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DIAZEPAM 5MG TABLETS BP
Active substance(s): DIAZEPAM
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking
! Keep this leaflet. You may need to read it again.
! If you have any further questions, ask your doctor or
! Your doctor has prescribed these tablets for you. Do not
pass them on to others. They 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 the leaflet, please tell your doctor or
In this leaflet:
1. What Diazepam Tablets are and what they are used for
2. Before you take Diazepam Tablets
3. How to take Diazepam Tablets
4. Possible side effects
5. How to store Diazepam Tablets
6. Further information
1. What Diazepam Tablets are and what they are used
Diazepam belongs to a group of medicines called
benzodiazepines. It works by depressing activity in the part of
the brain that controls emotion, by promoting the action of a
chemical called gamma-aminobutyric acid (GABA). Diazepam
is used in the treatment of anxiety, including that associated
with alcohol withdrawal, for sedation before minor medical
procedures and in conjunction with other medicines to relieve
muscle spasm. It may also be used in the management of
cerebral spasticity and as part of a treatment for epilepsy. In
children it is also used to treat night terrors and sleepwalking.
Anaesthetics as it can cause you to become more sedated
and may affect your breathing and heart.
Medicines used to treat mental disorders (e.g.
Medicines used to treat epilepsy (e.g. phenytoin).
Cimetidine, a drug used to treat ulcers of the stomach and
Rifampicin a drug used in the treatment of tuberculosis.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines including medicines
obtained without prescription.
Taking Diazepam Tablets with food and drink:
Diazepam should not be taken with alcohol as it will increase
the sedative effects of this medicine and therefore should be
Pregnancy and Breastfeeding:
Tell your doctor if you are, you think you might be or are
planning to become pregnant. You should not use Diazepam
tablets if you are breast-feeding or are planning to breast-feed
Ask your doctor or pharmacist for advice before taking any
Driving and using machines:
Do not drive or operate machinery when taking this medicine
as it may make you sleepy or affect your concentration.
Important information about some of the ingredients of
This product contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
Before you take Diazepam Tablets
Do not take Diazepam Tablets:
If you are allergic (hypersensitive) to diazepam or any of
the other ingredients in diazepam tablets.
! If you have breathing difficulties.
! If you suffer from any mental illness such as obsessions,
phobias (irrational fears) or schizophrenia.
! If you suffer from depression or anxiety associated with
! If you have a rare metabolic condition called porphyria.
! If you have myasthenia gravis (very weak muscles)
Take special care with Diazepam Tablets:
Tell your doctor before you start taking these tablets:
! If you have severe liver disease.
! If you have severe kidney disease.
! If you suffer from memory loss (amnesia).
! If you have a personality disorder.
! If you have a history of alcoholism or drug abuse.
! If you have suffered a loss or bereavement (diazepam can
affect the way you react to this).
! When diazepam is used for a long period of time as there is
a risk of becoming dependent on the drug and there is also
a risk of withdrawal symptoms when you stop taking it.
Taking other medicines:
Please tell your doctor if you are taking any of the following
! Tranquillisers used to treat anxiety (e.g. chlordiazepoxide).
! Sleeping tablets (e.g. temazepam)
! Medicines used for depression (e.g. amitriptyline).
! Strong pain killers known as narcotics including codeine,
morphine, methadone, fentanyl, oxycodone, meperidine,
hydromorphone and hydrocodone as it can cause you to
become more sedated and may affect your breathing and
3. How to take Diazepam Tablets
Always take Diazepam Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure. The tablets should be swallowed with a drink of
Anxiety: the usual dose is 2mg three times daily. Do not exceed
30mg per day, in divided doses. For sleeping problems
(insomnia) associated with anxiety, take 5 to 15 mg at bedtime.
This medicine should only be used to treat insomnia when it is
severe, disabling or causing extreme distress.
Alcohol withdrawal: 5 to 20mg, repeated if necessary after two
to four hours.
Muscle spasm: The usual adult dose is 2 to 15mg daily in divided
Muscle spasm in tetanus: 3 to 10mg per kg of bodyweight daily.
Management of cerebral spasticity: The usual dose in 2 to 60mg
daily in divided doses.
Epilepsy: 2 to 60 mg daily in divided doses.
Sedation before medical procedures: 5 to 20mg.
Night terrors and sleep walking in children: 1 to 5mg at bedtime.
Management of cerebral spasticity: for tension and irritability a
dose of 2 to 40mg daily in divided doses should be taken.
Muscle spasm in tetanus: 3 to 10 mg per kg of bodyweight daily.
Sedation before medical procedures: 2 to 10mg.
Elderly or very ill patients
The dose should not exceed half the adult dose.
If you take more Diazepam Tablets than you should:
If you swallow too many tablets or someone else accidentally
takes your medicine contact your doctor, pharmacist or
nearest hospital straight away.
The symptoms of overdose may include poor coordination in
the arms and legs, slurred speech, difficulty swallowing,
shaking, increased drowsiness and unusual excitement. In
severe overdose there may be decreased function of the lungs
and heart, difficulty breathing and coma.
If forget to take Diazepam Tablets:
Try to take Diazepam Tablets daily as prescribed. If you forget
to take a dose, take it as soon as you remember, then go on as
before. Never take a double dose to make up for a forgotten
If you stop taking Diazepam Tablets:
Do not stop taking Diazepam Tablets suddenly. Always ask your
Long term treatment with diazepam may lead to dependence
and the side effects of treatment withdrawal include
depression, nervousness, sleeping difficulties, irritability,
sweating, diarrhoea, confusion and convulsions (fits).
If you have any further questions on the use of Diazepam
Tablets ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Diazepam Tablets can cause side effects,
although not everyone gets them.
Contact your doctor or pharmacist as soon as possible if you
have these side effects:
Rare: (between 1 in 1000 patients and 1 in 10,000
! Yellowing of the skin and whites of the eyes, as this may
indicated you have a problem with your liver (e.g.
! Problems passing water.
! Stomach or bowel upset.
! Blurred vision or dizziness.
! Changes in libido (sexual desire).
! Skin rashes.
! Low blood pressure.
! Changes in blood cells, which may appear as changes in
bleeding times (e.g. increased bleeding times), nosebleeds,
bruising easily, frequent or persistent infections or
weakness and pale skin.
The following side effects may be mild and occur at the
beginning of the treatment. Contact your doctor if you are
concerned about these side effects.
Common: (between 1 in 10 patients to 1 in 100 patients)
Sedation (increased drowsiness)
Poor coordination in the arms and legs
If any of the side effects gets serious, or if you notice and side
effects not listed in this leaflet please tell your doctor or
How to store Diazepam Tablets
Keep out of the reach and sight of children.
Do not use Diazepam tablets after the expiry date which is
stated on the label.
The expiry date refers to the last day of the month.
Pots: Do not store above 25C. Store in the original container.
Keep the container tightly closed.
Blisters: Do not store above 25C. Store in the original
packaging. Keep in the outer carton.
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 is diazepam Ph Eur. Each tablet contains
5mg of diazepam.
The other ingredients are maize starch, lactose monohydrate,
sodium lauryl sulphate, sodium starch glycollate, stearic acid,
magnesium stearate and Yellow 1409 (E102).
What Diazepam Tablets look like and contents of the
Diazepam 5mg tablets are yellow, circular tablets engraved
with 'D5' on one side and a breakline on the reverse.
The tablets are supplied in pots containing 1000 tablets or in
blisters containing 28 tablets.
Marketing Authorisation Holder and Manufacturer
Special Concept Development (UK) Limited,
Units 1-7 Colonial Way, Watford,
Hertfordshire, WD24 4YR
Date leaflet last revised: June 2014