Active ingredients: Pinazepam
DOMAR® 2.5mg capsules
DOMAR® 5mg capsules
DOMAR® 10mg capsules
Indications Why is Domar used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY - Anxiolytic.
THERAPEUTIC INDICATIONS - Anxiety; tension and other somatic or psychiatric manifestations associated with anxiety syndrome. Insomnia. .
Benzodiazepines are only indicated when the disorder is severe, disabling, or makes the subject very uncomfortable.
Contraindications When Domar should not be used
Myasthenia gravis. Known hypersensitivity to the drug. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome.
Precautions for use What you need to know before taking Domar
Tolerance: Some loss of efficacy to the hypnotic effects of DOMAR® may develop after repeated use for a few weeks.
Dependence: The use of DOMAR® 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.
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 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 may occur on discontinuation of treatment in which the symptoms that led to treatment with DOMAR® recur in an aggravated form. It may be accompanied by other reactions, including mood changes, anxiety, aggravated. May be accompanied by other reactions, including mood changes, anxiety, restlessness, or sleep 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 posology) depending on the indication, but should not exceed four weeks for insomnia and eight to twelve weeks for anxiety, including a withdrawal period for anxiety. insomnia and eight to twelve weeks in the case of anxiety, including a gradual withdrawal period. Extending therapy beyond these periods should not occur without re-evaluation of the clinical situation. It may be helpful for the treating physician 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 the anxiety about these symptoms should they occur when the drug is discontinued.
Since pinazepam is a benzodiapezine with a long duration of action, a sudden switch from DOMAR is inadvisable. A sudden switch from DOMAR® to another benzodiapezine drug with a short duration of action is not recommended, as withdrawal symptoms may occur.
Amnesia: DOMAR® can induce anterograde 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).
Psychiatric and paradoxical reactions: Phenomena such as restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes may occur during treatment. In such cases, the use of the medicinal product should be discontinued. Such reactions are more frequent in children and the elderly.
Specific groups of patients: DOMAR® should not be given to children without careful consideration of the actual need for treatment; the duration of treatment should be as short as possible. The elderly should take a reduced dose (see posology). Likewise, a lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. DOMAR® is not indicated in patients with severe hepatic insufficiency as it can precipitate encephalopathy. DOMAR® is not recommended for the primary treatment of psychotic illness. DOMAR® should not be used alone to treat depression or anxiety associated with depression (suicide can be precipitated in treating depression or anxiety associated with depression (suicide can precipitate in such patients). ® should be used with extreme caution in patients with a history of drug or alcohol abuse.
DOMAR® contains lactose: in case of ascertained intolerance to sugars contact your doctor before taking the medicine. care before taking the medicine.
Interactions Which drugs or foods can change the effect of Domar
Concomitant intake with alcohol should be avoided. The sedative effect may be enhanced when the medicinal product is taken in conjunction with alcohol. This affects increased when the medicine 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, antipsychotics (neuroleptics), hypnotics, anxiolytics / sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines. In the case of analgesics, there may be an increase in antiepileptic, anesthetic and sedative antihistamines. In the case of analgesics, psychic euphoria may increase.
Compounds that inhibit certain liver enzymes (especially cytochrome P450) can increase the activity of DOMAR®.
Warnings It is important to know that:
PREGNANCY AND BREASTFEEDING If the product is prescribed to a woman of childbearing age, she must contact her doctor, both if she intends to become pregnant, and if she needs to contact her doctor, or if she intends to become pregnant. , and if you suspect you are pregnant, regarding the discontinuation of the medicine.
Do not administer in the first trimester of pregnancy. In the further period 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 in the newborn such as hypothermia may occur, during labor at high doses, effects in the newborn such as hypothermia, hypotonia and moderate respiratory depression due to the pharmacological action of the drug may occur.
In addition, infants born to mothers who took benzodiazepines chronically during pregnancy stages.In addition, infants born to mothers who took benzodiazepines chronically during late pregnancy may develop physical dependence and may have some advanced pregnancy may develop physical dependence and may present some degree to develop withdrawal symptoms in the postnatal period. Since benzodiazepines are excreted in breast milk, they should not be prescribed to breastfeeding mothers and are excreted in breast milk, they should not be prescribed to breastfeeding mothers.
EFFECTS ON ABILITY TO DRIVE OR USE MACHINES - Sedation, "amnesia", impaired concentration and muscle function can 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).
Dose, Method and Time of Administration How to use Domar: Posology
The dose of DOMAR® must be decided by the attending physician as it is very variable according to the characteristics of the subject being treated; treatment should be started with the lowest recommended dose and the maximum dose should not be exceeded.
Before starting treatment with DOMAR®, the patient should be monitored regularly to decrease the dose or frequency of dosing if necessary and to prevent overdose due to accumulation.
Anxiety: The recommended starting dose is 5 mg, divided into two administrations 12 hours apart. The severity of the case and the variability of the individual response may suggest, in the opinion of the treating physician, to continue the therapy with a different posology varying between 5 and 20 mg per day.
In the elderly, especially if debilitated, the starting dose should be reduced to 2.5 mg; the reduced starting dose is also advisable in patients with renal or hepatic insufficiency. In the opinion of the treating physician and on the basis of the individual response, a treating physician may subsequently be used and, based on the individual response, a different posology may subsequently be used.
In children, the use of benzodiazepines is not advisable; however, where it is deemed necessary to use them, the daily dose should be established by the treating physician, taking into account the weight and age of the subject.
Treatment should be as short as possible. The patient should be re-evaluated regularly and the need for continued treatment should be carefully considered particularly if the patient is symptom-free. The overall duration of treatment should generally not exceed 8-12 weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary, in which case this should not be done without reassessment of the patient's condition.
Insomnia: The recommended starting dose is 2.5-5 mg, taken before going to bed. In the elderly, especially if debilitated, the starting dose should not exceed 2.5 mg; the reduced starting dose is also advisable in patients with renal or hepatic insufficiency. In the opinion of the treating physician and on the basis of the individual response, a different posology may be used subsequently. subsequently a different dosage.
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 range 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; if so, it should not take place without reassessment of the patient's condition.
Overdose What to do if you have taken too much Domar
As with other benzodiazepines, an overdose of DOMAR® should not be life threatening, unless there is concomitant intake of other CNS depressants (including alcohol). 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 DOMAR®, vomiting should be induced (within one "hour) if the patient is conscious or gastric lavage with respiratory protection undertaken if the patient is patient is unconscious. If gastric lavage with respiratory protection 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.
Benzodiazepine overdose usually presents with varying degrees of central nervous system depression ranging from clouding to coma. In mild cases, central nervous system symptoms varying from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In severe cases, symptoms may include drowsiness, mental confusion and lethargy. In more severe cases, symptoms may include drowsiness, mental confusion and lethargy. severe, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very much include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. "FIumazenil" may be useful as an antidote.
Side Effects What are the side effects of Domar
Somnolence, sudden daytime sleep, dulling of emotions, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision. These phenomena usually occur at the beginning of muscle, ataxia, double vision. These phenomena usually occur at the beginning of therapy and usually disappear with subsequent administrations.
Other adverse reactions have occasionally been reported including: gastrointestinal disturbances, changes in blood and skin reactions. gastrointestinal, changes in the Iibido and reactions affecting the skin.
Amnesia: Anterograde amnesia can also occur at therapeutic dosages, but the risk increases at higher dosages. Amnesic effects may be associated with alterations in the higher dosages. Amnesic effects may be associated with behavioral changes (see special warnings and precautions).
Depression: During the use of DOMAR During the use of DOMAR® a depressive state can be unmasked, a pre-existing depressive state can be unmasked.
DOMAR® can cause reactions such as: restlessness, agitation, irritability, aggression, it can cause reactions such as: restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes. disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes.
Such reactions can be quite severe. They are more likely in children and the elderly.
Dependence: The use of DOMAR® (even at therapeutic doses) can lead to the development of physical dependence: suspension of therapy can cause rebound or withdrawal phenomena (see special warnings and precautions). Psychic dependence may occur. Possible benzodiazepine abuse.
Expiry and Retention
The expiry date shown on the package refers to the product in intact packaging, correctly stored.
WARNING - Warning: do not use the medicine after the expiry date shown on the package. packaging.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule of: 2.5 mg 5 mg 10 mg
contains:
ACTIVE PRINCIPLE:
pinazepam 2.5 mg 5 mg 10 mg
EXCIPIENTS 2.5 mg cps: lactose, magnesium stearate, titanium dioxide (E171), gelatin.
EXCIPIENTS 2.5 mg cps: lactose, magnesium stearate, titanium dioxide (E171), gelatin.
EXCIPIENTS cps 5 mg and 10 mg: lactose, magnesium stearate, titanium dioxide (E171), gelatin,
EXCIPIENTS cps 5 mg and 10 mg: lactose, magnesium stearate, titanium dioxide (E171), gelatin, indigo carmine (E 132), yellow iron oxide (E 172). indigo carmine (E 132), yellow iron oxide (E 172).
PHARMACEUTICAL FORM - PHARMACEUTICAL FORM - Capsules for oral use.
Capsules for oral use. Box of 25 capsules of 2.5 mg - Box of 25 capsules of 5 mg - Box of 25 capsules of 10 Box of 25 capsules of 2.5 mg - Box of 25 capsules of 5 mg - Box of 25 capsules of 10 mg.
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
DOMAR
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg 5 mg 10 mg capsule contains:
Active principle:
Pinazepam 2.5 mg 5 mg 10 mg
Excipients cps 2.5 mg:
Lactose, magnesium stearate. Shell constituents: titanium dioxide (E 171), gelatin.
Excipients cps 5 mg and 10 mg:
Lactose, magnesium stearate. Shell constituents: titanium dioxide (E 171), gelatin, indigo carmine (E 132), yellow iron oxide (E 172).
03.0 PHARMACEUTICAL FORM
Hard gelatin capsules for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Anxiety; Insomnia.
DOMAR is indicated only when the disorder is severe, disabling or subjecting the subject to severe discomfort.
04.2 Posology and method of administration
The dose of DOMAR must be decided by the attending physician as it is very variable according to the characteristics of the subject being treated; treatment should be started with the lowest recommended dose and the maximum dose should not be exceeded.
Before starting treatment with DOMAR, the patient should be monitored regularly to decrease the dose or frequency of dosing if necessary and to prevent overdose due to accumulation.
Anxiety: The recommended starting dose is 5 mg, divided into two administrations 12 hours apart. The severity of the case and the variability of the individual response may suggest, in the opinion of the treating physician, to continue the therapy with a different posology varying between 5 and 20 mg per day. In the elderly, especially if debilitated, the starting dose should be reduced to 2.5 mg; the reduced starting dose is also advisable in patients with renal or hepatic insufficiency. In the opinion of the treating physician and on the basis of the individual response, a different posology may subsequently be used.
In children, the use of benzodiazepines is not advisable; however, where it is deemed necessary to use them, the daily dose must be established by the treating physician, taking into account the weight and age of the subject.
Treatment should be as short as possible. The patient should be re-evaluated regularly and the need for continued treatment should be carefully considered, particularly if the patient is symptom-free. The overall duration of treatment should generally not exceed 8-12 weeks, including a gradual withdrawal period.
In certain cases, extension beyond the maximum treatment period may be necessary, in which case this should not be done without reassessment of the patient's condition.
Insomnia: The recommended starting dose is 2.5-5 mg, taken before going to bed. In the elderly, especially if debilitated, the starting dose should not exceed 2.5 mg; the reduced starting dose is also advisable in patients with renal or hepatic insufficiency. In the opinion of the treating physician and on the basis of the individual response, a different posology may be used subsequently.
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; if so, it should not take place without reassessment of the patient's condition.
04.3 Contraindications
Myasthenia gravis. Known hypersensitivity to the drug. Severe respiratory insufficiency. Severe hepatic insufficiency. Sleep apnea syndrome.
04.4 Special warnings and appropriate precautions for use
Tolerance: Some loss of efficacy to the hypnotic effects of DOMAR may develop after repeated use for a few weeks.
Dependence: The use of DOMAR can lead to the development of physical and psychological dependence. 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 the physical dependence has developed, the abrupt termination of treatment will be accompanied by withdrawal symptoms. These can consist of headache, muscle aches, extreme 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 the symptoms that led to treatment with DOMAR recur in an aggravated form may occur upon discontinuation of treatment. It may be accompanied by other reactions, including mood changes, anxiety, restlessness, or 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 posology) depending on the indication, but should not exceed four weeks for insomnia and eight to twelve weeks for anxiety, including a period of rest. gradual discontinuation. Extension of therapy beyond these periods should not occur without reassessment of the clinical situation. It may be helpful for the treating physician 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 patient is informed of the possibility of rebound phenomena, thus minimizing anxiety about these symptoms should they occur when the drug is discontinued.
Since pinazepam is a benzodiazepine with a long duration of action, a sudden switch from DOMAR to another benzodiazepine drug with a short duration of action is not recommended, as withdrawal symptoms may occur.
Amnesia: DOMAR can induce anterograde 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 Side Effects).
Psychiatric and paradoxical reactions: Phenomena such as restlessness, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes may occur during treatment. In such cases, the use of the medicinal product should be discontinued. Such reactions are more frequent in children and the elderly.
Specific groups of patients: DOMAR should not be given to children without careful consideration of the actual need for treatment; the duration of treatment should be as short as possible. Elderly people should take a reduced dose (see posology). Likewise, a dose lower is suggested for patients with chronic respiratory insufficiency due to the risk of respiratory depression. DOMAR is not indicated in patients with severe hepatic insufficiency as it can precipitate encephalopathy. DOMAR is not recommended for the primary treatment of psychotic illness. DOMAR should not be used alone to treat depression or anxiety associated with depression (suicide may have precipitated in such patients).DOMAR should be used with extreme caution in patients with a history of drug or alcohol abuse.
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.
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. increased psychic euphoria.
Compounds that inhibit certain liver enzymes (especially cytochrome P450) can increase the activity of DOMAR.
04.6 Pregnancy and lactation
If the product is prescribed to a woman of childbearing age, she should contact her doctor, both if she intends to become pregnant and if she suspects that she is pregnant, regarding discontinuation of the medicine.
Do not administer in the first trimester of pregnancy. In the further period the drug must 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 in 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 chronically during the late stages of pregnancy may develop physical dependence and may present to some degree to develop withdrawal symptoms in the postnatal period. Since benzodiazepines are excreted in breast milk, they should not be prescribed to mothers who are breastfeeding.
04.7 Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and muscle function can 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
Somnolence, sudden daytime sleep, dulling of emotions, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision. These phenomena usually occur 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 but the risk increases at higher dosages. Amnesic effects may be associated with behavioral changes (see special warnings and precautions).
Depression: A pre-existing depressive state may be unmasked during the use of DOMAR.
DONAR 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 children and the elderly.
Dependence: "The use of DOMAR (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. E" Possible benzodiazepine abuse.
04.9 Overdose
As with other benzodiazepines, an overdose of DOMAR 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 DOMAR, 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.
Benzodiazepine overdose usually presents with 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
Pinazepam is a benzodiazepine with general characteristics similar to those of diazepam. It acts mainly, at the level of the central nervous system, on the receptors directly activated by gamma-amino butyric acid (GABA), causing sedation, a decrease in the state of anxiety, muscle relaxation up to a hypnotic effect.
The distribution of benzodiazepine receptors in the brain is relatively ubiquitous: receptor sites exist on the neuronal membranes of the cortex, limbic bone, cerebellum, hippocampus and spinal cord.
05.2 "Pharmacokinetic properties
Benzodiazepines are rapidly and completely absorbed after oral administration: the peak plasma concentration occurs after 30-120 minutes. Benzodiazepines generally have a high lipid / water distribution coefficient, bind in a high percentage to plasma proteins, then are metabolized by microsomal oxidation and hydroxylation. Pinazepam crosses the placental barrier and is eliminated in breast milk.
Pinazepam is considered long-acting benzodiazepine (half-life of 10-15 hours); it is metabolized with the formation of two active derivatives in turn: demethyldiazepam (which has an average half-life of over 70 hours, depending on the hydroxylation phenotype) and oxazepam (which has a mean half-life of 8 hours and is eliminated by glucuronidation in the liver). The half-life of pinazepam is prolonged in neonates, the elderly and in patients with hepatic insufficiency.
05.3 Preclinical safety data
Preclinical studies have shown a high safety margin in the use of pinazepam.
The LD50 in the rat is 5819 mg / kg orally and 622 mg / kg by the intraperitoneal route; in mice it is 1302 mg / kg and 670 mg / kg respectively.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cps 2.5 mg: Lactose; magnesium stearate. Constituents of the shell: titanium dioxide (E 171); gelatin.
Cps 5 mg and 10 mg: Lactose; magnesium stearate. Shell constituents: titanium dioxide (E 171); gelatin; indigo carmine (E 132); yellow iron oxide (E 172).
06.2 Incompatibility
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06.3 Period of validity
5 years, as the product is properly stored and in intact packaging conditions.
Do not use the medicine after the expiry date stated on the package.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
Box of 25 capsules of 2.5 mg; in PVC / PVDC blister heat-sealed with aluminum / PVDC foil.
Box of 25 capsules of 5 mg; in PVC / PVDC blister heat-sealed with aluminum / PVDC foil.
Box of 25 capsules of 10 mg; in PVC / PVDC blister heat-sealed with aluminum / PVDC foil
06.6 Instructions for use and handling
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07.0 MARKETING AUTHORIZATION HOLDER
TEOFARMA S.r.l. - Headquarters: via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Factory: viale Certosa 8 / A - 27100 Pavia
08.0 MARKETING AUTHORIZATION NUMBER
25 capsules 2.5 mg: A.I.C .: 023191012
25 capsules 5 mg: A.I.C .: 023191024
25 capsules 10 mg: A.I.C .: 023191036
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
1975 - 2000
10.0 DATE OF REVISION OF THE TEXT
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