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- The medicine is a sleep aid from the group of benzodiazepines.
- The preparation is used for short-term treatment of sleep disorders.
- Benzodiazepines should only be used in sleep disorders of clinically significant severity.
- The medicine must not be taken,
- if you are allergic (hypersensitive) to nitrazepam, other benzodiazepines or any of the other ingredients of the product.
- in pathological muscle weakness (myasthenia gravis)
- in the case of existing or previous dependence on medicines, alcohol or drugs
- in severe disorders of respiratory function
- during sleep-accompanying respiratory failure (sleep apnea syndrome)
- in case of severe liver damage
- in disorders of muscle and motor coordination (spinal and cerebellar ataxias)
- in acute poisoning with alcohol, sleeping pills, analgesics or psychotropic drugs (neuroleptics, antidepressants, lithium)
Dosage of NITRAZEPAM 5
- Always take the medicine exactly as your doctor has told you. Please check with your doctor or pharmacist if you are not sure.
- Unless otherwise prescribed by the doctor, the usual dose is
- Treatment should be started at the lowest recommended dose. The maximum dose should not be exceeded.
- Adults usually receive ½ – 1 tablet of the drug (equivalent to 2.5 – 5 mg nitrazepam). The maximum dose may be increased to 2 tablets of the drug (equivalent to 10 mg nitrazepam).
- Older patients will receive ½ tablet of the drug (equivalent to 2.5 mg nitrazepam), as a maximum dose 1 tablet (equivalent to 5 mg nitrazepam).
- Duration of application
- The duration of treatment for sleep disorders with benzodiazepines should be as short as possible. It should not exceed 4 weeks, including the gradual withdrawal phase. An extension of the treatment beyond this period should not be done without another critical assessment of the condition by your doctor.
- Please talk to your doctor or pharmacist if you think that the effect of the medicine is too strong or too weak.
- If you take more of the medicine than you should
- In case of overdose or poisoning with the product, a doctor (eg about the poisoning emergency call) must be consulted immediately.
- Signs of (mild) overdose may include drowsiness, drowsiness, blurred vision, slurred speech, drop in blood pressure, arousal and movement insecurity, and muscle weakness. In cases of severe intoxication, deep sleep, loss of consciousness, respiratory disorder, and circulatory collapse may occur.
- The assessment of the severity of the poisoning and the determination of the therapeutic measures is carried out by the doctor.
- Medical measures for overdoses:
- Patients with mild signs of toxicity should sleep under medical supervision. In more severe cases, further measures (gastric lavage, circulatory stabilization, intensive monitoring) may be required. With continued consciousness it makes sense to induce vomiting early.
- Flumazenil is indicated for the abolition of the central depressant effects of benzodiazepines. It is used among others in the following field of application:
- “Abolition of benzodiazepine-induced sedation as part of therapeutic measures in inpatients”.
- If you forget to take the medicine
- Please do not take the missed dose, but continue to take the drug as prescribed by the doctor.
- If you stop taking the medicine
- Please do not stop or stop taking the medicine without talking to your doctor first.
- If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
- Take special care with the preparation
- if any of the following conditions apply to you.
- Below is a description of when to use the product only under certain conditions and with particular care. Please ask your doctor. This also applies if this information once applied to you.
- Benzodiazepines are not recommended for the sole treatment of certain mental disorders (psychoses).
- Benzodiazepines should not be used for the sole treatment of depression or anxiety associated with depression. It may be possible to increase the depressive symptoms if there is no appropriate treatment of the underlying disease with antidepressants.
- Benzodiazepines should be used with extreme caution in patients with a history of drug, alcohol and drug abuse.
- In patients with respiratory disorders or with disorders of the liver or kidney function – as is usual – caution and if necessary to reduce the dosage.
- The duration of treatment should be as short as possible when the product is used to treat sleep disorders. It should not exceed 4 weeks, including the gradual withdrawal phase. An extension of the treatment beyond this period should not be done without another critical assessment of the condition by your doctor.
- Children and adolescents
- The product should only be prescribed to children and adolescents after careful consideration of the benefit-risk balance.
- Elderly patients
- Even in elderly patients, special care should be taken and, if necessary, lower.
- Driving and using machines
- Drowsiness, memory impairment, reduced ability to concentrate, and impaired muscle function may adversely affect the ability to drive or work with machines. This is especially true after insufficient sleep time.
- In pregnancy, the drug should be prescribed only in exceptional cases for compelling reasons.
- If you become pregnant or suspect you may be pregnant during treatment with the product, please inform your doctor immediately so that he or she can decide whether to continue or stop the treatment.
- Prolonged intake of the medicine by pregnant women can cause withdrawal symptoms in the newborn. End-of-pregnancy or child-bearing use may result in lowered body temperature, decreased blood pressure, decreased breathing, reduced muscle tension, and drinking weakness in the newborn.
- The drug passes into breast milk and can accumulate there after repeated administration, so must be weaned with repeated ingestion or intake of high doses.
- Ask your doctor or pharmacist for advice before taking / using any medicine.
- Take the medicine in the evening immediately before going to bed with some liquid (eg half a glass of water).
- Please note that after ingestion a sufficient sleep time (7 – 8 hours) is guaranteed to prevent the risk of impaired responsiveness the following morning.
Interactions in NITRAZEPAM AL 5
- Taking the drug with other medicines
- Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
- In case of simultaneous use of the product with the following medicinal products, the effects of each other may increase:
- Sleeping, sedative and anesthetic
- anxiolytics (anxiolytics)
- Agent for the treatment of seizure disorders (antiepileptics)
- Medicines for allergies (antihistamines)
- Medicines for influencing the emotional and mental state (neuroleptics, antidepressants)
- muscle relaxants (muscle relaxants)
- The concomitant use of drugs that inhibit certain liver enzymes may increase the effect of the drug. Which includes:
- Agent for the treatment of gastritis and gastric ulcers such as cimetidine and omeprazole
- Macrolide-type antibiotics such as erythromycin
- Means for preventing pregnancy (“pill”)
- Taking the medicine with food and drink
- During treatment with the product, you should abstain from alcohol because alcohol can alter and enhance the effect of the drug in an unpredictable way. Also, the ability to drive and the ability to operate machines, thereby further affected.
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