| Information for
patients
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| Drug Information |
Nitrazepam belongs to a group of medicines called benzodiazepines. Nitrazepam tablets may be used for the short term treatment of sleeplessness, which is severe, disabling or distressing, and when sleepiness during the day is acceptable. |
| Drug Alert |
| Alert |
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| Before Consuming
the Medicine
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| Avoid Drug |
Do not take Nitrazepam tablets and tell your doctor if you
• are allergic (hypersensitive) to Nitrazepam or to other benzodiazepine medicines or to any of the other ingredients in your tablets
• are breathless or have difficulty breathing
• have a phobia (a fear of a particular object or situation), obsession or other mental illness
• have myasthenia gravis (a condition which causes muscles to weaken and tire easily)
• suffer from sleep apnoea ( a condition where you stop breathing whilst asleep)
• have severe liver disorders
• have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders). |
| Drug Special Care |
• a history of alcoholism or drug abuse
• problems with your heart and lungs, kidney or liver
• someone close to you who has recently died
• low blood levels of a protein called albumin
• a personality disorder
• a poor blood supply to the brain (arteriosclerosis).
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• Withdrawal – treatment should be gradually withdrawn.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. |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
• antidepressants, antipsychotics (to treat mental problems), antihistamines (to treat allergies), anaesthetics, lofexidine (to help relieve symptoms when you stop taking opioids), nabilone (to treat nausea and vomiting), hypnotics (to help you sleep), alpha blockers or moxonidine (to lower high blood pressure), muscle relaxants (eg baclofen, tizanidine) or probenecid (used to treat gout). Taking these medicines with Nitrazepam could make you very sleepy.
• some strong pain killers may give you a heightened sense of well being when taken with Nitrazepam, which can increase your desire to continue taking these medicines (dependency) or can make you very sleepy.
• caffeine and theophylline may reduce the sedative effects of Nitrazepam.
• medicines for epilepsy eg hydantoins, in particular phenytoin, or barbiturates (Nitrazepam can affect the blood levels of these medicines).
• cimetidine (for ulcers), oestrogen-containing contraceptives, disulfiram (to treat alcohol addiction), ritonavir (antiviral) or isoniazid (to treat tuberculosis) as these can cause Nitrazepam to be removed from the body more slowly than usual.
• rifampicin (an antibiotic) as this can cause Nitrazepam to be removed from the body more quickly than usual.
• levodopa (to treat Parkinson’s Disease) as Nitrazepam may cause levodopa to not work so well. |
| Drug Pregnancy Interaction |
You should not take Nitrazepam tablets if you are pregnant, planning to become pregnant or are breast feeding. If you take Nitrazepam tablets late in your pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing difficulties. If taken regularly during late pregnancy, your baby may develop withdrawal symptoms. Ask your doctor
or pharmacist for advice before taking any medicine. |
| Drug Breast feeding Interaction |
You should not take Nitrazepam tablets if you are pregnant, planning to become pregnant or are breast feeding. If you take Nitrazepam tablets late in your pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing difficulties. If taken regularly during late pregnancy, your baby may develop withdrawal symptoms. Ask your doctor
or pharmacist for advice before taking any medicine. |
| Drug Machinery Interaction |
Nitrazepam tablets may affect how your muscles work or may make you feel sleepy or forgetful. It make also impair your alertness (especially if you don’t have 7-8 hours uninterrupted sleep). Do not drive or use any tools or machines if you are affected in this way. |
| Drug More Information |
Do not drink alcohol while you are taking Nitrazepam tablets. Alcohol may increase the sedative effects of Nitrazepam tablets and make you very sleepy. |
| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
Adults: 5mg before going to bed, your doctor may increase this up to 10mg.
Elderly and debilitated patients: 2.5-5mg before going to bed. It is particularly important to take this medicine exactly as directed by the doctor.
Children under 12 years: Not recommended. |
| Drug Dose |
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. |
| Excess Drug Consumption |
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 clumsiness and loss of coordination, feeling sleepy or deep sleep, speech problems, muscle weakness or excitement. An extreme overdose may lead to coma (unrousable unconsciousness), reflex problems and breathing difficulties. |
| Forgot Drug Consumption |
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. |
| Stop Drug Consumption |
• Do not stop taking your medicine without telling your doctor as he may wish to gradually reduce the number of tablets you take before stopping them completely. If you stop taking Nitrazepam tablets suddenly, you may experience unpleasant side effects including depression, nervousness, irritability, sweating or diarrhoea. If you have been taking a high dose, you may occasionally experience confusion,\ convulsions or unusual behaviour.
• Treatment should be gradually withdrawn otherwise the symptoms you are being treated for may return more intense than before (rebound insomnia and anxiety). The risk of this happening is greater when you stop taking Nitrazepam suddenly. You may also experience mood changes, anxiety, restlessness or changes in sleep patterns.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. |
| Possible Side
Effects
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| General Information |
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| Common Drug Side Effects |
• allergic reaction: skin rashes, itching
• drowsiness, sedation, unsteadiness or clumsiness and loss of co-ordination (you may notice these even after a single dose and this may continue into the following day)
• confusion, memory loss, dependence, experiencing rage, excitement, depression with suicidal tendencies, headache, ‘spinning’ sensation, speech problems
• blood disorders, changes in sex drive, visual disturbances, low blood pressure, stomach upsets, yellowing of the skin or whites of the eyes (jaundice), muscle spasms, difficulty passing urine |
| Rare Drug Side Effects |
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| Very Rare Drug Side Effects |
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| Drug Side Effects Symptoms |
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| How to Store the
Medicine
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| How to Store the Medicine |
Keep out of the reach and sight of children. Store below 25°C in a dry place protected from light. Do not use Nitrazepam tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. |
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