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

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