DIAZEPAM TABLETS BP 10MG

Active substance: DIAZEPAM

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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
2
3
4
5
6

and what they are used for
Before you take
How to take
Possible side effects
How to store
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)
• are breathless or have difficulty 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
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• have myasthenia gravis (a condition which causes muscles to weaken and
tire easily)
• suffer from sleep apnoea ( a condition where you stop breathing whilst
asleep)
• 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 breastfeeding).

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
someone close to you 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 (risk of confusion or clumsiness causing you to fall or injure
yourself).
• smoke








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.
Especially:
• antidepressants, antipsychotics (to treat mental problems eg zotepine),
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
sleepy.
• some strong pain killers 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.
• 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 eg phenobarbital, phenytoin, carbamazepine, or
sodium valproate, (diazepam can affect the blood levels of these medicines).
• cimetidine or omeprazole (for ulcers), oestrogen-containing
contraceptives, erythromycin (an antibiotic), antifungals (fluconazole,
voriconazole) or isoniazid (to treat tuberculosis) as these can cause
diazepam to be removed from the body more slowly than usual.
• rifampicin (to treat infections) or theophylline (to treat asthma) as 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, diuretics (water tablets), nitrates
(for heart conditions) as these could lower your blood pressure too much.
• levodopa (to treat Parkinson’s Disease) as diazepam may cause levodopa to
not work so well.
• antacids (reduces stomach acid) may slow down absorption of diazepam in
the body.
Continued over page

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 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.

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.
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.
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.
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.

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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
effects including depression, nervousness, irritability, sweating , quick or irregular
heartbeat, muscle spasms, 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 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, Diazepam tablets can cause side-effects, although not everybody
gets them.
Stop treatment and contact a doctor at once if you have the following symptoms
of an allergic reaction e.g. itchy skin, rash, 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, 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, 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), seeing or sensing things that are not there, inappropriate behaviour,
difficulty concentrating, agitation/irritability, restlessness, experiencing rage,
excitement, numbed emotions, depression with suicidal tendencies, headache,
‘spinning’ sensation
• blood disorders (you may develop sore throats, nose bleeds or infections) changes
in sex drive, visual disturbances, low blood pressure, stomach upsets, yellowing of
the skin or whites of the eyes (jaundice)
• muscle spasms/shaking or weakness, breathing difficulties
• 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 tablets’.
If you notice any side effects, they get worse, or if you notice any not
listed, please tell your doctor or pharmacist.

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 look like and contents of the pack
Diazepam tablets are uncoated tablets in the following colours:
2mg- white, 5mg- yellow, 10mg- blue
Pack sizes are 28 tablets.
Marketing Authorisation Holder and
Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK.
Date of Revision: March 2011

Actavis, Barnstaple, EX32 8NS, UK

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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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