OXAZEPAM TABLETS 10MG

Active substance: OXAZEPAM

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PATIENT INFORMATION LEAFLET

Oxazepam 10mg and 15mg 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.
What is in this leaflet
1. What Oxazepam Tablets are and what they are used for
2. Before you take Oxazepam Tablets
3. How to take Oxazepam Tablets
4. Possible side-effects
5. How to store
6. Further Information

1. WHAT OXAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Oxazepam Tablets. Oxazepam is a member of a
group of medicines called ‘benzodiazepines’. Oxazepam is prescribed 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.
This medicine should be used for as short a time as possible and should not be
used for more than four weeks. If used for too long without a break, there is a risk
of becoming dependant or of having problems when you stop taking it.
When taking this medicine there is a risk of dependence (a need to keep taking
the medicine). The risk increases with the dose and length of treatment period.
The risk is greater if you have ever had a history of alcohol or drug abuse.

2. BEFORE YOU TAKE OXAZEPAM TABLETS
Do not take Oxazepam Tablets and tell your doctor:
• if you are allergic (hypersensitive) to Oxazepam or to other benzodiazepine
medicines or any of the ingredients in your tablets (see section 6)
• have a phobia (a fear of a particular object or situation), obsessions or other
mental illness
• if you have severe breathing or chest problems
• if you suffer from sleep apnoea (breathing problems when you are asleep)
• if you have myasthenia gravis (very weak or tired muscles)
• if you have serious liver problems
Talk to your doctor or pharmacist:
• if you are pregnant, or trying to become pregnant (see below)
• if you abuse or have in the past abused drugs or alcohol
• if you have any lung, kidney or liver problems
• if you are suffering from depression, since oxazepam may increase any suicidal
feelings which you may have
• if you have suffered from depression before, since it could recur during
treatment with oxazepam
• if you have a personality disorder
• if you suffer from breathing problems
• if you are suffering from an eye problem called glaucoma.
Taking Oxazepam with alcohol
Do not drink alcohol while you are taking Oxazepam tablets. Alcohol may
increase the sedative effects of Oxazepam tablets and make you very sleepy.
Other considerations
• Dependance – 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 you first started treatment, you should speak to your doctor.
• Withdrawal – treatment should gradually be 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’.
Taking other medicines
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), sedative
antihistamines eg chlorphenamine (to treat allergies), anaesthetics, lofexidine (to
help relieve symptoms when you stop taking opoids), 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) or
medicines containing alcohol. Taking these medicines with Oxazepam could
make you very sleepy.
• Some strong pain killers may give you a heightened sense of wellbeing when
taken with Oxazepam, which can increase your desire to continue taking these
medicines (dependency) or can make you very sleepy.
• Medicines for epilepsy eg hydantoins, in particular phenytoin, or barbiturates
(Oxazepam may make side effects more likely).
• 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.
• Antiviral medication, eg Zidovudine (this may remain in the body longer than
usual when used with Oxazepam) and Ritonavir (this can cause Oxazepam to
remain in the body longer than usual)
• Medicines to lower high blood pressure (increased effect)
• Medicines used to inhibit liver enzymes (increases effects of Oxazepam)
• Levodopa (to treat Parkinson’s Disease) as Oxazepam may cause levodopa to
not work as well).
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, might become pregnant or breastfeeding.
If you and your doctor decide that you should take this medicine towards the end
of your pregnancy (or during labour) this may harm your baby. The baby may
have a low body temperature, be listless, have breathing problems or difficulty in
feeding. Also, if you take this medicine regularly during your pregnancy, your
baby may get withdrawal symptoms.
Driving and using machines
Oxazepam may make you feel dizzy or sleepy during the day, or may affect your
concentration. This may affect your performance at skilled tasks such as driving
and operating machinery.
The medicine can affect your ability to drive as it may make you feel 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.
Important information about some of the ingredients of Oxazepam Tablets
This medicine contains lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
Please read the back of this leaflet.
* Trademark

24962702

GEN/OXP/PIL/263_08
12/08/2014

3. HOW TO TAKE OXAZEPAM TABLETS
Always take Oxazepam Tablets exactly as your doctor has told you. You should
not take Oxazepam Tablets for longer than 4 weeks. The label on your medicine
should also tell you. You should check with your doctor or pharmacist if you are
not sure. Oxazepam Tablets should be swallowed with water. Where possible, you
should aim to have 7-8 hours of undisturbed sleep after taking your tablets.
Adults
- Anxiety: The usual dose is one to two 15mg tablets three or four times daily.
Your doctor will tell you how often to take your tablets.
- Sleeping problems: 15-25mg one hour before going to bed, your doctor may
increase this up to a maximum of 50mg.
- Adults with liver or kidney problems: Your dosage may be reduced if you
suffer from kidney or liver problems.
Oxazepam Tablets are not recommended for use by children under 18 years of age.
Oxazepam is usually prescribed for short courses of treatment, lasting from a few
days to 4 weeks including a dose reduction at the end. This reduces the risk of
becoming dependent on Oxazepam Tablets, or suffering unpleasant effects when
you stop taking them. (See ‘If you stop taking Oxazepam Tablets’ section).
If you take more Oxazepam Tablets than you should
If anyone has taken an overdose of Oxazepam Tablets (that is more than the
doctor has prescribed), seek medical help immediately, either by calling your
doctor, or going to the nearest casualty department. Always take the labelled
medicine container with you, even if there are no tablets left.
If you forget to take Oxazepam Tablets
Do not take a double dose to make up for a forgotten tablet. If you forget to take
a tablet for anxiety, you should take it as soon as you remember if it is less than 3
hours since your usual time. If more than 3 hours has passed from when you
usually take your tablet, just take your next tablet when it is due.
If you stop taking Oxazepam Tablets
This medicine should not be stopped suddenly; keep taking it until your doctor
tells you how to reduce the dose slowly. If you stop taking the tablets suddenly
you may experience the following withdrawal effects:
• depression,
• nervousness,
• difficulty in sleeping,
• irritability,
• sweating,
• upset stomach/diarrhoea,
• or the symptoms you are being treated for can come back worse than before.
You may also experience mood changes, anxiety, restlessness, headaches,
muscle pains, and changes in sleep patterns. These effects may occur even after
taking low doses for a short period of time.
If you stop taking these tablets suddenly after being treated with high doses of
Oxazepam, you may experience confusion, hallucinations, tinnitus (ringing sounds
in your ears), shaking, faster heartbeat or fits.
Withdrawal may also cause unusual behaviour including aggressive outbursts,
excitement or depression with suicidal thoughts or actions.

4. POSSIBLE SIDE-EFFECTS
Like all medicines, Oxazepam Tablets can cause side-effects, although not
everybody gets them.
Contact your doctor immediately 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.
Tell your doctor if you notice any of the following side effects or notice 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 your 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.
Withdrawal symptoms: see Section 3, ‘If you stop taking Oxazepam tablets’.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side-effects not listed in this leaflet.
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
Keep this medicine out of the sight and reach of children.
Do not take Oxazepam Tablets after the expiry date which is stated on the carton
and blister after EXP. The expiry date refers to the last day of the month.
Store below 25°C in a dry place.
Return any unused tablets to your pharmacist. Only keep them if your doctor tells
you to. 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. FURTHER INFORMATION
What Oxazepam Tablets contain:
- The active substance is oxazepam. Each tablet contains either 10mg or 15mg
of oxazepam.
- The other ingredients are: lactose, maize starch and magnesium Stearate.
What Oxazepam Tablets look like and the contents of the pack
Oxazepam Tablets are white, round tablets with a flat face and bevelled edges.
A breakbar can be seen on one side with the imprint ‘10’ or ‘15’ on the other.
They are supplied in blister packs and cartons of 28 tablets.

POM
PL 17225/0014
Oxazepam 10mg Tablets
PL 17225/0015
Oxazepam 15mg Tablets
Marketing Authorisation Holder: Genus Pharmaceuticals,
Park View House, 65 London Road, Newbury, Berkshire RG14 1JN, UK.
Manufacturer: Haupt Pharma Münster GmbH,
Schleebrüggenkamp 15, 48159 Münster, Germany.
This leaflet was last revised in August 2014.

* Trademark

24962702

GEN/OXP/PIL/263_08
12/08/2014

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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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