Nitrazepam Tablets Bp 5mg
Nitrazepam 5mg Tablets
Read all of this leaflet carefully before you
start taking this medicine.
• 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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
Q What Nitrazepam tablets are and what they are used for
B Before you take How to take "4 Possible side effects
BH How to store
Further information
Q What Nitrazepam tablets are and what they are used for
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.
12 Before you take
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 (see section 6)
• 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).
Check with your doctor or pharmacist before taking Nitrazepam tablets if you have
• depression (with or without anxiety)
• 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).
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• the patient is a child
• are elderly
• epilepsy
• an illness/disorder which affects your mental state
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.'
Taking other medicines
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.
Taking Nitrazepam tablets with food and drink
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 and breast-feeding 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.
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Driving and using machines
Nitrazepam tablets may affect how your muscles work or may make you feel sleepy or forgetful. It may 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.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive
• 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
Nitrazepam tablets contain lactose (a type of sugar). If you have been told that you have intolerance to some sugars contact your doctor before taking this medicine.
_3| How to take
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: 2.5-5mg before going to bed. It is particularly important to take this medicine exactly as directed by the doctor.
Children under 12 years: Not recommended.
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 co-ordination, 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.
If you stop taking Nitrazepam tablets
• 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 difficulty sleeping, depression, nervousness, irritability, sweating, diarrhoea, confusion, unusual behaviour or seizures.
• 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
Like all medicines, Nitrazepam tablets can cause side-effects, although not everybody gets them.
Contact your doctor immediately if you notice the following: • Allergic reaction (hypersensitivity) - swelling of the face, lips, tongue or throat or difficulty breathing or swallowing.
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• Rash and other allergic skin reactions including skin that is red or itchy, pale or red irregular raised patches with severe itching (hives), circular irregular red patches on the skin of the hands and arms (Erythema Multiforme) and severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users)
Dizziness, drowsiness, unsteadiness, loss of co-ordination.
Uncommon (occurs in less than 1 in 100 users)
Confusion, sleeping problems including difficulty sleeping, reduced ability to concentrate, involuntary shakiness, muscle weakness.
Rare (occurs in less than 1 in 1,000 users)
Changes in the numbers and types of your blood cells, muscle cramps, changes in sex drive, muscle spasm of neck shoulders and body, headache, disturbed vision, a spinning sensation (vertigo), low blood pressure, breathing problems, feeling sick, upset stomach, disease of the liver causing yellowing of the skin or whites of the eyes, difficulty in passing water, changes in behaviour such as excitement, irritability, aggressiveness, believing something that is not true (delusions), rage, nightmares, seeing hearing or feeling things that are not there (hallucinations), disturbances in thinking (depression, mood swings, hallucinations, paranoia).
Unknown frequency
Dependence, total or partial memory loss, depression with or without suicidal tendencies, speech problems, double vision.
You may become dependent on the tablets and find it difficult to stop taking them or feel you need to take them more often than necessary (see Section 2 'Other Considerations'). If you stop taking the tablets suddenly you may suffer from withdrawal reactions (see Section 3 ' If you stop taking Nitrazepam tablets' for withdrawal symptoms).
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: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
T| How to store
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.
_6| Further Information
What Nitrazepam tablets contain:
• The active substance (the ingredient that makes the tablet work is Nitrazepam. Each tablet contains 5mg of the active ingredient.
• The other ingredients are lactose, magnesium stearate, maize starch and stearic acid.
What Nitrazepam tables look like and contents of the pack
Nitrazepam tablets are white, circular uncoated tablets Pack size is 28 tablets.
Marketing Authorisation Holder and Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK.
Date of Revision: June 2014
Actavis, Barnstaple, EX32 8NS, UK AAAG9620 50809730
