Active ingredients: Nitrazepam
Mogadon 5 mg compr
Why is Mogadon used? What is it for?
Mogadon belongs to the therapeutic category of nitrazepam-based hypnotics.
Short-term treatment of insomnia.
Benzodiazepines are indicated only when insomnia is severe, disabling and subjects the subject to severe discomfort.
Contraindications When Mogadon should not be used
Known individual hypersensitivity to nitrazepam or to any of the excipients; myasthenia gravis. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome.
Precautions for use What you need to know before taking Mogadon
Benzodiazepines should not be administered to children without assessment of the actual need for treatment; the duration of treatment should be as short as possible. Due to the highly variable individual reactivity to psychotropic drugs, the dosage of Mogadon should be set within prudent limits in elderly patients or debilitated (see Dose, method and time of administration). Likewise, a lower dose is suggested for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Benzodiazepines are not indicated in patients with severe hepatic insufficiency as they can precipitate the "encephalopathy. In patients with hepatic insufficiency the dosage of Mogadon should be appropriately reduced to avoid the appearance of accentuated secondary reactions. Patients under treatment with nitrazepam, as with any other psychotropic drug, should refrain from consuming alcoholic beverages while under the influence of the drug, as individual reactions are unpredictable. Benzodiazepines are not recommended for the primary treatment of psychotic illness. Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide can be precipitated in such patients). Benzodiazepines should be used with extreme caution in patients with a history of drug and alcohol abuse.
Pregnancy and breastfeeding
If Mogadon is prescribed to a woman of childbearing potential, she should be advised that, whether she intends to become pregnant or suspects she is pregnant, she should contact her doctor to consider stopping treatment. Do not administer in the first trimester of pregnancy. In the further period the product should be used only in case of real need and under the direct supervision of the doctor. If, for serious medical reasons, the product is administered during the last period of pregnancy or during labor at high doses, they can effects on the newborn occur, such as hypothermia, hypotonia and moderate respiratory depression due to the pharmacological action of the drug. In addition, newborns born to mothers who have taken benzodiazepines chronically during late pregnancy, may develop physical dependence and may present some risk to develop withdrawal symptoms in the postnatal period. Since benzodiazepines are excreted in breast milk, they should not be given to mothers who are breastfeeding. Should regular Mogadon be required, discontinuation of Mogadon is recommended. breastfeeding.
Interactions Which drugs or foods can change the effect of Mogadon
Concomitant alcohol intake should be avoided. The sedative effect may be enhanced when Mogadon is taken in conjunction with alcohol. This adversely affects the ability to drive or use machines. Association with central nervous system (CNS) depressants: the central depressive effect may be enhanced in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics / sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines. in the case of narcotic analgesics, increased euphoria may occur, leading to an increase in psychic dependence. Compounds that inhibit certain liver enzymes (especially cytochrome P 450) may increase the activity of benzodiazepines. To a lesser extent, this also applies to benzodiazepines which are metabolized only by conjugation.
Warnings It is important to know that:
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician to avoid unexpected undesirable effects from interaction. In case of prolonged treatment it is advisable to check the haematological picture and liver function.
Tolerance
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence
The use of benzodiazepines can lead to the development of physical and mental dependence on these drugs. The risk of dependence increases with dose and duration of treatment; it is greater in patients with a history of drug or alcohol abuse. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle aches, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. Insomnia and rebound anxiety: a transient syndrome in which the symptoms, which have led to treatment with benzodiazepines, recur in an aggravated form. It may be accompanied by other reactions, including mood changes, anxiety, restlessness, or sleep disturbances. Since the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, a gradual decrease in dosage is suggested.
Duration of treatment
The duration of treatment with Mogadon should be as short as possible (see Dose, method and time of administration) and not exceed 4 weeks, including a gradual withdrawal period. Extending therapy beyond this period should not take place without re-evaluation of the clinical situation. It may be useful to inform the patient when treatment begins that it will be of limited duration and to explain precisely how the dosage should be progressively decreased. It is important that the patient is informed of the possibility of rebound phenomena, thus minimizing anxiety about such symptoms should they occur upon discontinuation of Mogadon. When using benzodiazepines with a long duration of action, it is important to warn the patient that abrupt change to a benzodiazepine with a short duration of action is not recommended, as withdrawal symptoms may occur.
Amnesia
Benzodiazepines can induce anterograde amnesia. This happens most often several hours after ingestion of the drug and, therefore, to reduce the risk it should be ensured that patients can have an uninterrupted sleep of 7-8 hours (see side effects).
Psychiatric reactions and paradox
When benzodiazepines are used it is known that reactions such as restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes can occur. Should this occur during treatment with Mogadon, its administration should be discontinued. Such reactions are more frequent in children and the elderly. Based on the modalities of use, dose and individual sensitivity, sedation, amnesia, alteration of muscle concentration and function, which can be induced by the intake of Mogadon, as by that of other drugs of the same type of action, may adversely affect the ability to drive or use machines.If sleep duration has been insufficient, the likelihood of impaired alertness may be increased (see interactions).
The medicine is not contraindicated for people with celiac disease.
Dosage and method of use How to use Mogadon: Dosage
Composition
One tablet contains:
Active ingredient: nitrazepam 5 mg.
Excipients: starch, ethylcellulose, magnesium stearate, lactose.
Packs
20 tablets.
Dose
Adults: one tablet (5 mg). This average dose can be increased if necessary to 10 mg (2 tablets) in outpatient treatments and to 20 mg (4 tablets) in inpatient treatments.
Older subjects: 1/2 - 1 tablet.
Children (1 to 6 years): 1/2 - 1 tablet; (6 to 14 years): one tablet. Mogadon should be taken in the evening before going to bed.
Mode
The tablets can be chewed, swallowed whole or dissolved in a glass of water.
It is advisable to start treatment with the minimum dose indicated, subsequently increasing it, if necessary, after testing the individual reactivity; the maximum dose should not be exceeded.
Treatment should be as short as possible. The duration of treatment generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary; in this case, such extension of treatment should not occur without reassessment of the patient's condition.
The patient should be monitored regularly to decrease, if necessary, the dose or frequency of administration in order to prevent overdose due to accumulation.
Overdose What to do if you have taken too much Mogadon
As with other benzodiazepines, overdose should not be life threatening unless they have been taken at the same time as other CNS depressants (including alcohol). When treating overdose from any medicinal product, it should be noted that they may more substances have been taken.
In the event of an overdose of Mogadon, vomiting should be induced (within 1 hour) if the patient is conscious or gastric lavage, with airway protection, performed if the patient is unconscious. If stomach emptying is not beneficial, give activated charcoal to reduce absorption. Cardiovascular and respiratory functions should be closely monitored in the intensive care unit. Overdose with benzodiazepines usually results in varying degrees of CNS depression, ranging from "drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in severe cases, symptoms may include ataxia. , hypotonia, hypotension, respiratory depression, rarely coma and very rarely death Flumazenil may be a useful antidote.
Side Effects What are the side effects of Mogadon
Mogadon tolerance is very good. If the dosage is not adapted to individual needs, some side effects may nevertheless appear, particularly in elderly or debilitated patients, linked to excessive sedation (drowsiness during the day, dulling of emotions, reduced alertness, confusion, feeling of fatigue, headache, dizziness, muscle weakness, ataxia, double vision). These are signs of a relative overdose, which disappear either spontaneously within a few days, or after dose adjustment. Occasionally other adverse reactions have been reported to the use of benzodiazepines, which include: gastrointestinal disturbances, changes in libido and skin reactions.
Hypersensitivity reactions may occur in predisposed subjects.
Amnesia
Anterograde amnesia can also occur at therapeutic dosages of benzodiazepines, the risk increases at higher dosages. Amnesic effects may be associated with behavioral changes (see special warnings).
Depression
During the use of benzodiazepines a pre-existing depressive state can be unmasked. Benzodiazepines can cause reactions such as: restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes. These reactions can be quite severe. They are more likely in children and the elderly.
Dependence
The use of benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence: suspension of therapy can cause rebound or withdrawal phenomena (see special warnings). Psychic dependence may occur.
Abuse of benzodiazepines has been reported. It is advisable to consult your doctor or pharmacist in case of undesirable effects not mentioned in this leaflet.
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016.The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MOGADON 5 mg TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Mogadon 5 mg tablet contains:
Active ingredient: nitrazepam 5 mg.
03.0 PHARMACEUTICAL FORM
Tablets for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term treatment of insomnia.
Benzodiazepines are indicated only when insomnia is severe, disabling and subjects the subject to severe discomfort.
04.2 Posology and method of administration
Adults: one tablet (5 mg).
This average dose can be increased if necessary to 10 mg (2 tablets) in outpatient treatments and to 20 mg (4 tablets) in inpatient treatments.
Subjects in old age: ½ - 1 tablet
Children:
• (from 1 to 6 years): ½ - 1 tablet;
• (from 6 to 14 years): one tablet.
Mogadon should be taken in the evening before going to bed.
The tablets can be chewed, swallowed whole or dissolved in a glass of water.
It is advisable to start treatment with the minimum dose indicated, subsequently increasing it, if necessary, after testing the individual reactivity; the maximum dose should not be exceeded.
Treatment should be as short as possible. The duration of treatment generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary; in this case, such extension of treatment should not occur without reassessment of the patient's condition.
The patient should be monitored regularly to decrease, if necessary, the dose or frequency of administration in order to prevent overdose due to accumulation.
04.3 Contraindications
Known individual hypersensitivity to nitrazepam or to any of the excipients; myasthenia gravis. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome.
04.4 Special warnings and appropriate precautions for use
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician to avoid unexpected undesirable effects from interaction.
Patients under treatment with nitrazepam, as well as with any other psychotropic drug, should refrain from consuming alcoholic beverages while under the influence of the drug, as individual reactions are unpredictable.
In case of prolonged treatment it is advisable to check the haematological picture and liver function.
Tolerance
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence
The use of benzodiazepines can lead to the development of physical and psychological dependence on these drugs. The risk of dependence increases with dose and duration of treatment, and is greater in patients with a history of drug or alcohol abuse.
Once the physical dependence has developed, the abrupt termination of treatment will be accompanied by withdrawal symptoms. These can consist of headache, body aches, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound insomnia and anxiety: A transient syndrome may occur on discontinuation of treatment in which symptoms leading to treatment with benzodiazepines recur in an aggravated form. It may be accompanied by other reactions, including mood changes, anxiety, restlessness or sleep disorders.
Since the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, a gradual decrease in dosage is suggested.
Duration of treatment
The duration of treatment with Mogadon should be as short as possible (see posology) and not exceed 4 weeks, including a gradual withdrawal period.
Extending therapy beyond this period should not take place without re-evaluation of the clinical situation. It may be helpful to inform the patient when treatment begins that it will be of limited duration and to explain precisely how the dosage should be progressively decreased.
It is also important that the patient is aware of the possibility of rebound phenomena, thus minimizing anxiety about such symptoms should they occur upon discontinuation of Mogadon.
When using benzodiazepines with a long duration of action, it is important to warn the patient that abrupt change to a benzodiazepine with a short duration of action is not recommended, as withdrawal symptoms may occur.
Amnesia
Benzodiazepines can induce anterograde amnesia. This happens most often several hours after ingestion of the drug and, therefore, to reduce the risk it should be ensured that patients can have an uninterrupted sleep of 7-8 hours (see side effects).
Psychiatric reactions and paradox
When benzodiazepines are used it is known that reactions such as restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes can occur. Should this occur during treatment with Mogadon, its administration should be discontinued. Such reactions are more frequent in children and the elderly.
Specific groups of patients
Benzodiazepines should not be given to children without an assessment of the actual need for treatment; the duration of treatment should be as short as possible.
Due to the highly variable individual reactivity to psychotropic drugs, the dosage of Mogadon should be set within prudent limits in elderly or debilitated patients. (see posology).
Also a lower dose is suggested for patients with chronic respiratory failure due to the risk of respiratory depression.
Benzodiazepines are not indicated in patients with severe hepatic insufficiency as they can precipitate encephalopathy. In patients with hepatic insufficiency the dosage of Mogadon should be appropriately reduced to avoid the appearance of accentuated secondary reactions.
Benzodiazepines are not recommended for the primary treatment of psychotic illness.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide can be precipitated in such patients).
Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Concomitant alcohol intake should be avoided. The sedative effect may be enhanced when Mogadon is taken in conjunction with alcohol. This adversely affects the ability to drive or use machines.
Association with CNS depressants: the central depressive effect may be enhanced in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics / sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines.
In the case of narcotic analgesics, an increase in euphoria can occur, leading to an increase in psychic dependence.
Compounds that inhibit certain liver enzymes (especially cytochrome P450) may increase the activity of benzodiazepines. To a lesser extent, this also applies to benzodiazepines which are metabolized only by conjugation.
04.6 Pregnancy and breastfeeding
If Mogadon is prescribed to a woman of childbearing potential, she should be advised that, whether she intends to become pregnant or suspects she is pregnant, she should contact her doctor to consider stopping treatment.
Do not administer in the first trimester of pregnancy. In the further period the product must be used only in case of real need and under the direct supervision of the doctor.
If, for serious medical reasons, the product is administered during the last period of pregnancy or during labor at high doses, effects on the newborn may occur, such as hypothermia, hypotonia and moderate respiratory depression due to the pharmacological action of the drug.
Additionally, infants born to mothers who have chronically taken benzodiazepines during late pregnancy may develop physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Since benzodiazepines are excreted in breast milk, they should not be given to breastfeeding mothers.
If regular intake of Mogadon is required, it is advisable to stop breastfeeding.
04.7 Effects on ability to drive and use machines
Based on the modalities of use, dose and individual sensitivity, sedation, amnesia, alteration of muscle concentration and function, which can be induced by the intake of Mogadon, as by that of other drugs of the same type of action, may adversely affect the ability to drive or use machines.
If sleep duration has been insufficient, the likelihood of impaired alertness may be increased (see interactions).
04.8 Undesirable effects
Mogadon tolerance is very good. If the dosage is not adapted to individual needs, certain side effects may nevertheless appear, particularly in elderly or debilitated patients, linked to excessive sedation (drowsiness during the day, dulling of emotions, reduced alertness, confusion, feeling of fatigue, headache , dizziness, muscle weakness, ataxia, double vision). These are signs of a relative overdose, which disappear either spontaneously in a few days, or after dosage adjustment. Other adverse reactions have occasionally been reported to the use of benzodiazepines, including: gastrointestinal disturbances, changes in libido and skin reactions.
Hypersensitivity reactions may occur in predisposed subjects.
Amnesia
Anterograde amnesia can also occur at therapeutic dosages of benzodiazepines, the risk increases at higher dosages. Amnesic effects may be associated with behavioral changes (see special warnings and precautions).
Depression
During the use of benzodiazepines a pre-existing depressive state can be unmasked. Benzodiazepines can cause reactions such as: restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes. These reactions can be quite severe. They are more likely in children and the elderly.
Dependence
The use of benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence: discontinuation of therapy can cause rebound or withdrawal phenomena (see special warnings and precautions). Psychic dependence may occur.
Abuse of benzodiazepines has been reported.
04.9 Overdose
As with other benzodiazepines, overdose should not be life threatening unless they have been taken at the same time as other CNS depressants (including alcohol). When treating overdose from any medicinal product, it should be noted that they may more substances have been taken.
In the event of an overdose of Mogadon, vomiting should be induced (within 1 hour) if the patient is conscious or gastric lavage, with airway protection, performed if the patient is unconscious. If stomach emptying is not beneficial, give activated charcoal to reduce absorption. Cardiovascular and respiratory functions should be closely monitored in the intensive care unit.
Overdose with benzodiazepines usually results in varying degrees of CNS depression, ranging from "drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in severe cases, symptoms may include ataxia, hypotonia. , hypotension, respiratory depression, rarely coma and very rarely death.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Nitrazepam is a yellowish crystalline substance, insoluble in water, soluble in alcohol.
Mogadon rapidly induces sleep by protecting the physiological mechanisms that regulate the sleep-wake rhythm from impulses of emotional, sensorial and kinesthetic origin. In fact, the drug determines sleep not through a depression of the wake system, but by deactivating the latter through an attenuation of the afferent impulses.
05.2 Pharmacokinetic properties
Nitrazepam is absorbed from the gastrointestinal tract: the degree of absorption is subject to individual variations (60-90%). Approximately 40-80 minutes after administration of 5 mg of Mogadon, an average peak plasma concentration of 40 ng / ml is achieved. In younger people, the volume of distribution is 2 liters / kg. Two hours after administration, the concentration of nitrazepam in the cerebrospinal fluid is approximately 8% and after 36 hours approximately 16% of the plasma concentration.
The concentration in the cerebrospinal fluid therefore corresponds to the fraction of the active ingredient not bound to proteins in the plasma. The elimination of nitrazepam from the blood is biphasic. The mean elimination half-life is 30 hours and does not vary during long-term administration. With an uninterrupted dosage of 5 mg / day of Mogadon, steady state is achieved by approximately the fourth day with plasma concentrations of 40-60 ng / ml of nitrazepam.
Only a small percentage of the oral dose of Mogadon appears unchanged in the urine. The active substance is reduced in the liver to the 7-amino compound, which is metabolized in turn to 7-acetamidonitrazepam. In elderly patients, the volume of distribution is greater and the mean elimination half-life increases to 40 hours. The same trend occurs in patients with impaired hepatic function; renal function is of minor importance in this respect. Nitrazepam it crosses the placenta and passes into breast milk during lactation.
05.3 Preclinical safety data
Acute toxicity tests have shown LD50 values between 520 and 1800 / mg / kg after oral administration in the various animal species tested (mouse, rat, rabbit).
Experiences made on several generations of mice, rats, rabbits and dogs have not provided any evidence that Mogadon has a harmful action on embryonic development.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Excipients
• starch 243.0 mg
• ethylcellulose 10.0 mg
• magnesium stearate 0.5 mg
• lactose to taste to 550.0 mg
06.2 Incompatibility
No specific incompatibilities are known to date.
06.3 Period of validity
60 months. The expiry date refers to the unopened product correctly stored.
06.4 Special precautions for storage
The product is kept in normal environmental conditions.
06.5 Nature of the immediate packaging and contents of the package
Blisters, enclosed in a cardboard box together with the package leaflet, made of thermoformed plastic material coupled with aluminum tape.
Mogadon 20 tablets 5 mg.
06.6 Instructions for use and handling
No particular instructions for use.
07.0 MARKETING AUTHORIZATION HOLDER
Meda Pharma SpA
Viale Brenta 18
20139 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Mogadon 20 tablets 5 mg - AIC n. 020731081
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal June 2010
10.0 DATE OF REVISION OF THE TEXT
January 2012
