Nitrazepam 5mg Tablets Bp
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NITRAZEPAM 5 mg TABLETS BP
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
to others. It may harm them, even if includes any possible side effects not
- This medicine has been prescribed for you only. Do not pass it on their signs of illness are the same as yours
- If you get any side effects, talk to your doctor or pharmacist. This listed in this leaflet.
What is in this leaflet
1. What Nitrazepam Tablets are and what they are 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 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. 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).
- are allergic (hypersensitive) to any medicine known as a benzodiazepine (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam).
- suffer from lung or liver disease.
- suffer from difficulty breathing while awake or asleep.
- suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily).
- have a phobia (a fear of a particular object or situation), obsession or other mental illness
- suffer from porphyria (light sensitive skin rash).
- suffer from depression (with or without anxiety)
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.
- are older or the patient is a child
- have a poor blood supply to the brain
- suffer from epileptic seizures
- an illness/disorder which affects your mental state
- a personality disorder
- are pregnant or breast-feeding
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')
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, antipsychotics (to treat mental problems), narcotic analgesics, hypnotics (to help you sleep). Taking these medicines with nitrazepam could make you very sleepy.
- Medicines used to relieve pain or anaesthetics.
- Antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine).
- medicines for epilepsy e.g. hydantoin, in particular phenytoin or barbiturates
- cimetidine (for ulcers)
- Medicines that affect the liver (e.g. the antibiotic rifampicin).
Nitrazepam Tablets with food, drink and alcohol
Do not drink alcohol while you are taking Nitrazepam tablets. Alcohol may increase the sedative effects of Nitrazepam tablets and make you very sleepy
Pregnancy, Breast-feeding and Fertility
You should not take Nitrazepam tablets if you are pregnant, planning to become pregnant or are breast feeding. Avoid taking Nitrazepam tablets if you are breast-feeding as Nitrazepam 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, 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.
Nitrazepam tablets contain Lactose.
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
Always take Nitrazepam tablets exactly as your doctor has told you. You should not take Nitrazepam tablets for longer than 4 weeks. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets whole, with a glass of water.
Doses
Adults: 5mg before going to bed, your doctor may increase this up to 10mg.
Elderly and debilitated patients: 2.5mg before going to bed. It is particularly important to take this medicine exactly as directed by the doctor.
Children under 12 years: Not recommended.
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 (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 such as confusion, drowsiness, lack of coordination, reduced muscle tension, low blood pressure, slow heart beat, 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. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.
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 recurrence of sleep problems, depression, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, irritability, sweating, diarrhoea, headaches and muscle weakness. Rarely, you may experience confusion, mental disturbances and fits.
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
in your dosage will be over a longer taking this medicine. You may need If you have any further questions on
If you have taken benzodiazepines for a long time, the reduction period of time than would normally be required when you stop additional help. Your doctor will be able to discuss this with you. 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, delusion, 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 side effects: may affect up to 1 in 10 people
• drowsiness during the day or dizziness
• a feeling of emptiness
• reduced alertness or tiredness
• confusion
• headache
• poor muscle co-ordination or muscle weakness
• double vision
Rare side effects: may affect up to 1 in 1,000 people
• reduced blood pressure
• inability to pass urine
• yellowing of the eyes and skin (jaundice)
• an abnormality of the blood (blood dyscrasias)
Not Known: frequency cannot be estimated from the available data
• Dependence, giddiness, skin rashes, changes in the level of sexual desire, stomach upsets
If you are woken up soon after taking higher doses of medicine your memory may be temporarily affected.
If you are an older 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. 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
- Keep this medicine out of the sight and reach of children
- Do not use this medicine after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month
- Do not store above 250C. Store in the original container.
- 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
- Each Nitrazepam tablet contains 5mg of active ingredient Nitrazepam
- The other ingredients in Nitrazepam 5mg tablets are: lactose, starch, talc, stearic acid
What Nitrazepam Tablets look like and contents of the pack
- Nitrazepam 5mg Tablets are uncoated, white, flat bevel edged tablets with breakline on one face and stamped 'SPN5' on the other.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Limited,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Nitrazepam 5mg Tablets BP; PL 17907/0355 This leaflet was last revised in December 2013
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.