PACKAGE LEAFLET: INFORMATION FOR THE USER

Lorazepam 1 mg tablets Lorazepam 2.5 mg tablets

Lorazepam

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 gets 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

The name of your medicine is Lorazepam, called lorazepam or lorazepam tablets in the rest of the leaflet. The tablets contain lorazepam.

The active ingredient is lorazepam, which is a type of medicine called a benzodiazepine. It relieves anxiety and it is used for short periods to relieve anxiety that is severe, disabling, or causing you extreme distress, and to treat difficulties sleeping that are caused by anxiety. It may also be used as a sedative shortly before a dental or surgical operation.

2. BEFORE YOU TAKE LORAZEPAM

Do not take Lorazepam

•    if you are allergic (hypersensitive) to lorazepam, or to any other benzodiazepine, or any of the other ingredients of Lorazepam tablets, see section 6.

•    you have severe breathing or chest problems

•    you have very tired or very weak muscles, a condition called myasthenia gravis

•    you have serious liver problems

•    you suffer from breathing problems when you are asleep, a condition called sleep apnoea

•    you have a history of persistently abusing alcohol and / or drugs

•    you are breast feeding, as lorazepam may pass into breast milk (see Pregnancy and breast feeding below)

If any of the above apply to you, do not take

lorazepam and go back to your doctor.

Taking Lorazepam with food and drink

Do not drink any alcohol while taking lorazepam.

If you take your whole dose in the evening, it should not be taken until four hours after food; otherwise you may feel hungover the next day.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Lorazepam should not be used during pregnancy. If you are pregnant or might become pregnant do not take this medicine without talking to your doctor first. Lorazepam may cause damage to the unborn baby if taken during pregnancy. If you take lorazepam during late pregnancy or during labour, your baby, when born, may be less active than other babies, have soft and limp muscles, a low body temperature, and / or a low blood pressure, have breathing or feeding difficulties for a while, and be floppy. Your baby might not be able to respond to cold properly for a while. If you take lorazepam regularly in late pregnancy, your baby may develop withdrawal symptoms after birth.

Lorazepam may pass into the breast milk. Therefore it should not be taken while breast feeding, unless the expected benefit outweighs the potential risk for the baby. Your baby may otherwise suffer from sedation and difficulties in suckling. In this case, monitoring of the baby is recommended.

Driving and using machines

Do not drive, operate machinery, or perform any task requiring concentration while taking lorazepam. Lorazepam may make you sleepy or dizzy during the day, and affect your concentration. This may be worse if you have not had enough sleep at night.

This 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.

Take special care with Lorazepam

•    you are pregnant, or trying to become pregnant (see Pregnancy and breast feeding)

•    you have a personality disorder; it may mean you have a greater chance of becoming dependent upon lorazepam

•    you have any kidney or liver problems

•    you have suffered from depression before, as it might come back during lorazepam treatment

•    you are suffering from depression as lorazepam may increase any suicidal feelings or thoughts you may have

•    you suffer from breathing problems

•    you are suffering from difficulty in coordination, or you are taking a lot of medicines that affect the brain

•    you suffer from raised eye pressure, an eye condition called glaucoma

•    you are elderly, as you may be more likely to fall

Although lorazepam may still be suitable for

you, you should discuss any of the points

above that apply to you with your doctor or

pharmacist. Do this before taking lorazepam.

Important information about some of the ingredients of Lorazepam

These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE LORAZEPAM TABLETS

Always take Lorazepam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Lorazepam tablets should be swallowed with a glass of water.

A large bed time dose may cause sleepiness or dizziness the next day ('hangover effect'), particularly if you have insufficient sleep, around 7-8 hours is needed (please see 'Driving and using machines' section).

If you have been given lorazepam for anxiety or sleeping problems, treatment will usually last from a few days to 4 weeks, and will usually include a gradual reduction in dose at the end of treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Other medicines may affect the way lorazepam works. Lorazepam may also affect the way other medicines work.

Tell your doctor if you are taking:

•    Any other sedative or anti-anxiety medicines

•    Antidepressants

•    Strong pain killers, such as tramadol, codeine, morphine, methadone

•    Medicines for epilepsy, such as sodium valproate

•    Antihistamine medicines for allergies

•    Medicines for mood or mental disorders, such as chlorpromazine, clozapine, haloperidol, loxapine

•    Medicines for asthma, such as theophylline or aminophylline

•    Medicines for relaxing your muscles

•    A medicine for gout called probenecid

•    A medicine called scopalamine that may be used for gut problems or before an operation

Adults (over the age of 18 years):

Anxiety: The usual starting dose is 0.5 mg, taken 2 or 3 times a day, which may be increase up to 2.5 mg per day (maintenance dose). The daily dose can be divided in 2 or 3 separate doses taken during the day, or it can be taken as a single dose in the evening, four hours after food and 30 minutes before going to bed. Your doctor will tell you how often to take your tablets.

The maximum daily dose of 2.5 mg should not be exceeded.

Insomnia caused by anxiety: The usual starting dose is 1 mg before going to sleep, which may be increased to 1 mg to 2 mg before going to sleep.

Before surgery or dental operations: The usual dose is between 2 mg to 4 mg, taken one to two hours prior to the operation.

Older patients, and patients with kidney or liver problems may be given lower doses, about the usual starting dose is half the normal adult dose. Your doctor will see how you respond to the medicine and alter the dose if needed.

Children and adolescents:

Lorazepam should not be used in children and adolescents under 18 years of age, except for the following treatments.

4. POSSIBLE SIDE EFFECTS

Like all medicines, lorazepam can cause side effects, although not everybody gets them.

Aged 6 years or less:

Children under the age of six should not be treated with Lorazepam.

Aged 6-12 years:

Before surgery or dental procedures: The usual dose is between 0.5 mg to 1 mg, depending upon the weight of the child (0.05 mg / Kg body weight dose should not be exceeded), taken at least one hour before the operation.

Aged 13 -18 years of age:

Before surgery or dental procedures: The usual dose is between 1 to 4 mg, taken one to two hours before the operation.

The lorazepam 1 mg tablets can be broken to give two equal doses. Each half tablet contains 0.5 mg lorazepam.

The lorazepam 2.5 mg tablets can be broken to give two equal doses. Each half tablet contains 1.25 mg lorazepam.

Your doctor may adjust the dose to suit you, depending on how you respond, and how well you tolerate the tablets. Your doctor can explain more. Always follow the instructions of the doctor.

If you take more Lorazepam than you should

You must seek medical help immediately, either by calling your doctor, or going to the nearest hospital casualty department. Do not drive yourself - get a friend or neighbour to take you, or call an ambulance. Always take the medicine container with you, even if it is empty. The doctor will then know what it is you have taken. Signs of mild overdose include drowsiness, mental confusion, and lethargy; in more serious cases, difficulty speaking, slurred speech, clumsiness or unsteadiness, low muscle tone, dizziness, and loss of balance and co-ordination may occur.

If you forget to take Lorazepam

Do not take a double dose to make up for a forgotten dose.

If you are being treated for anxiety, and it is less than 3 hours since you forgot the dose, you should take it as soon as you remember and carry on as normal. If it is more than 3 hours, do not worry, simply take the next tablet when it is due.

If you are being treated for sleeping problems, only take the tablet if you have sufficient sleeping time.

While taking Lorazepam

Lorazepam tablets may affect your concentration and make you feel sleepy during the day.

Some elderly patients may feel dizzy after taking lorazepam, and may be in danger of falling.

You may get tolerant to lorazepam. The beneficial effects may be less apparent after several weeks of use.

If you are prescribed lorazepam for more than 4 weeks, your doctor may want to take blood samples occassionally to check your blood and liver. Lorazepam may occassionally affect liver function or your blood.

Dependence on lorazepam may occur after prolonged treatment. Lorazepam tablets are usually prescribed for short treatment course, from a few days to four weeks, including a dose reduction at the end of treatment. This lessens the chances of becoming dependent upon lorazepam, or suffering unpleasant effects when you stop taking it. See the next section for more details.

Immediately contact your doctor if you develop any of the following signs:

•    Sudden, severe allergic reaction, causing difficulty in breathing, dizziness

•    Serious allergic reaction with swelling of face, lips, and throat

•    Yellowing of the skin and the whites of the eyes

•    Breathing difficulties

•    Thoughts of harming, or killing yourself

•    Changes in your mental state such as: restlessness, agitation, irritability, aggressiveness, hallucinations, unusual behaviour and beliefs.

Tell your doctor or pharmacist if you get any of the following side effects:

Very common-affects more than 1 user in 10 :

•    Drowsiness, sedation

•    Tiredness

Common-affects 1 to 10 users in 100 :

•    Confusion, depression, unmasking of depression

•    Poor muscle control, dizziness

•    Muscle weakness, loss of strength

•    Lack of energy

Uncommon-affects 1 to 10 users in 1,000:

•    Feeling sick

•    Changes in sex drive, impotence, decreased orgasm

The following side effects have been reported with lorazepam, but the frequency cannot be estimated from the available data:

•    Low levels of red blood cells, white blood cells, and platelets, resulting in unexplained bruising or bleeding, pale skin, weakness / breathlessness, and / or frequent infections

•    Allergic skin reactions such as reddening, rash; hair loss

•    Low blood sodium levels, concentrated (very dark) urine

•    Very low body temperature

•    Loss of short term memory

•    Muscle spasms, difficulty opening the mouth fully, tendency to stick the tongue out of the mouth, slurred speech, and abnormal changes in body posture, difficulty concentrating, dizziness, spinning feeling, headache, shaking, fits, unconsciousness

•    Blurred vision, double vision

•    Low blood pressure

•    Sexual arousal

•    Anxiety, agitation, excitability, hostility, aggression, rage, sleep disturbances, seeing or hearing things that are not there-these are more likely to occur in children and the elderly

•    Lowered breathing rate, breath shortness, temporarily stopping breathing, including while asleep, worsening of asthma, difficulty in speaking and slurred speech

•    Constipation

•    Changes in liver function-your doctor will check for this

•    Changes in your blood-your doctor will check for this

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE LORAZEPAM

Store below 25^oC. Store in the original container to protect from light.

Keep out of the reach and sight of children.

Do not use Lorazepam after the expiry date which is stated on the carton after EXP; it is also stated on the blister. The expiry date refers to the last day of that month.

If you stop taking Lorazepam

After you have finished your prescribed treatment with lorazepam, your doctor will decide whether 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 lets your body get used to being without lorazepam, and lessens the chances of unpleasant effects when you stop taking them. Your doctor will tell you how to do this.

When you stop taking lorazepam you may experience withdrawal symptoms such as headache, muscle pain, anxiety, sleep disorders, tension, depression, restlessness, dizziness, feeling sick, diarrhoea, appetite loss, confusion, irritability, agitation, shaking, stomach and / or muscle pain, changes in heart beat, short term memory loss, high body temperature, and sweating. Your original difficulty sleeping may come back. If any of these signs occur, they usually do not last long. If you do suffer from any of these signs, ask your doctor for advice.

Do not stop taking lorazepam suddenly. You might have more serious withdrawal signs, such as loss of sense of reality, feeling unreal or detached from life, not able to feel emotion. Some patients have had numbness or tingling of the arms or legs, being sick, ringing in the ears, twitches, seeing or hearing things that are not there, fits, and being extra sensitive to touch, sound, and light. If you have any of these signs, immediately ask your doctor for advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 contains

•    The active substance is lorazepam, either 1 mg or 2.5 mg in a tablet

•    The other ingredients are: lactose monohydrate, povidone (K30), crospovidone, type A, maize starch, microcrystalline cellulose, sodium starch glycollate, Magnesium stearate and polacrillin potassium.

What Lorazepam looks like and contents of the pack

Lorazepam 1 mg: white, round, flat, bevelled, scored tablets, inscribed 1.0 Lorazepam 2.5 mg: white, round, flat, bevelled, scored tablets

Blister packs containing 10, 14, 15, 20, 28, 30, 50, 60, 90, 100 or (only available to pharmacies or hospitals) 500 tablets are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Limited

115 Narborough Road, Leicester, LE3 0PA, UK

Manufacturers

Farmaceutisch Analytisch Laboratorium Duiven B.V (FAL Duiven B.V)

Dijkgraaf, 6921, RK Duiven, The Netherlands.

Medochemie Ltd, Factory A-Z, Ayios Athanassios, Industrial Street, Limassol,

Cyprus.

This leaflet was last revised in April 2014