Oxazepam 10mg Tablets

• 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.

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

• You are allergic (hypersensitive) to Oxazepam, other benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
• You have a phobia (a very strong fear of something), obsessions or other mental disorders
• You suffer from severe liver disorders
• 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)

Talk to your prescriber before taking Oxazepam 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 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 prescriber 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 prescriber 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 prescriber 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 prescriber 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.

Oxazepam 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 Oxazepam, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

• 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
• have a personality disorder
• have glaucoma
• suffer from kidney disorders

Oxazepam may cause muscle relaxation, dizziness or drowsiness. Therefore, caution is advised as you may be at a greater risk of falling (see section 4 “Possible side effects”).

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:

• Barbiturates, used to treat anxiety and sleep disorders
• Medicines used to treat mental illness (antipsychotics)
• Strong pain relievers (narcotic analgesics, opioids)
• Medicines used to treat depression (antidepressants)
• Medicines to help you sleep (hypnotics)
• Anaesthetics
• Antihistamines, used to treat allergic conditions
• Lofexidine, used for drug and alcohol dependency
• Nabilone, used for feeling (nausea) or being sick (vomiting)
• Muscle relaxants, such as baclofen, tizanidine
• Oestrogen-containing contraceptives (‘the pill’)
• Antibacterial medicines, such as rifampicin
• Antiviral medicines, such as zidovudine or ritonavir
• Medicines for epilepsy (anticonvulsants), such as phenytoin, hydantoins
• Medicines for high blood pressure (antihypertensives), such as doxazosin (alpha blockers) or moxonidine
• Medicines used to treat Parkinson’s disease such as levodopa (dopaminergics)
• Probenecid, used to treat gout

Concomitant use of Oxazepam 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 Oxazepam 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.

Do not drink alcohol when you are taking this medicine. Alcohol may make you feel more sleepy than usual.

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

• Oxazepam should not be used during pregnancy, especially during the first and last trimesters. Oxazepam may cause foetal damage when administered to pregnant women.
• If you take Oxazepam during late pregnancy, your baby may develop withdrawal symptoms such as a low body temperature, floppy limbs, feeding problems and breathing difficulties.

Breast-feeding

Oxazepam is passed into breast milk and therefore you should not take Oxazepam whilst breastfeeding.

Oxazepam may make you feel drowsy, forgetful, dizzy 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:
  • 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.

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

• Anxiety: The recommended dose is 15-30mg three or four times a day.
• Anxiety associated with sleeplessness: 15-25mg one hour before going to bed. Your doctor may increase this up to a maximum of 50mg.

Elderly and patients sensitive to benzodiazepine medicines: 10-20mg three or four times a day.

Your dose may be reduced.

Oxazepam is not recommended for use in children.

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)

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.

It is important that you keep taking Oxazepam for as long as your doctor has told you to.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber 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 prescriber 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:

• Benzodiazepines: 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).

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 dependency or a personality disorder.

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).

• Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness
• Swelling of parts of the body (oedema)

• 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

• 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)
• 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”)
• 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)
• Falls
• Dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

Drug Withdrawal

When you stop taking Oxazepam, 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, 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 prescriber.

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 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.

Each tablet contains 10mg or 15mg of Oxazepam.

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).

• Oxazepam 10mg are white round flat tablets with a score line on one side and coded OXA 10 on the other side.
• Oxazepam 15mg are yellow round flat tablets with a score line on one side and coded OXA 15 on the other side.

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.

Product Licence Numbers:

• PL 11311/0526: Oxazepam 10mg Tablets
• PL 11311/0527: Oxazepam 15mg Tablets