at risk.
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.
Diazepam Tablets contain lactose
Diazepam Tablets contain lactose (a type of sugar). If you have
been told that you have an intolerance to some sugars contact
your doctor before taking this medicine.

3. How to take Diazepam Tablets
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
You should not take Diazepam Tablets for longer than 4 weeks.
The tablets should be swallowed whole with a glass of water.
Recommended dose
Adults
• Anxiety or mental health problems: 5mg-30mg each day, in
divided doses.
• To help you sleep: 5mg-15mg at bedtime.
• To help cerebral palsy or other spasticities: 5mg-60mg each
day, in divided doses.
• To help control muscle spasm: 5mg-15mg each day, in
divided doses.
• To help epilepsy: 2mg-60mg each day, in divided doses.
• To help with alcohol withdrawal symptoms: 5mg-20mg, which
may be repeated after 2 to 4 hours if necessary.
• Before dental treatment: 5mg the night before treatment, 5mg
on waking and 5mg two hours before the appointment.
• Before an operation: 5mg-20mg
Elderly or frail
If you are elderly or frail you are likely to be more sensitive to the
effects of Diazepam Tablets, such as confusion, and your doctor
will give you much lower doses. The dose should not be more
than half the adult dose.
Renal and/or hepatic impairment
If you have liver or kidney problems you may also be given a
lower dose.
Use in children
For tension and irritability in cerebral spasticity: 5mg-40mg each
day, in divided doses.
If your doctor has given your child Diazepam Tablets to take
before an operation, the usual dose is 2mg-10mg.
If you take more Diazepam 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 clumsiness and loss
of coordination, feeling sleepy or deep sleep, speech problems,
irregular or slow heartbeat, uncontrolled eye movement, muscle
weakness or excitement. An extreme overdose may lead to coma
(unrousable unconsciousness), reflex problems and breathing
difficulties.
If you forget to take Diazepam Tablets
If you forget to take a dose, just take the next dose at the usual
time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Diazepam Tablets
• Do not stop taking your medicine without telling your doctor
as she/he may wish to gradually reduce the number of tablets
you take before stopping them completely. If you stop taking
Diazepam 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 intensely
than before (rebound insomnia and anxiety). The risk of this
happening is greater when you stop taking Diazepam Tablets
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 this medicine can cause side effects in some
people, although not everybody gets them.
Serious side effects
If you notice any of the following, stop taking Diazepam Tablets
and contact your doctor immediately:
Uncommon: may affect up to 1 in 100 people
• Respiratory depression (very slow and/or shallow breathing)
Rare: may affect up to 1 in 1,000 people
• Respiratory arrest (cessation of breathing)
• Unconsciousness
• Jaundice (yellowing of your skin or the white of your eyes)

Very rare: may affect up to 1 in 10,000 people
• Anaphylaxis (severe allergic reaction) with symptoms such as
sudden wheezing, swelling of your lips, tongue and throat or
body, rash, fainting or difficulties to swallow
Other side effects
Very common: may affect more than 1 in 10 people
• Drowsiness
Common: may affect up to 1 in 10 people
• Fatigue
• Withdrawal symptoms (for possible symptoms please see ‘If
you stop taking Diazepam Tablets’ in Section 3)
• Confusion
• Loss of coordination of muscle movements (ataxia) and other
movement disorders, tremor
Uncommon: may affect up to 1 in 100 people
• Muscle weakness
• Memory loss
• Difficulty in concentrating
• Balance disorders
• Dizziness
• Headache
• Slurred speech
• Stomach and intestinal problems such as nausea, vomiting,
constipation, diarrhoea
• Increased salivation
• Allergic skin reactions in the form of itching, skin redness and
swelling and skin rash.
Rare: may affect up to 1 in 1,000 people
• Mental side effects such as excitation, agitation, restlessness,
irritability, aggressiveness, memory loss, delusion, rages,
psychoses, nightmares or hallucinations. May be or become
serious. These side effects are more likely to occur in children
or the elderly. Talk to your doctor.
• Decreased alertness
• Depression
• Emotional withdrawal
• Insomnia (problems sleeping)
• Heart problems such as slow heartbeat (bradycardia), heart
failure and cessation of heartbeat (cardiac arrest).
• Low blood pressure, fainting (syncope)
• Increased mucus in the lungs
• Dry mouth
• Increased appetite
• Changes in certain liver enzymes as seen in blood tests
• Lack of ability to urinate, loss of bladder control (leakage of
urine)
• Breast enlargement in men
• Impotence, changes in sexual drive (libido)
• Blood disorders (you may develop sore throats, nose bleeds
or infections)
Very rare: may affect up to 1 in 10,000 people
• Low levels of white blood cells (leukopenia)
• Higher level of a certain enzyme in the blood (transaminase)
Not known: frequency cannot be estimated from the available
data
• Blurred vision, double vision and involuntary eye movements
(these side effects disappear after you have stopped taking
diazepam)
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 Diazepam Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the container tightly closed and
store in the original container or package in order to protect from
light.
Do not use this medicine after the expiry date that is stated on
the carton, bottle or blister after EXP. This date refers to the last
day of that month.
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 Diazepam Tablets contain
Each tablet contains 2 mg, 5 mg or 10 mg of the active ingredient
diazepam.
Diazepam 2 mg and 5 mg Tablets also contain colloidal silicon
dioxide, maize starch, magnesium stearate and lactose.
Diazepam 5 mg Tablets also contain yellow iron oxide (E172) and
quinoline yellow lake (E104).
Diazepam 10 mg Tablets contain dextrin, maize starch,
magnesium stearate, lactose and indigo carmine lake (E132).
What Diazepam Tablets look like and contents of the pack
Diazepam 2 mg Tablets: Flat white tablets with bevelled edges, 8
mm diameter. One face is embossed with “DZ” and “2”
separated by a breakline. The reverse face is plain.
Diazepam 5 mg Tablets: Flat, pale yellow tablets with bevelled
edges, 8 mm diameter. One face is embossed with “DZ” and “5”
separated by a breakline. The reverse is plain.
Diazepam 10 mg Tablets: Flat, blue tablets with bevelled edges,
8 mm diameter. One face is embossed with “DZ” and “10”
separated by a breakline. The reverse is plain.
Diazepam 2 mg, 5 mg and 10 mg Tablets are available in blister
packs of 28 tablets and pots of 21, 100, 250, 500 and 1000
tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sovereign Medical, Sovereign House, Miles Gray Road, Basildon,
Essex, SS14 3FR.
Manufacturer
Waymade Plc, Sovereign House, Miles Gray Road, Basildon,
Essex, SS14 3FR.
This leaflet was last revised in July 2016

Received Date:
CDL JOB No. :
Required By :

22/07/2016
62281
27/07/2016

PRODUCT NAME: Diazepam Tabs

2, 5, 10mg 28s
PIP CODE:
GB 724-8115-APIL
COMPONENT: Leaflet
SIZE:
210x477 mm
MARKET:
Grat Britain
PRODUCT SITE:
TBC
SCALE: 100%
COLOURS: Black
DATE: 26/07/2016
FONT SIZE:
9 pt
VERSION NO:
5
AMENDED BY:
VK
PROJECT:
Sovereign Medical

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................
Signature ..........................................................................
Name .................................................................................
Date ...................................................................................

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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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