Active ingredients: Triazolam
SONGAR 0.25 mg hard capsules
SONGAR 0.375 mg / ml oral drops, solution
Indications Why is Songar used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Hypnotics and sedatives: benzodiazepine derivatives.
THERAPEUTIC INDICATIONS
Short-term treatment of insomnia. Benzodiazepines are only indicated when the disorder is severe, debilitating, or causes the person to suffer severe discomfort.
Contraindications When Songar should not be used
Songar is contraindicated in patients with known hypersensitivity to benzodiazepines, triazolam or any of the excipients of Songar (see Composition section). Songar is also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome. Co-administration of triazolam with ketoconazole, itraconazole, nefazodone, efavirenz and HIV protease inhibitors is contraindicated (see section Interactions).
Do not administer to children (see section Precautions for use), pregnant and breastfeeding (see section Special warnings).
Precautions for use What you need to know before taking Songar
Caution should be used in patients with mild to moderate hepatic insufficiency being treated with Triazolam.
Respiratory depression and apnea have been reported infrequently in patients with impaired respiratory function.
Benzodiazepines produce an additive effect when administered together with alcohol or other CNS depressants. Concomitant alcohol intake is not recommended. Triazolam should be used with caution when taken in combination with other CNS depressants (see Interactions section).
Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse.
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.
Triazolam should be used primarily for the occasional short-term treatment of insomnia, generally for no longer than 7-10 days, up to a maximum of 4 weeks (see section Dose, Method and Time of Administration). periods longer than two weeks requires a complete reassessment of the patient.
Withdrawal reactions:
Once physical dependence has developed, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms. These may consist of headache, body aches, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following may occur. symptoms: muscle and abdominal cramps, vomiting, sweating, tremors, derealization, depersonalization, hypersensitivity / intolerance to sounds, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures. Discontinuation of treatment A transient syndrome may occur in which the insomnia leading to treatment with benzodiazepines recurs in a more severe form than in the initial phase. It may be accompanied by other reactions, including mood changes, anxiety, restlessness or sleep disturbances. Because the risk of withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, a gradual decrease in dosage is recommended.
Although benzodiazepines are not depressogenic, they can be associated with mental depression which may or may not be associated with suicidal thoughts or actual suicide attempts. This happens in a rare and unpredictable way. Therefore triazolam should be used with caution and the quantity of the prescription should be limited in patients with signs and symptoms of depressive disorders and suicidal tendencies.
Duration of treatment:
The duration of treatment should be as short as possible (see section 4.2), and should not exceed four 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 is started that it will be of limited duration and to explain precisely how the dosage should be progressively decreased. It is also important that the the patient is informed of the possibility of rebound phenomena, thus minimizing the anxiety about these symptoms should they arise when the drug is discontinued.
There is evidence that, in the case of short-acting benzodiazepines, withdrawal symptoms may become manifest within the dosing interval between doses, particularly for high doses.
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 Undesirable Effects).
Caution should be exercised in the elderly and / or in debilitated patients. In elderly and / or debilitated patients, it is recommended that triazolam treatment is started with 0.125 mg to decrease the possibility of developing excessive sedation, dizziness or decreased coordination ability.
In other adult patients a dosage of 0.25 mg is recommended (see section Dose, method and time of administration). Triazolam is not recommended for children and adolescents below 18 years of age as there are insufficient data on safety and efficacy.
Psychiatric and paradoxical reactions:
When using benzodiazepines it is known that reactions such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, behavioral changes can occur. Should this occur, the use of the medicinal product should be discontinued. These reactions are more frequent in children and the elderly.
Specific patient groups:
Benzodiazepines should not be given to children without careful evaluation of the actual need for treatment and possible risks; if treatment is deemed necessary, its duration should be as short as possible.
The elderly should take a reduced dose (see section Dose, method and time of administration). Likewise, 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) and / or with severe renal insufficiency.
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.
Complex events related to sleep behavioral disturbances, such as drowsiness while driving (that is, when driving while not fully alert after taking a hypnotic-sedative, with amnesia of the event) have been reported in patients who were not perfectly alert after taking a sedative-hypnotic, including triazolam. These and other complex events related to sleep behavioral disturbances can occur with sedative hypnotics, including triazolam taken alone in therapeutic doses. Consumption of alcohol and other depressants. the Central Nervous System together with hypnotic-sedatives seems to increase the risk of such behaviors, as do hypnotic sedatives taken at doses higher than the maximum recommended dose. sedatives should be strongly considered in patients who report such events (see sections fo "Undesirable Effects"). Serious anaphylactoid reactions and anaphylactic reactions, including rare fatal cases of anaphylaxis, have been reported in patients receiving triazolam. Cases of angioedema, including that of the tongue, glottis, or larynx have been reported in patients who received the first or subsequent doses of hypnotics.
Interactions Which drugs or foods can modify the effect of Songar
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Pharmacokinetic interactions can occur when triazolam is administered with medicinal products that interfere with its metabolism. Compounds that inhibit certain liver enzymes (particularly cytochrome P4503A4) can increase the concentration of triazolam and enhance its activity. Data from clinical trials with triazolam, in vitro studies with triazolam and clinical trials with drugs metabolized similarly to triazolam , have provided evidence of varying levels of interaction and possible interactions with triazolam in a large number of drugs. Based on the level of interaction and the type of data available, the following recommendations should be followed:
- concomitant administration of triazolam with ketoconazole, itraconazole and nefazodone is contraindicated;
- Interactions involving HIV protease inhibitors (eg ritonavir) and triazolam are complex and time-dependent. Low dose ritonavir causes consistent impairment of triazolam clearance (less than 4% of control values), prolongation of the elimination half-life and potentiation of clinical effects. Concomitant administration of triazolam and HIV protease inhibitors it is contraindicated (see "Contraindications" section); concomitant administration of triazolam with other azole antifungals is not recommended;
- it is recommended to use caution and to consider a dose reduction when triazolam is administered concomitantly with cimetidine or macrolide antibiotics, such as erythromycin, clarithromycin and troleandomycin;
- Caution is advised when triazolam is administered concomitantly with isoniazid, fluvoxamine, sertraline, paroxetine, diltiazem and verapamil;
- oral contraceptives and imatinib may potentiate the clinical effects of triazolam due to inhibition of the CYP3A4 isoenzyme. Caution is advised in case of concomitant use with triazolam;
- rifampicin and carbamazepine cause induction of CYP3A4, therefore the effects of triazolam may decrease significantly during rifampicin or carbamazepine therapy. Patients should be switched to alternative hypnotic drugs which are predominantly eliminated as glucuronides.
- Efavirenz inhibits the oxidative metabolism of triazolam and can cause fatal effects such as prolonged sedation and respiratory depression. As a precaution, concomitant treatment is therefore contraindicated.
- Apripitant: Potentiation of clinical effects may occur in case of concomitant use with triazolam due to inhibition of the CYP3A4 enzyme. This interaction may require a reduction in the dose of triazolam.
- Benzodiazepines produce an additive effect when administered with alcohol or other CNS depressants. Concomitant alcohol intake is not recommended.Triazolam should be used with caution when taken in combination with other sedative substances. Potentiation of central depressive effects may occur in the case of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics / sedatives, antidepressant agents, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines. In the case of narcotic analgesics, potentiation of euphoria leading to an increase in psychic dependence may occur (see section Precautions for use).
- An increase in bioavailability has been noted when triazolam is taken at the same time as grapefruit juice.
Warnings It is important to know that:
Ask your doctor or pharmacist for advice before taking any medicine.
PREGNANCY AND BREASTFEEDING
There are insufficient data on Triazolam to assess its safe use during pregnancy and lactation.
If Triazolam is prescribed to a woman of childbearing potential, she should be advised to contact her doctor, both if she intends to become pregnant, if she suspects she is pregnant, and regarding discontinuation of the drug; if, for absolute medical necessities, Triazolam 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 taken benzodiazepines on a chronic basis during late pregnancy may develop physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Data on teratogenicity and effects on postnatal development and behavior following treatment with benzodiazepines are inconsistent. Early studies with other benzodiazepines have shown that in utero exposure may be associated with malformations. Subsequent studies with benzodiazepines have not provided clear evidence of malformations. Babies exposed to benzodiazepines during the last trimester of pregnancy or during labor have presented with both flaccid infant syndrome and neonatal withdrawal symptoms. If triazolam is used pregnant or the patient becomes pregnant while taking triazolam, patients should be informed of the potential danger to the fetus. Triazolam should not be used by mothers who are breastfeeding.
Effects on ability to drive and use machines.
Songar may impair the ability to drive or use machines. Sedation, amnesia, impaired concentration and muscle function may adversely affect these abilities. Patients should be advised not to drive or operate machinery during treatment until daytime sleepiness or dizziness has been ruled out. If sleep duration has been insufficient, the likelihood of impaired alertness may be increased (see "Precautions for use").
Important information about some of the ingredients
SONGAR 0.375 mg / ml oral drops, solution contains a small amount of alcohol, less than 100 mg per 20-drop dose.
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.
Dosage and method of use How to use Songar: Dosage
Treatment should be as short as possible. Duration of treatment: triazolam should be used primarily for the short-term treatment of occasional insomnia, generally for no more than 7-10 days and in any case no longer than two weeks. In certain cases, extension beyond the maximum treatment period: this should not occur without reassessment of the patient's condition.
Treatment should be started at the lowest recommended dose. The maximum dose should not be exceeded.
Dosage:
Adults:
Capsules: ½ capsule (ie 1 tablet contained in the capsule equal to 0.125 mg) 1 capsule (equal to 0.25 mg);
Oral drops, solution: 10-20 drops (corresponding to 0.125 mg-0.25 mg)
Senior citizens:
Capsules: ½ capsule (ie 1 tablet contained in the capsule equal to 0.125 mg);
Oral drops, solution: 10 drops (corresponding to 0.125 mg)
Patients with impaired hepatic and / or renal function: ½ capsule (i.e. 1 tablet contained in the capsule equal to 0.125 mg) or 10 drops of solution (corresponding to 0.125 mg)
Songar should be taken at bedtime.
Periodic monitoring of the patient is recommended during the duration of treatment.
Instructions for Use:
SONGAR 0.25 mg Capsules, hard
For the administration of 0.125 mg open the capsule by turning one end slightly and take one of the two tablets contained therein.
Keep the other tablet in the closed capsule, which can be swallowed as such next time.
SONGAR 0.375 mg / ml oral drops, solution
One drop of Songar oral drops, solution corresponds to 0.0125 mg of Triazolam.
It is recommended to take Songar oral drops, solution diluted in water.
Overdose What to do if you have taken too much Songar
Symptoms of triazolam overdose are amplifications of its pharmacological action and include somnolence, speech disturbances, motor coordination disorders, ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. Serious consequences are rare unless other drugs and / or ethanol have been ingested concomitantly.
Treatment of overdose mainly consists of supporting respiratory and cardiovascular functions. The value of dialysis has not been determined. Flumazenil may be useful as an antidote used in addition to cardiovascular and respiratory support treatments associated with overdose. In the treatment of overdose of any drug, the possibility that other substances have been taken at the same time should be considered.
Following an overdose of oral benzodiazepines, vomiting should be induced (within one "hour) if the patient is conscious or gastric lavage with respiratory protection undertaken if the patient is unconscious. improvement with stomach emptying, activated charcoal should be given to reduce absorption. In case of accidental ingestion / intake of an overdose of Songar, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of SONGAR, ask your doctor or pharmacist.
Side Effects What are the side effects of Songar
Like all medicines, SONGAR can cause side effects, although not everybody gets them.
Frequency of adverse events observed in placebo-controlled clinical trials and in post marketing experience with frequency "not known".
Classification:
Very common (≥ 1/10)
Common (≥1 / 1 00 to <1/10)
Uncommon (≥1 / 1000 to <1/100)
Rare (≥1 / 10,000 to <1/100 0)
Very rare (<1/10,000)
Not known
Disorders of the immune system
Not known: Anaphylactic shock, anaphylactoid reactions, angioedema, allergic edema, hypersensitivity (see section 4.4)
Psychiatric disorders
Uncommon: Confusional state, insomnia *
Not known: Aggression. Hallucinations, somnambulism, anterograde amnesia, restlessness, agitation, irritability, delirium, anger, nightmares, psychosis, inappropriate behavior (see section 4.4)
Nervous system disorders
Common: Somnol enza, dizziness, ataxia, headache
Uncommon: Memory changes
Not known: Syncope, sedation, decreased level of consciousness, speech disturbances, attention disturbances, dysgeusia
Eye disorders
Uncommon: Visual impairment
Respiratory, thoracic and mediastinal disorders
Not known: In patients with impaired respiratory function: respiratory depression
Skin and subcutaneous tissue disorders
Rare: Skin eruption
Musculoskeletal and connective tissue disorders
Rare: Myasthenia
Diseases of the reproductive system and breast
Not known: Changes in libido
Injury, poisoning and procedural complications
Not known: falls
* these undesirable effects also occurred in the post-marketing phase
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. Undesirable effects can also be reported directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date indicated on the package. The expiry date indicated refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date indicated on the package.
The validity of SONGAR 0.375 mg / ml oral drops, solution after first opening is 30 days, do not use after this period (write down the date of first opening in the space provided on the box)
Store at a temperature not exceeding 25 ° C.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.
Composition and pharmaceutical form
COMPOSITION
SONGAR 0.25 mg hard capsules
One capsule contains
Active ingredient: Triazolam 0.25 mg
(in each capsule there are two tablets of 0.125 mg
Excipients: microgranular cellulose, dibasic calcium phosphate dihydrate, talc, amorphous silica, magnesium stearate, E 132, gelatin.
SONGAR 0.375 mg / ml oral drops, solution
1 ml (corresponding to 30 drops) contains:
Active ingredient: Triazolam 0.375 mg
1 drop equal to 0.033 ml contains 0.0125 mg of Triazolam
Excipients: Sodium saccharin, Lemon flavor, Orange flavor, Propylene glycol, Ethanol, Purified water.
PHARMACEUTICAL FORM AND CONTENT
Hard capsules Pack of 10 capsules each containing 2 tablets; Pack of 20 capsules each containing 2 tablets.
Oral drops, solution 19 ml bottle with dropper.
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
SONGAR
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
SONGAR 0.25 mg hard capsules
One capsule contains
Active principle:
Triazolam 0.25 mg
(each capsule contains two tablets of 0.125 mg)
SONGAR 0.375 mg / ml oral drops, solution
1 ml (corresponding to 30 drops) contains
Active principle:
Triazolam 0.375 mg
For excipients see 6.1
03.0 PHARMACEUTICAL FORM
Hard capsules (containing 2 tablets)
Oral drops, solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term treatment of insomnia.
Benzodiazepines are only indicated when the disorder is severe, debilitating, or makes the subject very uncomfortable.
04.2 Posology and method of administration
Treatment should be as short as possible. The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary; this should not be done without reassessment of the patient's condition.
Treatment should be started with the lowest recommended dose.
The maximum dose should not be exceeded.
Dosage:
Adults:
Capsules: ½ capsule (ie 1 tablet contained in the capsule equal to 0.125 mg) -1 capsule (equal to 0.25 mg); Oral drops, solution: 10-20 drops (corresponding to 0.125 mg-0.25 mg)
Senior citizens:
Capsules: ½ capsule (ie 1 tablet contained in the capsule equal to 0.125 mg); Oral drops, solution: 10 drops (corresponding to 0.125 mg)
Patients with impaired hepatic and / or renal function.
½ capsule (ie 1 tablet contained in the capsule equal to 0.125 mg) or 10 drops of solution (corresponding to 0.125 mg).
SONGAR should be taken at bedtime.
Treatment should be started at the lowest recommended dose.
Periodic monitoring of the patient is recommended during the duration of treatment.
SONGAR 0.25 mg hard capsules
For the administration of 0.125 mg open the capsule by turning one end slightly and take one of the two tablets contained therein. Keep the other tablet in the closed capsule, which can be swallowed as such the next time.
SONGAR 0.375 mg / ml oral drops, solution
One drop of SONGAR oral drops, solution corresponds to 0.0125 mg of Triazolam.
It is recommended to take SONGAR oral drops, solution diluted in water.
04.3 Contraindications
Myasthenia gravis. Hypersensitivity to the active substance or to any of the excipients. Severe respiratory insufficiency. Severe hepatic insufficiency.
Sleep apnea syndrome. Do not administer to children (see section 4.4), pregnant and lactating (see section 4.6).
04.4 Special warnings and appropriate precautions for use
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 seizures.
Rebound insomnia and anxiety: A transient syndrome in which symptoms that led to treatment with benzodiazepines recur in an aggravated form may occur on discontinuation of treatment. It may be accompanied by other reactions, including mood changes, anxiety, restlessness or disturbances As 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 should not exceed four 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 is started that it will be of limited duration and to explain precisely how the dosage should be progressively decreased.
Furthermore, it is important that the patient is informed of the possibility of rebound phenomena, thus minimizing anxiety about these symptoms should they arise when the drug is discontinued.
There is evidence that, in the case of short-acting benzodiazepines, withdrawal symptoms may become manifest within the dosing interval between doses, particularly for high doses.
Treatment interruption:
As with any other benzodiazepine, the dosage of triazolam should be gradually reduced as stopping abruptly or too quickly can lead to withdrawal symptoms.
Withdrawal symptoms may include mild dysphoria and insomnia or present as major syndromes with muscle and abdominal cramps, vomiting, sweating, tremors.
Seizures of withdrawal may occasionally occur following a rapid decrease or abrupt discontinuation of triazolam therapy.
These symptoms, especially the more severe ones, are generally more common in those patients who have been treated with excessive doses for prolonged periods of time. However, withdrawal symptoms have also been reported following abrupt discontinuation of therapeutic doses of benzodiazepines. Therefore abrupt discontinuation should be avoided and a gradual reduction of the dosage should be prescribed (see section 4.2).
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).
Psychiatric and paradoxical reactions:
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, the use of the medicinal product should be discontinued. These reactions are more frequent in children and the elderly.
Specific patient groups:
Benzodiazepines should not be given to children without careful consideration of the actual need for treatment and possible risks; if treatment is deemed necessary, its duration should be as short as possible.
Elderly people should take a reduced dose (see section 4.2).
Likewise, 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) and / or with severe renal insufficiency.
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).
Complex events related to sleep behavioral disturbances, such as drowsiness while driving (that is, when driving while not fully alert after taking a hypnotic-sedative, with amnesia of the event) have been reported in patients who were not perfectly alert after taking a sedative hypnotic, including triazolam. These and other complex events related to sleep behavioral disturbances can occur with sedative hypnotics, including triazolam taken alone in therapeutic doses. Consumption of alcohol and other depressants. the Central Nervous System together with hypnotic-sedatives appears to increase the risk of such behaviors, as do hypnotic-sedatives taken at doses above the maximum recommended dose. Due to the risk for the patient and the community, discontinuation of treatment with hypnotic-sedatives should be strongly considered in patients who report such events (see par rafo 4.8).
Serious anaphylactoid reactions and anaphylactic reactions, including rare fatal cases of anaphylaxis, have been reported in patients receiving triazolam. Cases of angioedema, including that of the tongue, glottis, or larynx have been reported in patients receiving the first or subsequent doses of sedative hypnotics, including triazolam (see section 4.8).
Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse.
Patients who habitually abuse alcohol and / or drugs, when being treated with benzodiazepines must be kept under strict medical supervision, due to the predisposition of these subjects to addiction and dependence.
For the same reason, patients must be warned of the dangers associated with the simultaneous intake of alcohol or other drugs having a depressant action on the CNS.
SONGAR 0.375 mg / ml oral drops, solution contains a small amount of alcohol, less than 100 mg per 20-drop dose.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
Concomitant intake with alcohol should be avoided. The sedative effect may be enhanced when the medicinal product is taken in conjunction with alcohol. This adversely affects the ability to drive or use machines.
Combination with CNS depressant drugs: 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.
Substances that inhibit some 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 lactation
There are insufficient data on Triazolam to assess its safe use during pregnancy and lactation.
If Triazolam is prescribed to a woman of childbearing potential, she should be advised to contact her doctor, both if she intends to become pregnant, if she suspects she is pregnant, and regarding discontinuation of the drug; if, for absolute medical necessities, Triazolam 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 taken benzodiazepines on a chronic basis during late pregnancy may develop physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period. Since benzodiazepines are excreted in breast milk, they should not be given to breastfeeding mothers.
04.7 Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and muscle function can adversely affect the ability to drive and use machines. If sleep duration has been insufficient, the likelihood of impaired alertness may be increased (see section 4.5).
04.8 Undesirable effects
Drowsiness during the day, dulling of emotions, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision. These phenomena occur mainly at the beginning of therapy and usually disappear with subsequent administrations.
Other adverse reactions have occasionally been reported including: gastrointestinal disturbances, changes in libido and skin reactions.
Amnesia:
Anterograde amnesia can also occur at therapeutic dosages, the risk increases at higher dosages. Amnesic effects may be associated with behavioral changes (see section 4.4).
Depression:
A pre-existing depressive state may be unmasked during the use of benzodiazepines.
Psychiatric and paradoxical reactions
Benzodiazepines or benzodiazepine-like compounds can cause reactions such as restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes, syncope and sleepwalking (see section 4.4).
Such 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 section 4.4). Psychic dependence may occur.
Abuse of benzodiazepines has been reported.
Immune system disorders:
hypersensitivity reactions including angioneurotic edema, anaphylactoid reactions, allergic edema and anaphylactic shock have been reported (see section 4.4)
04.9 Overdose
As with other benzodiazepines, an overdose is not expected to be life-threatening unless concomitant other CNS depressants (including alcohol) are taken.
In the treatment of overdose of any drug, the possibility that other substances have been taken at the same time should be considered.
Following an overdose of oral benzodiazepines, vomiting should be induced (within one "hour) if the patient is conscious or gastric lavage with respiratory protection undertaken if the patient is unconscious.
If no improvement is observed with stomach emptying, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in emergency therapy.
Overdosage of benzodiazepines usually results in varying degrees of central nervous system depression ranging from clouding 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" can be useful as an antidote.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Hypnotics and sedatives: benzodiazepine derivatives
ATC code: N05CD05
Triazolam is a benzodiazepine with anxiolytic, sedative and hypno-inducing properties as well as with possible muscle-relaxing and anticonvulsant characteristics.
05.2 "Pharmacokinetic properties
In adults, following a single dose of 0.25 mg, a Cmax of 2.02 ± 0.15 ng / mL is achieved at a Tmax of 0.96 ± 0.1 h.
The elimination half-life is 1.5 - 5.5 hours.
In the elderly, Cmax increases by approximately 50%. Tmax and t½ remain unchanged.
In healthy volunteers the volume of distribution was approximately 0.67 L / kg (range 0.57 - 0.86 L / kg after a dose of 0.125 - 1 mg).
Triazolam binds to plasma proteins, with a free fraction between 9.9 and 25.7%.
The fraction remains unchanged in the elderly.
Triazolam is metabolised by cytochrome P450. There is one active metabolite: a-hydroxybenzodiazepine, which has a t½ of 3.9 hours.
05.3 Preclinical safety data
The toxicological data relating to the experimental animal are as follows:
LD50, intraperitoneal administration - mouse, 2.473 mg / kg
LD50, intraperitoneal administration - rat, greater than 5,000 mg / kg
LD50, oral administration - rat, greater than 5,000 mg / kg.
Chronic toxicity studies conducted on Wistar rats at doses of 10 and 30 mg / kg / day and on Beagle dogs at a dose of 10 mg / kg / day, treated for 25 weeks by oral administration, did not reveal any toxicological effects. Teratogenesis studies conducted on pregnant rats and rabbits from the 6th to the 18th day of pregnancy, treated at doses of 0 - 10 and 30 mg / kg / day for oral administration, did not reveal any changes in the reproductive parameters observed. .
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
SONGAR 0.25 mg hard capsules
Microgranular cellulose, dibasic calcium phosphate, talc, precipitated silica, magnesium stearate, E 132, gelatin.
SONGAR 0.375 mg / ml oral drops, solution
Sodium saccharin, Lemon flavor, Orange flavor, Ethanol, Propylene glycol, Purified water
06.2 Incompatibility
In the absence of compatibility studies, SONGAR 0.375 mg / ml oral drops, solution must not be mixed with other medicinal products.
06.3 Period of validity
SONGAR 0.25 mg hard capsules: 3 years
SONGAR 0.375 mg / ml oral drops, solution: 2 years
Shelf life after first opening the container: 30 days
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
SONGAR 0.25 mg hard capsules
Opaque blister packaged, together with the package leaflet, in cardboard boxes.
10 capsules of 0.25 mg, each containing 2 tablets of 0.125 mg
20 capsules of 0.25 mg each containing 2 tablets of 0.125 mg.
SONGAR 0.375 mg / ml oral drops, solution
19 ml polyethylene bottle with dropper and child resistant closure packed together with the package leaflet, in cardboard boxes.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
VALEAS s.p.a. - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - 20133 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
SONGAR 0.25 mg hard capsules - 10 capsules - AIC n ° 024731073
SONGAR 0.25 mg hard capsules 20 capsules - AIC n ° 024731097
SONGAR 0.375 mg / ml oral drops, solution - 19 ml bottle - AIC n ° 024731111
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
SONGAR 0.25 mg hard capsules - 10 capsules Apr-1992 / May-2005
SONGAR 0.25 mg hard capsules - 20 capsules Oct-2002 / May-2005
SONGAR 0.375 mg / ml oral drops, solution - 19 ml bottle Mar-2007
10.0 DATE OF REVISION OF THE TEXT
21/1/2009
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