Patient leaflet - Oxazepam tablets 15 mg

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.

Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

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 before taking this medicine if you:

are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
feel you need to take more of Oxazepam Tablets to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your doctor who will discuss your treatment and may change your dose or switch you to an alternative medication.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:

headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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.

Oxazepam may cause muscle relaxation and caution is advised as you may be at a greater risk of falling (see section 4).

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.

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 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) 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).

Concomitant use of this product and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe this product together with opioids the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, might become pregnant or breast- feeding.

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.

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.

Your doctor should have discussed with you how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

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

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms such as:

headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

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.
Unknown frequency: dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

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, increased risk of falling
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.

Drug Withdrawal

When you stop taking Oxazepam Tablets, you may experience drug withdrawal symptoms, which include:

headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking Oxazepam Tablets, it could be a sign that you have become addicted.

You may feel the need to keep taking the medication for longer than your doctor recommended
You feel you need to use more than the recommended dose
You are using the medicine for reasons other than prescribed
When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your doctor.

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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store. 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.

Prescription needed?	Yes, prescription-only medicine (POM)
Controlled drug	Yes, Schedule 4 of the Misuse of Drugs Regulations? Controlled drugs are medicines that UK law controls more strictly because they can be misused or cause dependence. The Misuse of Drugs Regulations 2001 divide them into 5 schedules: schedule 1 has the strictest rules, schedule 5 the lightest. Schedule 4 has lighter rules. Its part I covers benzodiazepines and similar sleeping tablets, for example diazepam or zopiclone. A prescription is valid for 28 days and usually covers up to 30 days of treatment. Travelling abroad: you can usually carry up to 3 months' supply. Take your prescription or a letter from your doctor to show it is yours, and check the rules of the country you are going to (GOV.UK). Never give it to anyone else.
Active substance	Oxazepam
Strength	15 mg
Pharmaceutical form	Oral tablet
How is it taken	Oral
Excipients	Lactose (hydrous), maize starch and magnesium stearate.
Pack sizes	28 tablet
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	36 months.
Storage	Store in a dry place below 25°C.
Drug group (ATC)	N Nervous system drugs N05 Psycholeptics N05B Anxiolytics N05BA Benzodiazepine derivative anxiolytics N05BA04 oxazepam
Marketing authorisation	PL 17225/0015 (first authorised 1 October 1999)
Marketing authorisation holder	Genus Pharmaceuticals Holdings Limited
Codes	GTIN 5030451001252 · BNF 04010200

Oxazepam tablets 15 mg – patient leaflet, side effects, dosage