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OXAZEPAM TABLETS BP 15MG

Active substance(s): OXAZEPAM

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Oxazepam 10mg and
15mg 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.

Other considerations

In this leaflet:
1 What Oxazepam tablets are and what
they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

Taking other medicines

1 W
 hat Oxazepam tablets are and what they are
used for

Oxazepam belongs to a group of medicines called benzodiazepines.
Oxazepam tablets may be used for the short term (maximum of 2-4
weeks) treatment of anxiety, which is disabling or distressing and may
be associated with sleeplessness or other illnesses.

2 Before you take

Do not take Oxazepam tablets and tell your doctor if you
• are allergic (hypersensitive) to oxazepam or to other
benzodiazepine medicines or to any of the other ingredients in your
tablets (see section 6)
• are breathless or have difficulty breathing
• have a phobia (a fear of a particular object or situation), obsessions
or other mental illness
• 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.
Check with your doctor or pharmacist before taking Oxazepam
tablets if you
• suffer from depression (with or without anxiety)
• have a history of alcoholism or drug abuse
• have problems with your lungs, liver or kidneys
• have a personality disorder
• have porphyria (an inherited condition causing skin blisters,
abdominal pain and brain or nervous system disorders).

Continued top of next column

•D
 ependence - 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.
• T olerance – 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.
•W
 ithdrawal – treatment should be gradually withdrawn. Withdrawal
symptoms occur with Oxazepam tablets even when normal doses
are given for short periods of time. See Section 3, ‘If you stop taking
Oxazepam tablets.’
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. Especially:
• a ntidepressants, antipsychotics (to treat mental problems),
sedative antihistamines eg chlorphenamine (to treat allergies),
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, muscle
relaxants (eg baclofen, tizanidine), probenecid (used to treat gout).
Taking these medicines with Oxazepam could make you very sleepy.
• some strong pain killers may give you a heightened sense of well
being when taken with Oxazepam, which can increase your desire
to continue taking these medicines (dependency) or can make you
very sleepy.
•m
 edicines for epilepsy eg hydantoins, in particular phenytoin, or
barbiturates (Oxazepam may make side effects more likely).
•o
 estrogen-containing contraceptives, as these can cause
Oxazepam to be less effective.
• r ifampicin (an antibiotic) as this can cause Oxazepam to be removed
from the body more quickly than usual.
• medicines to lower high blood pressure (increased effect).
• l evodopa (to treat Parkinson’s Disease) as Oxazepam may cause
levodopa to not work so well.

Taking Oxazepam tablets with food and drink

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

Pregnancy and breast-feeding

You should not take Oxazepam tablets if you are pregnant, planning
to become pregnant or are breast feeding. If you take Oxazepam
tablets late in your 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

Oxazepam tablets may affect how your muscles work or may
make you feel sleepy or forgetful. It may also impair your alertness
(especially if you don’t have enough uninterrupted sleep). Do not
drive or use any tools or machines if you are affected in this way.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
Continued over page

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Oxazepam 10mg & 15mg 28 Tablets PIL - UK
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Oxazepam Tablets
10 & 15mg x 28’s (UK)
JDE No.:

50868131

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6693
Date Sent:
31/07/15
Technologist: R.Wrey
Technically Approved

* Please note that only Actavis Global Artwork Studios are permitted to make
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• 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

4 Possible Side Effects

Like all medicines, Oxazepam tablets can cause side-effects, although not
everybody gets them.
Contact your doctor at once if the following symptoms occur:
• restlessness, agitation, irritability, aggressiveness, delusion, experiencing
rages, nightmares, hallucinations (seeing or hearing things that are not
there), psychoses (loss of contact with reality), inappropriate behaviour
(more likely to occur in children and the elderly), depression with feelings
of suicide.

Talk to your doctor or pharmacist if you are not sure whether it is safe for
you to drive while taking this medicine.

Tell your doctor if you notice any of the following side effects or notice any
other effects not listed:
• mild drowsiness and light-headedness may occur during the first few days
of treatment.
• allergic reaction: skin rashes, itching
• dizziness, fainting, loss of co-ordination, ‘spinning’ sensation or headache
with or without drowsiness, tiredness
• becoming less alert, disorientation, dreams, confusion, excitement,
numbed emotions, slurred speech or speech disorder, loss of memory,
lack of muscle control / co-ordination, difficulty in controlling movements,
changes in perception
• changes in blood cells, if you notice increased bruising, nosebleeds, sore
throats, infections, excessive tiredness, breathlessness on exertion, or
abnormal paleness of the skin, you should tell you doctor who may want
to have a blood test, reduction in white blood cells, changes in sex drive,
blurred or double vision, low blood pressure, muscle weakness, tremor,
fever, tiredness
• stomach upsets or cramps, feeling sick, changes in saliva
• yellowing of the skin or whites of the eyes (jaundice), increased
liver enzymes seen in tests, difficulty passing urine, water retention,
incontinence

Important information about some of the ingredients of
Oxazepam tablets

Oxazepam 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 Oxazepam tablets exactly as your doctor has told you. You
should not take Oxazepam tablets for longer than 4 weeks. You should
check with your doctor or pharmacist if you are not sure.
You should make sure you are able to have 7-8 hours of uninterrupted sleep.
Swallow the tablets whole, with a glass of water.
Doses
• Anxiety: 15-30mg three or four times a day.
•A
 nxiety associated with sleeplessness: 15-25mg one hour before going
to bed, your doctor may increase this up to a maximum of 50mg.
• E lderly and patients sensitive to benzodiazepine drugs: 10-20mg three
or four times a day.
• Children: Not recommended.
These tablets should be taken as instructed - swallowed with water. This
medicine should be taken for as long as your doctor tells you to, it may
be dangerous to stop without their advice. Treatment should not usually
exceed 2-4 weeks and should be gradually withdrawn as adverse effects,
such as anxiety, depression, headache, insomnia, tension and sweating
have been observed on abrupt withdrawal.

Withdrawal symptoms: see Section 3, ‘If you stop taking Oxazepam
tablets.’

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

If you take more Oxazepam 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 loss of coordination, feeling sleepy, confusion, lethargy,
rapid eye movements, speech problems. An extreme overdose may
lead to low blood pressure, breathing difficulties or coma (unrousable
unconsciousness).

By reporting side effects you can help provide more information on the
safety of this medicine.

5 How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place protected from light.
Do not use Oxazepam 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.

If you forget to take Oxazepam 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.

If you stop taking Oxazepam 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 Oxazepam tablets suddenly, you
may experience unpleasant side effects including headaches, muscle
pain or cramp, extreme anxiety, tension, stomach cramps, insomnia,
being sick, confusion, ringing in the ears, involuntary movements, ‘pins
and needles’, depression or sweating. If you have been taking a high
dose, you may occasionally experience confusion, convulsions, unusual
behaviour (derealisation (feeling the world around you is not real) or
depersonalisation (feeling your mind is becoming separated from your
body), such as hypersensitivity to light, noise and physical contact,
abnormally acute hearing and painful sensitivity to sound numbness and
tingling of the extremities, hallucinations.
• Treatment should be gradually withdrawn otherwise the symptoms you
are being treated for may return more intense than before (rebound
insomnia and anxiety).

6 Further Information

What Oxazepam tablets contain:

• The active substance (the ingredient that makes the tablet
work) is Oxazepam. Each tablet contains either 10mg or
15mg of the active ingredient.
• The other ingredients are colloidal silica, lactose, magnesium
stearate, maize starch, microcrystalline cellulose (E460).
• The 10mg tablets also contain sodium lauryl sulfate.
What Oxazepam tablets looks like and contents of the
pack
Oxazepam tablets are white, uncoated tablets.
Pack sizes are 28 tablets.
Marketing Authorisation Holder and Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK.

The risk of this happening is greater when you stop taking Oxazepam
suddenly. You may also experience mood changes, anxiety, restlessness or
changes in sleep patterns.

Date of Revision: August 2015.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
Continued top of next column
50868131 AAAI2038

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Oxazepam 10mg & 15mg 28 Tablets PIL - UK
item no:
print proof no:
origination date:
originated by:
approved for print/date

AAAI2038
1
18.08.15

1. Black
148 x 210 Reel fed

min pt size:

7pt

Actavis UK

4.
5.
6.
Non Printing Colours

Technical Approval

revised by:

2.
3.

pharmacode:

DR

revision date:

supplier:

dimensions:

colours/plates:

date sent:

NA

technically app. date:

NA

1. Profile
2.
3.

Oxazepam Tablets
10 & 15mg x 28’s (UK)
JDE No.:

50868131

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6693
Date Sent:
31/07/15
Technologist: R.Wrey
Technically Approved

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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