Lorazepam Tablets Bp 2.5 Mg
Lorazepam Tablets BP 1 mg and 2.5 mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Lorazepam is and what it is used for
2. Before you take Lorazepam
3. How to take Lorazepam
4. Possible side effects
5. How to store Lorazepam
6. Further information
1. WHAT LORAZEPAM IS AND WHAT IT IS USED FOR
Lorazepam is a member of a group of medicines called benzodiazepine anxiolytics.
This medicine will help to relieve
• severe anxiety (feelings of fear or nervousness) alone or
• severe anxiety with insomnia (sleeping difficulties) or
• severe anxiety with other mental illness.
2. BEFORE YOU TAKE LORAZEPAM
Do NOT take Lorazepam Tablets and talk to your doctor if you
• have ever had an allergic (hypersensitivity) reaction to lorazepam or benzodiazepines or any other ingredients of this medicine
• suffer from myasthenia gravis (a disorder in which your muscles are weak and tire easily),
• have sleep apnoea (difficulty breathing while asleep);
• suffer from serious liver problems,
• suffer from severe breathing problems
• suffer from mental illness, such as phobias or obsessions
Take special care with Lorazepam
Tell your doctor before you start to take this medicine if you:
• have any kidney or liver problems
• have ever suffered from an illness caused by problems with the blood vessels in your brain, for example a stroke;
• have ever been treated for a drink problem or drug abuse;
• have an ongoing mental condition such as a personality disorder or chronic psychosis, since this will increase the likelihood of you becoming dependant on Lorazepam.
• have had depression since it could re-occur during treatment
• suffer from depression since lorazepam may increase any suicidal feelings you may have
• suffer from breathing problems
suffer from the eye problem, Glaucoma
Other considerations
• Dependence - there is a risk of dependence when taking this medicine, which increases with dose and length of treatment. The risk of dependence is greater in patients with a history of alcohol or drug abuse.
• Rebound phenomena (the tendency of a medication, when discontinued, to cause a return of the symptoms being treated to be more severe than before) e.g. anxiety and withdrawal symptoms: Your doctor will explain that these effects are unlikely when treatment is limited to a short duration and withdrawn gradually.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• tranquillisers, sleeping tablets, sedatives,
• drugs for depression or your nerves,
• strong pain killers such as methadone, anaesthetics e.g. midazolam
• drugs for epilepsy e.g. sodium valproate,
• antihistamines,
• drugs for moods or mental disorders e.g. Clozapine;
• probenecid for gout;
• theophylline and aminophylline for conditions affecting the lungs such as asthma.
• are taking drugs that are broken down in the liver (such as Cimetidine), (ask your doctor or pharmacist if you are not sure);
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines). This because Lorazepam can affect the way some other medicines work. Also some medicines can affect the way Lorazepam works.
Taking Lorazepam with food and drink
DO NOT drink alcohol while you are taking Lorazepam tablets, as lorazepam may increase the effects of alcohol.
Pregnancy and breast-feeding
Lorazepam is NOT recommended if you are pregnant, planning to become pregnant or during pregnancy.
• Benzodiazopines, including Lorazepam may cause damage to the foetus if taken during early pregnancy.
• If you take Lorazepam during late pregnancy or labour, your baby, when born may be less active than other babies, have a low body temperature, be floppy or have breathing and feeding problems for a while. Your baby’s response to the cold might be temporarily impaired also.
• If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms after birth.
Contact your doctor immediately for advice before you stop taking this medicine, if you suspect you are pregnant or intend to become pregnant.
Talk to your doctor or pharmacist if you are breast-feeding, since the drug may pass into breast milk. Driving and using machines
Lorazepam may cause drowsiness, memory loss, impair concentration and movement.
If affected, DO NOT drive or operate machinery.
Drinking alcohol may make the above symptoms worse (see ‘Taking lorazepam with food and drink).
The 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.
Important information about some of the ingredients of Lorazepam Tablets:
Patients who are intolerant to lactose should note that Lorazepam Tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Lorazepam Tablets 2.5 mg also contain the colouring agent, sunset yellow FCF (E110). This may cause an allergic reaction.
3. HOW TO TAKE LORAZEPAM
Always take Lorazepam Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist when you are not sure.
The usual adult dose is:
• 1 mg - 4 mg a day in divided doses.
Children and adolescents:
• Children should NOT take Lorazepam Tablets.
Liver, kidney and breathing problems:
Please tell your doctor and follow the doctor’s instructions closely.
Taking this medicine
• Your doctor will only give you Lorazepam Tablets for up to four weeks. During this time, the number of tablets you take will be gradually reduced.
• While your tablets are being reduced you may notice changes in your mood, you may feel anxious, become restless and have trouble sleeping. You may feel similar to the way you did before you started to take your tablets. This is a side effect of reducing the tablets that will pass.
Talk to your doctor, if you take Lorazepam for longer than four weeks and feel you
• cannot carry on your normal business without taking them (become dependent on the tablets) or
• need to take more to get the same effect (build up a tolerance to the tablets).
• 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.
If you take more Lorazepam tablets than you should
If you (or someone else) swallow too many tablets or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause the following effects may occur: drowsiness, confusion, lethargy, difficulty in controlling movements, hypotonia (decreased muscle tone), low blood pressure (dizziness), shallow breathing and loss of consciousness
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Lorazepam
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Lorazepam
Do NOT stop taking your medicine without talking to your doctor first even if you feel better. Your doctor
will want to gradually reduce your dose of Lorazepam, before you finally stop taking this medicine. This
allows your body to get used to being without Lorazepam and reduce the risk of unpleasant effects.
• If you suddenly stop taking Lorazepam, you may experience side effects such as headaches, muscle pain, tension, anxiety, irritability, restlessness depression, insomnia (difficulty sleeping), confusion, numbness or pins and needles in your fingers and toes, hallucinations, become very sensitive to light, noise and physical contact, feel strange and things may seem unreal, have fits, involuntary movements, vomiting, tinnitus (ringing in your ears), twitching and convulsions.
• On stopping Lorazepam, you may experience symptoms such as headaches, muscle or stomach pains, anxiety, tension, depression, restlessness, sweating, sleep problems, confusion or irritability. If these symptoms do occur, they do not usually last for long. If you suffer from any of these symptoms, ask your doctor for advice.
• If you suffer from any of the following symptoms; loss of the sense of reality, tinnitus (ringing sounds in your ears), numbness or tingling of your arms or legs, vomiting, twitching, hallucinations, convulsions, or effects on sight, hearing or touch, ask your doctor for advice immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lorazepam may have side effects, although not everybody gets them.
Stop taking Lorazepam and tell your doctor immediately or go to the casualty department at your nearest
hospital if the following happens:
• Anaphylactic and anaphylactoid reaction (A sudden feeling of illness, anxiety, shivers, itch, a pale or red skin, sweating, sometimes breathlessness, quick heartbeat and shock)
• An allergic reaction (swelling of the tongue, face, lips, mouth or throat which may cause difficulty in swallowing or breathing).
• Develop signs of jaundice (yellowing of the skin or the whites of the eyes)
• Thoughts of harming or killing yourself or changes in your mental state
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Very common (affecting more than one person in 10):
• Sedation, drowsiness
• tiredness
Common (affecting less than one person in 10 but more than one person in 100):
• ataxia (shaky or unsteady movements), dizziness or light-headedness
• confusion, depression (low mood) or may disguise the depression (low mood)
• muscle weakness
• lack of energy (asthenia)
Uncommon (affecting less than one person in 100 but more than one person in 1,000):
• nausea
• change in sex drive, impotence, decreased orgasm
Unknown (data to calculate significant frequencies):
• Blood disorders which can include lower levels of red blood cells, white blood cells and platelets (known as blood dyscrasias). Symptoms of this include unexplained bruising, bleeding, pale skin, weakness and/or breathlessness, mouth ulcers and/or frequent infections.
• Abnormally concentrated urine, low levels of sodium in the blood
• Loss of inhibitions, euphoria
• Paradoxical reactions including anxiety, agitation, excitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal and hallucinations, loose your grip with reality (delusions)
• Extrapyramidal symptoms include involuntary trembling, dizziness, visual disturbances, (including double vision (diplopia) and blurred vision), slurred speech (dysarthria), headache, fits (convulsions), memory loss (amnesia), coma. These are common in elderly people.
• Low blood pressure (hypotension)
• Reduced breathing rate, shortness of breath, temporary cessation of breathing, including during sleep
• Worsening of chronic obstructive lung disease
• Constipation
• Increase in specific enzyme (bilirubin, liver transaminases and alkaline phosphatase)
• Allergic skin reactions, hair loss
• Low body temperature (hypothermia)
• Sweating
• Change in appetite
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your
doctor.
5. HOW TO STORE LORAZEPAM Keep out of reach and sight of children.
You should keep your tablets in a cool, dry place and away from light.
Keep them in the pack they came in. Do not put them into another container.
Do not use Lorazepam Tablets after the expiry date that is stated on the outer packaging. 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. FURTHER INFORMATION
What Lorazepam tablets contain:
• The active ingredient is lorazepam.
• The other ingredients are lactose, maize starch, povidone, water, sodium starch glycollate, colloidal silicon dioxide and magnesium stearate (inactive ingredients). The l mg tablets also contain the colour E132 (indigo carmine). The 2.5 mg tablets contain the colour, E110 (sunset yellow FCF).
What Lorazepam Tablets look like and contents of the pack:
• Each tablet contains Lorazepam BP 1 mg or 2.5 mg of the active ingredient. lorazepam.
• Lorazepam Tablets l mg are blue in colour.
• Lorazepam Tablets 2.5 mg are orange-peach in colour.
The Lorazepam 1 & 2.5 mg Tablets are available in pack sizes of 7, 14, 21, 28, 30, 56, 60, 84, 90, 100, 112, 120, 250, 500 and 1000 tablets. Lorazepam 1 mg Tablets are also available as a 50 tablets pack size.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Norton Healthcare, Royal Docks, London, E16 2QJ Company responsible for manufacture: Norton (Waterford) Ltd, Waterford, Ireland. This leaflet was last revised: June 2014 PL number 00530/0080-1.