PATIENT INFORMATION LEAFLET
LORAZEPAM TABLETS
GENUS PHARMACEUTICALS
A Wyeth Company
Please read this leaflet carefully before you start to take your medicine. It provides important information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
WHAT IS IN YOUR MEDICINE?
The name of your medicine is Lorazepam Tablets. The capsule-shaped tablets come in two strengths: blue tablets containing 1mg of the active ingredient lorazepam or yellow tablets containing 2.5mg lorazepam.
Lorazepam Tablets also contain lactose (67mg per 1mg tablet; 65.5mg per 2.5mg tablet), microcrystalline cellulose, polacrilin potassium, magnesium stearate and the following colouring: Blue tablet: indigo carmine, El3Z; Yellow tablet: tartrate, E102.
Both the 1mg and the 2.5mg tablets are supplied in packs of 100 tablets. However, your doctor may prescribe a different number of tablets for you.
Lorazepam is a member of a group of medicines called benzodiazepines. It can help to relieve anxiety.
MARKETING AUTHORISATION HOLDER: Genus Pharmaceuticals, Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH.
MANUFACTURER: Wyeth Medica Ireland, Little Connell, Newbridge, Co. Kildare, Republic of Ireland.
WHAT DOES YOUR MEDICINE DO?
Lorazepam is prescribed as short-term therapy for anxiety, or sleeping difficulties due to anxiety. It may also be used as a sedative before surgery or operative dental treatment.
BEFORE YOU TAKE YOUR MEDICINE
YOU SHOULD NOT TAKE LORAZEPAM IF:
You have severe breathing a chest problems.
You are allergic to benzodiazepines or any of the ingredients in Lorazepam Tablets (see the list under "What is in your medicine").
You have "myasthenia gravis" (very weak or tired muscles).
You have serious liver problems.
You suffer from "sleep apnoea" (breathing problems when you are asleep).
You are breast feeding, since the drug may pass into breast milk.
TELL YOUR DOCTOR OR PHARMACIST IF:
You are pregnant or trying to become pregnant (see below).
You abuse or have in the past abused drugs or alcohol.
You have a personality disorder If so, you have a greater chance of becoming dependent on lorazepam.
You have any kidney or liver problems.
You have suffered from depression before since it could re-occur during treatment with lorazepam. You are suffering from depression, since lorazepam may increase any suicidal feelings which you may have.
You suffer from breathing problems.
You suffer from an eye problem called glaucoma.
You are taking any other medicines, including those which have not been prescribed a doctor, since they may affect the way Lorazepam works. Lorazepam may also affect the way other drugs work.
In particular, you should tell your doctor if you are taking any other sedative, anti-anxiety drugs, antidepressants, strong pain killers (e.g. methadone), drugs for epilepsy antihistamines, drugs for mood or mental disorders (e.g. chlorpromazine), loxapine or clozapine. The dose of these drugs may need to be reduced before you can take Lorazepam.
Benzodiazepines, including Lorazepam, may cause damage to the foetus if taken during early pregnancy. Therefore, do not take this medicine if you are pregnant or might become pregnant without consulting your doctor. 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. 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.
The 2.5mg Lorazepam Tablet contains the colour tartrazine (E102) which can cause allergic reactions, including asthma. Allergy to tartrazine is more likely if you are also allergic to aspirin. Each tablet also contains the equivalent of 0.25mg of potassium. Too much potassium may be harmful if you are on a low potassium diet.
THINGS TO NOTE BEFORE TAKING YOUR MEDICINE
Tell your doctor or pharmacist that you are taking Lorazepam before taking any other medicine or if you enter hospital for treatment.
Some people feel sleepy or drowsy during the day when taking Lorazepam. Do not drive or use machinery until you are sure you are not affected.
You should avoid alcohol while you are taking Lorazepam, since this may make you very drowsy. 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 drugs like Lorazepam have occasionally affect blood and liver function.
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 it (See "Stopping Your Medicine", below).
TAKING YOUR MEDICINE
Your doctor will tell you how many tablets to take, and how often to take them. The label on your medicine should also tell you. However, if it doesn't, or you are not sure, ask your doctor or pharmacist (chemist).
If you have been given Lorazepam tablets for anxiety or sleeping problems, treatment will usually last from a few days to 4 weeks and will usually include a dose reduction at the end.
Lorazepam tablets should be swallowed with water.
Adults (and children over 13 years of age):
Anxiety: 1 to 4mg daily in divided doses. Your doctor will tell you how often to take your tablets.
Sleeping Problems: 1 to 2mg before going to sleep. You should make sure that you will be able to sleep for 7 to 8 hours before taking your tablets.
Before Surgery: 2 to 3mg the night before your operation and 2 to 4mg one or two hours before your operation.
Children (between 5 and 13 years of age):
Before Surgery: The dose is usually between 0.5 and 2.5mg (depending on your child's weight) at least one hour before your child's operation.
Lorazepam is not recommended for the treatment of anxiety or sleeping problems in children. Nor is it recommended for children below 5 years of age.
Elderly: Older patients may be given lower doses. They may respond to half the usual adult dose or less.
WHAT TO DO IF YOU FORGET TO TAKE A 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, don't worry, just take your next tablet when it is due.
NEVER TAKE A DOUBLE DOSE OF TABLETS
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.
WHAT TO DO IF YOU TAKE TOO MANY TABLETS
If anyone has an overdose of Lorazepam tablets (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.
STOPPING YOUR MEDICINE
After you have finished your prescribed treatment with Lorazepam, your doctor will decide whether or not you need further treatment.
The number of Lorazepam Tablets and how often you take them should always be reduced slowly before you stop taking them altogether. This allows your body to get used to being without your tablets, and reduces the risk of unpleasant effects when you stop taking them. Your doctor will tell you how to do this.
On stopping Lorazepam, you may experience symptoms such as headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Your original sleeplessness may also return. If you suffer from any of these symptoms, ask your doctor for advice.
Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as a loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have experienced numbness or tingling of the arms or legs, vomiting, tinnitus (ringing sounds in your ears), twitching, hallucinations, convulsions and hypersensitivity to light, sound and touch. If you suffer from any of these symptoms, ask your doctor for advice immediately.
THINGS TO BE AWARE OF WHILST TAKING YOUR MEDICINE
Occasionally, you may have unwanted effects whilst taking Lorazepam. These are usually not serious and do not last long. However, you should tell your doctor if any of the following symptoms are severe or become troublesome:
- daytime drowsiness
- dizziness
- reduced alertness
- sleep problems
- confusion,
depression
- memory loss or forgetfulness
- numbed emotions, fatigue
- muscle
weakness
- poor muscle control
- stomach upsets, nausea, changes in appetite
- headaches
- problems with vision
- skin problems
- changes in sex drive
If you experience any of the following more rare 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
- nightmares
- hallucinations
- personality changes
- abnormal behaviour or false beliefs
You should tell your doctor or pharmacist if you have any other unwanted effect not mentioned above.
Other rare unwanted effects (which you may not be aware of whilst taking Lorazepam) include blood or liver function changes, or low blood pressure.
STORING YOUR MEDICINE
You should not take Lorazepam after the expiry date shown on the label.
Lorazepam Tablets should be kept in a cool, dry place. They should be stored safely, where children cannot see or reach them.
Return any unused tablets to your pharmacist. Only keep them if your doctor tells you to.
REMEMBER this medicine is only for YOU. Only a doctor can prescribe it for you. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.
Leaflet prepared: 21 January 1998 · CI 5682-1
Update: Lorazepam: Patient Information Leaflet, Genus Pharmaceuticals, January 2008
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