Active ingredients: Lorazepam
LORAZEPAM DOROM 1 mg tablets
LORAZEPAM DOROM 2.5 mg tablets
LORAZEPAM DOROM 20 mg / 10 ml oral drops, solution
Why is Lorazepam Dorom used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Anxiolytic.
THERAPEUTIC INDICATIONS
Anxious reactions, nervous tension. Anxiety-depressive syndromes. Sleep disorders.
Benzodiazepines are only indicated when the disorder is severe, disabling, or makes the subject very uncomfortable
Contraindications When Lorazepam Dorom should not be used
Myasthenia gravis, known hypersensitivity to benzodiazepines, severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome, narrow-angle glaucoma.
Precautions for use What you need to know before taking Lorazepam Dorom
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 "Dose, method and time of administration") depending on the indication, but should not exceed four weeks for insomnia and eight to twelve weeks in the case of " anxiety, including a period of gradual withdrawal. Extending therapy beyond these periods should not occur without reassessment of the clinical situation. The dosage must be progressively decreased, rebound phenomena are possible when the drug is discontinued.
In case of prolonged treatment, it is advisable to carry out checks on the blood picture and liver function.
There is evidence that, in the case of benzodiazepines with a short duration of action, withdrawal symptoms may become manifest within the dosing interval between doses, particularly for high doses.
When using benzodiazepines with a long duration of action, it is important to warn the patient that abrupt change to a benzodiazepine with a short duration of action is not recommended, as withdrawal symptoms may appear.
Amnesia:
Benzodiazepines can induce antegrade amnesia. This happens most often several hours after ingestion of the drug and therefore, to reduce the risk, you should have 7-8 hours of uninterrupted sleep (see section "Side Effects").
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 Lorazepam Dorom should be discontinued. These reactions are more frequent in children and the elderly.
Interactions Which drugs or foods can modify the effect of Lorazepam Dorom
The association with other psychotropic drugs requires particular caution and surveillance by the physician to avoid unexpected undesirable effects from 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 euphoria, leading to an increase in psychic dependence.
Compounds that inhibit certain liver enzymes (especially cytochrome P450) may increase the activity of benzodiazepines. To a lesser extent, this also applies to benzodiazepines which are metabolized only by conjugation.
Warnings It is important to know that:
Benzodiazepines should not be given to children without careful assessment of the actual need for treatment, the duration of treatment should be as short as possible. The elderly should take a reduced dose (see section "Dose, method and time of administration"). Similarly, a lower suggested dose should be given to patients with chronic respiratory failure due to the risk of respiratory depression. respiratory, low blood pressure and impaired liver and / or kidney function.
Such patients should be monitored regularly during lorazepam therapy (as recommended with other benzodiazepines and other psychopharmacological agents).
Benzodiazepines are not indicated in patients with severe hepatic insufficiency as they can precipitate encephalopathy. Benzodiazepines are not indicated for the primary treatment of psychotic illness. Benzodiazepines should not be used alone to treat depression or anxiety associated with psychotic illness. depression. Benzodiazepines should be used with extreme caution in patients with a history of drug or alcohol abuse.
In patients treated for a long time with benzodiazepines, and particularly in epileptics, it is advisable to gradually suspend therapy by administering decreasing doses of the drug.
Do not administer in the first trimester of pregnancy; in the following period the product must be used only in case of real need and under the direct supervision of the doctor.
If Lorazepam Dorom 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. If, for serious medical reasons, the product is administered during the last period of pregnancy, or during labor at high doses, effects on the newborn may occur such as hypothermia, hypotonia and moderate respiratory depression due to the pharmacological action of the drug. Additionally, infants born to mothers who have taken benzodiazepines chronically 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.
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.
Keep this medicine out of the reach and sight of children.
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 "Interactions" section)
Dosage and method of use How to use Lorazepam Dorom: Dosage
Due to the characteristics of LORAZEPAM DOROM, which associates a considerable activity with good tolerability, the best results will be achieved by adapting the dosage to the individual patient and to the characteristics of the clinical picture in progress.
Anxiety:
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.
In adult patients, indicative it is recommended: 1 tablet of 1 mg, 1-3 times a day or 10-20 drops, 1-3 times a day.
In severe cases: ½ - 1 tablet of 2.5 mg, 1-3 times a day or 20-50 drops, 1-3 times a day.
Insomnia:
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. Treatment should be started with the lowest recommended dose.
The maximum dose should not be exceeded.
In adult patients as an indication it is recommended: 1 to 2.5 mg or 20-50 drops, to be administered in the evening.
In the treatment of elderly patients the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above, however an initial dosage of 1-2 mg per day in divided doses is recommended, to be adapted according to the needs and tolerability.
Instructions for use of the bottle:
- To open the bottle, press and unscrew at the same time.
- Then press the plastic cap to get the powder to fall and shake until completely dissolved.
- To get the drops out, remove the cap and turn the bottle upside down.
- To close, press and screw at the same time.
- To reopen, press and unscrew at the same time.
The solution is valid for 30 days.
Overdose What to do if you have taken an overdose of Lorazepam Dorom
As with other benzodiazepines, an overdose is not expected to pose a risk to life 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. Benzodiazepine overdose usually results in varying degrees of CNS depression ranging from clouding to coma. In severe cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death.
Flumazenil can be useful as an antidote.
Side Effects What are the side effects of Lorazepam Dorom
Like all medicines LORAZEPAM DOROM can cause side effects, although not everybody gets them.
Drowsiness during the day, dulling of emotions, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision. These phenomena occur mainly at the start 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 "Precautions for" use ").
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.
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 "Precautions for use"). Psychic dependence can occur. Abuse of benzodiazepines has been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
See the expiration date printed on the package. Warning: do not use the medicine after the expiry date indicated on the package.
This date refers to the intact product correctly stored.
Tablets: Do not store above 25 ° C.
COMPOSITION
Tablets 1 mg
Each tablet contains: active ingredient: lorazepam 1 mg.
Excipients: lactose monohydrate, pregelatinised starch, povidone, magnesium stearate, E110.
2.5 mg tablets
Each tablet contains: active ingredient: lorazepam 2.5 mg.
Excipients: lactose monohydrate, pregelatinised starch, povidone, magnesium stearate.
Oral drops, solution
The tank cap contains: active ingredient: 20 mg lorazepam.
Excipient: mannitol.
Bottle: alcohol, purified water.
20 drops (0.5 ml) contain:
lorazepam 1 mg.
PHARMACEUTICAL FORM AND CONTENT
Tablets for oral use:
box of 20 tablets of 1 mg and 20 tablets of 2.5 mg.
Oral drops, solution:
bottle of 10 ml of 0.2% solution.
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
LORAZEPAM DOROM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Every 1 mg tablet contains
- lorazepam 1 mg
Every 2.5 mg tablet contains
- lorazepam 2.5 mg
1 Falcone of oral drops, solution contains
- lorazepam 20 mg
20 drops (0.5ml) contain:
lorazepam mg 1
03.0 PHARMACEUTICAL FORM
Tablets.
Oral drops, solution.
04.0 CLINICAL INFORMATION
04.1 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.
04.2 Posology and method of administration
Due to the characteristics of LORAZEPAM DOROM, which associates a considerable activity with good tolerability, the best results will be achieved by adapting the dosage to the individual patient and to the characteristics of the clinical picture in progress.
Anxiety :
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.
In adult patients, indicative it is recommended: 1 tablet of 1 mg, 1-3 times a day or 10-20 drops, 1-3 times a day.
In severe cases: ½ - 1 tablet of 2.5 mg, 1-3 times a day or 20-50 drops, 1-3 times a day.
Insomnia :
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.
Treatment should be started with the lowest recommended dose.
The maximum dose should not be exceeded.
In adult patients as an indication it is recommended: 1 to 2.5 mg or 20-50 drops, to be administered in the evening.
In the treatment of elderly patients the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above, however an initial dosage of 1-2 mg per day in divided doses is recommended, to be adapted according to the needs and tolerability.
04.3 Contraindications
Myasthenia gravis.
Hypersensitivity to benzodiazepines.
severe respiratory failure.
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 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) depending on the indication, but should not exceed four weeks for insomnia and eight to twelve weeks for anxiety, including a gradual withdrawal period. . Extension of therapy beyond these periods should not occur without re-evaluation of the clinical situation. The patient should be informed when treatment is initiated that it will be of limited duration and precisely how the dosage should be progressively decreased.
In addition, the patient should be informed of the possibility of rebound phenomena, thus minimizing anxiety about such symptoms should they occur upon discontinuation of the drug.
There is evidence that, in the case of benzodiazepines with a short duration of action, withdrawal symptoms may become manifest within the dosing interval between doses, particularly for high doses.
When using benzodiazepines with a long duration of action, it is important to warn the patient that abrupt change to a benzodiazepine with a short duration of action is not recommended, as withdrawal symptoms may appear.
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 LORAZEPAM DOROM should be discontinued. These reactions are more frequent in children and the elderly.
Specific groups of patients:
Benzodiazepines should not be given to children without careful assessment of the actual need for treatment, the duration of treatment should be as short as possible. The elderly should take a reduced dose (see section 4.2). Likewise, a lower dose should be given to patients with chronic respiratory insufficiency due to the risk of respiratory depression. The same precautionary measures should be adopted for patients with chronic respiratory insufficiency due to the risk of respiratory depression, cardio-respiratory insufficiency, low blood pressure and impaired function hepatic and / or renal. Such patients should be monitored regularly during lorazepam therapy (as recommended with other benzodiazepines and other psychopharmacological agents). Benzodiazepines are not indicated in patients with severe hepatic insufficiency as they may precipitate l "encephalopathy. Benzodiazepines are not indicated 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.
In patients treated for a long time with benzodiazepines, and particularly in epileptics, it is advisable to gradually suspend therapy by administering decreasing doses of the drug.
04.5 Interactions with other medicinal products and other forms of interaction
The association with other psychotropic drugs requires particular caution and surveillance by the physician to avoid unexpected undesirable effects caused by the 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 euphoria, leading to an increase in psychic dependence.
Compounds that inhibit certain liver enzymes (especially cytochrome P450) may increase the activity of benzodiazepines. To a lesser extent, this also applies to benzodiazepines which are metabolized only by conjugation.
04.6 Pregnancy and lactation
Do not administer in the first trimester of pregnancy; in the following period the product must be used only in case of real need and under the direct supervision of the doctor.
If Lorazepam Dorom 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.
If, for serious medical reasons, the product is administered during the last period of pregnancy, or during labor at high doses, effects on the newborn may occur such as hypothermia, hypotonia and moderate respiratory depression due to the pharmacological action of the drug.
Additionally, infants born to mothers who have taken benzodiazepines chronically 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 start 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.
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.
04.9 Overdose
As with other benzodiazepines, an overdose is not expected to pose a risk to life 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. Benzodiazepine overdose usually results in varying degrees of CNS depression ranging from clouding to coma. 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
Lorazepam is: 7-chloro-1,3-dihydro-3-hydroxy-5 (o-chlorophenyl) -2H-1,4-benzodiazepin-2-one.
The results of the investigations aimed at verifying the possible cardiocirculatory and respiratory effects have shown that lorazepam, administered orally or endoperitoneally, does not influence the systemic arterial pressure, on the electrocardiogram and on the pneumogram.
From the experimental tests aimed at evaluating its pharmacological activity it was found that LORAZEPAM DOROM:
- induces sleep following non-hypnotic doses of esorbarbital and prolongs it by hypnotic doses of the same barbiturate;
- possesses anticonvulsant activity, demonstrated against chemical (strychnine, pentamethylenetetrazole) and physical (electroshock) convulsive agents;
- it has an inhibiting effect on spontaneous motor activity;
- it has significant inhibitory activity against methamphetamine-induced hypermotility.
This pharmacological spectrum is characteristic of psychoactive benzodiazepine derivatives, commonly referred to as anxiolytics.
05.2 "Pharmacokinetic properties
Following oral administration, LORAZEPAM DOROM is readily absorbed from the gastrointestinal tract, with a bioavailability of approximately 90%.
Pharmacokinetic studies have found that the highest serum concentrations of lorazepam (free and conjugated) are acquired 2-3 hours after administration: the pharmacological effects generally disappear within the 6th-8th hour, although serum levels are also appreciable at 24th hour. The plasma half-life of unconjugated lorazepam is approximately 12-16 hours. Lorazepam binds 85-90% to plasma proteins.
The volume of distribution of lorazepam is 1.3 L / kg.
Approximately 2/3 of the administered doses are excreted in the urine, in the form of glucuronide, within 96 hours, while the faeces contain less than 1% of free lorazepam. central nervous system, no active metabolites appear to be produced.
In infants it appears that lorazepam conjugation occurs slowly as its glucuronide is detectable in the urine for more than seven days. Glucuronidation of lorazepam can competitively inhibit bilirubin conjugation, leading to hyperbilirubinemia in the neonate.
There is no evidence of excessive accumulation of lorazepam when administered for up to 6 months, nor is there evidence of induction of drug-metabolizing enzymes. Lorazepam is not a substrate for N-dealkylating enzymes of the cytochrome P450 system, nor is it significantly hydrolyzed.
Comparative studies in young and elderly subjects have shown that the pharmacokinetics of lorazepam remain unchanged with advancing age. In patients with diseases (hepatitis, alcoholic cirrhosis) no changes in absorption, distribution, metabolism and excretion have been reported. As with other benzodiazepines, the pharmacokinetics of lorazepam may be altered in renal insufficiency.
05.3 Preclinical safety data
In the toxicity tests on animals the product did not show potential for both acute treatment (LD50> 4000 mg / kg / os in mice and rats) and protracted.
No teratogenic or embryotoxic effects were shown in rats, mice and rabbits for oral administration.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Tablets 1 and 2.5 mg :
Lactose monohydrate, pregelatinised starch, povidone, magnesium stearate, E 110 (only for 1 mg tablets).
Oral drops :
In the tank cap: mannitol; in the bottle: alcohol, purified water.
06.2 Incompatibility
Not known.
06.3 Period of validity
Tablets - 2 years.
Oral drops - 3 years. After reconstitution: 30 days.
06.4 Special precautions for storage
Tablets: Do not store above 25 ° C.
Oral drops: there are no special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Box of 20 tablets 1 mg
Box of 20 tablets 2.5 mg
The tablets are housed in blister packs of polyvinyl chloride opacified with titanium dioxide, coupled and heat-sealed to an aluminum foil.
Bottle 10 ml oral drops
Glass bottle with solution and powder reservoir cap with built-in dropper made of polypropylene.
The bottle is closed with a flip off cap and overcap.
06.6 Instructions for use and handling
Bottle Oral drops :
- to open the bottle, press and unscrew at the same time
- then press the plastic cap to get the powder to fall and shake until completely dissolved
- to get the drops out, remove the cap and turn the bottle upside down.
- to close, press and screw at the same time
- to reopen, press and at the same time unscrew.
07.0 MARKETING AUTHORIZATION HOLDER
DOROM S.r.l. - Via Messina, 38 - 20154 Milan Sales agent: Teva Italia S.r.l. - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Box of 20 tablets 1 mg - A.I.C. 033227012
Box of 20 tablets 2.5 mg - A.I.C. 033227024
Bottle 10 ml oral drops, 0.2% solution - A.I.C. 033227036
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Box of 20 tablets 1 mg - August 2004
Box of 20 tablets 2.5 mg - August 2004
Bottle 10 ml oral drops, 0.2% solution - August 2004
10.0 DATE OF REVISION OF THE TEXT
March 2012
