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OXAZEPAM TABLETS BP 30MG

Active substance(s): OXAZEPAM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Oxazepam 10mg, 15mg and 30mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may want 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 known as benzodiazepine anxiolytics.
Oxazepam is intended for short term use (approximately 2-4 weeks) to relieve severe anxiety.
2) What you need to know before you take Oxazepam
Do not take Oxazepam if:
 You are allergic (hypersensitive) to Oxazepam, other benzodiazepine anxiolytics or any of the
other ingredients of this medicine (listed in section 6)
 It is intended for the treatment of depression, a phobia (a very strong fear of something),
obsessions, other mental disorders or mild anxiety
 You suffer from severe liver problems
 You suffer from breathing difficulties
 You suffer from myasthenia gravis (muscle weakness)
 You suffer from sleep apnoea syndrome (a condition where the throat relaxes during sleep and
interrupts normal breathing)
Warnings and precautions
Talk to your doctor before taking Oxazepam if:
 Taking Oxazepam can lead to a dependency (addiction). See section 3 “If you stop taking
Oxazepam”
 Oxazepam should not be used alone to treat depression or anxiety associated with depression as
the use of benzodiazepines may release suicidal tendencies in depressed patients
 Oxazepam may cause a loss of memory (amnesia). This may occur several hours after taking the
medicine and therefore to reduce the risk, you should ensure that you will be able to have 7-8
hours of uninterrupted sleep
 You have a history of alcohol or drug dependency
Other medicines and Oxazepam
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which may interact with or be affected by Oxazepam:
 Medicines used to treat mental illness (antipsychotics)
 Strong pain relievers (narcotic analgesics)
 Medicines used to treat depression (antidepressants)
 Medicines used to treat anxiety and sleep disorders (anxiolytics, sedatives)
 Anaesthetics
 Antihistamines, used to treat allergic conditions














Lofexidine, used for drug and alcohol dependency
Nabilone, used for feeling (nausea) or being sick (vomiting)
Tizanidine, used to treat muscle pain
Oestrogen-containing contraceptives (‘the pill’)
Antibacterial medicines, such as rifampicin
Antiviral medicines, such as zidovudine or ritonavir
Medicines for epilepsy (antiepileptics), such as phenytoin, hydantoins
Medicines for high blood pressure (antihypertensives), such as doxazosin (alpha blockers) or
moxonidine
Medicines for Parkinson’s disease such as levodopa (dopaminergics)
Baclofen, used as a muscle relaxant
Probenecid, used to treat gout
Medicines which inhibit the activity of liver enzymes and thereby increase the effects of
Oxazepam

Taking Oxazepam with food and drink and alcohol
Do not drink alcohol when you are taking this medicine. Alcohol may make you feel more sleepy than
usual.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Pregnancy
 If your doctor has decided that you should take Oxazepam during late pregnancy or at high doses
during labour, your baby may have a low body temperature, floppy limbs and breathing difficulties.
 If you take Oxazepam regularly in late pregnancy, your baby may develop withdrawal symptoms
when born.
Breast-feeding
Oxazepam is passed into breast milk and therefore you should not take Oxazepam whilst
breastfeeding.
Driving and using machines
Oxazepam may make you feel drowsy, forgetful or cause muscular problems. Do not drive or use
machinery if affected.
This 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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the
information provided with the medicine and
o 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
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before taking this medicine.
3) How to take Oxazepam
Always take Oxazepam exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.



These tablets are to be taken orally.
The score line is not intended for breaking the tablet.



You should take Oxazepam for the shortest time possible and treatment should not exceed 4
weeks for insomnia (difficulty sleeping) and 8-12 weeks for anxiety (including time to gradually
reduce your dose).

Adults
 The recommended dose to treat severe anxiety is 30mg to 60mg three times a day.
 The recommended dose to treat less severe anxiety is 30mg three times a day and 30mg at night.
 If you suffer from severe sleeping problems, you may be given 60mg at night.
Elderly
 If you are elderly, you should take a reduced dose which should not exceed half the
recommended adult dose.
 You may be more susceptible to the sedative effects (sleepiness) of this medicine.
Patients with breathing difficulties
A lower dose is recommended.
Patients with liver problems
You should not take this medicine.
Use in children
Oxazepam.is not recommended for use in children.
If you take more Oxazepam than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency
department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
Symptoms of overdose include: drowsiness, confusion, speech difficulties (dysarthia),
uncontrollable eye movement (nystagmus) lack of energy (lethargy). In more serious cases,
symptoms may include unsteadiness/clumsiness (ataxia), muscle weakness (hypotonia), low blood
pressure (hypotension), breathing more slowly or weakly than usual (respiratory depression), coma
(rare), death (very rare)
If you forget to take your Oxazepam
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do
not take a double dose to make up for a forgotten dose.
If you stop taking Oxazepam
It is important that you keep taking Oxazepam for as long as your doctor has told you to.
Do not stop taking your tablets suddenly. Your doctor will tell you how to reduce your dose gradually.
This will reduce the risk of withdrawal symptoms
While your dose is being gradually reduced, you may notice a recurrence of symptoms; mood
changes, anxiety, restlessness and have trouble sleeping. You may feel similar to the way you did
before you started to take Oxazepam. This is a side effect of reducing your tablets and will pass
Dependancy
There is a possibility that you may become dependent on (addicted to) Oxazepam. This is more likely
if you take higher doses and/or are taking Oxazepam long term. The risk of dependency further
increases if you have a history of alcoholism, drug dependancy or a personality disorder.
Withdrawal
Withdrawal symptoms may last for weeks or months and possible symptoms include:extreme anxiety,
shaking (tremor) including involuntary movements, difficulty sleeping (insomnia), depression,
problems with your perception, confusion, fits (convulsions), muscle cramps, headaches, tension,
restlessness, irritability, stomach problems, being sick (vomiting) and sweating.
More severe withdrawal symptoms include: a feeling of loss of identity/feeling detached from yourself
(depersonalisation or derealisation), sensitivity to light, noise (including tinnitus) and physical contact,
numbness or tingling in the hands or feet (paraesthesia), seeing or hearing things that are not real
(hallucinations).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Oxazepam can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms:
 Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness
 Swelling of parts of the body (oedema)
If you experience any of the following symptoms, particularly if you are elderly, your treatment
may need to be stopped:
 Aggressive outbursts, agitation, irritability, rages
 Seeing or hearing things that are not real (hallucinations), delusions
 Restlessness
 Nightmares/dreams
 Mental health problems (including confusion, excitement), inappropriate behaviour
Side effects (Frequency not known)
 Mild drowsiness. If this side effect becomes troublesome, your dose may need to be reduced
 Disorientation
 Lack of energy (lethargy)
 Skin rashes (with or without itching)
 Feeling sick (nausea)
 Changes in your sex drive
 Fever
 Feeling tired (fatigue)
 Slurred speech or a difficulty in speaking (dysarthria)
 Shakiness (tremor)
 Increased liver enzymes (detected through blood test)
 Jaundice (yellowing of the skin or the whites of the eyes)
 Low blood pressure (hypotension) or high blood pressure (hypertension)
 Blood disorders
 Reduction in white blood cells (leucopenia)
 Muscle weakness
 Saliva changes
 Stomach problems
 Difficulty passing urine
 Inability to control the flow of urine (incontinence)
 Loss of memory (see section 2 “Warnings and precautions”)
 Visual disturbances including blurred or double vision
 Headache
 Feeling of dizziness or “spinning” (vertigo)
 Feeling less alert or numbed emotions
 Dizziness, lightheadedness. If this side effect becomes troublesome, your dose may need to be
reduced
 Difficulty in controlling movements (ataxia)
 Fainting (syncope)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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/blister after EXP. The
expiry date refers to the last day of that month.
Store in a cool dry place.
Store in the original container in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.

6) Contents of the pack and other information
What Oxazepam contains:
Each tablet contains 10mg, 15mg or 30mg of Oxaxepam.
The other ingredients are: lactose, maize starch, pregelatinised maize starch and magnesium
stearate.
The 15mg tablets also contain colour E104 (quinoline yellow) and E127 (Anstead Dispersed Pink).
The 30mg tablets also contain colour E127 (Anstead Dispersed Pink).
What Oxazepam looks like and the contents of the pack:
 Oxazepam 10mg are white. compressed FBE tablets with a breakline on one side, or coded OXA
10 and breakline one side, twin triangle logo on reverse
 Oxazepam 15mg are yellow. compressed FBE tablets with a breakline one side, or coded OXA
15 and breakline one side, twin triangle logo on reverse
 Oxazepam 30mg are pink. compressed FBE tablets with breakline one side, or coded OXA 30
and breakline one side, twin triangle logo on reverse
Oxazepam is available in:
Oxazepam Tablets are available in containers or blister packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90,
100, 112, 120, 250, 500 or 1000 tablets.
Not all pack sizes or pack types may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St. Neots
Cambridgeshire
PE19 8ET
UK
Product Licence Numbers:
PL 11311/0526: Oxazepam 10mg Tablets
PL 11311/0527: Oxazepam 15mg Tablets
PL 11311/0528: Oxazepam 30mg Tablets
This leaflet was last revised in June 2016
Till-ver.2.1s

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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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