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Terms Of Use

NITRAZEPAM

Brand Name(s) : Mogadon, Somnite
Warnings
Uses
Side Effects
Precautions
Interactions
Overdose

NITRAZEPAM WARNINGS

Nitrazepam should be used with caution in: the elderly, women who are pregnant or who are breastfeeding, patients with liver or kidney problems, acute porphyria (an inherited blood disorder, causing skinblisters, belly pain and brain or nervous system disorders), myasthenia gravis, a history of drug of alcohol abuse, depression or anxiety with depression, respiratory diseases, or personality disorders.

It should not be used in: those under 18 years of age, patients with respiratory depression (when breathing is slower an/or less deep than normal), those with unstable myasthenia gravis (a muscle weakness disease), acute pulmonary insufficiency (failure of the pulmonary valve in the heart, permitting blood to back-flow into the right ventricle), severe liver problems, sleep apnoea syndrome (when breathing stops temporarily when asleep), a phobia (irrational fear of something), an obsession or chronic psychosis.

Also see list of precautions and interactions.

STORAGE

Protect from light and store in a dry place below 25°C.

NITRAZEPAM USES

What is it used for?

  • Nitrazepam is used for the short term treatment of sleeplessness (insomnia).
  • It is a tranquilliser (medicine that has a calming effect), sometimes known as sedatives or sleeping pills.
  • It is used to treat insomnia.
  • In general this drug is used to treat insomnia, but only in the short term, where the insomnia is severe, disabling or distressing and when sleepiness during the day is acceptable.
  • Benefits of being on this drug can include relief from insomnia.

Listed below are the typical uses of nitrazepam.

  • Short-term treatment of insomnia when it is severe, disabling or causing distress, where daytime sedation (sleepiness) is acceptable.

On occasion your doctor may prescribe this medicine to treat a condition not on the above list.

HOW TO USE/TAKE

How often do I take it?

  • Take this medication by mouth, usually once-daily before going to bed. Swallow tablets whole, and take with a glass of water. It is also available in liquid form (as a suspension) for oral use.
  • Use this medication regularly in order to get the most benefit from it.
  • Remember to use it at the same time each day - unless specifically told otherwise by your doctor.
  • It may take a while before the full benefit of this drug takes effect.
  • Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

  • Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

  • You may need to avoid driving or operating machinery as this medication may make you sleepy, forgetful or less alert than normal. Consult your doctor or pharmacist for more details.

When can I stop?

  • Always complete the full course as prescribed by your doctor.

NITRAZEPAM SIDE EFFECTS

  • Daytime sleepiness
  • Feeling lightheaded
  • Reduced alertness
  • Headache
  • Dizziness
  • Confusion (particularly in the elderly)
  • Muscle weakness
  • Lack of co-ordination and balance (ataxia; particularly in the elderly)
  • Memory loss (amnesia)
  • Addiction (dependence).
This is not a complete list of possible side effects. If any of these persist or you consider them severe then inform your doctor.

Tell your doctor immediately if you develop any of the following symptoms: amnesia, dependence, feeling depressed and/or having thoughts of self harm or suicide, limp or weak muscles, jaundice (yellowing of the eyes and/or skin).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

NITRAZEPAM PRECAUTIONS

Before taking nitrazepam, tell your doctor or pharmacist if you are allergic to it; or to other sedative drugs; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: respiratory depression (when breathing is slower an/or less deep than normal), unstable myasthenia gravis (a muscle weakness disease), acute pulmonary insufficiency (failure of the pulmonary valve in the heart, permitting blood to back-flow into the right ventricle), severe liver problems, sleep apnoea syndrome (when breathing stops temporarily when asleep), a phobia (irrational fear of something), an obsession or chronic psychosis.

Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: any liver or kidney problems, heart conditions or mental illnesses, sleep disorders, or a history of alcohol or drug abuse.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

  • Alcohol should be avoided as it may intensify side-effects such as drowsiness brought about by nitrazepam, and may be very dangerous.

The elderly: nitrazepam should be used with caution in the elderly as it may worsen side-effects caused by nitrazepam, such as confusion or lack of co-ordination.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

The safety of nitrazepam has not been established during pregnancy. Ask your doctor or pharmacist if you have any doubts or questions about this.

First trimester: avoid
Second trimester: not recommended
Third trimester: avoid.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Nitrazepam is not safe to take if you are breastfeeding.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

NITRAZEPAM INTERACTIONS

Before using this medicine, tell your prescriber of all the medicines you are taking including prescription medicines and medicines you have bought over the counter without a prescription. Tell your prescriber if you are taking vitamins or complementary remedies such as herbal products, as these can also interact with medicines.

If you are taking more than one medicine, these may interact with each other. Your prescriber may decide to use medicines which interact with each other if the benefit outweighs the risks. In these cases, the dose of your medicines may need to be adjusted or you may be monitored more closely.

The following medicines may interact with nitrazepam:

  • Sodium oxybate (used to treat muscular weakness associated with extreme sleepiness)
  • Antidepressants such as amitriptyline, clomipramine and mirtazapine
  • Painkillers and general anaesthetics
  • Antihistamines (used for treating allergies) that cause drowsiness e.g. chlorphenamine
  • Antibiotics e.g. rifampicin
  • Antivirals e.g. ritonavir

This information does not contain all possible interactions. Therefore, tell your prescriber of all the products you are using before taking this medicine.

If you have a question or want to discuss anything about your medicine, speak to your local pharmacist.

NITRAZEPAM OVERDOSE

Symptoms of an overdose may include: drowsiness, mental confusion, difficulty speaking, and lethargy. In serious cases, symptoms may include lack of co-ordination and balance (ataxia), decreased muscle tone or floppiness (hypotonia), low blood pressure (hypotension), breathing difficulties, coma and death.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of nitrazepam or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

MISSED DOSE

Nitrazepam must only be taken at bedtime. If you forget to take your dose at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day. Do not take a double dose to make up for a forgotten dose.

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Source: Selected from data included with permission and copyrighted by Boots UK Limited. This copyrighted material is sourced from a licensed data provider and is not for distribution, except as may be authorised by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse events, nor should it be construed to indicate that use of a particular medicine is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any medicine, changing any diet, or discontinuing any course of treatment.

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