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Active substance: DIAZEPAM

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231-30-83648-Z LEA DIAZEPAM 2mg, 5mg AND 10mg TAB TUK



07 May 2015




Pharma code 37


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
• have problems with your heart and lungs or have severe kidney
• have low blood levels of a protein called albumin
• have a poor blood supply to the brain (arteriosclerosis)
• are elderly (risk of confusion or clumsiness causing you to fall or
injure yourself)
• smoke.

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.
• 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 if you are pregnant, planning to
become pregnant or are breast-feeding. 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,
Other important things to remember when taking Diazepam:
floppiness, and breathing and feeding difficulties. If this medicine is
• Dependence: When taking this medicine there is a risk of
dependence (a need to keep taking the medicine). The risk increases taken regularly in late pregnancy, your baby may develop withdrawal
symptoms. Ask your doctor or pharmacist for advice before taking
with the dose and length of treatment period. The risk is greater if
you have ever had a history of alcohol or drug abuse, or suffer from any medicine.
a personality disorder.
Driving and using machines
• Withdrawal: When stopping this medicine you may experience
• Your tablets may make you confused, forgetful, drowsy, unsteady
withdrawal effects and withdrawal symptoms occur with Diazepam
or affect your co-ordination along with other side effects that can
even when normal doses are given for short periods of time. (see
affect everyday activities (see Possible side effects). These effects
section 3, If you stop taking Diazepam). Treatment should be
may be increased if you have not had enough sleep. DO NOT drive
gradually withdrawn.
or operate machinery if you are affected.
• Tolerance: if after a few weeks you notice that the tablets are not
working as well as they did when first starting treatment, you
The medicine can affect your ability to drive as it may make you
should speak to your doctor.
sleepy or dizzy.
• Behavioural effects may occur while taking Diazepam (see section 4,
• Do not drive while taking this medicine until you know how it
Possible Side Effects)
affects you.
• To reduce the risk of amnesia (loss of memory), you should make
• It is an offence to drive if this medicine affects your ability to
sure that you are able to have an uninterrupted sleep of at least
7 hours
• Tell the hospital or dentist you are taking Diazepam if you are to
However, you would not be committing an offence if:
have an operation requiring an anaesthetic.
• The medicine has been prescribed to treat a medical or dental
Taking other medicines
problem and
Avoid Diazepam in combination with:
• You have taken it according to the instructions given by the
• sodium oxybate (used to prevent attacks of cataplexy (episodes of
prescriber or in the information provided with the medicine and
muscle weakness that begin suddenly and last for a short time) in
• It was not affecting your ability to drive safely
patients who have narcolepsy (a sleep disorder that may cause
extreme sleepiness, sudden uncontrollable urge to sleep during
Talk to your doctor or pharmacist if you are not sure whether it is
daily activities, and cataplexy)).
safe for you to drive while taking this medicine.
• zidovudine (HIV/AIDS drug).


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Talk to your doctor if you are taking any of the following:
• antidepressants e.g. amitriptyline, fluvoxamine or fluoxetine,
antipsychotics e.g. chlorpromazine, haloperidol (to treat mental
problems e.g zotepine), antihistamines with a sedative effect (for
allergies) e.g. chlorphenamine, promethazine, , general
Read all of this leaflet carefully before you start taking this medicine.
anaesthetics, lofexidine (to help relieve symptoms when you stop
• Keep this leaflet. You may need to read it again.
taking opioids), nabilone (to treat nausea and vomiting), hypnotics
• If you have any further questions, ask your doctor or pharmacist.
e.g. temazepam, zopiclone (to help you sleep), alpha blockers or
• This medicine has been prescribed for you. Do not pass it on to others.
moxonidine (to lower high blood pressure), muscle relaxants (e.g
It may harm them, even if their symptoms are the same as yours.
baclofen, tizanidine), anxiolytics/sedatives e.g. lorazepam,
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
Taking these medicines with diazepam could make you very
section 4.
• some strong pain killers (e.g. codeine, co-proxamol) may give you
a heightened sense of well being when taken with diazepam, which
1. What Diazepam is and what it is used for
can increase your desire to continue taking these medicines
2. Before you take Diazepam
(dependency) or can make you very sleepy.
3. How to take Diazepam
• lofexidine (used for the management of withdrawal symptoms in
4. Possible side effects
patients undergoing heroin or opiate detox), nabilone (used for
5. How to store Diazepam
treatment of feeling and being sick), disulfiram (to treat alcohol
6. Further information
addiction), baclofen and tizanidine (used to relieve muscle
spasms). 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,
Diazepam Tablets belong to a group of drugs called benzodiazepines
carbamazepine, or sodium valproate, (diazepam can affect the
which promote sleep and relieves anxiety by altering brain activity
blood levels of these medicines).
concerned with emotion.
• cimetidine or omeprazole or esomeprazole (for ulcers),
Diazepam is used:
oestrogen-containing contraceptives, erythromycin (an antibiotic),
• for the short term (2 - 4 weeks) relief of severe anxiety
antifungals (itraconazole, ketoconazole, fluconazole, voriconazole)
• to relax muscles
or isoniazid (to treat tuberculosis) as these can cause diazepam to
• for the short term relief of difficulty in sleeping (when it is severe
be removed from the body more slowly than usual.
and causing distress)
• rifampicin (to treat infections) or theophylline (to treat asthma) as
• to relax or sedate people undergoing certain uncomfortable medical
this can cause diazepam to be removed from the body more
quickly than usual.
• amrenavir or ritonavir (antivirals) as these can make you feel
sleepy for longer or cause difficulty breathing.
• medicines to lower high blood pressure (e.g. hydralazine,
minoxidil, sodium nitroprusside), diuretics (water tablets), nitrates
DO NOT take Diazepam if you:
(for heart conditions), ACE inhibitors (used to treat high blood
• are allergic (hypersensitive) to diazepam or benzodiazipines, or any
pressure, e.g. perindopril, captopril), alpha-blockers (used to treat
of the other ingredients of this medicine
high blood pressure , e.g. alfuzosin, prazosin), angiotensin–II
• have long-term or severe liver problems
receptor antagonists (used to treat high blood pressure, e.g.
• suffer from severe breathing problems
valsartan), calcium channel blockers (used to treat high blood
• suffer from sleep apnoea (difficulty breathing while asleep)
pressure, e.g. amlodipine), adrenergic neurone blockers (used to
• suffer from myasthenia gravis (a disorder where muscles become
treat high blood pressure, e.g. reserpine), beta-blockers (used to
weak and tire easily)
treat high blood pressure, e.g. bisoprolol) as these could lower
• suffer from mental illness, such as phobias, or obsessions
your blood pressure too much.
• suffer from depression (with or without anxiety) or hyperactivity
• levodopa (to treat Parkinson’s Disease) as diazepam may cause
• have porphyria (an inherited condition causing skin blisters,
levodopa to not work so well.
abdominal pain and brain or nervous system disorders)
• antacids (reduces stomach acid) may slow down absorption of
• suffer from hyperkinesia (a state of overactive restlessness)
diazepam in the body.
• planning a pregnancy or are pregnant (see below Pregnancy and
• cisapride (used to treat gastric reflux)

DIAZEPAM 2 mg, 5 mg
and 10 mg TABLETS



231-30-83648-Z LEA DIAZEPAM 2mg, 5mg AND 10mg TAB TUK


07 May 2015


Important information about some of the ingredients of Diazepam
• 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.

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



Like all medicines, Diazepam can cause side effects, although not
everybody gets them.

Stop taking the tablets and tell your doctor immediately or go to
the casualty department at your nearest hospital if the following
Always take Diazepam Tablets exactly as your doctor has told you. You • an allergic reaction (swelling of the lips, face or neck leading to
severe difficulty in breathing; skin rash or hives).
should check with your doctor or pharmacist if you are not sure. You
This is a very serious but rare side effect. You may need urgent
should continue to take these tablets for as long as your doctor tells
medical attention or hospitalisation.
you to. The tablets should be swallowed with a drink of water.



Your doctor will decide on the correct dosage; the usual dose is:
• Adults: 2 mg three times daily. If your symptoms are severe you
may be given 15 – 30 mg daily taken in divided doses.
Muscle spasm:
• Adults: 2 - 60 mg daily taken in divided doses.
• Children : 2 - 40 mg daily taken in divided doses.
For both adults and children the dose is dependent on the
symptoms, your doctor will decide on the correct dosage.
Trouble in sleeping associated with anxiety:
• Adults: 5 - 15 mg before going to bed. Do not take more than the
maximum dose.
• Adults: 5 - 20 mg
• Children: 2 - 10 mg

Tell your doctor immediately if you suffer from:
• behavioural changes such as restlessness, agitation, irritability,
aggressiveness, delusions, rages, nightmares, seeing or sensing
things that are not there, psychiatric disorders and inappropriate
behaviour, as your treatment may be stopped.

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.

Rarely, jaundice (characterised by the yellowing of the skin or the
whites of the eyes) and very rarely increased levels of liver enzymes
in the blood may occur.

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.

Withdrawal effects are known to occur (see section 3, If you stop
taking Diazepam)

Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:
• drowsiness, sedation, tiredness, slurred speech, light-headedness,
unsteadiness or
clumsiness and loss of co-ordination (you may notice these even
after a single dose and this may continue into the following day)
• confusion (particularly in the elderly), memory loss (which may be
experienced several hours after taking diazepam. If possible, to
reduce the risk allow 7 to 8 hours of uninterrupted sleep after
taking), poor concentration, excitement, numbed emotions,
reduced alertness depression with suicidal tendencies, headache,
‘spinning’ sensation, difficulty sleeping, anxiety
Your doctor will want to carefully assess children given Diazepam and
• blood disorders (you may develop sore throats, nose bleeds or
keep length of treatment as short as possible.
infections) changes in sex drive, low blood pressure
• muscle spasms/shaking or weakness, difficulty in controlling
Elderly and Debilitated (very frail) patients:
movements, breathing difficulties
Normally the starting dose is half of the ordinary adult dose. If you are
• incontinence or problems passing urine.
elderly or frail you are likely to be more sensitive to the effects of
• you feel you are abusing or becoming dependant on this product
Diazepam, such as confusion, and your doctor will give you much
• visual disturbances, blurred or double vision
lower doses. The dose should not be more than half the adult dose.
• nausea, vomiting, stomach problems, dry mouth, diarrhoea,
Patients with liver problems:
constipation, the production of too much or too little saliva
Your doctor may prescribe a lower dose.
• skin reactions.

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.
Signs of an overdose include clumsiness and loss of coordination,
feeling sleepy or deep sleep, speech problems or slurred speech,
irregular or slow heartbeat, difficulty in controlling movements,
uncontrolled eye movement, muscle weakness or excitement, low
blood pressure. An extreme overdose may lead to coma (unrousable
unconsciousness), reflex problems and breathing difficulties.
Please take this leaflet, any remaining tablets, and the container with
you to the hospital or doctor so that they know which tablets were
If you forget to take Diazepam
If you forget to take a tablet, take one as soon as you remember,
unless it is nearly time to take the next one. DO NOT take a double
dose to make up for a forgotten tablet.
If you stop taking Diazepam
DO NOT stop taking your tablets suddenly, or without your doctor
telling you, as you may suffer from withdrawal effects.
If your doctor decides to stop your tablets, they will reduce the dose
gradually to minimise any withdrawal effects, which may include:
• headache, muscle pain, tension
• severe anxiety, confusion, restlessness, depression, nervousness,
sweating, quick or irregular heartbeat, muscle spasms, shaking,
loss of appetite, feeling or being sick, stomach cramps or diarrhoea
and irritability.
• in severe cases of withdrawal you may experience a feeling of
things being unreal, a feeling of detachment from your
surroundings, numbness and tingling in the hands and feet, sounds
seeming to be louder than usual and which can sometimes be
painful if the sound is loud, sensitivity to light or touch,
hallucinations and fits.
• 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 changes in sleep
patterns. Even when you stop taking Diazepam gradually, you may
feel anxious, depressed and restless and have difficulty sleeping.
You may also experience sweating and diarrhoea. If this happens
go to your doctor for advice.


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Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.



Keep out of the reach and sight of children.
These tablets should be stored at or below 25oC and protected from
moisture and light in the package or container supplied. Do not
transfer them to another container.
Do not use Diazepam after the expiry date that is stated on the outer
packaging. 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.



What Diazepam Tablets contain:
• The active ingredient is diazepam 2 mg, 5 mg, or 10 mg.
• The other ingredients are lactose monohydrate, powdered
cellulose, maize starch and magnesium stearate (E572). The 5 mg
tablet also contains the colours quinoline yellow (E104) and
sunset yellow (E110). The 10 mg tablet contains the colour indigo
carmine (E132).
What Diazepam Tablets look like and contents of the pack:
• Diazepam Tablets 2 mg are white, flat, bevel edged tablets. They
are engraved “Berk 2” with a breakline on reverse or “2” with a
breakline on reverse.
• Diazepam Tablets 5 mg are yellow, flat, bevel edged tablets. They
are engraved “Berk 5” with a breakline on reverse or “5” with a
breakline on reverse.
• Diazepam Tablets 10 mg are blue, flat, bevel edged tablets. They
are engraved “Berk 10” with a breakline on reverse or “10” with a
breakline on reverse.
The tablets are available in pack sizes of 7, 10, 14, 21, 28, 30, 56, 60,
84, 90, 100, 110, 112, 120, 150, 160 or 168.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: May 2015
PL 00289/0164-0166


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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.