Document: leaflet MAH GENERIC_PL 00289-0149 change

• label-leaflet MAH GENERIC_PL 00289-0149
• leaflet MAH GENERIC_PL 00289-0149

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ItevaUK Ref: 231-30-84121-Y LEA TEMAZEPAM A/S TABS TUK<DEB Version: 1    24 November 2014

FRONT

TEMAZEPAM 10 mg AND 20 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    Keep this leaflet.You may need to read it again.

•    Ifyou haveanyfurtherquestions,askyour doctor or pharmacist.

•    This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even iftheir symptoms are the same as yours.

•    If you get any side effects, talkto your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1.    What Temazepam is and what it is used for

2.    Before you take Temazepam

3.    How to take Temazepam

4.    Possible side effects

5.    How to store Temazepam

6.    Further information

OWHAT TEMAZEPAM IS AND WHAT IT IS USED FOR

Temazepam is an anti-anxiety drug which is used in the short-term to help people sleep.

It belongs toa group ofdrugs called benzodiazepines.

Temazepam is used for:

• short-term treatment ofinsomnia (difficulty in sleeping) which is severe, disabling or causing extreme distress • pre-medication before minor surgery or other procedures.

before you take temazepam

Do NOT take Temazepam if you:

• are allergic (hypersensitive) to temazepam or other benzodiazepines (e.g. diazepam) or any ofthe other ingredients ofthis medicine (see section 6)

• have difficulty in breathing or lung problems

• have a condition called sleep apnoea syndrome (where breathing stops during sleep)

• have myasthenia gravis (a condition where the muscles become weak and tire easily)

• havesevereliverproblems • have a history of mental illness, such as obsessions or phobias (irrational fears)

• suffer from anxiety or psychotic illness. Temazepam tablets may unmaskor worsen symptoms.

• are breast-feeding • areachildunderthe ageof18years.

Take special care with Temazepam

Talk to your doctor before you start to take

this medicine if you:

• are elderly or frail. Ifyou get up at night, take care as there is an increased risk of falling and consequently of hip fractures due to muscle relaxant effect ofthe tablets • have long-term lung, kidney or liver problems

• have history of breathing problems. Whilst taking Temazepam tablets your breathing may become less forceful.

• have a history of problems with alcohol or drug abuse (your risk of dependence is higher)

• suffer from mental illness, depression or depression with anxiety • have recently suffered a bereavement (if Temazepam is taken to help sleep during periods of bereavement it may stop you coming to terms with the loss)

• are or suspect that you are pregnant. Taking other medicines Tell your doctor or pharmacist ifyou are taking or have recently taken any other medicine including medicines obtained without a prescription. Temazepam tablets may influence the effect and/or side effects ofother medicines. Ifyou see another doctor or go into hospital, particularly ifyou are having an operation under anaesthesia tell the doctor which medicines you use.

The following medicines may increase the sedating effect ofTemazepam tablets:

• medicinestotreatmentalillness (antipsychotics)

• medicines to treat depression, such as phenelzine and amitriptyline • other sleeping pills, such as zopiclone • anxiolytic or sedative drugs, such as diazepam

• narcotics (strong pain killers) such as codeine, morphine. Feelings ofexcitement (euphoria) may increase, which in turn increase the chance on physical or mental dependence.

• medicinesusedtotreatepilepsy • anaesthetics (used during surgery)

• sedativeantihistamines,such as promethazine

• medicines used to treat high blood pressure, such as doxazosin and lofexidine

• nabilone (used to treat vomiting and nausea)

• cisapride (used for stomach disorders)

•    muscle relaxants, such as baclofen and tizanidine.

Zidovudine and ritonavir (retroantiviral drugs used to treat HIV infection and AIDS)

- may cause an increase in concentration of temazepam in the blood.

Theophylline (used to treat asthma) - may decrease the effect of temazepam.

Disulfiram (used to treat alcohol dependence) - inhibits the metabolism of temazepam and increasesthe riskof temazepam poisoning.

Fluvoxamine (used to treat depression) -increases the concentration oftemazepam in the blood.

Cimetidine (used to treat stomach ulcers) -decreases the blood concentration of temazepam in the blood.

Rifampicin (an antibacterial drug) -increases the metabolism oftemazepam and decreases the temazepam blood concentration.

Clozapine medicines used to treat psychoses.

Temazepam:

•    increasesordecreasesthelevelof phenytoin

•    increasestheeffectsofsodium oxybate (used to treat narcolepsy with cataplexy -sleep disorders with sudden and transient loss of muscle tone)

•    possibly reduces the effects of levodopa (used to treat Parkinson's disease)

•    enhancesthe blood pressure lowering effect ofanti-hypersensitive medicines (e.g. moxonidine, beta-blockers).

Important information about some of the ingredients of Temazepam

•    Patients who are intolerant to lactose should notethatTemazepam Tablets contain a small amount of lactose. Ifyour doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Important safety messages about Temazepam:

•    When taking this medicine there is a risk ofdependence (a need to keep taking the medicine).The risk increases with the dose and length oftreatment period.The risk is greater ifyou have ever had a history of alcohol or drug abuse, or suffer from a personality disorder.

•    Close medical supervision is required when taking this medicine.Your doctor will ensure that you take the lowest effective dose and this should be taken for the shortest possible time and not exceed 4 weeks.

•    You may become tolerant to the effects of Temazepam afteryou have been taking it repeatedly for a few weeks (see section 3, How to take Temazepam)

•    When stopping this medicine you may experience withdrawal effects (see section 3, If you stop taking Temazepam)

•    Behavioural effects may occur while taking Temazepam (see section 4, Possible Side Effects)

•    To reduce the risk ofamnesia (loss of memory), you should make sure that you are able to have an uninterrupted sleep of at least 7-8 hours

•    Ifyou have been givenTemazepam for premedication, you should be accompanied home.

Taking Temazepam with food and drink

Do NOT drink alcohol while taking these tablets, as taken together they could make you feel very drowsy which could be dangerous.

Pregnancy and breast-feeding

Ifyou are pregnant, planning to become pregnant or breast-feeding, askyour doctor or pharmacist for advice before taking this medicine.

Ifyour doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, and breathing and feeding difficulties. Ifthis medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.

Driving and using machines

Yourtablets may make you feel drowsy during the day, make you forgetful and impair your concentration, vision and muscle function. Also you will be less alert if you have not been able to sleep for long enough. If affected, do NOT drive or operate machinery.

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 ifthis 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.

BACK

Talkto your doctor or pharmacist ifyou are not sure whether it is safe for you to drive while taking this medicine.

^ HOWTOTAKE TEMAZEPAM

Always take Temazepam exactly as your doctor has told you.You will be given the lowest effective dose for the shortest possible time. If there is anything you are not sure about check with your doctor or pharmacist.

The tablets should be swallowed preferably with a glass ofwater.

Yourdoctorwill decidethe correct dosage; the usual dose is:

Insomnia

•    Adults: 10-20 mg should be taken when going to bed orupto 30 minutes before going to bed. Very occasionally, the dose may be increased to 30-40 mg daily.

•    Elderly patients: the dose is 10 mg daily. Very occasionally, this may be increased to 20 mg daily.

•    Children: TemazepamisNOT recommended for use in children underthe age of18 years.

For patients who have certain problems with blood vessels or their liverthe dosage may be lower.

Do NOT change the dose yourself. Premedication

•    Adults: 20-40 mg should betaken 30-60 minutes before surgery.

•    Elderly: Lowerdoses may be required by elderly patients, up to halfthe normal adult dose may be adequate.

•    Children: Temazepamisnot recommended for use in children underthe age of18 years.

If you take more Temazepam than you should

Ifyou (or someone else) swallow a lot ofthe tablets all together, or ifyou think a child has swallowed any ofthe tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, difficulty in controlling movements, slurred speech and involuntary eye movements; coma, low blood pressure and breathing problems can also occur.

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 Temazepam Ifyou fall asleep without having taken a dose and wake up some hours later, do not take the missed dose. If necessary, return to your normal dose schedule the following night. Do not take a double dose to make up for a forgotten dose.

If you stop taking Temazepam You will be told by your doctor to stop taking the tablets as soon as is possible and the dose will be reduced gradually.You should not stop taking the tablets suddenly or without medical advice. Ifthe tablets are stopped abruptly or the dose reduced too rapidly you may get unpleasant effects. These withdrawal effects can include headache, muscle pain, tension, severe anxiety, confusion, depression, restlessness, irritability and sweating. In severe cases of withdrawal you may experience a feeling of things being unreal, a feeling of detachment from your surroundings, numbness and tingling in the hands and feet, sounds seeming to be louder than usual and which can sometimes be painful ifthe sound is loud, sensitivity to light or touch, hallucinations, involuntary movements, being sick (vomiting) and fits. In addition, problems with sleeping, feeling restless and anxious and mood changes may return. Ifyou experience these or any other unusual effects when you stop taking Temazepam, speakto your doctor.

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

^4 POSSIBLE SIDE EFFECTS

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

Ifthe following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling ofthe lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately ifyou suffer from:

•    behavioural changes such as restlessness, agitation, irritability, aggressiveness, delusions, excitement, rages, nightmares, hallucinations, confusion, psychiatric disorders and inappropriate behaviour, as your treatment may be stopped; you are more likely to suffer these effects ifyou are elderly.

Teva Pharmaceuticals Europe B.V

1.3.2 mockup-pil-uk-pl-00289-0148-0149-temazepam-10mg-20mg-tablets

Approvals

Signed by	Meaning of Signature	Server Date
Annette Huggett	Regulatory Affairs Approval	12-Jan-2015 01:26:11 PM

REG0068681 Version 1.2 Approved Page 3 of 3