_ _ _ _ _ _n nogen Pharma \

PACKAGE LEAFLET: INFORMATION FORTHE USER

¹ Nitrazepam 5mg Tablets

I [nitrazepam]

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

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again.

doctor or pharmacist or nurse.

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only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

ll. What Nitrazepam Tablets are and what they , are used for

2.    What you need to know before you take I Nitrazepam Tablets

3.    How to take Nitrazepam Tablets

4.    Possible side effects

o. How to store Nitrazepam Tablets

16. Contents of the pack and other information

1. WHAT NITRAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR

Nitrazepam belongs to a group of drugs known as benzodiazepines which are central nervous system (CNS) depressants (medicines that slow down the |nervous system).

Nitrazepam Tablets are used for:-•

sleeping), when it is severe or disabling or subjecting the individual to extreme stress.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITRAZEPAM TABLETS

,Do not take Nitrazepam Tablets ifyou:

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I other benzodiazepines e.g diazepam or any of ' the other ingredients of Nitrazepam Tablets. i See section 6.

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disease

syndrome where you temporarily stop breathing during sleep

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gravis (your muscles, particularly the eyelids, face, throat and limbs are weak and tire easily)

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|* Have a phobia (a fear of a particular object or situation), obsession or other mental illness L Nitrazepam Tablets are not for use in anyone under 18 years of age

L Are suffering from chronic mental illness or any other mental disorder.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Nitrazepam Tablets ifyou:

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i problem, as your dose may be reduced •

drink alcohol or use drugs while taking Nitrazepam Tablets

|* Suffer from depression or have recently suffered the death of a close friend or relative |* Are pregnant or breast-feeding • Are suffering or have suffered from a mental | illness.

|Because Nitrazepam Tablets relax the muscles, elderly patients should take extra care when they ^et up at night as there is a risk offalls and ^consequently of injuries including hip fractures.

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Other considerations

•    Dependence - when taking this medicine there is a risk of dependence, which increases with the dose and duration oftreatment and also in patients with a history of alcoholism and drug abuse.

•    Tolerance - if after a few weeks you notice that the tablets are not working as well as they did when first starting treatment, you should speak to your doctor.

•    Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occurwith Nitrazepam Tablets even when normal doses are given for short periods of time. See Section 3, 'Ifyou stop taking Nitrazepam Tablets.'

This medicine should not be used alone in the treatment of depression or anxiety associated with depression because of the risk of suicide.

Other medicines and Nitrazepam Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

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and phenobarbital) analgesics)

(antidepressants) and hypnotics) tuberculosis

blood pressure if used with a general anaesthetic

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(antipsychotics and neuroleptics)

•    Sedative antihistamines used to treat allergies.

•    Strong pain killers

•    Medicines for treating epilepsy (e.g. phenytoin and phenobarbital)

•    Preparations containing aluminimum hydroxide (e.g. antacids)

•    Medicines used for stomach ulcers (e.g. cimetidine).

Alcohol should be avoided as this may increase the sedative effects of Nitrazepam.

Taking Nitrazepam Tablets with food, drink and alcohol

Do not drink alcohol for as long as you are taking Nitrazepam Tablets. Alcohol will increase the effects ofthe tablets and this can be dangerous.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice if you are pregnant, planning on becoming pregnant or are breast-feeding.

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

Please check with your doctor if you are taking these tablets and want to breast-feed your baby. This medicine is found in breast milk and should therefore not be given to breast-feeding mothers.

Driving and using machines

These tablets can cause some people to feel dizzy or drowsy. If you are affected do not drive or operate machinery as your alertness may be impaired.

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.

f It is an offence to drive if this medicine affects I your ability to drive.

I However, you would not be committing an I offence if:

I . The medicine has been prescribed to treat I a medical or dental problem and I . 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 I    safely.

frhere is further information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law

The effects are usually mild and infrequent in nature. The elderly or debilitated patients are more susceptible to these effects.

Allergic reactions may occur rarely with symptoms such as rash, itching, swelling | of the face, wheeziness, shortness of breath, tightness in the chest, fever, low i blood pressure and feeling dizzy

particularly when standing up, yellowing |_ _

of the skin or whites of the eyes, unusual bruising or bleeding. If any of these occur STOP taking the medicine and contact a doctor immediately.

[Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking |this medicine.

|Nitrazepam Tablets contain lactose

If you have been told by your doctor that you have ^n intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE NITRAZEPAM TABLETS

Always take Nitrazepam Tablets exactly as your ploctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

This medication may commonly cause:

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alertness and confusion, tiredness, headache, dizziness, muscle weakness, double vision, lightheadedness and slurred speech.

Rare side effects include:

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breathing, nausea, constipation, changes in salivation, blurred/double vision, slurred speech, skin rashes, problem with urinating, incontinence, mental depression, trembling, headache, confusion and changes in libido.

Swallow the tablets with water.

^The recommended dose is:-

Adults: 5mg before bedtime. This may be

increased to 10mg.

Elderly and debilitated patients: The dosage should be half that recommended for adults or less.

Children

Your doctor will decide which dose is best for you. The lowest effective dose should be used.

These tablets are not recommended for long-term use. Treatment should not exceed 4 weeks.

The treatment will be gradually reduced to prevent withdrawal symtoms.

There have been isolated reports of blood disorders, changes in personality, behaviour problems and outbursts of anger or excitement. There have also been rare reports ofdepression, sometimes with thoughts ofsuicide.

Many ofthe above mentioned side effects should disappear when treatment is stopped.

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 the Yellow Card Scheme at: 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 NITRAZEPAM TABLETS

Ilfyou take more Nitrazepam Tablets than you should

[This medicine should be taken at the prescribed time only. If you take too many tablets by mistake Contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet |pack with you.

|lfyou stop taking Nitrazepam Tablets

Do not stop taking Nitrazepam Tablets suddenly as |this may cause withdrawal symptoms including depression, headaches, muscle weakness, Nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, [recurrence of sleep problems, irritability, sweating and diarrhoea. Abrupt withdrawal may result in puicidal tendencies.

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Do not store above 25°C. Store in the original package.

In case of any visible signs of deterioration, you should return your tablets to your pharmacist. Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children

6. CONTENTS OF THE PACK AND OTHER INFORMATION

iln severe cases the following symptoms may occur:

b changes in behaviour • numbness and tingling of the extremities b fits

l over-sensitivity to light, noise and touch p hallucinations

Jf you have taken benzodiazepines for a long time, the reduction in your dosage will be over a longer period of time than would normally be required when you stop taking this medicine. You may need additional help.

Your doctor will be able to discuss this with you. your doctor before you stop taking these

Ilfyou forget to take Nitrazepam Tablets

.If you have forgotten to take a dose, leave out that dose completely. This medicine should be taken at the prescribed time only. If you fail to take it then skip the missed dose and continue the regular dosing schedule.

Consult

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side Effects, although not everyone gets them.

What Nitrazepam Tablets contain:

Each tablet contains 5mg nitrazepam.

The other ingredients are: maize starch, lactose monohydrate, pregelatinised maize starch, magnesium stearate, sodium starch glycollate.

What Nitrazepam Tablets look like and contents of the pack

Nitrazepam Tablets are white, flat beveled edged scored tablets, engraved with logo on one side and with a breakline and A287 on the other side.

Nitrazepam Tablets are packed into packs of 28,

30, 42, 50, 56, 60, 84, 90,100, 112, 250, 500 or 1000.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate, Riverside

Way, Dartford, DA1 5BS, UK.

Manufacturer:

Regent Laboratories Limited

Cunard Road, North Action, London, NW10 6PN,

United Kingdom.

This leaflet was last revised in September 2015.