Nitrazepam Tablets 5mg
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Patient Information Leaflet
NITRAZEPAM 5MG TABLETS
Read all of this leaflet carefully before you start
to take your 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 or nurse. This includes any possible side effects not listed in this leaflet._
In this leaflet
1. What Nitrazepam is and what it is used for
2. What you need to know before you take
Nitrazepam
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 is and what it is used for
• Nitrazepam belongs to the group of medicines called benzodiazepines.
• Nitrazepam may be used for the short term treatment of insomnia.
• Nitrazepam shortens the time taken to fall asleep and lengthen the duration of sleep,
• It can help overcome any difficulties in getting to sleep, but does not cure underlying cause of insomnia.
2. What you need to know before you take Nitrazepam
• Do not take Nitrazepam and tell your doctor if you
• are allergic to the group of medicine called benzodiazepines, or you are allergic to any of the ingredient (listed in section 6)
• are suffer from breathing problems,
• are suffering from phobia ( fear of particular object or situation), obsession or psychiatric illness
• suffer from a condition known as sleep apnoea syndrome (where you stop breathing whilst asleep)
• have severe liver or kidney disorder
• have myasthenia gravis ( a condition which causes muscles to weaken and tire easily)
• have porphyria ( an inherited condition causing skin blisters, abdominal pain or nervous disorder)
• Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:
• have depression and anxiety
• have a history of alcoholism or drug abuse
• have problems with your heart, lungs, kidney or liver
• have personality disorder
• have low blood level, a poor blood supply to the brain
• have an illness/disorder which affects your
mental state
• are taking any other medicines, including those not prescribed by your doctor like tranquillisers, sleep inducing drugs and other such medicines
• Other considerations
• Dependence - there is a risk of dependence when taking these tablets, which increases with the duration of treatment and also in patients with a history of alcoholism and drug abuse.
• Tolerance - Speak to your doctor, if you notice tablets are not working as well as they did when first starting the treatment.
• 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
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicine, including medicines obtained without prescription, especially if you are already taking:
• medicine to treat ulcer (e.g. cimetidine)
• anaesthetics (to help relieve symptoms when you stop taking opioids)
• antidepressant (to treat mental problems)
• alpha blockers or moxonidine (to lower high blood pressure)
• muscle relaxant (e.g. baclofen, tizanidine)
• lofexidine (to help relieve symptoms when you stop taking opioids)
• nabilone (to treat nausea and vomiting)
• strong pain killer may give you a heightened sense of well being when taken with Nitrazepam, which can increase your desire to continue taking these medicines
• caffeine and theophylline may reduce the sedative effects of Nitrazepam
• antihistamines ( to treat allergies)
• certain antibiotics (e.g.rifampicin)
• oestrogen containing contraceptives
• disulfiram (to treat alcohol addiction)
• antiviral or isoniazid (to treat tuberculosis)
• levodopa (to treat Parkinson’s Disease)
• medicines to treat epilepsy (e.g. phenytoin)
• alcohol regularly or use recreational drugs
• Taking Nitrazepam 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.
• Effect on drive and operating machinery
Nitrazepam may make you sleepy or affect your concentration. This may affect your performance at skilled tasks e.g. driving and operating machinery. Alcohol will increase the sedative effects of Nitrazepam and should therefore be avoided. Do not drive or use any tools or machines if you are affected.
• Pregnancy and breast feeding
Do not take this medicine if you are pregnant, might become pregnant, or are breast feeding, 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.
If this medicine is taken regularly in late pregnancy your baby may develop withdrawal symptoms. Ask your doctor or pharmacist for advice before taking any medicine.
• Nitrazepam tablet contains lactose
Nitrazepam tablets contain lactose, if you have been told that you have intolerance to lactose tell your doctor before taking this medicine.
3. How to take Nitrazepam
Always take this medicine exactly as your doctor has told you. The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist. Doses:
• Adults - The usual dose is 5mg before retiring; this dose may if necessary be increased to 10 mg.
• Children - Not recommended for use in children under 12 years of age. Product is not recommended for children use.
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• Elderly and debilitated patients - The usual dose is 2.5 - 5mg before retiring it is important to take this medicine as directed by your doctor.
The lowest dose, which can control symptoms, should be used; it should not be continued beyond four weeks. Long-term Chronic use is not recommended. Treatment should always be ended by reducing dosage gradually, patients who have taken Nitrazepam for a long time may require a longer period during which dosage are reduced. Treatment if possible should be intermittent.
• If you take more Nitrazepam than you should
If you or anyone else has swallowed a lot of the tablets all together contact your nearest hospital casualty department or 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 a dose
If you forget to take a tablet, leave it until the next dose is due. Do not take two doses together.
• 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 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 (reboundinsomnia 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.
4. Possible side effects
Like all medicines, Nitrazepam tablets can cause side effects in some people.
• 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.
• 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:
• Common (occurs in less than 1 in 10 users) Dizziness, drowsiness, unsteadiness, loss of coordination.
• 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).
Benzodiazepines are not recommended for the primary treatment of psychotic illness.
♦ 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.
5. How to store Nitrazepam
Keep all medicines out of the sight and reach of children
• Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
• Keep the container tightly closed.
• Store in the original container.
• Store in a cool and dry place away from bright light.
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 BP. Each tablet contains 5 mg of the active ingredient.
• The other ingredients are: lactose, maize starch, pregelatinised maize starch, colloidal silicon dioxide, stearic acid and magnesium stearate. See end of section 2 for further information on lactose.
• What Nitrazepam Tablets look like and contents of pack
• Creamy white tablets with bevel edge, embossed ‘N/5’on one face and ‘PV’ on the other.
• Pack sizes of Nitrazepam Tablets are: “28, 56, 500 & 1000” tablets. Not all pack sizes may be marketed.
Marketing Authorization holder and Manufacture:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:_0208 997 5433_
To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.
PL 04556 / 0001
Reference: 00010613/01
Date leaflet last revised: June 2013