Active ingredients: Flurazepam (Flurazepam monohydrochloride)
Dalmadorm 15 mg hard capsules
Dalmadorm 30 mg hard capsules
Why is Dalmadorm used? What is it for?
Short-term treatment of insomnia
Benzodiazepines are indicated only when the insomnia is severe, disabling or subjecting the subject to severe distress.
Contraindications When Dalmadorm should not be used
Hypersensitivity to the active substance or to any of the excipients.
Myasthenia gravis. Severe respiratory insufficiency. Severe pulmonary insufficiency. Respiratory depression. Severe hepatic insufficiency. Sleep apnea syndrome. Obsessive or phobic states. Chronic psychosis.
Precautions for use What you need to know before taking Dalmadorm
Due to the highly variable individual reactivity to psychotropic drugs, the posology of Dalmadorm should be set within prudent limits in elderly or debilitated patients (see Dose, method and time of administration).
Due to the "muscle relaxant effect c" is the risk of falls and consequent fractures in the elderly. 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 Dalmadorm should be appropriately reduced to avoid the appearance of accentuated secondary reactions. Dalmadorm is not indicated in children.
Patients under treatment with Dalmadorm, 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.
Benzodiazepines are not recommended for the primary treatment of psychotic illness. Dalmadorm is not indicated in patients with spinal or cerebellar ataxia.
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.
Interactions Which medications or foods can change the effect of Dalmadorm
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Concomitant alcohol intake should be avoided. The sedative effect may be enhanced when the drug 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 of Dalmadorm may be enhanced in cases of concomitant use with barbiturates, antipsychotics (neuroleptics), hypnotics, anxiolytics / sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines: anticonvulsants, antihypertensives and beta blockers this potentiation is sometimes used for therapeutic purposes. Administration of theophylline or aminophylline may reduce the sedative effect of benzodiazepines.
In the case of narcotic analgesics, increased euphoria may occur leading to an increase in psychic dependence. Elderly patients require special supervision
When Dalmadorm is used in conjunction with anti-epileptic drugs, side effects and toxicity may be more evident, particularly with hydantoins or barbiturates or combinations that contain them. This requires special attention in adjusting the dosage in the initial stages of treatment.
Concomitant intake with muscle relaxants may enhance the relaxing effect of flurazepam.
It has been noted that compounds which inhibit certain liver enzymes (especially cytochrome P450) eg. cimetidine, omeprazole and disulfuram, reduce the clearance of benzodiazepines and may enhance their action and that of known inducers of liver enzymes eg. rifampicin may increase the clearance of benzodiazepines.
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 the case of prolonged treatment it is advisable to carry out checks on the haematological picture and liver function, in order to ensure that there are no changes from the norm .
Tolerance
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence
The use of flurazepam, like that of other 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; it is greater in patients with a history of drug abuse. drugs or alcohol or in patients with severe personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided, and treatment should be discontinued gradually. Once physical dependence has developed, the term abrupt of treatment even in patients receiving normal therapeutic doses for short periods will be accompanied by withdrawal symptoms. These may consist of depression, nervousness, mood swings, rebound insomnia, sweating, diarrhea, 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 seizures. In rare cases, discontinuation of treatment following excessive dosage can cause confusion, psychotic manifestations and convulsions. Abuse of benzodiazepines has been reported.
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 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 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 reassessment 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 informed of the possibility of rebound phenomena, thus minimizing the anxiety about these symptoms should they occur when the drug is discontinued. When using benzodiazepines with a long duration of action, such as flurazepam, it is important to warn the patient that abrupt change to a short-acting benzodiazepine is not recommended, as withdrawal symptoms may occur.
Amnesia
Benzodiazepines can induce antegrade amnesia. This occurs 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). period of maximum drug activity, memory may be impaired.
Psychiatric reactions and paradox
When benzodiazepines are used, it is known that rare behavioral effects such as paradoxical aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes, onset of depression with suicidal tendencies are known. Extreme care must therefore be used when prescribing benzodiazepines to patients with personality disorders. Should this occur during treatment with Dalmadorm, its administration should be discontinued. These reactions can be quite severe and are more common 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 Dalmadorm, as well 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).
Fertility, pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
If Dalmadorm is prescribed to a woman of childbearing age, 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.
Pregnancy
There is no evidence for the safety of the drug in pregnancy or evidence from animal work that it is harmless. Therefore, Dalmadorm is not recommended during pregnancy, especially during the first and last trimesters, unless there are compelling reasons. During pregnancy, the drug should be administered 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 irregularities in fetal heart rate, hypothermia, hypotonia and moderate respiratory depression due to the action. pharmacological 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.
Feeding time
There are no data available on the passage of flurazepam into breast milk. Since benzodiazepines are excreted in breast milk, breastfeeding is not recommended. If regular Dalmadorm intake is required, it is recommended that breastfeeding be discontinued.
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 Dalmadorm, as well 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).
Important information about some of the excipients.
Dalmadorm contains lactose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Dosage and method of use How to use Dalmadorm: Dosage
Considering the great variety of forms of insomnia treatable with Dalmadorm it is advisable to adopt an individual dosage, taking into consideration the severity of the insomnia and the patient's response to treatment, within dosage limits between 15 mg and 60 mg. Usual in adults are 15 mg or 30 mg at bedtime. It is advisable to start with 15 mg and increase this dose, if necessary, after testing for individual reactivity. Patients with severe insomnia may require a dosage of 30 mg, but residual wake-up effects associated with anxiolytic effect.
The maximum dose should not be exceeded (no more than 60mg). If possible, treatment should be done intermittently. 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. Long-term chronic treatment is not recommended. Flurazepam is a long-lasting benzodiazepine. duration of action, the patient should be monitored regularly to decrease, if necessary, the dose or frequency of administration in order to prevent overdose due to accumulation. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. The help of a specialist may be appropriate. There is little information regarding the efficacy and safety of benzodiazepines used in the long term.
Elderly or debilitated patients
The elderly are particularly susceptible to the undesirable effects of Dalmadorm. The starting dose should not exceed 15 mg. If organic brain changes are present, the Dalmadorm dosage should not exceed 15 mg.
Patients with impaired renal or hepatic function
The starting dose is 15 mg and in general it should not be exceeded, the dosage may need to be reduced.
Patients with chronic pulmonary insufficiency
In patients with chronic pulmonary insufficiency, the dosage may need to be reduced.
Children
Dalmadorm is not for pediatric use.
Method of administration
Oral use. Swallow with water, without chewing.
Overdose What to do if you have taken too much Dalmadorm
As with other benzodiazepines, an overdose of Dalmadorm presents few problems in management and should not pose a fatal hazard unless concomitant intake of other CNS depressants (including alcohol) is involved. In the treatment of overdose of any medication, it is necessary to keep in mind that other substances may have been taken at the same time. In case of ingestion of an excessive dose of Dalmadorm, it is necessary to induce vomiting (within 1 hour) if the patient is conscious or carry out a gastric lavage, with protection of the airways if the patient is unconscious. If emptying the stomach is of no benefit, administer 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 clouding to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy.
In severe cases, symptoms may include dysarthria, impaired vision and dystonia ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. Therapy consists of the administration of the specific antagonist, flumazenil. Patients requiring this intervention should be closely monitored in the hospital (see separate prescribing information). Physicians should be aware of a risk of epilepsy in association with treatment. with flumazenil, especially in long-term benzodiazepine users and cyclical overdoses of antidepressants
If arousal occurs, barbiturates should not be used. In case of accidental ingestion / intake of an overdose of Dalmadorm, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Dalmadorm, ask your doctor or pharmacist.
Side Effects What are the side effects of Dalmadorm
Like all medicines, Dalmadorm can cause side effects, although not everybody gets them.
Common side effects include daytime sleepiness, emotional poverty, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia and diplopia. These phenomena are dose related and are rare at the recommended dosage; they occur mainly at the start of therapy and usually disappear with repeated administration or after dose adjustment. The elderly are particularly sensitive to the effects of centrally depressant drugs.
The possible side effects are listed below, according to the following classification:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Disorders of the blood and lymphatic system
Frequency not known: Blood disorders (e.g. thrombocytopenia, leukopenia, agranulocytosis, pancytopenia).
Disorders of the immune system
Rare: hypersensitivity (e.g. angioedema).
Psychiatric disorders
Common: emotional poverty.
Frequency not known: confusional state, hallucinations, addiction, withdrawal syndrome, rebound effect, depression, paradoxical reactions (e.g. anxiety, sleep disturbance, insomnia, nightmares, restlessness, agitation, irritability, aggression, delirium, psychotic disturbances, abnormal behavior , emotional disturbances, suicide attempt, suicidal ideation).
Nervous system disorders
Common: somnolence, decreased alertness, ataxia, dizziness, headache, dysgeusia.
Frequency not known: extrapyramidal disorders, anterograde amnesia.
Eye disorders
Rare: visual impairment (eg diplopia).
Ear and labyrinth disorders
Rare: dizziness.
Vascular pathologies
Rare: hypotension.
Respiratory, thoracic and mediastinal disorders
Rare: respiratory depression (especially at night).
Gastrointestinal disorders
Rare: abdominal pain, nausea.
Hepatobiliary disorders
Very rare: jaundice, increased liver enzymes.
Skin and subcutaneous tissue disorders
Rare: skin reactions (e.g. rash).
Musculoskeletal and connective tissue disorders
Common: muscle weakness. Due to the "muscle relaxant effect c" is the risk of falls and consequently fractures in the elderly.
Renal and urinary disorders
Rare: urinary retention.
Diseases of the reproductive system and breast
Rare: libido disorders.
General disorders and administration site conditions
Common: fatigue.
Dalmadorm tolerance is very good. If the dosage is not adapted to individual needs, however, certain side effects may appear, particularly in elderly or debilitated patients, linked to excessive sedation, such as drowsiness during the day, dulling of emotions, reduced alertness, confusion, feeling of fatigue, headache, dizziness, muscle weakness, ataxia, double vision These phenomena are dose related and are not common in the recommended dosages, they are signs of a relative overdose, which usually disappear, or spontaneously (with repeated administrations) in a few days, or after dosage adjustment. Other adverse reactions have occasionally been reported to the use of benzodiazepines, including: gastrointestinal disturbances, libido changes and skin reactions. Hypersensitivity reactions (eg angioedema) may occur in susceptible individuals.
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
A pre-existing depressive state can be unmasked during the use of benzodiazepines. Benzodiazepines can cause reactions such as: restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes. Such reactions can be quite severe. They are more likely in 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). Psychic dependence may occur. Abuse of benzodiazepines has been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiration. see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
Composition and pharmaceutical form
Composition
Dalmadorm 15 mg: one capsule contains Active ingredient: flurazepammonehydrochloride 16.4 mg equal to flurazepam base 15 mg. Excipients: magnesium stearate, talc, lactose.
Dalmadorm 30 mg: one capsule contains Active ingredient: flurazepam monohydrochloride 32.8 mg equal to flurazepam base 30 mg. Excipients: magnesium stearate, talc, lactose.
Pharmaceutical form and content
Dalmadorm 15 mg: 30 hard capsules.
Dalmadorm 30 mg: 30 hard capsules.
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
DALMADORM HARD CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
A capsule of Dalmadorm 15 mg contains:
Active principle: flurazepam monohydrochloride 16.4 mg
(equivalent to flurazepam base 15 mg)
Excipients with known effects: lactose
A capsule of Dalmadorm 30 mg contains:
Active principle: flurazepam monohydrochloride 32.8 mg
(equivalent to flurazepam base 30 mg)
Excipients with known effects: lactose
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Hard capsules for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term treatment of insomnia.
Benzodiazepines are indicated only when the insomnia is severe, disabling or subjecting the subject to severe distress.
04.2 Posology and method of administration
Considering the great variety of forms of insomnia treatable with Dalmadorm, it is advisable to adopt an individual dosage taking into consideration the severity of the insomnia and the patient's response to treatment, within dosage limits between 15 mg and 60 mg.
The usual adult doses are 15 mg or 30 mg at bedtime. It is advisable to start with 15 mg by increasing this dose, if necessary, after testing the individual reactivity. Patients with severe insomnia may require a dosage of 30 mg, but residual waking effects associated with anxiolytic effects are more common at this dosage.
The maximum dose should not be exceeded (no more than 60mg).
If possible, treatment should be done intermittently. 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. Long-term chronic treatment is not recommended.
Since flurazepam is a long-acting benzodiazepine, the patient should be monitored regularly to decrease, if necessary, the dose or frequency of administration in order to prevent overdose due to accumulation.
Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. The help of a specialist may be appropriate. There is little information regarding the efficacy and safety of benzodiazepines used in the long term.
Elderly or debilitated patients
The elderly are particularly susceptible to the undesirable effects of Dalmadorm. The starting dose should not exceed 15 mg. If organic brain changes are present, the Dalmadorm dosage should not exceed 15 mg.
Patients with impaired renal or hepatic function
The starting dose is 15 mg and in general it should not be exceeded, the dosage may need to be reduced.
Patients with chronic pulmonary insufficiency
In patients with chronic pulmonary insufficiency, the dosage may need to be reduced.
Children
Dalmadorm is not for pediatric use.
Method of administration
Oral use.
Swallow with water, without chewing.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Myasthenia gravis. Severe respiratory insufficiency. Severe pulmonary insufficiency. Respiratory depression. Severe hepatic insufficiency. Sleep apnea syndrome. Obsessive or phobic states. Chronic psychosis.
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. In the case of prolonged treatment it is advisable to carry out checks on the haematological picture and liver function, in order to ensure that there are no changes from the norm .
Patients under treatment with Dalmadorm, 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.
Tolerance
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence
The use of flurazepam, like that of other benzodiazepines, can lead to the development of physical and psychological dependence. The risk of addiction increases with dose and duration of treatment; it is greater in patients with a history of drug or alcohol abuse or in patients with severe personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided, and treatment should be discontinued gradually. Once physical dependence has developed, abrupt termination of treatment also in patients receiving normal therapeutic doses for short periods it will be accompanied by withdrawal symptoms. These may consist of depression, nervousness, mood changes, rebound insomnia, sweating, diarrhea, 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 seizures. In rare cases, discontinuation of treatment following excessive dosage can cause confusion, psychotic manifestations and convulsions.
Abuse of benzodiazepines has been reported.
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 should be as short as possible (see section 4.2) and not exceed 4 weeks, including a gradual withdrawal period.
Extending therapy beyond this period should not occur without reassessment 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 informed of the possibility of rebound phenomena, thus minimizing the anxiety about these symptoms should they occur when the drug is discontinued.
When using benzodiazepines with a long duration of action, such as flurazepam, it is important to warn the patient that abrupt change to a short-acting benzodiazepine is not recommended, as withdrawal symptoms may occur.
Amnesia
Benzodiazepines can induce antegrade amnesia. This occurs most often several hours after ingestion of the drug and, therefore, to reduce the risk it should be ensured that patients can have 7-8 hours of uninterrupted sleep (see section 4.8).If the patient wakes up during the drug's peak period, memory may be impaired.
Psychiatric reactions and paradox
When benzodiazepines are used, it is known that rare behavioral effects such as paradoxical aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes, onset of depression with suicidal tendencies are known. Extreme care must therefore be used when prescribing benzodiazepines to patients with personality disorders. Should this occur during treatment with Dalmadorm, its administration should be discontinued. These reactions can be quite severe and are more common in children and the elderly
Specific groups of patients
Due to the highly variable individual reactivity to psychotropic drugs, the posology of Dalmadorm should be set within prudent limits in elderly or debilitated patients (see section 4.2).
Due to the "muscle relaxant effect c" is the risk of falls and consequent fractures in the elderly.
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 Dalmadorm must be suitably reduced to avoid the appearance of accentuated secondary reactions.
Dalmadorm is not indicated for children. Benzodiazepines are not recommended for the primary treatment of psychotic illness.
Dalmadorm is not indicated in patients with spinal or cerebellar ataxia.
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.
Important information about some of the ingredients
Dalmadorm contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
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 the drug 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 barbiturates, antipsychotics (neuroleptics), hypnotics, anxiolytics / sedatives, antidepressants, narcotic analgesics, antiepileptics, sedative anesthetics and antihistamines, anticonvulsants, antihypertensives and beta blockers: This enhancement is sometimes usable for therapeutic purposes.
Administration of theophylline or aminophylline may reduce the sedative effect of benzodiazepines.
In the case of narcotic analgesics, an increase in euphoria can occur, leading to an increase in psychic dependence.
Elderly patients require special supervision
When Dalmadorm is used in combination with anti-epileptic drugs, side effects and toxicity may be more evident, particularly with hydantoins or barbiturates or combinations that contain them. This requires special attention in adjusting the dosage in the initial stages of treatment.
Concomitant intake with muscle relaxants may enhance the relaxing effect of flurazepam.
It has been noted that compounds which inhibit certain liver enzymes (especially cytochrome P450) eg. cimetidine, omeprazole and disulfuram, reduce the clearance of benzodiazepines and may enhance their action and that of known inducers of liver enzymes eg. rifampicin may increase the clearance of benzodiazepines.
04.6 Pregnancy and lactation
Fertility
If Dalmadorm is prescribed to a woman of childbearing age, 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.
Pregnancy
There is no evidence for the safety of the drug in pregnancy or evidence from animal work that it is harmless. Therefore, Dalmadorm is not recommended during pregnancy, especially during the first and last trimesters, unless there are compelling reasons.
During pregnancy, the drug should be administered 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 irregularities in fetal heart rate, hypothermia, hypotonia and moderate respiratory depression due to the action. pharmacological 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.
Feeding time
There are no data available on the passage of flurazepam into breast milk. Since benzodiazepines are excreted in breast milk, breastfeeding is not recommended
In case it is necessary to take Dalmadorm regularly, 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 Dalmadorm, as well 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 section 4.5).
04.8 Undesirable effects
Common side effects include daytime sleepiness, emotional poverty, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia and diplopia. These phenomena are dose related and are rare at the recommended dosage; they occur mainly at the start of therapy and usually disappear with repeated administration or after dose adjustment. The elderly are particularly sensitive to the effects of centrally depressant drugs.
Within the system organ class, adverse reactions are listed in order of frequency, using the following categories:
Very common (1/10)
Common (1/100,
Uncommon (1 / 1,000,
Rare (1 / 10,000 y
Very rare (
Not known (frequency cannot be estimated from the available data)
Disorders of the blood and lymphatic system
Frequency not known: Blood disorders (e.g. thrombocytopenia,
leukopenia, agranulocytosis, pancytopenia).
Disorders of the immune system
Rare: hypersensitivity (e.g. angioedema).
Psychiatric disorders
Common: emotional poverty.
Frequency not known: confusional state, hallucinations, addiction, withdrawal syndrome, rebound effect, depression, paradoxical reactions (e.g. anxiety, sleep disturbance, insomnia, nightmares, restlessness, agitation, irritability, aggression, delirium, psychotic disturbances, abnormal behavior , emotional disturbances, suicide attempt, suicidal ideation).
Nervous system disorders
Common: somnolence, decreased alertness, ataxia, dizziness, headache, dysgeusia.
Frequency not known: extrapyramidal disorders, anterograde amnesia.
Eye disorders
Rare: visual impairment (eg diplopia).
Ear and labyrinth disorders
Rare: dizziness
Vascular pathologies
Rare: hypotension.
Respiratory, thoracic and mediastinal disorders
Rare: respiratory depression (especially at night).
Gastrointestinal disorders
Rare: abdominal pain, nausea.
Hepatobiliary disorders
Very rare: jaundice, increased liver enzymes.
Skin and subcutaneous tissue disorders
Rare: skin reactions (e.g. rash).
Musculoskeletal and connective tissue disorders
Common: muscle weakness. Due to the "muscle relaxant effect c" is the risk of falls and consequently fractures in the elderly.
Renal and urinary disorders
Rare: urinary retention.
Diseases of the reproductive system and breast
Rare: libido disorders.
General disorders and administration site conditions
Common: fatigue.
Tolerance to Dalmadorm is very good. If the dosage is not adapted to individual needs, however, certain undesirable effects may appear, particularly in elderly or debilitated patients, linked to excessive sedation, such as drowsiness during the day, dulling of emotions, reduced alertness, confusion, feeling of fatigue, headache, dizziness, muscle weakness, ataxia, double vision. These phenomena are dose related and are not common in the recommended dosages, they are signs of a relative overdose, which usually disappear, either spontaneously (with repeated administrations) 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 (e.g. angioedema) 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 section 4.4).
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 serious.
They are more likely in 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 section 4.4). Psychic dependence may occur.
Abuse of benzodiazepines has been reported.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "Italian Medicines Agency Website: http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
As with other benzodiazepines, an overdose of Dalmadorm presents few problems in management and should not be life threatening unless there is concomitant intake of other CNS depressants (including alcohol). In the treatment of overdose of any medication, it should be borne in mind that other substances may have been taken at the same time.
In case of ingestion of an excessive dose of Dalmadorm, it is necessary to induce vomiting (within 1 hour) if the patient is conscious or to perform a gastric lavage, with protection of the airways, 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 clouding to coma.
In mild cases, symptoms include drowsiness, mental confusion, and lethargy. In severe cases, symptoms may include dysarthria, impaired vision and dystonia ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Therapy consists of the administration of the specific antagonist, flumazenil. Patients requiring this intervention should be closely monitored in the hospital (see separate prescribing information). Physicians should be aware of a risk of epilepsy in association with treatment. with flumazenil, especially in long-term benzodiazepine users and in cyclical overdoses of antidepressants.
If arousal occurs, barbiturates should not be used.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Hypnotics and sedatives, benzodiazepine derivatives, ATC code N05CD01.
Flurazepam is a white to slightly straw-colored crystalline powder, odorless, soluble in water, alcohol and chloroform, slightly soluble in acetone and almost insoluble in ether; possesses a molecular weight of 424.3.
Through a selective action at the level of central structures important for the regulation of the sleep-wake rhythm, flurazepam allows the induction of a sleep very similar to the physiological one. The drug shortens the time to fall asleep, reduces the frequency of nocturnal awakenings and extends the total duration of sleep.
Falling asleep occurs on average after about 20 minutes and sleep lasts for 7-8 hours.
05.2 "Pharmacokinetic properties
After oral administration of 30 mg in humans, a blood peak of about 2 ng / ml is reached between the first and second hour.
Flurazepam is metabolised in the body by the liver resulting in the formation of at least 4 metabolites, of which N-dealkylflurazepam is the predominant active metabolite; these metabolites undergo hepatic glucuronide conjugation and subsequent renal elimination.
When administered radiolabelled, 81% of the radioactivity is excreted in the urine and 9% in the faeces.
The half-life of flurazepam is approximately 3 hours, that of its major metabolite is 47-100 hours. The apparent volume of distribution of unchanged flurazepam is 3.4 l / kg and that of its major metabolite is 22. l / Kg.
Plasma protein binding is 97%.
With a dosage of 30 mg / day, steady state is reached after 7-10 days and concentrations are approximately 5-6 times higher than those obtained on the first day of administration.
05.3 Preclinical safety data
The limited data available do not indicate a mutagenic potential of flurazepam. There are no long-term carcinogenicity studies. Acute toxicity tests have shown LD50 values between 560 and 1232 mg / kg per os and between 84 and 200 mg / kg after parenteral administration in the different species of animals tested (mouse-rat-rabbit).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
1 capsule contains
Dalmadorm 15 mg
Excipients
Magnesium stearate 0.5 mg
Talc 8.5 mg
Lactose to taste to 140.0 mg
Constituents of the operculum
Gelatin 37.40 mg
Titanium Dioxide 1.56 mg
Natural color E172 0.05 mg
Dalmadorm 30 mg
Magnesium stearate 1.0 mg
Talc 8.5 mg
Lactose to taste to 140.0 mg
Constituents of the operculum
Gelatin 37.40 mg
Titanium Dioxide 0.97 mg
Natural color E172 0.58 mg
06.2 Incompatibility
Not known.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C
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.
Dalmadorm 30 capsules 15 mg
Dalmadorm 30 capsules 30 mg
06.6 Instructions for use and handling
No special instructions for disposal.
07.0 MARKETING AUTHORIZATION HOLDER
Meda Pharma SpA
Via Felice Casati, 20 - 20124 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Dalmadorm 15 mg AIC N. 022717021
Dalmadorm 30 mg AIC N. 022717045
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal June 2010
10.0 DATE OF REVISION OF THE TEXT
12/2015
