PACKAGE LEAFLET: INFORMATION FOR THE USER Nitrazepam 5mg Tablets

Nitrazepam

(Referred to as Nitrazepam Tablets in the remainder of the leaflet)

Read all of this leaflet carefully before you

start to take this medicine.

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

-    If you have any further questions, please 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In 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

The name of your medicine is Nitrazepam Tablets. The active ingredient in your medicine is nitrazepam. Nitrazepam Tablets belong to a group of medicines called benzodiazepines which are used as sedatives.

Nitrazepam Tablets are used to treat severe sleeplessness problems (insomnia) and the worry such sleeping problems may cause.

2. Before you take Nitrazepam Tablets

Do not take Nitrazepam Tablets if you

•    are allergic (hypersensitive) to nitrazepam, or other benzodiazepines, or to any of the other ingredients in this medicine (see section 6. Further information)

•    suffer from breathing problems (respiratory depression)

•    suffer from a condition known as acute pulmonary insufficiency (a severe heart condition causing shortness of breath and fatigue)

•    suffer from a condition known as porphyria (an inherited condition causing skin blisters, abdominal pain, and brain or nervous system disorder)

•    have severe liver problems

•    suffer from a condition known as myasthenia gravis (a muscle disorder causing extreme weakness)

•    suffer from a condition known as sleep apnoea syndrome (where you stop breathing whilst asleep)

•    suffer from mental problems such as phobias, obsessive behaviour or chronic psychosis (seeing or hearing things that are not there)

•    suffer from untreated depression or worry caused by depression.

•    have a head injury

•    are pregnant or planning to become pregnant

Take special care with Nitrazepam Tablets if you

•    have kidney or liver problems

•    are awoken during medication, recall may be impaired, (a condition called anterograde amnesia)

•    are going through bereavement

•    suffer from a condition known as chronic pulmonary insufficiency (a long term serious heart condition)

•    suffer from a condition known as glaucoma (increased pressure in the eyes)

•    suffer from conditions such as arteriosclerosis (poor blood supply to the brain), muscle weakness or gout

•    have a history of alcoholism or drug abuse

•    suffer from epilepsy

•    are taking other medicines, particularly clozapine, known as CNS depressants

•    are elderly or infirm, there is an increased risk of falls or developing dementia.

•    have recently taken nitrazepam or other benzodiazepines

•    have personality disorders, including depression or excessive aggression.

Nitrazepam Tablets must not be given to anyone who is unconscious or in a coma.

The hypnotic effect of nitrazepam may decrease after repeated use for a few weeks.

Speak to your doctor if you are switching from a different benzodiazepine, as withdrawal symptoms may develop.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines can affect or be affected by treatment with Nitrazepam Tablets:

•    medicines, called CNS depressants, such as antipsychotics, anxiolytics, sedatives, antidepressants, other hypnotics, strong painkillers and anaesthetics, and sedative anti-histamines

•    anti-hypertensives, used to treat high blood pressure, such as alpha blockers and moxonidine

•    benzodiazepines, used as sedatives to treat sleeping problems

•    clozapine, used to treat schizophrenia

•    isoniazid, used in the treatment and prevention of tuberculosis

•    disulfiram, used to treat alcoholism

•    cimetidine and omeprazole, used to treat peptic ulcers and heartburn

•    oral contraceptives

•    antibiotics, erythromycin and rifampicin

•    fluvoxamine, used in the treatment of depression

•    probenecid, used to treat gout

•    sodium valproate, carbamazepine, phenobarbital and phenytoin, used to treat epilepsy

•    theophylline, used to treat asthma and COPD (smoker's cough)

•    levodopa, used to treat Parkinson’s Disease

•    medicines called muscle relaxants, such as baclofen.

•    Diuretics (water tablets)

•    Nitrates, used in the treatment of angina.

•    Sodium oxybate, used to prevent episodes of sudden onset of sleep (narcolepsy) with muscle weakness

Tobacco and marijuana (cannabis) will affect the way Nitrazepam Tablets work.

Some of the ingredients of coffee (caffeine) and chocolate (theobromine) will affect the way Nitrazepam Tablets work.

Taking Nitrazepam Tablets with food and drink

Alcohol can affect the way Nitrazepam Tablets work making you feel extremely drowsy.

During treatment with Nitrazepam Tablets, talk to your doctor before consuming alcoholic drinks.

Pregnancy

Check with your doctor before you use Nitrazepam Tablets if you are pregnant or are thinking of becoming pregnant. Your doctor will decide if you should take them.

Breast-feeding

Do not breast-feed if you are taking Nitrazepam Tablets.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery

You may experience sedation, amnesia, impaired concentration, dizziness, blurred vision and impaired muscular function. Nitrazepam Tablets will make you feel drowsy especially if you have consumed alcohol. Talk to your doctor before driving or using tools or machines. Do not drive or use tools or machines if you are affected in this way.

This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you.

It may be an offence to drive if your ability to drive safely is affected.

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

Important information about some of the ingredients of Nitrazepam Tablets

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicine.

3. How to take Nitrazepam Tablets

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

Adults

The usual dose is one to two Nitrazepam Tablets taken before going to bed.

The elderly or infirm

The usual dose is between a half and one Nitrazepam Tablet taken before going to bed.

Your doctor may decide to give you a lower dose.

Patients with liver or kidney problems

Your doctor will assess your condition and decide the dose.

Children

Children should not take Nitrazepam Tablets.

Your doctor will decide for how long you should take Nitrazepam Tablets. You should not take Nitrazepam Tablets for more than 4 weeks. Your doctor will decide when you should stop taking your medicine and will gradually reduce your dose over a suitable period of time.

If you have taken Nitrazepam Tablets for a long time your doctor may decide to reduce your medicine very slowly.

If you take more Nitrazepam Tablets than you should

If you accidentally take too many tablets, you should contact your doctor or go to your nearest hospital casualty department immediately. Take this leaflet and any unused tablets with you to show the doctor.

The symptoms of mild overdose include feeling confused, drowsiness, reduction in your level of awareness, problems co-ordinating movement, slurred speech, feeling dizzy or light headed, especially when standing up, muscle weakness and breathing problems.

The symptoms of severe overdose include severe breathing difficulties, deep coma, inability to sleep and fits (convulsions). As the level of nitrazepam drops, you may become extremely agitated and have serious difficulty sleeping. You may also experience other withdrawal effects (see section below “If you stop taking Nitrazepam Tablets”).

The doctor will assess your condition and decide how to treat your overdose. You will be monitored and you may be given a medicine called flumazenil to reduce the effects of the overdose. In addition you may be given activated charcoal to reduce the absorption of nitrazepam. When taken alone in overdose, nitrazepam presents few problems in management and should not present a threat to life unless combined with other CNS depressants (including alcohol).

If you forget to take Nitrazepam Tablets

If you forget to take your medicine take it as soon as you remember. If it is almost time for your next dose do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

If you stop taking Nitrazepam Tablets

You may experience withdrawal symptoms, especially if you stop taking your medicine suddenly. The risk of withdrawal increases if you have been taking a high dose, if you have been taking the tablets for a long time or if you have a history of nitrazepam withdrawal, alcohol or drug abuse. Rare but serious withdrawal symptoms include a feeling of detachment from oneself and his/her surroundings (depersonalisation), numbness and tingling of the hand and/or feet.

Other possible withdrawal effects include:

•    sleeping problems

•    anxiety

•    restlessness

•    confusion

•    mood changes, depression

•    problems concentrating

•    headaches and feeling dizzy

•    ringing in your ears (tinnitus)

•    loss of appetite

•    shaking and sweating

•    irritability

•    changes in your senses (sight, taste, touch, hearing)

•    feeling sick or being sick

•    diarrhoea

•    stomach ache

•    changes in your heart rate, pulse and blood pressure

•    muscle twitching

•    muscle aches and cramps

•    feeling confused or afraid

•    fits

•    hallucinations and vivid dreams.

Speak to your doctor if you notice these symptoms. Do not stop taking your medicine unless your doctor tells you to.

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

•    muscle aches or cramps

•    sleepiness, confusion and slurring of your speech

5. How to store Nitrazepam Tablets

6. Further information

4. Possible side effects

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

The side effects of Nitrazepam Tablets are usually mild and occur rarely. Elderly or infirm patients are more likely to experience side effects. Your doctor will decide on the lowest dose necessary to reduce the risk of side effects.

The following side effects may be experienced when taking Nitrazepam Tablets:

•    allergic reactions

•    hypotension (low blood pressure)

•    addiction to your medicine, particularly if you have a history of alcoholism or drug misuse

•    headaches

•    fits (convulsions)

•    vertigo

•    feeling dizzy or light headed, especially when standing up

•    problems with your eye-sight

•    dry mouth and increased production of saliva

•    stomach problems, feeling sick (nausea)

•    tiredness

•    feeling like you have a hangover

•    reduced alertness

•    hypothermia

•    blood disorders (shown in blood tests)

•    pale stools, dark urine, yellowing of the skin or eyes (jaundice)

•    weakness of your muscles

This is a service provided by the Royal National Institute of Blind People.