_ _ _ _ _ _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.

L Keep this leaflet. You may need to read it I 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.

|ln this leaflet:

1.    What Nitrazepam Tablets are and what they are used for

2.    Before you take Nitrazepam Tablets

3.    How to take Nitrazepam Tablets

4.    Possible side effects

5.    How to store Nitrazepam Tablets ,6. Further 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:-|* Short term treatment of insomnia (trouble sleeping), when it is severe or disabling or subjecting the individual to extreme stress.

2. BEFORE YOU TAKE NITRAZEPAM TABLETS

•    Withdrawal - treatment should be gradually withdrawn.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.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

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

•    Preparations containing aluminium hydroxide (e.g antacids)

•    Medicines used for epilepsy (antiepileptics)

•    Medicines used for stomach ulcers e.g cimetidine

•    Medicines used for pain management (narcotic analgesics)

•    Medicines used to treat depression (antidepressants)

•    Medicines used to induce sleep (tranquilisers and hypnotics)

•    Rifampicin an antibacterial used to treat tuberculosis

•    Some anaesthetics as it can dangerously lower blood pressure if used with a general anaesthetic

•    Medicines used to treat psychosis (antipsychotics and neuroleptics)

•    Sedative antihistamines used to treat allergies.

•    Strong pain killers.

Do not take Nitrazepam Tablets ifyou:

l are hypersensitive (allergic) to nitrazepam, other benzodiazepines e.g diazepam or any of the other ingredients of Nitrazepam Tablets.

•    have difficulty breathing or any kind of lung I disease

•    suffer from a condition called sleep apnoea

'    syndrome where you temporarily stop

i    breathing during sleep

•    have been diagnosed as having myasthenia gravis (your muscles, particularly the eyelids, face, throat and limbs are weak and tire easily)

[• have a severe liver disorder

•    have a phobia (a fear of a particular object or situation), obsession or other mental illness

•    are a child. This medicine should not be used in | children

•    are suffering from chronic mental illness or any other mental disorder.

Nake special care with Nitrazepam Tablets

Consult your doctor before taking Nitrazepam tablets if you:

•    are elderly or have a kidney, liver or respiratory problem, as your dose may be reduced

•    have disease of the arteries, kidney or liver

l have acute closed angle glaucoma (increase I pressure in the eye)

L suffer from epilepsy (fits)

» if you are suffering from or have a history of alcohol and drug abuse

[• have had someone close to you die recently. [Other considerations

•    Dependence - when taking this medicine there is a risk ofdependence, which increases with the dose and duration of treatment 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.

L___________

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

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.

•    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 Nitrazepam Tablets

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking |Nitrazepam Tablets.

3. HOW TO TAKE NITRAZEPAM TABLETS

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

ISwallow the tablets with water.

lusual dose:-

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

[These tablets are unsuitable for 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.

Ifyou 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.

.Ifyou 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, re bound [insomnia, irritability, sweating and diarrhoea. Abrupt withdrawal may result in suicidal [tendencies.

Consult your doctor before you stop taking these gablets.

Ifyou forget to take Nitrazepam Tablets

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

Minor side effects include:

• Low blood pressure, dizziness, difficulty in 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.    I

There have been isolated reports of blood^L 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. STORING NITRAZEPAM TABLETS

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. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, nitrazepam tablets can cause side effects, although not everyone gets them.

^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 ^uch as rash, itching, swelling ofthe face, wheeziness, shortness of breath, tightness in the bhest, fever, low blood pressure and feeling dizzy particularlywhen standing up. Ifany ofthese occur STOP taking the medicine and contact a doctor immediately.

Ifyou sufferfrom the following side effects Inform your doctor:

•    Jaundice with symptoms of yellowing of the skin or the whites of the eyes.

^This medication may commonly cause:

•    Drowsiness, numbed emotions, reduced

I alertness and confusion, tiredness, headache,

I    dizziness, muscle weakness, blurred vision,

¹    lightheadedness and slurred speech.

What Nitrazepam Tablets contain:

Nitrazepam Tablets contain 5mg of the active substance nitrazepam in each tablet.

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 amended in October 2014

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