DIAZEPAM TABLETS BP 5MG

Active substance: DIAZEPAM

View full screen / Print PDF » Download PDF ⇩

Transcript
Diazepam 2mg, 5mg and 10mg 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:
1. What Diazepam tablets are and what
they are used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

1. What Diazepam tablets are
and what they are used for

Diazepam belongs to a group of medicines
called benzodiazepines. Diazepam helps
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. Before you take

Do not take Diazepam tablets and tell
your doctor if you
• are allergic (hypersensitive) to diazepam

or to other benzodiazepine medicines
or to any of the other ingredients in your
tablets (see section 6)
• breathing problems, which may be

severe, including slow and/or shallow
breathing
• suffer from depression (with or without

anxiety) or hyperactivity
• have a phobia (a fear of a particular

object or situation) or other mental illness
• have myasthenia gravis (a condition

which causes muscles to weaken and
tire easily)
• suffer from sleep apnoea (a sleep

disorder where you have abnormal
pauses in breathing during sleep)
• have severe liver disorders
• have porphyria (an inherited condition

causing skin blisters, abdominal pain and
brain or nervous system disorders)
• planning a pregnancy or are pregnant

(see below Pregnancy and breast-feeding).
Check with your doctor or pharmacist
before taking Diazepam tablets if you
• have a history of alcoholism or drug

abuse
• have problems with your heart and

lungs or have severe kidney failure
• have someone close to you that has

recently died
• have low blood levels of a protein called

albumin
• have a personality disorder
• have a poor blood supply to the brain

(arteriosclerosis)
• are elderly Diazepam tablets can cause

confusion and have effects on muscles
causing falls and injuries.
• have breathing difficulties
• smoke

• suffer from depression
• have suicidal thoughts
• 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. 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.’
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 (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 (antifungal 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 reduct 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)
Taking Diazepam tablets with 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.
Pregnancy and breast-feeding
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. 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.
Important information about some of
the ingredients of Diazepam tablets
Diazepam 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 Diazepam tablets exactly as
your doctor has told you. You should not
take Diazepam 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
• 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

• Loss of coordination of muscle

movements (ataxia) and other movement
disorders, tremor

Children
For tension and irritability in cerebral
spasticity: 5mg-40mg each day, in divided
doses.

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
suddenly. You may also experience mood
changes, anxiety, restlessness or changes
in sleep patterns.

If your doctor has given your child
Diazepam tablets to take before an
operation, the usual dose is 2mg-10mg.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

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.

4. Possible Side Effects

Rare: affects 1 to 10 users in 10,000
• 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)

If you have liver or kidney problems you
may also be given a lower dose.
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
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 Diazepam tablets
• Do not stop taking your medicine
without telling your doctor as he may
wish to gradually reduce the number of

Like all medicines, Diazepam tablets can
cause side-effects, although not everybody
gets them.
Tell your doctor if you notice any of the
following side effects or notice any other
effects not listed:
Some side effects can be serious
and may require immediate medical
treatment:
Uncommon: affects 1 to 10 users in 1,000
• Respiratory depression (very slow and/or
shallow breathing)
Rare: affects 1 to 10 users in 10,000
• Respiratory arrest (cessation of breathing)
• Unconsciousness
• Jaundice (yellowing of your skin or the
white of your eyes)
Very rare: affects less than 1 user in 10,000
• 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: affects more than 1 user
in 10
• Drowsiness
Common: affects 1 to 10 users in 100
• Fatigue
• Withdrawal symptoms (for possible

symptoms please see ‘If you
stop taking Diazepam tablets’ in
Section 3)
• Confusion

Uncommon: affects 1 to 10 users in 1,000
• 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.

Very rare: affects less than 1 user in 10,000
• 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 dissappear after you have stopped
taking diazepam)
Withdrawal symptoms: see Section 3, ‘If
you stop taking Diazepam tablets.’

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.
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.
Do not store above 25°C.
Do not use Diazepam 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 Diazepam tablets contain:
• The active substance (the ingredient that
makes the tablet work) is diazepam. Each
tablet contains either 2mg, 5mg or 10mg
of the active ingredient.
• The other ingredients are lactose,
magnesium stearate, maize starch and
stearic acid.
• The 5mg tablets also contain quinoline
yellow (E104).
• The 10mg tablets also contain HT Lake
(E132).
What Diazepam tablets looks like and
contents of the pack
Diazepam tablets are uncoated tablets in
the following colours: 2mg- white, 5mgyellow, 10mg- blue
Pack sizes are 28 tablets.
Marketing Authorisation Holder and
Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK.
Date of Revision: May 2014

Actavis, Barnstaple, EX32 8NS, UK
AAAG7010 50780615

Expand view ⇕

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.

Hide
(web2)