Patient leaflet - LORAZEPAM 1 MG TABLETS

LORAZEPAM

1 mg & 2.5 mg 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 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
are breast-feeding, since the drug may pass into breast milk planning a pregnancy or are pregnant.

If you have been only prescribed Lorazepam Tablets for anxiety and no other medications, please consult with your doctor whether other medications should also be prescribed.

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
have a personality disorder. If so, you have greater chance of becoming dependent on lorazepam
suffer from depression or mental health problems, as Lorazepam may increase any suicidal feelings
suffer from breathing problems
have any problems with your liver, lungs or kidneys
are suffering from an eye problem called glaucoma e.g. high pressure within the eye.

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.

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

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:

sedatives (e.g. barbiturates or antihistamines), anti-anxiety drugs, anti-depressants, strong pain killers (e.g. methadone), drugs for epilepsy (e.g. phenobarbital or valproate), antihistamines, or drugs for mood or mental disorders (e.g. chlorpromazine, loxapine or clozapine), drugs for cataplexy; treating HIV; to treat delusions or hallucinations; to help with indigestion (e.g. omeprazole); muscle relaxants (e.g. baclofen and tizanidine); drugs for addiction treatment (e.g. lofexidine and disulfiram); TB drugs such as isoniazid; antibiotics such as erythromycin; drugs to treat high blood pressure; Parkinson's disease drugs e.g. levodopa; oestrogen-containing contraceptives and drugs for asthma (theophylline). The dose of these drugs may need to be reduced before you can take Lorazepam

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.

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.

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.

Grapefruit juice should be avoided as they can affect the way that Lorazepam Tablets work.

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. Benzodiazepines, including lorazepam, may cause damage to the foetus if taken during early pregnancy.

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. Your baby’s response to the cold might be temporarily impaired.

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

The recommended dose is

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 experience any of the following serious unwanted effects, you should tell your doctor immediately (these effects are more likely to occur in children and elderly patients):

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 e.g. frequent sore throats, mouth ulcers, weakness and pale skin as these are symptoms of blood dyscrasia.

Impaired consciousness (e.g. 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 e.g. difficulty in breathing, swelling of the lips, mouth, tongue, throat, hands, feet and /or severe faintness or dizziness.

Jaundice e.g. yellowing of the skin, eyes, nose, mouth, pale coloured stools (faeces) and dark coloured urine.

Other side effects

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

Daytime drowsiness.

Common (may affect around 1 in 100 people):

Dizziness, poor muscle control, muscle weakness, fatigue.

Rare (may affect around 1 in 1,000 people):

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

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

Trembling or shaking.

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

Increased risk of falling.

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 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 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.

Do not throw away any medicines via wastewater. 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 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