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What's in Nitrazepam?

The white tablet contains 5 mg nitrazepam as the active ingredient.

What is Nitrazepam and when is it used?

You were prescribed Nitrazepam by your doctor, and you should only use medication as recommended. The active ingredient in this medication is nitrazepam, which is a benzodiazepine class drug. The sleep-inducing properties of nitrazepam are well-documented. When taken in the evening, it begins to act in 30 to 60 minutes and aids in a good night's sleep. Nitrazepam is prescribed by your doctor or other health care provider if you are an insomniac and need therapy. A variety of factors contribute to these symptoms, including a tendency toward irritability or a tendency toward overusing one's emotions (such as wrath), concern, or fear. If your child has a sleep condition, don't let them take this preparation. Nitrazepam has antispasmodic qualities in addition to its sleep-inducing effects. If this is the case, don't be shocked if the doctor prescribe Nitrazepam at greater dosages for the youngster.

What precautions should be taken?

Even if you don't feel sleepy or dull the next day, you probably took too much of the medication. Sleeping medications have a more adverse effect on the elderly. If you're not sure, talk to your doctor or pharmacist.

When should Nitrazepam not be used?

The use of nitrazepam should be avoided in the following situations:

severe respiratory failure, severe muscle weakness, hypersensitivity to nitrazepam or any of the drug's other benzodiazepines or other components (myasthenia gravis),
During slumber, cease all breathing (sleep apnea syndrome)
severe hepatic disease,
Cerebellar or spinal ataxias result from nerve cell death in the cerebellum or spinal cord, as do acute alcohol, sedative, sleeping pill, or painkiller poisoning, as do psychiatric drug poisoning (neuroleptics, antidepressants, lithium),
Children and teenagers suffering from insomnia.
What are the possible adverse effects of Nitrazepam?
Mental confusion, depression (manifestation of pre-existing depression), lightheadedness, headaches, and dizziness are all common symptoms. Other symptoms include difficulty breathing, increased mucus production in the lungs, muscle weakness, and urinary retention or involuntary and uncontrolled urine loss are less common, but they can all lead to fatigue.

Delirium, sleep disruptions, impaired thinking, balance issues, motor issues, tremors, and problems with motor coordination are all possible side effects that could occur.

The following side effects are extremely rare: changes in the blood picture, allergic reactions, impaired sex drive, addiction, withdrawal symptoms, mood swings, anxiety, agitation and drug abuse, excitement, aggression and delusional ideas. Other symptoms include nightmares, hallucinations, psychotic disorders, epilepsy, spinning dizziness and visual disturbances.

When they do occur, severe allergic or inflammatory skin and mucous membrane reactions (rash and blisters, for example on the hands, feet and arms as well as within the mouth) might occur along with significant well-being impairment and fever.

A very small percentage of people will experience anaphylaxis, hypersensitivity responses, or even angioedema (a swelling of the skin or mucous membranes).

If this occurs, discontinue therapy and see a doctor very away.

Treatment with Nitrazepam has been associated with speech problems that haven't been quantified in terms of frequency.

If you experience any adverse effects that aren't listed here, call your doctor or pharmacist right away.

• 
  What else needs to be taken into account?

  The medicinal product should not be used beyond the date indicated with "EXP" on the container.

  Store at room temperature (15-25 ° C) and out of the reach of children.

  Your doctor or pharmacist, who have detailed professional information, can give you further information.

  How to use Nitrazepam?

  Adults: usually 1 tablet in the evening before bedtime.

  A half dosage (½ tablet) is usually sufficient for elderly, thin or particularly sensitive patients.

  In the presence of brain disease, older people should not take more than one 5 mg Nitrazepam tablet per day.

  The tablets can be chewed, swallowed whole or dissolved in water.

  Children suffering from seizures (epilepsy): the specialist decides in each individual case whether treatment with Nitrazepam is appropriate and also determines the appropriate dosage for your child. The dosage indicated should not be changed without consulting your doctor.

  Do not change the prescribed dosage on your own initiative. If you think that the action of the medicine is too weak or too strong, talk to your doctor or pharmacist.

   

  When is caution required when administering Nitrazepam?

  Before using Nitrazepam as a sleeping pill, a thorough medical examination should be conducted to establish the cause of the insomnia.

  Addiction

  After taking it for a few weeks, some loss of sleep inducing effect may occur.

  Risk of addiction

  Taking Nitrazepam, as with all benzodiazepine preparations, can cause addiction. This can occur especially as a result of uninterrupted intake for prolonged periods (in some cases already after a few weeks) and in the case of high doses. The risk increases in cases of alcoholism, drug abuse and certain mental illnesses.

  To minimize the risk of an addiction developing, observe the following:

  • only take Nitrazepam if your doctor prescribes it;
  • do not under any circumstances increase the dose prescribed by your doctor;
  • inform your doctor that you intend to stop taking the medicine; in case of prolonged use, a gradual reduction of the dose is recommended;
  • the doctor will periodically decide whether to continue the treatment;
  • the intake for prolonged periods (generally for more than four weeks) can only be done under strict medical supervision.

  Manifestations of abstinence

  Suddenly stopping the drug may result in withdrawal symptoms, even if the drug was taken for a short time and at normal dosage. Depression, headaches, difficulty concentrating, muscle weakness, nervousness, unusually heightened anxiety, states of tension, tremor, restlessness, mental confusion, mood changes, insomnia, irritability, sweating, diarrhea, muscle cramps and abdominal, perception disturbances, as well as, rarely, delusional ideas and seizures. In severe cases, derealization (distorted perception of the environment), depersonalization (dissociation of the sense of self), numbness and tingling in the arms and legs, hypersensitivity to light, can also be observed. to noises and body contact, hallucinations and epileptic seizures. These manifestations usually subside after two to three weeks.

  Marked recurrence of insomnia and anxiety after discontinuation

  Upon discontinuation of treatment, the same symptoms that led to treatment with Nitrazepam may reappear in a transient and marked form. They can be accompanied by other reactions, such as mood swings, anxiety and agitation. Abrupt discontinuation of treatment increases the risk of withdrawal symptoms or accentuated reappearance of insomnia, therefore gradual dose reduction is recommended.

  Memory disturbances

  Benzodiazepines can cause memory gaps related to the post-intake period. This state usually occurs a few hours after taking it and can last for several hours. This means that after taking the medicine you may take actions that you may not remember later. This risk increases with increasing dosage and concomitant alcohol intake. Sufficiently long and uninterrupted sleep (7-8 hours) can reduce this risk. If he is awakened at the moment when the drug exerts its most intense effect, his memory capacity may be reduced.

  Psychic and "paradoxical" reactions

  When benzodiazepines are used, especially in elderly patients or children, psychic and so-called "paradoxical" reactions may occur, i.e. effects contrary to those expected by the action of the drug such as, for example, aggression, restlessness, mental confusion, agitation, irritability , excitability, delusional ideas, temper tantrums, nightmares, hallucinations, psychosis, inappropriate behavior and other behavioral disorders. Pre-existing depressions with suicidal tendencies are also possible. In such cases, treatment with this medicine should be discontinued.

  Switching from one benzodiazepine drug to another should only be done by prescription.

  Tell your doctor about any heart, respiratory, kidney or liver disease, as well as if you have or have had in the past from alcohol, medication or drug addiction.

  Due to the relaxing effect on the muscles, the risk of falls and consequently of bone fractures may be increased, especially in elderly people who get up at night.

  Tell your doctor if you have an intolerability to certain types of sugars (lactose intolerance).

  This medicine can reduce the ability to react, the ability to drive a vehicle and the ability to use tools or machines! In case of insufficient sleep duration, the risk of a reduction in the level of attention also increases.

  Pre-existing depressions may develop or worsen during treatment with benzodiazepines, including Nitrazepam. If you suffer from depression, you can only take Nitrazepam if the symptoms of this depression are treated with suitable medicines.

  Simultaneous intake of alcohol and / or medications with tranquilizing action

  Alcoholic beverages and medications with a tranquilizing or sedative (sleep-promoting) action (e.g. tranquilizers, sleeping pills, antidepressants, antipsychotics, anxiolytics, various pain relievers, antiallergics and other preparations that act on the brain and nerves, narcolepsy medications , antihypertensives, beta blockers, as well as muscle relaxants) may possibly enhance the effect of Nitrazepam. Individual reactions are unpredictable and may be, for example, inaccurate, clumsy or slow. The association with alcohol and / or with these medications can also cause excessive sedation, up to a state similar to sleep and an impairment (up to inhibition) of breathing and / or the cardiovascular system. Therefore, if you are to take Nitrazepam as a sleeping pill,

  The simultaneous intake of valerian can enhance or reduce the effect of Nitrazepam.

  The combination with strong painkillers (eg opioids) can lead to an excessive feeling of euphoria and thus lead to psychological dependence more quickly.

  The concomitant use of Nitrazepam and opioids (strong pain relievers, addiction substitution medications and some antitussive medications) increases the risk of drowsiness, breathlessness, coma and can be fatal. Consequently, concomitant use should be avoided if possible.

  If your doctor prescribes Nitrazepam in combination with opioid medicines, the dose and duration of concomitant treatment should be limited by your doctor.

  It may be helpful to inform friends or relatives of the aforementioned effects. Contact your doctor if you suddenly feel drowsy or wheezy.

  Other active substances can also enhance the action of benzodiazepines and benzodiazepine-like active substances. Examples are medicaments for fungal diseases (azole antifungals), medications for gastric hyperacidity (eg cimetidine, omeprazole), HIV medications (antiretroviral protease inhibitors), contraceptives ("pill" ), antibiotics such as erythromycin, medicines for hypertension or coronary heart disease (so-called calcium channel blockers), antidepressants (selective serotonin reuptake inhibitors), medicines used to treat alcohol dependence (such as disulfiram) or antiepileptics (eg valproic acid, topiramate, hydantoin and barbiturates).

  Some medicaments for serious infectious diseases such as p. ex. tuberculosis (rifampicin) or medications for asthma or 'smoker's lung' (chronic obstructive pulmonary disease) and even St. John's wort preparations may reduce the effect or duration of action of benzodiazepines.

  Tell your doctor or pharmacist just in case

  • suffer from other diseases,
  • suffer from allergies or
  • take or apply other medicines externally (even if purchased on your own initiative)!

  
  Can Nitrazepam be given during pregnancy or breastfeeding?

  Tell your doctor if you are pregnant, intend to become pregnant or if you are breastfeeding.

  In the event of an established or desired pregnancy, Nitrazepam can only be taken on prescription.

  Nitrazepam passes into breast milk. Therefore, during breastfeeding, you must give up taking Nitrazepam.

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