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OXAZEPAM 10 MG TABLETS

Active substance(s): OXAZEPAM

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Oxazepam
10 mg and 15 mg
Tablets
Oxazepam

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 yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Oxazepam is and what it
is used for
2. What you need to know before
you take Oxazepam
3. How to take Oxazepam
4. Possible side effects
5. How to store Oxazepam
6. Contents of the pack and
other information
1. What Oxazepam is and what
it is used for
Oxazepam belongs to a group of
medicines called benzodiazepines.
Oxazepam increases the actions of a
naturally occurring substance called
GABA, in the brain.
Oxazepam is used for the short-term
(2 - 4 weeks) treatment of anxiety, which is
severe, disabling, distressing and which may
be associated with sleeplessness or with
other illnesses.

Pharmacode
2. What you need to know before you
take Oxazepam

Pharmacode

Do not take Oxazepam
• if you are allergic to oxazepam, other
benzodiazepines, or any of the other
ingredients of this medicine (listed in
section 6)
• if you have severe breathlessness or
breathing difficulties
• if you suffer from Myasthenia Gravis (a
condition which causes muscles to weaken
and tire easily)
• if you have a phobia or obsession, or you
are being treated for a mental illness
• if you suffer from sleep apnoea (a condition
where you stop breathing when asleep)
• if you have severe problems with your liver
• if you are pregnant, might become
pregnant or are breast-feeding
Warnings and precautions
Talk to your doctor or pharmacist before
taking Oxazepam
• if you have problems with your liver,
kidneys or lungs
• if someone close to you has recently died
• If you have a history of alcoholism or drug
abuse. The risk of dependence to Oxazepam
increases in these patients, and with the
dose and length of treatment
• If you have a personality disorder
• if you suffer from depression (with or
without anxiety)
• if you have porphyria (an inherited
condition causing skin blisters, abdominal
pain and brain or nervous system disorders)
Other considerations when taking
Oxazepam are:
• Tolerance – if after a few weeks you notice
that the tablets are not working as well
as they did when you first started taking
them, you should see your doctor, as an
adjustment of your dose may be required.
• Dependence – when taking this type of
medicine there is a risk of dependence, which
increases with dose and length of treatment.
There is a greater risk in patients with a
history of alcohol or drug abuse.
• Withdrawal – treatment should be gradually
withdrawn. Some patients find that their
symptoms of difficulty sleeping and anxiety
reoccur when stopping treatment. This may
be accompanied by other reactions (see
section 3 of this leaflet under ‘If you stop
taking Oxazepam’).
• Amnesia – Oxazepam can cause memory
loss. To reduce the risk you should
ensure you are able to have 7-8 hours of

uninterrupted sleep.
• Psychiatric and ‘paradoxical’ reactions –
Oxazepam can cause restlessness, agitation,
irritability, aggressiveness, delusions (false
beliefs), rages, nightmares, hallucinations,
psychoses, inappropriate behaviour
and other behavioural disturbances. If
you experience any of these symptoms
Oxazepam treatment should be stopped.
Other medicines and Oxazepam
Tell your doctor if you are taking any of the
following medicines:
• antidepressants, antipsychotics, sedatives
(to calm you down), hypnotics (to help
you sleep) or strong pain killers e.g.
morphine, codeine, anaesthetics, sedating
antihistamines, lofexidine (to help relieve
symptoms when you stop taking opioids),
nabilone (to treat nausea and vomiting),
alpha blockers or moxonidine, muscle
relaxants (e.g. baclofen, tizanidine),
probenecid (used to treat gout).
These medicines act in the same way as
Oxazepam and could make you very sleepy
• medicines for epilepsy e.g. barbiturates or
phenytoin. These can make the side effects
of Oxazepam worse.
• oestrogen-containing contraceptives, as
these can cause Oxazepam to be
less effective.
• rifampicin (an antibiotic) as this can cause
Oxazepam to be removed from the body
more quickly than usual.
• antivirals such as zidovudine as Oxazepam
can cause zidovudine to be removed from
the body more slowly, or ritonavir (as this
can cause Oxazepam to be removed from
the body more slowly).
• medicines to lower high blood pressure as
Oxazepam can increase the effect of these
medicines.
• levodopa (to treat Parkinson’s disease) as
Oxazepam may reduce the effects of
levodopa.
Tell your doctor or pharmacist
if you are taking, have recently
taken or might take any other
medicines.
Oxazepam with alcohol
Do not drink alcohol while you
are taking Oxazepam. Alcohol
may increase the sedative
effects of Oxazepam and make
you very sleepy.
Pregnancy and breastfeeding
You should not take
Oxazepam if you are pregnant,
planning to become pregnant or if you
are breast-feeding. If you take Oxazepam
late in your pregnancy or during labour
your baby might have a low body
temperature, floppiness, breathing and
feeding difficulties. If you take this medicine
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
Oxazepam may make you feel sleepy, forgetful,
affect your concentration or may affect how
your muscles work. Do not drive or use any
tools or machines if you are affected in this
way and do not drink alcohol, as this will make
these effects worse.
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.
Oxazepam contains lactose (a type of sugar).
If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before
taking this product.

Pharmacode

Package leaflet: Information for the user

3. How to take Oxazepam
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
The number of tablets you take will depend
on what you are taking the tablets for. You
should not take Oxazepam for longer than
4 weeks, including time required for gradual
reduction of your dosage. Oxazepam should
be gradually withdrawn as adverse effects
have been observed on abrupt withdrawal.
Swallow the tablets whole with a glass
of water.

Date: 27 JAN 2014
Description Oxazepam 10/15mg 28
Component Type Leaflet
Affiliate Item Code 312331
Superceded Affiliate Item Code 10002841
TrackWise PR No. N/A
MA No.

04569/0102 & 0103

Packing Site/Printer Alphapharm
Supplier Code N/A
Sign-offs

Pharma Code TBC

No. of colours
Colours

1

Page Count
Black

SAP No. NA
Vendor Job No. 218576
Proof No. 5
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

Non-Print
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Time: 09:56
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Equate CMYK
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Dimensions 133 x 425.45mm

Body Text Size 9.5pt

Use in Adults
If you are taking the tablets for severe
anxiety the recommended dose is
15-30 mg three or four times daily.
If you are taking Oxazepam to help you sleep
if you have anxiety, the recommended dose
is 15-25 mg, but some patients may need up
to 50 mg. The dose should be taken one hour
before bedtime.
If you suffer from liver or kidney problems,
you may be prescribed a lower dose.
Use in children
Benzodiazepines should not be given to
children without careful assessment of the
need to do so; the duration of treatment
must be kept to a minimum.
Use in elderly and patients sensitive to
benzodiazepines
The recommended dose for severe anxiety is
10-20 mg three or four times daily.
If you have liver or kidney problems or
breathing difficulties you may be given a
lower dose.
If you take more Oxazepam than
you should
If you take more Oxazepam than you should
contact your doctor or nearest hospital
emergency department immediately. Take
the container and any remaining tablets
with you. Symptoms of an overdose include
drowsiness, confusion, difficulty speaking,
rapid eye movements and lack of energy.
More serious cases may cause loss of
coordination, low muscle strength, low blood
pressure, breathing difficulties or coma.
If you forget to take Oxazepam
If you forget to take a dose of Oxazepam take
it as soon as you remember, unless it is almost
time for your next dose, in which case miss
out the forgotten dose completely and carry
on as normal. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Oxazepam
Do not stop taking your
medicine without telling your
doctor. Treatment should be
gradually withdrawn as the
symptoms that Oxazepam
was used to treat will return
with more intensity than before
(rebound insomnia). Other
withdrawal symptoms could
include anxiety, restlessness
and mood changes; these will
however disappear with time.
If you have become physically
dependent on Oxazepam,
sudden withdrawal of treatment could lead
to symptoms such as depression, anxiety,
headaches, muscle pain, nervousness,
tension, restlessness, sleeplessness, irritability,
sweating or diarrhoea and occasionally
confusion, convulsions, unusual behaviour.
Other symptoms, such as persistent ringing in
the ears, involuntary movements, tingling or
numbness, abdominal pain, muscle cramps
and vomiting, may also occur. In more severe
cases, hypersensitivity to light, noise and
physical contact, hallucinations and epileptic
seizures have also been reported.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects

Description Oxazepam 10/15mg 28
Component Type Leaflet
Affiliate Item Code 312331
Superceded Affiliate Item Code 10002841
TrackWise PR No. N/A
MA No.

04569/0102 & 0103

Packing Site/Printer Alphapharm
Supplier Code N/A
Sign-offs

Pharma Code TBC

Psychological dependence may occur
meaning you think you cannot ever
sleep without taking Oxazepam. Use
(even at therapeutic doses) may lead to
physical dependence, which may result
in you suffering withdrawal effects and a
recurrence of your problems if you suddenly
stop Oxazepam treatment.
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 Oxazepam
Keep this medicine out of the sight and
reach of children.
Do not use Oxazepam after the expiry date
which is stated on the carton after 'EXP'.
The expiry date refers to the last day of that
month.
Store below 25°C. Store in the original
package. Store your medicine in a cool dry
place, away from light.
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 Oxazepam contains
• The active substance is oxazepam:
Each Oxazepam 10 mg tablet contains
10 mg of oxazepam.
Each Oxazepam 15 mg tablet contains
15 mg of oxazepam.
• The other ingredients are:
Oxazepam 10 mg tablets: lactose
monohydrate, maize starch, isopropyl
alcohol, povidone K30, magnesium
stearate, sodium starch glycollate.
Oxazepam 15mg tablets: lactose
monohydrate, maize starch, magnesium
stearate, quinoline yellow, erythrosine.
What Oxazepam looks like and contents of
the pack
Oxazepam 10 mg tablets: White tablet
marked 'OM' break line '10' on one side and
'G' on the other.
Oxazepam 15mg tablets: Pale yellow tablet
marked 'OM' break line '15' on one side and
'G' on the other
Oxazepam is available in blisters containing
28 tablets and containers containing 100,
250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
UK
Manufacturer
Generics [UK] Ltd. Potters Bar, Hertfordshire,
EN6 1TL, UK
Gerard Laboratories, 35-36 Baldoyle
Industrial Estate, Grange Road, Dublin 13,
Ireland

This leaflet was last revised in
January 2014

312331

Date: 27 JAN 2014

Time: 09:56

No. of colours
Colours

1

Page Count
Black

SAP No. NA
Vendor Job No. 218576
Proof No. 5
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

Pharmacode

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If you get any of the following serious side
effects, tell your doctor immediately.
Your doctor will need to gradually stop
your treatment:
• feeling over excited, nervous or irritable
• experiencing rage
• having nightmares and hallucinations
(feeling or seeing things that are not there)
• exhibiting inappropriate behaviour
• feeling restless, agitated, aggressive
• suffering from delusions (false beliefs)
and psychoses
• feeling depressed with suicidal thoughts
• memory loss
• jaundice (yellowing of the skin and whites
of the eyes)
Many of these side effects are more likely to
occur in children and the elderly.
The following side effects happen
predominantly at the start of the
treatment and usually disappear with
repeated administration:
• drowsiness during the day
• numbed emotions
• reduced alertness
• confusion
• headache
• dizziness, spinning sensation
• fainting
• feeling tired
• double vision
• lack of muscle coordination (ataxia)
• muscle weakness.

Other side effects that occur
occasionally are:
• stomach upset, feeling sick
• skin rashes or itching
• changes in sexual drive
• oedema (swollen hands and feet)
• blood problems, including low white
blood cells which may cause frequent
infections such as fever, severe chills, sore
throat or mouth ulcers
• feeling unusually tired
• low blood pressure which may cause
dizziness or lightheadedness
• blurred vision, disorientation,
dreams, tremor
• slurred speech or difficulty in speaking,
salivation changes
• loss of control of your bladder or difficulty
passing urine
• an increase in liver enzymes (shown in a
blood test)

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xxx

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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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