Lorazepam 1mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
LORAZEPAM 1 mg & 2.5 mg TABLETS
Read is leaflet carefully before you startN
taking this medicine because it contains important information for you.
- 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 possible side effects not listed in this leaflet, see section 4.
WHAT IS IN THIS LEAFLET
1. What Lorazepam is and what is it 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
1. WHAT LORAZEPAM IS AND WHAT IS IT USED FOR
Lorazepam belongs to a group of medicines called the benzodiazepines. It is used in adults:
• for the short-term (usually 2-4 weeks) treatment of severe or disabling anxiety
• insomnia (difficulty in sleeping) due to anxiety
• before dental or surgical procedures to cause sleepiness and help with relaxation
Lorazepam is not recommended for use in children.
If you are not sure why you have been prescribed these tablets then please ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORAZEPAM
Do not take Lorazepam and tell your doctor if you:
• are allergic to Lorazepam, other benzodiazepines, or to any of the other ingredients in the tablets (listed in section 6 of this leaflet)
• have severe liver, lung or breathing problems
• have muscle weakness sometimes causing difficulty breathing (myasthenia gravis)
• suffer from breathing problems when you are asleep (sleep apnoea)
• suffer from depression, mental health problems, irrational fears (phobias) or obsessions
• suffer from abnormally increased or uncontrolled muscular movements
Warnings and precautions
Tell your doctor or pharmacist before taking Lorazepam if you:
• have a history of alcohol or drug abuse, as medicines such as Lorazepam are prone to abuse
• suffer from depression or mental health problems, as Lorazepam may increase any suicidal feelings
• have any problems with your liver, lungs or kidneys
Medicines such as Lorazepam may lead to:
• addiction - you may become dependent on these tablets. Any risk is more likely with high doses and prolonged treatment . Addiction is also more likely if you have a history of alcohol or drug abuse, or you suffer from mental health problems.
• tolerance - Lorazepam may become less effective after a few weeks. If you think that the tablets are not working as well as they did, you should consult your doctor.
• withdrawal - you may experience withdrawal effects if your treatment is stopped suddenly. Withdrawal symptoms can occur with Lorazepam even when normal doses are given for short periods of time (see section 3; ‘If you stop taking Lorazepam’).
When taking Lorazepam, you should ensure you sleep well for 7-8 hours every night.
Other medicines and Lorazepam
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Lorazepam works:
• other medicines to calm you down and help you sleep, such as alprazolam, nitrazepam, or zopiclone
• medicines for mental health problems, such as haloperidol, clozapine, risperidone or lithium
• sodium oxybate to reduce daytime sleepiness or sudden loss of muscle strength
• medicines for depression, such as amitriptyline, dosulepin (tricyclic antidepressants), fluoxetine, paroxetine (selective serotonin re-uptake inhibitors -SSRIs), or mirtazapine
• opioid painkillers, such as tramadol, codeine or buprenorphine
• medicines for epilepsy, such as carbamazepine, phenytoin, primidone or valproate
• medicines to treat high blood pressure and chest pain, such as captopril, enalapril (ACE inhibitors), doxazosin, prazosin (alpha-blockers), candesartan, losartan (angiotensin-II receptor antagonists), amlodipine, nifedipine (calcium-channel blockers), guanethidine (adrenergic neurone blockers), propranolol, atenolol (beta-blockers), clonidine, methyldopa (centrally acting antihypertensives), glyceryl trinitrate, isosorbide mononitrate (nitrates), hydralazine, minoxidil, sodium nitroprusside (vasodilators), bendroflumethiazide, furosemide, amiloride (diuretics)
• some medicines to treat HIV infections, such as ritonavir, indinavir or sequinavir
• antihistamines for allergies, such as promethazine or chlorphenamine
• aminophylline or theophylline for asthma
• hormones used for contraception or hormone replacement therapy (HRT)
• probenecid for gout
If you are going to be given a general or local anaesthetic, are going into hospital, or having treatment for other conditions, tell your doctor, dentist or nurse that you are taking Lorazepam.
Lorazepam with food, drink and alcohol
Alcohol, even in small amounts, may increase the sedative effects of Lorazepam and make you feel very sleepy. Do not drink alcohol while taking Lorazepam.
Caffeine may reduce the effects of Lorazepam. You should avoid drinking large amounts of tea, coffee and drinks containing caffeine while taking Lorazepam.
Pregnancy and breast-feeding
Do not take Lorazepam tablets if you are pregnant, planning a pregnancy or are breast-feeding, unless your doctor has advised you to take them.
If you take Lorazepam late in your pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing and feeding difficulties.
If you take this medicine regularly during late pregnancy, your baby may become dependent on Lorazepam and may develop withdrawal symptoms after birth.
Make sure you follow your doctor’s advice.
Driving and using machines
Lorazepam can affect your ability to drive and use machines as it may make you sleepy or dizzy. Avoid alcohol as it can increase these effects.
Do not drive or use machines 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:
- Lorazepam 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.
Lorazepam contains lactose
Lorazepam Tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Lorazepam.
3. HOW TO TAKE LORAZEPAM
Always take Lorazepam exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Lorazepam should be swallowed with water.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition. You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. Typically, Lorazepam will not be prescribed for more than 4 weeks. This will reduce the risk of addiction.
Adults:
Anxiety: 1-4 mg daily in divided doses
Insomnia due to anxiety: 1-2 mg at bedtime, only when
required and not for regular use.
Before surgery or dental treatment: Your doctor or dentist will decide the correct dose depending upon the surgery or treatment you are undergoing.
Elderly or debilitated (weak or frail): Half the normal adult dose may be sufficient. Follow your doctor's advice.
Patients with liver or kidney problems: Do not take Lorazepam if you suffer from severe liver problems. Lower doses may be sufficient if you suffer from mild to moderate liver problems or kidney problems. Follow your doctor’s advice.
Children: Not recommended
If you take more Lorazepam than you should
Contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you so that the doctor knows what has been taken.
In mild cases, symptoms of an overdose include:
• drowsiness
• confusion
• tiredness
In more serious cases, symptoms may include:
• difficulty in controlling movements (ataxia)
• reduced muscle tone (hypotonia)
• low blood pressure
• difficulty breathing
• coma
If you forget to take Lorazepam Do not worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lorazepam
You should not stop taking Lorazepam suddenly as:
- the risk of withdrawal symptoms is greater
- the symptoms you are being treated for may return more intensely than before
Your doctor will advise you on reducing your dose gradually.
If you stop Lorazepam suddenly you may experience symptoms such as: headache, muscle pain, tension, extreme anxiety, restlessness, confusion, irritability, feeling detached from yourself and your surroundings, numbness and tingling of the hands and feet (‘pins and needles’), hallucinations, fits or increased sensitivity to light, sound or touch, mood changes and sleep disturbances.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lorazepam can cause side effects, although not everybody gets them.
If you get the following side effects, STOP TAKING this medicine and tell your doctor immediately:
• an allergic reaction to lorazepam, the signs of which can include red raised lumps (hives), rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty swallowing or breathing, shortness of breath, wheezing
If you get any of the following side effects, tell your doctor as soon as possible:
• restlessness, agitation, irritability, aggressive outbursts, violent anger, mood swings, nightmares, hallucinations (feeling or seeing things that are not there), unusual behaviour or false beliefs (delusions). These effects are more likely to occur in children and elderly patients.
• blood disorders causing unexplained bleeding or bruising
• yellowing of the skin and whites of the eyes (jaundice)
Tell your doctor or pharmacist if you develop any of the following side effects:
Effects on the brain and central nervous system:
drowsiness, sedation, difficulty controlling movements, headache, confusion, depression, slurred speech or difficulty in speaking, changes in your sex drive, trembling or shaking, temporary memory loss
Effects on the ears: a feeling of dizziness or spinning (vertigo)
Effects on the heart and blood vessels: low blood pressure
Effects on the respiratory system: difficulty breathing
Effects on the digestive system: changes in the amount of saliva, stomach upsets (e.g. nausea or constipation)
Effects on the liver: increase in some liver enzymes (detected in blood test)
Effects on the muscles and bones: muscle weakness
Effects on the kidneys and urinary system: difficulty passing urine (urinary retention), loss of bladder control (incontinence)
If you have been taking Lorazepam for some time, you may:
• develop physical and mental dependence; you may find it difficult to stop taking the tablets or feel the need to continue taking them for longer than is necessary
• experience withdrawal effects by stopping it suddenly. The symptoms of withdrawal are described in Section 3 ‘If you stop taking Lorazepam’ of this leaflet.
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 LORAZEPAM
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lorazepam Tablets contain
The active ingredient in Lorazepam 1 mg and 2.5 mg Tablets is lorazepam.
The other ingredients are lactose, microcrystalline cellulose, talc, sodium starch glycollate and magnesium stearate. Lorazepam 2.5 mg Tablets also contain erythrosine (E127).
What Lorazepam Tablets look like and contents of the pack
Lorazepam 1 mg Tablets are round white tablets with the marking MP60 on one side.
Lorazepam 2.5 mg Tablets are pink capsule shaped tablets with the marking MP61 on one side and a break line engraved on the other.
The tablets come in blisters packs and containers of 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41 - 43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
Manufacturer
Custom Pharmaceuticals Limited,
Conway Street, Hove,
East Sussex BN3 3LW
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 06/2016.
GE0034-0035/O/PIL1/GE1
LORAZEPAM 1 mg & 2.5 mg TABLETS
Read is leaflet carefully before you startN
taking this medicine because it contains important information for you.
- 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 possible side effects not listed in this leaflet, see section 4.
WHAT IS IN THIS LEAFLET
1. What Lorazepam is and what is it 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
1. WHAT LORAZEPAM IS AND WHAT IS IT USED FOR
Lorazepam belongs to a group of medicines called the benzodiazepines. It is used in adults:
• for the short-term (usually 2-4 weeks) treatment of severe or disabling anxiety
• insomnia (difficulty in sleeping) due to anxiety
• before dental or surgical procedures to cause sleepiness and help with relaxation
Lorazepam is not recommended for use in children.
If you are not sure why you have been prescribed these tablets then please ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORAZEPAM
Do not take Lorazepam and tell your doctor if you:
• are allergic to Lorazepam, other benzodiazepines, or to any of the other ingredients in the tablets (listed in section 6 of this leaflet)
• have severe liver, lung or breathing problems
• have muscle weakness sometimes causing difficulty breathing (myasthenia gravis)
• suffer from breathing problems when you are asleep (sleep apnoea)
• suffer from depression, mental health problems, irrational fears (phobias) or obsessions
• suffer from abnormally increased or uncontrolled muscular movements
Warnings and precautions
Tell your doctor or pharmacist before taking Lorazepam if you:
• have a history of alcohol or drug abuse, as medicines such as Lorazepam are prone to abuse
• suffer from depression or mental health problems, as Lorazepam may increase any suicidal feelings
• have any problems with your liver, lungs or kidneys
Medicines such as Lorazepam may lead to:
• addiction - you may become dependent on these tablets. Any risk is more likely with high doses and prolonged treatment . Addiction is also more likely if you have a history of alcohol or drug abuse, or you suffer from mental health problems.
• tolerance - Lorazepam may become less effective after a few weeks. If you think that the tablets are not working as well as they did, you should consult your doctor.
• withdrawal - you may experience withdrawal effects if your treatment is stopped suddenly. Withdrawal symptoms can occur with Lorazepam even when normal doses are given for short periods of time (see section 3; ‘If you stop taking Lorazepam’).
When taking Lorazepam, you should ensure you sleep well for 7-8 hours every night.
Other medicines and Lorazepam
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Lorazepam works:
• other medicines to calm you down and help you sleep, such as alprazolam, nitrazepam, or zopiclone
• medicines for mental health problems, such as haloperidol, clozapine, risperidone or lithium
• sodium oxybate to reduce daytime sleepiness or sudden loss of muscle strength
• medicines for depression, such as amitriptyline, dosulepin (tricyclic antidepressants), fluoxetine, paroxetine (selective serotonin re-uptake inhibitors -SSRIs), or mirtazapine
• opioid painkillers, such as tramadol, codeine or buprenorphine
• medicines for epilepsy, such as carbamazepine, phenytoin, primidone or valproate
• medicines to treat high blood pressure and chest pain, such as captopril, enalapril (ACE inhibitors), doxazosin, prazosin (alpha-blockers), candesartan, losartan (angiotensin-II receptor antagonists), amlodipine, nifedipine (calcium-channel blockers), guanethidine (adrenergic neurone blockers), propranolol, atenolol (beta-blockers), clonidine, methyldopa (centrally acting antihypertensives), glyceryl trinitrate, isosorbide mononitrate (nitrates), hydralazine, minoxidil, sodium nitroprusside (vasodilators), bendroflumethiazide, furosemide, amiloride (diuretics)
• some medicines to treat HIV infections, such as ritonavir, indinavir or sequinavir
• antihistamines for allergies, such as promethazine or chlorphenamine
• aminophylline or theophylline for asthma
• hormones used for contraception or hormone replacement therapy (HRT)
• probenecid for gout
If you are going to be given a general or local anaesthetic, are going into hospital, or having treatment for other conditions, tell your doctor, dentist or nurse that you are taking Lorazepam.
Lorazepam with food, drink and alcohol
Alcohol, even in small amounts, may increase the sedative effects of Lorazepam and make you feel very sleepy. Do not drink alcohol while taking Lorazepam.
Caffeine may reduce the effects of Lorazepam. You should avoid drinking large amounts of tea, coffee and drinks containing caffeine while taking Lorazepam.
Pregnancy and breast-feeding
Do not take Lorazepam tablets if you are pregnant, planning a pregnancy or are breast-feeding, unless your doctor has advised you to take them.
If you take Lorazepam late in your pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing and feeding difficulties.
If you take this medicine regularly during late pregnancy, your baby may become dependent on Lorazepam and may develop withdrawal symptoms after birth.
Make sure you follow your doctor’s advice.
Driving and using machines
Lorazepam can affect your ability to drive and use machines as it may make you sleepy or dizzy. Avoid alcohol as it can increase these effects.
Do not drive or use machines 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:
- Lorazepam 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.
Lorazepam contains lactose
Lorazepam Tablets contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Lorazepam.
3. HOW TO TAKE LORAZEPAM
Always take Lorazepam exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Lorazepam should be swallowed with water.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition. You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. Typically, Lorazepam will not be prescribed for more than 4 weeks. This will reduce the risk of addiction.
Adults:
Anxiety: 1-4 mg daily in divided doses
Insomnia due to anxiety: 1-2 mg at bedtime, only when
required and not for regular use.
Before surgery or dental treatment: Your doctor or dentist will decide the correct dose depending upon the surgery or treatment you are undergoing.
Elderly or debilitated (weak or frail): Half the normal adult dose may be sufficient. Follow your doctor's advice.
Patients with liver or kidney problems: Do not take Lorazepam if you suffer from severe liver problems. Lower doses may be sufficient if you suffer from mild to moderate liver problems or kidney problems. Follow your doctor’s advice.
Children: Not recommended
If you take more Lorazepam than you should
Contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you so that the doctor knows what has been taken.
In mild cases, symptoms of an overdose include:
• drowsiness
• confusion
• tiredness
In more serious cases, symptoms may include:
• difficulty in controlling movements (ataxia)
• reduced muscle tone (hypotonia)
• low blood pressure
• difficulty breathing
• coma
If you forget to take Lorazepam Do not worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lorazepam
You should not stop taking Lorazepam suddenly as:
- the risk of withdrawal symptoms is greater
- the symptoms you are being treated for may return more intensely than before
Your doctor will advise you on reducing your dose gradually.
If you stop Lorazepam suddenly you may experience symptoms such as: headache, muscle pain, tension, extreme anxiety, restlessness, confusion, irritability, feeling detached from yourself and your surroundings, numbness and tingling of the hands and feet (‘pins and needles’), hallucinations, fits or increased sensitivity to light, sound or touch, mood changes and sleep disturbances.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lorazepam can cause side effects, although not everybody gets them.
If you get the following side effects, STOP TAKING this medicine and tell your doctor immediately:
• an allergic reaction to lorazepam, the signs of which can include red raised lumps (hives), rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty swallowing or breathing, shortness of breath, wheezing
If you get any of the following side effects, tell your doctor as soon as possible:
• restlessness, agitation, irritability, aggressive outbursts, violent anger, mood swings, nightmares, hallucinations (feeling or seeing things that are not there), unusual behaviour or false beliefs (delusions). These effects are more likely to occur in children and elderly patients.
• blood disorders causing unexplained bleeding or bruising
• yellowing of the skin and whites of the eyes (jaundice)
Tell your doctor or pharmacist if you develop any of the following side effects:
Effects on the brain and central nervous system:
drowsiness, sedation, difficulty controlling movements, headache, confusion, depression, slurred speech or difficulty in speaking, changes in your sex drive, trembling or shaking, temporary memory loss
Effects on the ears: a feeling of dizziness or spinning (vertigo)
Effects on the heart and blood vessels: low blood pressure
Effects on the respiratory system: difficulty breathing
Effects on the digestive system: changes in the amount of saliva, stomach upsets (e.g. nausea or constipation)
Effects on the liver: increase in some liver enzymes (detected in blood test)
Effects on the muscles and bones: muscle weakness
Effects on the kidneys and urinary system: difficulty passing urine (urinary retention), loss of bladder control (incontinence)
If you have been taking Lorazepam for some time, you may:
• develop physical and mental dependence; you may find it difficult to stop taking the tablets or feel the need to continue taking them for longer than is necessary
• experience withdrawal effects by stopping it suddenly. The symptoms of withdrawal are described in Section 3 ‘If you stop taking Lorazepam’ of this leaflet.
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 LORAZEPAM
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lorazepam Tablets contain
The active ingredient in Lorazepam 1 mg and 2.5 mg Tablets is lorazepam.
The other ingredients are lactose, microcrystalline cellulose, talc, sodium starch glycollate and magnesium stearate. Lorazepam 2.5 mg Tablets also contain erythrosine (E127).
What Lorazepam Tablets look like and contents of the pack
Lorazepam 1 mg Tablets are round white tablets with the marking MP60 on one side.
Lorazepam 2.5 mg Tablets are pink capsule shaped tablets with the marking MP61 on one side and a break line engraved on the other.
The tablets come in blisters packs and containers of 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41 - 43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
Chatfield Road, off York Road,
London SW11 3SE
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 06/2016.
GE0034-0035/O/PIL2/GE1