Patient leaflet - NITRAZEPAM 5 MG TABLETS
3. how to take nitrazepam tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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. If you think that the effect of your medicine is too weak or too strong, talk to your doctor.
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
These tablets are not recommended for children.
You may not need to take this medicine every night.
Take the medicine just before going to bed. Make sure that you can sleep without interruption 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 talk to your doctor. The treatment will be gradually reduced to prevent withdrawal symptoms.
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 (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.
Signs of an overdose include slowing down of the nervous system ranging from tiredness to coma. Other symptoms may include confusion, drowsiness, lack of co-ordination, reduced muscle tension, low blood pressure, difficulty speaking, breathing difficulties, in rare cases overdose may lead to coma (unrousable unconsciousness) and in very rare cases may lead to death.
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.
If 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 recurrence of sleep problems, depression, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, irritability, sweating, diarrhoea, headache and 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 medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine 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. Your doctor may want you to stop taking this medicine.
Common side effects (may affect up to 1 in 10 i people)
> drowsiness during the day ।
! dizziness
! a feeling of emptiness
! reduced alertness
! tiredness
! confusion
! headache
! poor muscle co-ordination
! muscle weakness
! double vision.
Rare side effects (may affect up to 1 in 1,000 people)
! spinning sensation (vertigo)
! 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 this 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 they may decide to change your dose.
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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store nitrazepam tablets
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 label. The expiry date refers to the last day of that month.
Plastic containers should be stored in the original package. Keep the container tightly closed. Blister packs should be kept in the outer carton.
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 protect the environment.
6. contents of the pack and other information
What Nitrazepam Tablets contain
The active substance is nitrazepam. Each tablet contains 5 mg 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 bevelled edged tablets, with a breakline.
Nitrazepam Tablets are available in packs of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.
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
Fine Foods & Pharmaceuticals NTM S.p.A
Via Grignano, 43 – 24041 Brembate (Bergamo)
Italy
This leaflet was last revised in February 2020.
ENV02
5001140
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, pharmacist or nurse.
! 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
What Nitrazepam Tablets are and what they are used for
What you need to know before you take Nitrazepam Tablets
How to take Nitrazepam Tablets
Possible side effects
How to store Nitrazepam Tablets
Contents of the pack and other information
1. WHAT NITRAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR
Nitrazepam belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect). Nitrazepam 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, disabling or subjecting the individual to extreme stress.
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 to nitrazepam, other benzodiazepines (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam) or any of the other ingredients of this medicine (listed in section 6)
! 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 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
Talk to your doctor, pharmacist or nurse before taking Nitrazepam Tablets if you:
! Have a long-term lung, liver or kidney disease
! Have abused alcohol or drugs. You must not 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 suffering or have suffered from a mental illness.
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 considerations
! Dependence – when taking this medicine there is a risk of dependence, 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
! Withdrawal - treatment should be gradually withdrawn. Withdrawal symptoms occur with Nitrazepam Tablets even when normal doses are given for short periods of time. See section 3, ‚if you 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.