Lorazepam 0.5 mg Tablets

• 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 side effects not listed in this leaflet (see section 4).

1. What Lorazepam is and what it is used for
2. What you need to know before you take Lorazepam
3. How to take Lorazepam
4. Possible side effects
5. How to store Lorazepam
6. Contents of the pack and other information

• are allergic to benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
• have severe breathing or chest problems
• have myasthenia gravis (very weak or tired muscles)
• have serious liver problems
• suffer from sleep apnoea (breathing problems when you are asleep)
• are breast-feeding, since the drug may pass into breast milk
• are planning a pregnancy or are pregnant

If you have been only prescribed Lorazepam for anxiety and no other medicines, please ask your doctor whether other medicines should also be prescribed.

Talk to your prescriber 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 lorazepam 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.

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.

Tell your doctor or pharmacist if you:

• have a personality disorder. If so, you have a greater chance of becoming dependent on lorazepam
• have kidney or liver problems
• are suffering from depression, since lorazepam may increase any suicidal feelings which you may have
• have suffered from depression before, since it could re-occur during treatment with lorazepam
• suffer from breathing problems
• are suffering from an eye problem called glaucoma, such as high pressure within the eye

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Lorazepam may affect the way other medicines work. In particular, you should tell your doctor if you are taking:

• any other sedative (such as barbiturates or antihistamines)
• anti-anxiety medicines, anti-depressants
• strong pain killers (such as methadone)
• medicines for epilepsy (such as phenobarbital or valproate)
• antihistamines or medicines for mood or mental disorders (such as chlorpromazine, loxapine or clozapine)
• medicines for catalepsy
• medicines treating HIV
• medicines to treat delusions or hallucinations
• medicines to help with indigestion (such as omeprazole)
• muscle relaxants (such as baclofen and tizanidine)
• medicines for addiction treatment (such as lofexidine and disulfiram)
• anti-tuberculosis medicines such as isoniazid
• antibiotics such as erythromycin
• medicines to treat high blood pressure
• Parkinson’s disease medicines such as levodopa
• oestrogen-containing contraceptives
• medicines for asthma (theophylline).

The dose of these medicines may need to be reduced before you can take lorazepam.

Taking Lorazepam at the same time as 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, taking them at the same time should only be considered when other treatment options are not possible. However, if your doctor does prescribe this medicine together with opioids the dose and duration of the 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 earlier in this section. Contact your doctor when experiencing such symptoms.

Lorazepam is not recommended for the treatment of anxiety or sleeping problems in children. Nor it is recommended for children below 5 years of age.

Do not drink grapefruit juice and drinks containing caffeine as they can affect the way that Lorazepam work.

Do not drink alcohol.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine - do not take Lorazepam unless your doctor tells you to.

Benzodiazepines, including lorazepam may cause damage to the unborn baby when administered to pregnant women. If you take this medicine during late pregnancy or during labour, your baby, when born, may be less active than other babies, have a low body temperature, be floppy, or have breathing or feeding difficulties for a while. You baby’s response to the cold might be temporarily impaired. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms after birth.

Do not take this medicine if you are breast-feeding, since it may pass into breast milk, and cause the baby to be less active and unable to suckle.

Lorazepam may make you feel dizzy, sleepy or forgetful during the day, or may affect your concentration. This may affect performance at skilled tasks such as driving or operating machinery by affecting your vision or muscle function. Do not take part in any other activities where this could put yourself or others at risk.

Avoid alcohol while you are taking lorazepam, since this may make you very drowsy and seriously affect your ability to drive or use machines.

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.

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

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium free’.

Children (between 5 and 13 years of age)

• Before surgery: the dose is usually between 0.5 and 2.5 mg (depending on your child’s weight) at least 1 hour before your child’s operation

• Older patients may be given lower doses. They may respond to half the usual adult dose or less.

Lorazepam 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 Lorazepam, or suffering unpleasant effects when you stop taking them. (See ‘If you stop taking Lorazepam’ section).

The beneficial effect of Lorazepam may be less apparent after several weeks of use. If you are given Lorazepam for more than 4 weeks, your doctor might want to take blood samples occasionally to check your blood and liver, since medicines like Lorazepam have occasionally affected blood and liver function.

If anyone has taken an overdose of Lorazepam (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.

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 forget to take a tablet for sleeping problems, only take it if you will be able to sleep for 7 to 8 hours afterwards.

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 may 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).

Patients taking ani-depressants and patients with seizure disorders may be more likely to experience convulsions (fits).

If you suffer from any of these symptoms, ask your doctor for advice immediately.

• restlessness, agitation, irritability, aggressiveness, violent anger, sleeping difficulties, nightmares, hallucinations, personality changes, sexual arousal, abnormal behaviour or false beliefs
• unexplained bleeding and/or bruising; increased risk of infections such as frequent sore throats, mouth ulcers, weakness and pale skin as these are symptoms of blood dyscrasia
• impaired consciousness (such as reduced alertness, confusion, disorientation, fainting) as this may ultimately lead to coma
• thoughts of harming or killing yourself, becoming dependent on Lorazepam
• severe allergic reactions such as difficulty in breathing, swelling of the lips, mouth, tongue, throat, hands, feet and /or severe faintness or dizziness
• jaundice such as yellowing of the skin, eyes, nose, mouth, pale coloured stools (faeces) and dark coloured urine

Very common (may affect more than 1 in 10 people):

• daytime drowsiness

Common (may affect up to 1 in 10 people):

• dizziness
• poor muscle control
• muscle weakness
• fatigue

Rare (may affect up to 1 in 1,000 people):

• depression
• numbed emotions, act or show emotions, a feeling of well-being for no reason
• difficulty controlling urges and impulses to speak, slurred speech
• appetite changes
• sleep problems
• changes in sex drive, decreased orgasm, erectile dysfunction
• headache
• memory loss or forgetfulness
• problems with vision including double vision or blurred vision
• worsening of sleep apnoea (such as loud snoring, restlessness and choking/gasping during the night)
• breathing difficulties
• stomach upsets, nausea, constipation
• changes in the amount of salvia in the mouth
• skin problems such as rushes and inflammation
• blood or liver function changes
• low blood pressure or low body temperature

Very rare (may affect up to 1 in 10,000 people):

• trembling or shaking

Not known (frequency cannot be estimated from the available data):

• increased risk of falling
• dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

Drug Withdrawal

When you stop taking lorazepam, 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 lorazepam, 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, pharmacist or nurse. This includes any 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.

• The active substance is lorazepam. Each tablet contains 0.5 mg of lorazepam.
• The other ingredients are lactose monohydrate, mesh 200; sodium ascorbate; pollacrillin potassium; lactose; cellulose, microcrystalline; magnesium stearate.

Lorazepam tablets are off-white to pale beige, approximately 4.7 mm round shape, uncoated tablets, plain on both sides.

The tablets are packed into OPA/Al/PVC//Al blisters.

Pack size: 28 tablets.

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