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Active substance(s): DIAZEPAM / DIAZEPAM / DIAZEPAM

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DIAZEPAM PIL 29.07.2013:DIAZEPAM PIL 1617180713-01


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Patient Information Leaflet


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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What is Diazepam and what it is used for
2. What you need to know before you take Diazepam
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 is Diazepam and what it is 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 e.g.
migraine or tension headache and have a fast heart beat and may occur
alone or with insomnia (trouble sleeping) or mental health problems.
• helping muscle 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
• can take before operation to help with relaxation and to cause
In children
• helping to treat tension and irritability caused by cerebral spasticity
• helping to treat muscle spasm caused by tetanus(when taken with other
• Can use before operation but only with extreme caution (see section 2)

2. What you need to know before you take Diazepam

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)
• have severe breathing or chest problems
• are taking anti-psychotics, antidepressants, hypnotics, antihistamines
• have a phobia (a fear of a particular object or situation) or other
mental illness
• have ‘myasthenia gravis’ (very weak or tired muscles)
• suffer from ‘sleep apnoea’ (breathing problem when you are asleep)
• have serious liver problems
• suffer from a condition called ‘porphyria’ (inherited condition
causing skin blisters, abdominal pain and brain or nervous system
• have suffered from depression before
• planning a pregnancy or are pregnant (see below pregnancy and
breast feeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking this tablet if you
• have a history of alcoholism or drug abuse
• have problems with your lungs, heart, and liver or have severe
kidney failure
• have suffered a loss of bereavement
• have suicidal feelings, Since diazepam may increase the suicidal
• have low blood levels of a protein called albumin
• have personality disorder
• have poor blood supply to the brain (atheriosclerosis)
• are elderly (risk of confusion or clumsiness causing you to fall or
injure yourself)
• suffer from eye problem called glaucoma

• smoke
• are children (extreme caution required as the effects and timing of
action/response of diazepam used before operation in children may be
unreliable and/or paradoxical)
Other considerations
• 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.
• 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:
• antidepressants (eg fluvoxamine), antipsychotics ( to treat mental
problem eg zotepine), anxiolytics/sedatives (eg lorazepam),
antihistamines (to treat allergies), general anaesthetics, lofexidine
(to help relieve symptoms when you stop taking opioids), nabilone (to
treat nausea and vomiting), hypnotics (to help you sleep), alpha
blockers or moxonidine (to lower high blood pressure), muscle
relaxants (eg baclofen, tizanidine). Taking these medicines with
diazepam could make you very sleep
• some strong pain killers
• disulfiram (to treat alcohol addiction)
• medicine for epilepsy eg: phenobarbital, phenytoin, carbamazepine,
or sodium valproate
• cimetidine or omeprazole (for ulcers), oestrogen-containing,
contraceptives, erythromycin (an antibiotic), antifungal
(fluconazole, voriconazole) or isoniazid (to treat tuberculosis)
• rifampicin (to treat infections) or theophylline (to treat asthma)
• amrenavir or ritonavir (antivirals)
• medicines to lower high blood pressure, diuretics (water tablets),
nitrates (for heart conditions)
• levodopa (to treat Parkinson’s Disease)
• cisapride (to treat gastric reflux)
• antacids (reduces stomach acid)
Taking Diazepam tablets with food, drink and alcohol
• 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 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 in
late 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
You should not drive, operate machinery or take part in such activities
where, if affected, you could put yourself or others at risk as these
tablets can make you sleepy, forgetful; have poor co-ordination along
with other side effects that can affect everyday activities (see possible
side effects).
Diazepam tablet contains lactose
Diazepam tablets contain lactose (a type of sugar). If you have been told
that you have intolerance to some sugars contact you doctor before
taking this medicine.

3. How to take Diazepam

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.

DIAZEPAM PIL 29.07.2013:DIAZEPAM PIL 1617180713-01


Swallow the tablets whole, with a glass of water.
• Anxiety state: 2-5mg three times daily.
• To help you sleep: 5-15mg before retiring.
• Cerebral Spasticity: 2-60mg daily in divided dose.
• To help with alcohol withdrawal symptoms: 5-20mg, repeated if
necessary in 2-4 hours.
• Muscle spasm: 2-15mg in divided dose.
• Muscle spasm in tetanus: 3-10mg/kg daily by nasogastric tube.
• Epilepsy: 2-60mg daily in divided doses.
• Pre-medication: 5-20mg.
• For tension and irritability in cerebral spasticity: Child 5-12 years:
initially 5mg twice a day
Adolescent 12 to 18 years: initially 10mg twice daily
Maximum 40 mg daily in divided doses
• Muscle spasm in tetanus: children/ adolescents3-10mg/kg daily by nasogastric tube.
• Pre medication: use with extreme caution (increase risk of
inappropriate response- see section 2) 2-10mg before the procedure.
Elderly or debilitated patients
• Doses should not exceed half the adult dose. Treatment should always
be tapered off gradually (increased sensitivity to CNS effect)
• Patients with liver or kidney problems may also be given a lower dose.
• Patients who have taken benzodiazepam for prolonged time may
require a longer period of dosage reduction and specialist help may be
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
immediately. Signs of overdose include clumsiness and loss of
coordination, feeling sleepy or deep sleep, speech problems, irregular or
slow heartbeat, uncontrolled eye movement, muscle weakness or
paradoxical excitation. An extreme overdose may lead to coma
(unrousable unconsciousness), reflex problems and breathing

If you forget to take Diazepam tablets
If you forget to take your medicine for anxiety, you should take it as
soon as you remember if it is less than 3 hours since your usual time. If
more than 3 hours have passed, then just continue taking your next dose;
do not try to catch up by doubling up the dosage.

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 tablets you take before
stopping them completely. If you stop taking diazepam tablets
suddenly, you may experience unpleasant side effect including
depression, nervousness, irritability, sweating, quick or irregular
heartbeat, muscle spasm, shaking, loss of appetite, feeling or being
sick, stomach cramps or diarrhoea. If you have been taking a high
dose, you may occasionally experience confusion or unusual
behaviour. Patients at risk of convulsions may be more susceptible to
suffering fits on withdrawal.
• 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 change 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, although not
everybody gets them. If you experience any of the following serious side
effects, tell your doctor IMMEDIATELY
Symptoms of an allergic reaction e.g. itchy skin, swelling of the face, lips,
tongue or throat, or difficulty breathing or swallowing.
Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:
• drowsiness, tiredness, reduced alertness and muscle weakness are the
most common side effects
• sedation, slurred speech, dizziness, light-headedness, unsteadiness or
clumsiness and loss of co-ordination
• confusion, memory loss (which may be experienced several hours after
taking diazepam. If possible, to reduce the risk allow 7 to 8 hours of

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uninterrupted sleep after taking), seeing or sensing things that are not
there, inappropriate behaviour, difficulty in concentration,
agitation/irritability, restlessness, experiencing rage, excitement,
nightmares, numbed emotions, depression with suicidal tendencies,
headache, ‘spinning’ sensation
• blood disorders (you may develop sore throats, nose bleeds or
infections), yellowing of the skin or whites of the eyes (jaundice),
increased levels of liver enzymes in the blood
• changes in sex drive, enlargement of breasts in men
• visual disturbances, blurred or double vision
• low blood pressure
• stomach upsets, dry mouth, nausea, vomiting, constipation
• muscle spasms/shaking or weakness, breathing difficulties
• incontinence or difficulty passing urine, increase in amount of saliva
• you feel you are abusing or becoming dependant on this product
Withdrawal symptoms: see section 3, ‘if you stop 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:
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Diazepam

• Do not use this medicine after the expiry date stated on the
label/carton/bottle. The expiry date refers to the last day of that month.
• Store below 25˚c. Protect from light and moisture.
• Store in the original container. Keep the container tightly closed.
Keep all the medicines out of the sight and reach of children.
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 2mg tablets contain:
• The active substance is tablets contains 2mg of the active
ingredient diazepam B.P
• The other ingredients are lactose, maize starch, magnesium
stearate, colloidal silicon dioxide and sodium starch glycollate.
What Diazepam 5mg tablets contain:
• The active substance is tablets contains 5mg of the active ingredient
diazepam B.P
• The other ingredients are lactose, maize starch, magnesium stearate,
colloidal silicon dioxide, sodium starch glycollate and Tartrazine
What Diazepam 10mg tablets contain:
• The active substance is tablets contains 10mg of the active
ingredient diazepam B.P
• The other ingredients are lactose, maize starch magnesium stearate,
colloidal silicon dioxide, sodium starch glycollate and aluminium lake
patent blue V.
See end of section 2 for further information on lactose
What Diazepam tablets look like and contents of the pack:
• Diazepam 2mg tablets are white, flat, circular tablets with a bevelled
edge and breakline. Embossed ‘D/2’ on one face, ‘PV’ on the other.
• Diazepam 5mg tablets are yellow, flat, circular tablets with a
bevelled edge and breakline. Embossed ‘D/5’ on one face, ‘PV’ on
the other.
• Diazepam 10mg tablets are Blue, flat, circular tablets with a bevelled
edge and breakline. Embossed ‘D/10’ on one face, ‘PV’ on the other.
Pack sizes are Diazepam 2mg, 5mg & 10mg tablets are available in
the pack sizes of 28, 30, 50, 56, 100, 250, 500 and 1000 tablets. Not all
pack sizes may be marketed.

Marketing Authorization Holder and Manufacture:
Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
0208 997 5433
To request a copy of this leaflet in large print or audio format, please contact
the licence holder at the address (or telephone, fax) above.
Date leaflet last revised: July 2013

PL 04556/0016, 04556/0017 & 04556/0018
Reference: 001617180713/01

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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.