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Lorazepam Tablets 2.5mg

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Document: leaflet MAH GENERIC_PL 04416-0095 change

PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Lorazepam Tablets 1 mg and 2.5 mg


(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 Tablets are and what they are used for

2.    Before you take Lorazepam Tablets

3.    How to take Lorazepam Tablets

4.    Possible side effects

5.    How to store Lorazepam Tablets

6.    Further Information



IWhat Lorazepam Tablets are and what they are used for

Lorazepam Tablets contain lorazepam as the active ingredient. This belongs to a group of medicines known as benzodiazepines, which have sedative and muscle relaxing properties.

Lorazepam Tablets are used for the short term treatment of anxiety, which may or may not be associated with sleeping problems and is severe, disabling, or causing unacceptable distress. Lorazepam Tablets are also used as a sedative and pre-medication before investigative or surgical procedures, such as dental surgery.

2 Before you take Lorazepam Tablets


DO NOT take Lorazepam Tablets if you have:

•    an allergy (hypersensitivity) to lorazepam or any of the other ingredients in the tablets (see Section 6: Further information)

•    myasthenia gravis (extreme tiredness and weakness of selected muscles, symptoms of which may include drooping of the upper eyelid, double vision or speech difficulties)

•    difficulties in breathing

•    sleep apnoea syndrome (when you stop breathing while asleep)

•    severe liver damage.

Take special care with Lorazepam Tablets if you:

•    are suffering with depression, or anxiety associated with depression, and are not taking any other medication

•    have an alcohol or drugs problem, or a history of this. If so, you have a greater chance of becoming dependant on lorazepam.

•    have a history of a personality disorder

•    have kidney problems

•    suffer with muscular weakness.

•    you are going to have an operation which requires an anaesthetic, tell the hospital or surgery that you are taking Lorazepam Tablets in advance.

Lorazepam Tablets are not recommended for the treatment of mild anxiety.

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.

In particular, please tell your doctor if you are taking any of the following:

•    antidepressants e.g. lithium, citalopram

•    medicines to treat severe mental illnesses e.g. amisulpride, olanzapine

•    medicines to help you sleep e.g. temazepam, zolpidem

•    medicines to treat anxiety e.g. diazepam

•    narcotic analgesics (strong painkillers) e.g. morphine, fentanyl, oxycodone

•    anti-epileptic medicines e.g. phenytoin, carbamazepine

•    antihistamines (for allergies and hayfever) that cause drowsiness e.g. chlorphenamine, ketotifen

•    an antibiotic called Rifampicin.


Taking Lorazepam Tablets with food and drink

Do not drink alcohol while taking Lorazepam Tablets.

It can interfere with the usual effect of the medicine. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.

Do not take this medicine if you are pregnant, might become pregnant, or are breast-feeding. If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby may have a low body temperature, floppiness and breathing difficulties. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms. Discuss any concerns with your doctor.

Lorazepam is found in breast milk. Therefore, do not take lorazepam whilst breast-feeding.

Driving and using machines

These tablets may cause drowsiness, loss of concentration (especially if you have not had enough sleep), and loss of muscle function, which may adversely affect your ability to drive and use machines. Do not drive or operate machines whilst taking Lorazepam Tablets if you notice these effects.

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

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 How to take Lorazepam Tablets

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

Usually the course of treatment with lorazepam will be as short as possible. If you are being treated for severe anxiety and phobia or severe and disabling insomnia you will be reassessed regularly by your doctor and treatment should not continue for more than 2 to 4 weeks. This includes a tapering off period.

Lorazepam Tablets should be swallowed with water.

Continued on the next page >>


Adults

For severe anxiety and phobia:

1 mg to 4 mg per day, in divided doses.

For severe and disabling insomnia:

1    mg to 2 mg before bed-time.

For premedication:

2    mg to 3 mg the night before the operation, 2 mg to 4 mg, 1 to 2 hours before the operation.

Children aged 5 to 13 years

For premedication: 0.5 mg to 2.5 mg (at 0.05 mg per kilogram of the child’s body weight, to the nearest 0.5 mg), not less than 1 hour before the operation.

Dentistry:    1 mg to 2.5 mg, 1% to 2 hours

before dental treatment. For dental surgery, dosage as for premedication.

Elderly patients may be given a lower dose.

Patients with liver or kidney disease or with breathing difficulties may be given a lower dose.

If you have the impression that the effect of Lorazepam Tablets is too strong or too weak, talk to your doctor or pharmacist.

If you take more Lorazepam Tablets than you should

If you may have taken more Lorazepam Tablets than you should, tell your doctor or pharmacist. If you have accidentally taken one extra dose, this is unlikely to be a cause for concern. However, if you or someone else may have taken more than one extra dose or a large overdose, contact your doctor or local hospital accident and emergency department immediately.

If you forget to take Lorazepam Tablets

Do not take a double dose to make up for forgotten individual doses. Do not worry if you have forgotten to take your medicine. Wait until the next dose is due and carry on as normal. If you are concerned, consult your doctor or pharmacist.

If you stop taking Lorazepam Tablets

DO NOT stop taking the tablets until the doctor has told you to. It is possible that your body has become dependant on lorazepam.

If you wish to stop taking these tablets before the end of the course, discuss this with your doctor.

Lorazepam Tablets need to be withdrawn gradually to allow your body to get used to being without lorazepam and reduce the risk of unpleasant side effects (see the information on “Dependence” under Section 4: Possible side effects).

4 Possible side effects


Dependence

The use of lorazepam may lead to dependence. If you stop taking it suddenly you may get withdrawal symptoms or rebound phenomena.

Withdrawal symptoms include:

•    headaches

•    muscle pain

•    extreme anxiety, tension

•    restlessness, irritability

•    confusion.

In severe cases the following may occur:

•    a state of feeling unreal or strangely altered

•    abnormally sensitive hearing

•    numbness and tingling in the fingers and toes

•    hypersensitivity to light, noise and physical contact

•    hallucinations

•    fits.

Rebound phenomena occur when the symptoms that led to treatment with lorazepam temporarily return in a more severe form when treatment is stopped. This may be accompanied by mood changes, anxiety or sleep disturbances and restlessness. If you are concerned about this, discuss it with your doctor.

Behavioural effects

The following effects have been reported with benzodiazepines such as lorazepam:

•    restlessness, irritability

•    agitation

•    aggressiveness, rages

•    delusion, hallucinations

•    nightmares

•    mental disorders

•    inappropriate behaviour or other unwanted behavioural effects.

These effects may be severe and are more likely to occur in children and the elderly. Tell your doctor immediately if you experience any of these effects, as your doctor may want you to stop taking your medicine.

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 Tablets


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

At the start of treatment, you may notice the following:

•    tiredness, reduced alertness, feeling drowsy during the day

•    numbed emotions

•    confusion, dizziness

•    loss of coordination, weak muscles

•    headache

•    nausea and vomiting, changes in saliva

•    slurring of speech or difficulty in speaking

•    tremors

•    visual disturbances (e.g. double vision).

These effects usually disappear after you have been taking lorazepam for a while.

Occasionally, the following effects have been reported:

•    stomach upsets

•    changes in sex drive

•    blood disorders (e.g. unexplained bruising, pale skin)

•    jaundice (yellowing of the skin or whites of the eyes)

•    skin reactions.

You may feel depressed after taking Lorazepam Tablets.

Memory loss

Lorazepam may cause memory loss. To reduce the risk of this happening, make sure you get 7-8 hours of uninterrupted sleep.


Keep out of the reach and sight of children.

Do not use Lorazepam Tablets after the expiry date which is stated on the carton after EXP. 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 substance is lorazepam. Each tablet

contains 1 mg or 2.5 mg.

The other ingredients are lactose, microcrystalline cellulose, talc, sodium starch glycollate and indigo carmine lake (E132) colouring (see Section 2: Further information about some of the ingredients of Lorazepam Tablets).

What Lorazepam Tablets look like and contents of the pack

Lorazepam 1 mg tablets are pale blue capsule shaped tablets and Lorazepam 2.5 mg tablets are yellow capsule shaped tablets.

The 1mg tablets are available in Securitainer packs of 28, 100, 500 and 1,000 tablets, and blister packs of 30 or 100 tablets.

The 2.5mg tablets are available in Securitainer packs of 28, 100 and 500 tablets, and blister packs of 30 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Leaflet prepared: 08/2014


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