Document: leaflet MAH GENERIC_PL 04569-0332 change

• leaflet MAH BRAND_PLPI 10383-2132
• leaflet MAH GENERIC_PL 04569-0332

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Package leaflet: Information for the patient

TEMAZEPAM 10 mg AND 20 mg TABLETS

(Temazepam)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

•    If you have further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

What is in this leaflet:

1.    What Temazepam is and what it is used for

2.    What you need to know before you take Temazepam

3.    How to take Temazepam

4.    Possible side effects

5.    How to store Temazepam

6.    Contents of the pack and other information.

1.    What Temazepam is and what it is used for

Temazepam belongs to a group of medicines called benzodiazepines or hypnotics. Benzodiazepines are used to make you feel less anxious, they can also be used to make you feel sleepy, relax your muscles and stop or prevent fits. Temazepam can be used for the following:

•    difficulty sleeping (insomnia), when your lack of sleep is causing you a lot of distress

•    to be given before minor surgery and other similar procedures (pre-medication) to make you feel more relaxed (or less anxious).

2.    What you need to know before you take Temazepam

Do not take Temazepam:

•    if you are allergic to temazepam, or any other benzodiazepine medicine (such as diazepam or nitrazepam), or any of the other ingredients in this medicine (listed in section 6)

•    if you suffer from long term fatigue and muscle weakness (myasthenia gravis)

•    if you suffer from irregular breathing whilst asleep (sleep apnoea syndrome)

•    if you have severe lung or liver problems

•    if you are under 18years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking Temazepam:

•    if you have a history of alcohol or drug abuse

•    if you have liver or kidney problems

•    if you have lung problems

•    if you are suffering from depression or anxiety associated with depression

•    if you find that you need to get up regularly during the night, for example to go to the loo

•    if you have a personality disorder such as schizophrenia.

Other medicines and Temazepam

Tell    r or pharmacist if you are taking,

have recently taken or might take any other medicines, including medicines obtained without a prescription, or the following:

•    other medicine to help you get to sleep e.g. nitrazepam, chloral hydrate

•    any other medicine to treat nervousness, feeling anxious, or for depression

•    any medicine to treat severe mental health illnesses

•    disulfiram used in the treatment of alcohol dependence

•    strong pain killers e.g. morphine

•    antihistamines that cause drowsiness, normally used to treat allergies but may also be used to help you sleep

•    any medicine to treat Parkinson's disease

•    medicine to treat convulsions or fits (epilepsy)

•    any other medicine that can make you feel drowsy or less alert as temazepam may increase this effect

•    the contraceptive pill.

If you are going to have an operation or need an anaesthetic, tell the doctor or dentist that you are taking Temazepam. If you take Temazepam before a minor operation or procedure it is important that you have someone to accompany you home.

Temazepam with alcohol

Do not drink alcohol while you are taking Temazepam as it may make you feel more sleepy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before take this medicine.

Do not take Temazepam if you are pregnant, might become pregnant or are breastfeeding. However, if your 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 difficulties when born. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.

If taken whilst breast-feeding, temazepam may be present in the breast milk.

Driving and using machines

Temazepam may make you sleepy or affect your concentration, memory or how your muscles work. This may affect your ability to drive or operate machinery. Do not drive or operate machinery until you are sure you are not affected.

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.

Temazepam contains lactose

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

3. How to take Temazepam

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole. If you take Temazepam for sleeping difficulties (insomnia) your doctor will usually give you Temazepam for a maximum of 4weeks, this will include a period of time when your dose is reduced slowly before you stop taking Temazepam. Reducing your dose slowly will help to reduce the risk of side effects from withdrawal of the product.

It is also important that you are able to have 7-8 hours of uninterrupted sleep after taking your tablet. If you are late getting to bed or your sleep is interrupted you may suffer from unwanted side effects such as memory loss or feeling drowsy. You may also behave strangely or differently to how you would normally behave. Also, as this medicine is a muscle relaxant, people who have taken Temazepam and get up during the night are at greater risk of falling and fracturing their hip. The risk of this occurring is greater in older people.

At high doses taken for a long period of time, it is possible that you may become dependent on your medicine. If this happens to you, you must speak to you doctor.

Adults

Insomnia

The recommended dose is 10mg or 20 mg half an hour before going to bed. In certain cases your doctor may increase the dose to 30 mg or 40 mg.

Pre-medication

The recommended dose is 20-40 mg, half an hour to one hour before your procedure.

Older people

Insomnia

Older people usually require smaller doses of 10mg half an hour before going to bed, but in certain cases the dose may be increased to 20 mg.

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Pre-medication

The recommended dose is 10-20 mg, half an hour to one hour before your procedure.

Use in children and adolescents

Temazepam is not recommended for use in children or adolescents younger than 18 years of age.

People with breathing difficulties or liver problems

If you have a long-term problem with your breathing or problems with your liver your doctor may recommended that you take a lower dose.

If you take more Temazepam than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include drowsiness, confusion and a general feeling of sluggishness (lethargy). In more serious cases of overdose, symptoms include uncontrollable movements, floppiness, shallow or slow breathing, dizziness, lightheadedness or fainting on standing up or unconsciousness (including coma, which can, rarely, become fatal).

If you forget to take Temazepam

If you are still likely to have uninterrupted sleep of 7-8 hours, then take it as soon as you remember. Otherwise, if you miss a dose do not take a double dose to make up for a forgotten dose. Take your normal dose the following night.

If you stop taking Temazepam

You should only stop taking this medicine when your doctor tells you. Do not suddenly stop. if this happens you may suffer from side effects such as feeling nervous, depressed, irritable, suffer from sleep problems, sweating, being sick,confusion, psychosis, fits or shaking.

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

4. Possible side effects

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

In some patients, particularly older people, Temazepam can cause unusual reactions. If any of the following happen, tell your doctor or pharmacist. You may need to stop taking Temazepam or lower your dose:

•    restlessness

•    agitation

•    irritability

•    aggressiveness

•    delusions (beliefs which are not normally consistent with reality)

•    rage

•    nightmares

•    hallucinations (feeling, hearing or seeing things which are not there)

•    psychoses (severe thought disturbances)

•    odd or unusual behaviour.

Other side effects are:

•    drowsiness, tiredness or less alert during the next day, reduced alertness, sleep disturbances (such as restless sleep)

•    numbed emotions, depression or worsening of existing depression

•    confusion, reduced ability to concentrate, memory loss (this may also be accompanied by odd or unusual behaviour)

•    headaches, dizziness, double vision

•    low blood pressure, which may make you feel dizzy or faint when you stand up

•    muscle weakness or lack of co-ordination

•    lack of sex drive

•    dry mouth, stomach pain or diarrhoea

•    skin rashes

•    unusual bruising or bleeding or an increase in the number of infections (such as sore throat) that you may get - this may be a sign of changes in the number of different types of blood cells

•    changes in the way your liver works (this may show up in blood tests).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via

www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide

more information on the safety of this

medicine.

5.    How to store Temazepam

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the bottle, container, blister or carton after 'EXP¹. The expiry date refers to the last day of that month.

Store below 25°C.

Bottles: Keep the container tightly closed and replace the cap immediately after use in order to protect from moisture.

Blisters: Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other informationWhat Temazepam contains

Each tablet contains 10mg or 20 mg of temazepam as the active substance. The other ingredients are lactose monohydrate, maize starch, gelatin, talc and magnesium stearate.

What Temazepam looks like and contents of the pack

Your medicine comes as a white to pale yellow round tablet in either two strengths of 10mg or 20 mg. The tablets are marked 'T/10' for the 10mg and 'T/20' for the 20 mg on one side and 'G' on the other.

Temazepam is available in amber glass bottles, plastic containers or blisters of 7,

10, 14, 28, 30, 56, 60, 84, 90, 100, 250and 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire. EN6 1TL, UK

Manufacturer

Generics (UK) Ltd. Station Close, Potters Bar, Herts, EN6 1TL, UK.

Gerard Laboratories, Baldoyle Industrial Estate, Dublin 13, Ireland.

Mylan Hungary Kft, H-2900 Komarom,

Mylan utca 1, Hungary.

This leaflet was last revised in:    432008

05/2014    0000000

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