Nitrazepam 5 Mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nitrazepam 5mg tablets
Nitrazepam
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 any 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 Nitrazepam Tablet is and what it is used for
2. What you need to know before you take Nitrazepam Tablets
3. How to take Nitrazepam Tablets
4. Possible side effects
5. How to store Nitrazepam Tablets
6. Contents of the pack and other information
1. What Nitrazepam Tablet is and what it is used for
Nitrazepam Tablets belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect).
Nitrazepam Tablets shortens the time taken to fall asleep and lengthens the duration of sleep. Nitrazepam Tablets are used for the short term treatment of sleeplessness (also known as insomnia) when it is severe.
Nitrazepam Tablets help you to sleep but do not cure the underlying cause of your insomnia, which you should discuss with your doctor.
2. What you need to know before you take Nitrazepam Tablets
Do not take Nitrazepam Tablets if you:
• are allergic (hypersensitive) to nitrazepam or any of the other ingredients of Nitrazepam Tablets (these are listed in section 6, “Contents of the pack and other information”).
• are allergic (hypersensitive) to any medicine known as a benzodiazepine (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam).
• suffer from lung disease.
• suffer from difficulty breathing while awake or asleep.
• suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily).
• are suffering from a psychiatric illness or a personality disorder (severe mental problems).
• have a severe liver condition.
Nitrazepam Tablets are not for use in anyone under 18 years of age.
Warnings and precautions
Tell your doctor before you take these tablets if you:
• have a long-term lung, liver or kidney disease.
• suffer from depression or have recently suffered the death of a close friend or relative.
• are suffering or have suffered from a mental illness.
• have abused alcohol or drugs. You must not drink alcohol or use drugs while taking Nitrazepam Tablets.
• are pregnant or breast-feeding.
Because Nitrazepam Tablets relax the muscles, elderly patients should take extra care when they get up at night as there is a risk of falls and consequently of injuries including hip fractures.
Other medicines and Nitrazepam Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved. In particular, tell your doctor if you are taking any of the following medicines:
• Antidepressants, other tranquillisers or sleeping pills, or other such medicines that act on the brain and nerves.
• Medicines used to relieve pain or anaesthetics.
• Antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine).
• Medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
• Medicines that affect the liver (e.g. the antibiotic rifampicin).
Nitrazepam Tablets with food and drink
Do not drink alcohol for as long as you are taking Nitrazepam Tablets. Alcohol will increase the effects of the tablets and this can be dangerous.
Pregnancy and breast-feeding and fertility
Tell your doctor before taking Nitrazepam Tablets if you are pregnant, think that you are pregnant or intend to become pregnant during treatment.
Your doctor will then decide whether you should take this medicine.
Tell your doctor before taking Nitrazepam Tablets if you are breast-feeding. Avoid taking Nitrazepam Tablets if you are breast-feeding as Nitrazepam Tablets passes into breast-milk.
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 and feeding difficulties. Also, your unborn baby may be at risk of developing dependency to this medicine and after birth may be at some risk of developing withdrawal symptoms.
Driving and using machines
Nitrazepam Tablets may cause side effects such as reduced alertness, confusion, tiredness, dizziness, poor muscle co-ordination and double vision. This may affect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side effects.
The medicine can affect your ability to drive. Do not drive while taking this medicine until you know how it affects you.
It may be an offence to drive if your ability to drive safely is affected. 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
Lactose: Nitrazepam Tablets contain lactose. Therefore, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Nitrazepam Tablets
Your doctor will find the lowest dose to control your symptoms.
The dose that your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight.
Always take Nitrazepam Tablets exactly as your doctor has told you. Do not change the prescribed dose yourself. You should check with your doctor or pharmacist if you are not sure how to take this medicine.
If you think that the effect of your medicine is too weak or too strong, talk to your doctor.
Nitrazepam Tablet is not for use in children.
The usual starting dose is 5 mg (one tablet). However, if you are elderly or suffer from a lung, liver or kidney condition, or are generally unwell, your starting dose will not usually be more than 2.5 mg (half a tablet).
You may not need to take this medicine every night.
Swallow the tablet(s) whole with water or another non-alcoholic drink.
Take the medicine just before going to bed. Make sure that you can sleep without interruptions for 7 to 8 hours after taking the tablets.
Treatment will not normally be continued for more than four weeks.
Nitrazepam Tablets may become less effective if you take them for more than four weeks. If you think that your medicine is no longer working or your insomnia does not improve, you should consult your doctor. Also, you may become dependent on the tablets if you use them at high doses and for long periods. Therefore,
Nitrazepam Tablets are not suitable for long-term use and after a few weeks it is worth trying to get by without these tablets. This will help to prevent you becoming used to nitrazepam and reduce the risk of dependence.
Withdrawal symptoms may occur when you stop taking nitrazepam tablets (see section below When you stop taking Nitrazepam Tablets). Do
not stop taking Nitrazepam Tablets without speaking to your doctor.
If you take more Nitrazepam Tablets than you should
If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.
If you forget to take Nitrazepam Tablets
Do not take a double dose to make up for a forgotten dose. Instead you should simply continue with the next dose when it is due.
When you stop taking Nitrazepam Tablets
Your doctor will advise you when to stop taking the tablets.
Do not stop taking Nitrazepam Tablets abruptly. You may experience withdrawal effects if your treatment is stopped suddenly. This is less likely if your dose is gradually reduced towards the end of your treatment.
Withdrawal symptoms may include:
• a recurrence of sleep problems
• depression
• nervousness
• extreme anxiety
• tension
• restlessness
• confusion
• mood changes
• irritability
• sweating
• diarrhoea
• headaches
• muscle weakness
In severe cases the following symptoms may occur:
• changes in behaviour
• numbness and tingling of the extremities
• fits
• over-sensitivity to light, noise and touch
• hallucinations
If 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nitrazepam Tablets can cause side effects, although not everybody gets them.
Changes in behaviour may occur rarely. These changes may include aggression, excitement, confusion, restlessness, agitation, irritability, rages, hallucinations, nightmares and depression.
If these behavioural symptoms occur, you must inform your doctor. He/she may want you to stop taking this medicine.
Common: may affect up to 1 in 10 people
• drowsiness during the day
• a feeling of emptiness
• reduced alertness
• confusion
• tiredness
• headache
• dizziness
• muscle weakness
• poor muscle co-ordination
• double vision
Rare: may affect up to 1 in 1,000 people
• giddiness
• reduced blood pressure
• stomach upsets
• skin rashes
• changes in your vision other than double vision
• changes in the level of sexual desire
• inability to pass urine
• yellowing of the eyes and skin (jaundice)
• an abnormality of the blood (blood dyscrasias)
If you are woken up soon after taking the medicine your memory may be temporarily affected.
If you are an elderly patient, you may be more susceptible to side effects. If this happens, tell your doctor and he/she may decide to change your dose.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via For UK:
Yellow Card Scheme
Website: www.mhra.gov.uk/vellowcard
For Malta:
ADR Reporting Website:
www.medicinesauthority.gov.mt/adrportal. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nitrazepam Tablets
Store this medicine out of the sight and reach of children. Store the bottle or blister in the original outer carton in order to protect from light.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the bottle or blister and the outer carton after “EXP”. The expiry date refers to the last day of that month.
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 information
What Nitrazepam Tablets contains
-The active substance in this medicine is called nitrazepam. Each 5 mg tablet contains the following excipients: Lactose monohydrate,
Maize starch, Sodium starch glycolate (Type A), Talc (E553b), Magnesium stearate.
What Nitrazepam Tablets looks like and contents of the pack
Nitrazepam Tablets are white to off white round, flat, bevel edged tablets, debossed with 'DM' on one side and plain on other side.
Tablets are available as PVC/ PVdC - Aluminium blister packed in a box or HDPE Bottle pack.
Each box of PVC/ PVdC - Aluminium blister contains either 10, 20, 25, 28, 30, 50, 60 or 100 tablets.
Each HDPE bottle contains either 30, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage house, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF,
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage house, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF,
United Kingdom
Wessling Hungary Kft Foti ut 56., Budapest 1047,
Hungary
This leaflet was last revised in 05/2016.
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