OXAZEPAM TABLETS 10MG

Active substance: OXAZEPAM

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OXAZEPAM 10 mg,
15 mg & 30 mg
TABLETS
(oxazepam)

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 Oxazepam is and what it
is used for.
2. Before you take Oxazepam.
3. How to take Oxazepam.
4. Possible side effects.
5. How to store Oxazepam.
6. Further information.
1. WHAT OXAZEPAM IS AND
WHAT IT IS USED FOR
Oxazepam belongs to a group of
medicines called
benzodiazepines. It is not clear
exactly how this medicine works but it is
thought that Oxazepam increases the
actions of a naturally occurring
substance called GABA, in the brain.
Oxazepam is used for the shortterm (2-4 weeks) treatment of anxiety,
which is severe, disabling, distressing
and which may be associated with
sleeplessness or with other illnesses.

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2. BEFORE YOU TAKE OXAZEPAM
Do not take Oxazepam:
• if you are allergic (hypersensitive) to
oxazepam or any of the other
ingredients in your tablets
• 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 are being treated for 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.

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.

Taking other medicines - Tell you 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.
These medicines act in the same way
as oxazepam and could make you very
sleepy
• anaesthetics or sedative antihistamines.
• medicines for epilepsy e.g. barbiturates
or phenytoin.
These can make the side effects of
oxazepam worse.
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including
medicines obtained without a
prescription.

Pregnancy and
breast-feeding - 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 (please see the
next section).

Driving and using machines - Oxazepam
may make you feel sleepy or affect your
concentration. 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.

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

Important information about some of
the ingredients of Oxazepam Oxazepam 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxazepam can cause
side effects, although not everybody
gets them.

3. HOW TO TAKE OXAZEPAM

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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.

If you have become physically
dependent on Oxazepam, sudden
withdrawal of treatment could lead to
symptoms such as depression, anxiety,
headaches, nervousness, sleeplessness,
irritability, sweating or diarrhoea and
occasionally confusion, convulsions or
unusual behaviour. Other symptoms,
such as persistent ringing in the ears,
involuntary movements, tingling or
numbness, convulsions, abdominal and
muscle cramps and vomiting, may also
occur. In more severe cases, it has also
been reported hypersensitivity to light,
noise and physical contact,
hallucinations and epileptic seizures.

Ask your doctor or pharmacist for advice
before taking any medicine.

Adults - If you are taking the tablets for
severe anxiety the usual dose is 15-30 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 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 such withdrawal
symptoms could include
anxiety, restlessness and
mood changes, these will however
disappear with time.

Taking Oxazepam with food
and drink - Do not drink
alcohol while you are taking
Oxazepam. Alcohol may
increase the sedative effects
of Oxazepam and make you
very sleepy.

Always take Oxazepam exactly as your
doctor has told you. You should 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 anxiety for longer than
8 to 12 weeks, including the time
required for gradual reduction of your
dosage. For insomnia associated with
anxiety, the maximum duration of
treatment is 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.

Elderly - The recommended dose for
severe anxiety is 10-20 mg three or four
times daily.

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
• feeling weak and tired
• double vision
• lack of muscle coordination (ataxia)
• muscle weakness.
Other side effects that occur
occasionally are:
• stomach upsets
• skin rashes or itching
• lack of sexual drive
• oedema (swollen hands and feet)
• blood problems

• jaundice (yellowing of the skin and
whites of the eyes)
• feeling unusually tired.
The following side effects have also
been reported:
• 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.
These effects may be severe and are
more likely in the elderly. When these
reactions occur, you should tell your
doctor immediately as your doctor will
need to stop your treatment.
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.
If any side effect gets serious,
or if you notice any side effects
not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE OXAZEPAM
• Keep your tablets out of the reach and
sight 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 your medicine
in a cool dry place, away from light.
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 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 Oxazepam.
Each Oxazepam 30 mg tablet contains
30 mg of Oxazepam.
• The other ingredients are lactose
monohydrate, maize starch and
magnesium stearate. The 10 mg tablet
contains isopropyl alcohol, povidone
and sodium starch glycollate. The 15 mg
and 30 mg tablets also contain
Quinoline Yellow and Erythrosine.
What Oxazepam looks like and
contents of the pack - The Oxazepam
10 mg tablet is white and marked 'OM' breakline - '10' on one side and 'G' on
the other. The Oxazepam 15 mg tablet
is pale yellow and marked 'OM' breakline - '15' on one side and 'G' on
the other. The Oxazepam 30 mg tablet
is orange and marked 'OM' - breakline '30' on one side and 'G' on the other.
Oxazepam is available in blisters
containing 28 tablets and bottles
containing 100, 250, 500 and 1,000
tablets. Not all pack sizes may be
marketed.

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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

If you suffer from liver or kidney
problems, you may be prescribed a
lower dose.

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Take special care with Oxazepam - You
should tell your doctor before taking
this medicine if:
• you have problems with your liver,
kidneys or lungs
• someone close to you has recently died
• 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
• you have a personality disorder.

If you are taking Oxazepam to help you
sleep, the usual dose is 15-25 mg, but
some patients may need up to 50 mg.
The dose should be taken one hour
before bedtime.

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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Marketing Authorisation Holder and
Manufacturer: Generics [UK] Limited t/a
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

This leaflet was last approved in:
December 2010

10002841

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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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