Anseren - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Ketazolam

Anseren 15 mg hard capsules
Anseren 30 mg hard capsules
Anseren 45 mg hard capsules

Why is Anseren used? What is it for?

Anseren contains the active substance ketazolam, which is part of the medicines known as benzodiazepines.

Anseren is indicated for the treatment of:

  • anxiety, tension and other somatic or psychiatric conditions characterized by a state of anxiety
  • insomnia.

Your doctor will only prescribe Anseren for you if your ailment is severe, it negatively affects your daily life and creates severe discomfort.

Contraindications When Anseren should not be used

Do not take Anseren

  • if you are allergic to ketazolam, other benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
  • if you suffer from myasthenia gravis, a disease which causes weakness in the muscles
  • if you have severe breathing problems (severe respiratory failure)
  • if you have severe liver problems (severe liver failure)
  • if you have a condition that does not make you breathe well at night (sleep apnea)
  • if you have a form of glaucoma, a disease that causes increased pressure in the eye called acute angle glaucoma
  • if you have acute alcohol poisoning, analgesics (medicines to reduce pain), hypnotics (medicines to induce sleep), neuroleptics (psychotropic drugs), antidepressants (medicines for depression), lithium (medicines for mood disorders).

Precautions for use What you need to know before you take Anseren

Talk to your doctor or pharmacist before taking Anseren.

Tell your doctor:

  • if you have been abusing drugs or alcohol in the past
  • if you are elderly or debilitated, as a dose reduction may be needed (see section 3 How to take Anseren)
  • if you have brain injuries (especially arteriosclerosis)
  • if you have kidney problems
  • if you suffer from "heart failure (heart failure)
  • if you have breathing problems (chronic respiratory failure)
  • if you have liver problems (liver failure) or suffer from mental confusion due to liver failure (hepatic encephalopathy);
  • if you notice that after a few weeks the medicine does not work as well as it did at first (tolerance)

Interactions Which drugs or foods can modify the Anseren effect

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are using:

  • medicines that reduce the activity of the central nervous system:
    • antipsychotics (medicines used in psychiatric disorders)
    • hypnotics (medicines that induce sleep)
    • anxiolytics / sedatives (medicines to reduce anxiety and relax)
    • antidepressants (medicines for depression)
    • narcotic analgesics (medicines used to reduce pain)
    • antiepileptics (medicines for epilepsy)
    • anesthetics
    • sedative antihistamines (medicines for allergies that cause sleepiness)
  • muscle relaxants (medicines that relax the muscles)
  • medicines that increase ketazolam levels in the blood
  • beta-blockers (medicines for high blood pressure, heart problems and heart rhythm disturbances)
  • glycosides (heart medicines)
  • anticoagulants (medicines that reduce blood clotting)
  • medicines for diabetes
  • contraceptives taken by mouth.

Anseren with alcohol

Do not take Anseren with alcohol, as this increases its sedative effect. This may adversely affect your ability to drive or use machines.

Warnings It is important to know that:

Dependence: There is a risk of dependence when taking this medicine, i.e. the need to continue taking the medicine. The risk increases with dose and duration of treatment. It is higher if you have abused drugs or alcohol in the past. Dependence on the drug can also occur at therapeutic doses and if you have no risk factors.

Withdrawal: When you abruptly stop taking Anseren you may experience withdrawal symptoms, such as headache, body aches, extreme anxiety, tension, restlessness, confusion and irritability (see section "If you stop taking Anseren").

Withdrawal symptoms may also appear when switching from a long-acting benzodiazepine to a short-acting benzodiazepine. Therefore, such a substitution is not recommended.

After "discontinuation of treatment" symptoms called "rebound phenomena" may also occur, that is, you may experience, more intensely, the symptoms that led you to take this medicine (insomnia and rebound anxiety) (see section 3 "If you stop taking Anseren").

The risk of onset of withdrawal and rebound symptoms is greater when you stop taking Anseren suddenly, therefore it is recommended to gradually decrease the dose.

Duration of treatment: The duration of treatment should be as short as possible and should not exceed 4 weeks for the treatment of insomnia and 8-12 weeks for the treatment of anxiety, including a gradual withdrawal period (see section 3 "How to take Anseren").

Amnesia: Amnesia (memory loss) can occur. This most often happens several hours after ingestion of the medicine. To reduce the risk of amnesia, make sure you get 7-8 hours of uninterrupted sleep.

Behavioral reactions: May manifest behavioral disturbances (paradoxical psychiatric reactions). If you experience behavioral disturbances, stop taking the medicine immediately (see section 4 "Possible side effects"). These reactions are more frequent in children and the elderly. Anseren is not recommended for psychotic illnesses and should not be used alone for treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.

Children and adolescents

Anseren should not be given to patients under the age of 18.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must not take Anseren during the first trimester of pregnancy. After the first trimester of pregnancy, your doctor will consider whether the benefits to you clearly outweigh the risks to the fetus before prescribing Anseren.

You should not take Anseren if you are breastfeeding because benzodiazepines, including ketazolam, pass into breast milk.

Driving and using machines

Anseren can impair the ability to drive and use machines because it can cause sedation, memory loss (amnesia), impaired concentration and function of muscles. If you have had little sleep during the night or if you have consumed alcohol these effects may increase.

Dose, Method and Time of Administration How to use Anseren: Posology

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

Unless otherwise prescribed, the recommended dose is 30 mg per day. Take the capsules with some liquid, preferably in the evening before going to sleep.

Based on individual response, the dose may vary from 15 mg to 75 mg per day.

Your doctor will start treatment with the lowest possible dose. He will also check you regularly at the start of treatment to evaluate the possibility of reducing the dose or the frequency of administration. Be careful not to exceed the maximum dose.

Your doctor will prescribe Anseren for you as soon as possible. In some cases the doctor, after a "careful evaluation, may decide to let you continue the treatment beyond the maximum duration, but only after having carefully evaluated your condition.

Treatment of anxiety

The total duration of treatment should not exceed 8-12 weeks, including the period of gradual withdrawal of the medicine.

Your doctor will periodically evaluate your condition and the need for regular treatment with Anseren, particularly if you no longer have symptoms of anxiety.

Treatment of insomnia

The duration of treatment usually ranges from a few days to two weeks, up to a maximum of four weeks, including the period of gradual withdrawal of the medicine.

Use in particular patients

In elderly, debilitated, or patients with liver or kidney problems, the doctor will carefully consider whether to reduce the dose of Anseren.

Use in children and adolescents

Anseren should not be given to patients under the age of 18.

If you forget to take Anseren

Do not take a double dose to make up for a forgotten dose.

If you stop taking Anseren

Do not abruptly stop taking Anseren.

Anseren can be addictive; if this happens, when you stop taking Anseren abruptly the symptoms that led you to take this medicine (anxiety and insomnia) may become more intense and you may experience other symptoms such as mood swings and restlessness.

Withdrawal symptoms may appear, such as headaches, muscle aches, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases of abstinence, derealization (feeling that things are not real), depersonalization (feeling of detachment from the surrounding environment), intolerance to sounds (hyperacusis), numbness and tingling of hands and feet, sensitivity to light, to noise may appear. and physical contact, hallucinations (seeing and hearing things that are not there) or seizures.

This is more the case when treatment is stopped abruptly. If your doctor has decided to stop treatment, he will reduce the dose gradually to minimize withdrawal symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken too much Anseren

In case of accidental ingestion of an overdose of Anseren, notify your doctor immediately or go to the nearest hospital.

After ingestion of an overdose, the following symptoms may occur:

  • clouding of the senses
  • mental confusion
  • drowsiness
  • numbness
  • loss of movement coordination (ataxia)
  • decreased muscle tone (hypotonia)
  • decrease in blood pressure
  • reduced ability to breathe
  • rarely coma
  • very rarely death.

Ingestion of an excessive dose of benzodiazepines, including Anseren, is not expected to be life-threatening, except in the case of concomitant use of alcohol or medicinal products that reduce central nervous system activity (see section "Other medicines and Anseren ").

Side Effects What are the side effects of Anseren

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately and stop treatment if you experience:

  • restlessness
  • agitation
  • irritability
  • aggression
  • delirium
  • anger
  • nightmares
  • hallucinations (seeing and hearing things that aren't there)
  • psychosis
  • behavioral changes.

These effects are symptoms of a "paradoxical psychiatric reaction" and can be quite severe.

They are more likely in the elderly.

Side effects that occur more frequently at the start of treatment

  • drowsiness
  • reduction of emotions
  • reduction of vigilance
  • confusion
  • fatigue
  • headache
  • dizziness
  • muscle weakness
  • loss of movement coordination (ataxia)
  • double vision

These side effects usually disappear with continued treatment.

Other side effects which may occur with the administration of Anseren

  • upset stomach or intestines
  • changes in sexual desire
  • reactions affecting the skin
  • visual disturbances
  • speech disorders in which words are pronounced slowly and incorrectly (dysarthria)
  • tremors
  • low blood pressure
  • yellow discoloration of the skin, mucous membranes and eye
  • weight gain
  • increased appetite
  • dry mouth or increased salivation
  • urinary incontinence or urine retention
  • reduction in the number of white blood cells in the blood (neutropenia)
  • changes in the menstrual cycle
  • pain in the muscles
  • memory loss (amnesia) (see section "Warnings and precautions")
  • worsening of pre-existing depression
  • addiction (see section "Warnings and precautions").

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at 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

Do not store above 25 ° C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package after Expires. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Anseren contains

  • The active ingredient is ketazolam. Each hard capsule contains 15 mg or 30 mg or 45 mg of ketazolam.
  • The other ingredients are: calcium carmellose, hydrogenated vegetable oil.
  • The constituents of the capsules are: gelatin, titanium dioxide (E171) and (only for 30 mg and 45 mg capsules) indigo carmine (E 132).

Description of what Anseren looks like and contents of the pack

Each pack of Anseren 15 mg hard capsules contains 30 capsules for oral use of 15 mg.

Each pack of Anseren 30 mg hard capsules contains 15 capsules for oral use of 30 mg.

Each pack of Anseren 45 mg hard capsules contains 10 capsules for oral use of 45 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.

Further information on Anseren can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

ANSEREN HARD CAPSULES

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

Active ingredient: ketazolam.

Each hard capsule contains 15 mg, 30 mg or 45 mg of ketazolam.

03.0 PHARMACEUTICAL FORM -

Hard capsules.

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 -

Unless otherwise prescribed, the average daily dose is 30 mg, to be taken with a little liquid, preferably in the evening, before going to bed.

Based on the individual response, this dosage can vary from 15 to 75 mg / day, trying to administer the minimum effective dose, particularly in elderly, debilitated or organic brain disease patients.

Treatment should be started with the lowest recommended dose.

The maximum dose should not be exceeded.

In the treatment of elderly patients and patients with impaired hepatic and / or renal function, the posology must be carefully established by the physician who will have to evaluate a possible reduction of the dosages indicated above.

The patient should be monitored regularly at the start of treatment to decrease the dose or frequency of intake if necessary to prevent overdose due to accumulation.

Treatment should be as short as possible.

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.

Anxiety

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.

Insomnia

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.

04.3 Contraindications -

Like other benzodiazepines, the product should not be used in cases of: myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, sleep apnea syndrome, individual known hypersensitivity to ketazolam or other benzodiazepines.

Ketazolam is also contraindicated in the presence of acute angle glaucoma in acute form and in acute poisoning by alcohol, analgesics, hypnotics, neuroleptics, antidepressants, lithium.

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 physical dependence has developed, abrupt discontinuation 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 leading to treatment with benzodiazepines recur in an aggravated form may occur upon discontinuation of treatment. It may be accompanied by other reactions, including mood changes, anxiety, restlessness or sleep disturbances. 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 4.2. "Posology and method of administration"), but should not exceed 8-12 weeks in the case of anxiety and related symptoms, including a gradual withdrawal period. Extending therapy beyond these periods should not occur without re-evaluation of the clinical situation, including monitoring of blood count and liver function. It may be helpful to inform the patient when treatment is initiated 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 ketazolam is a long-acting benzodiazepine, it is important to warn the patient that abrupt change to a benzodiazepine with a short duration of action is inadvisable, as withdrawal symptoms may occur.

Amnesia

Benzodiazepines 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 4.8. "Undesirable Effects").

Psychiatric reactions and paradox

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 the elderly.

Specific groups of patients

ANSEREN should not be given to patients under the age of 18.

The elderly should take a reduced dose (see 4.2. "Posology and method 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.

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.

Similarly to other psychotropic drugs active on the central nervous system, ANSEREN should be used with caution in debilitated patients, in those with organic brain lesions (especially atherosclerotic), with impaired renal function or with heart failure.

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. In the case of narcotic analgesics, increased euphoria may occur by leading to an increase in psychic dependence. In the case of antiepileptics, the simultaneous administration of ANSEREN can also lead to an increase in the frequency and severity of grand mal attacks, such as to justify an increase in the dosage of anticonvulsant treatment; similarly, abrupt discontinuation of ANSEREN treatment may be accompanied by an increase in the frequency and / or severity of seizures.

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.

ANSEREN can enhance the action of muscle relaxants.

Finally, ANSEREN should be administered with caution in patients treated with beta-blockers, glycosides, anticoagulants, antidiabetics and oral contraceptives because the type of interaction with ketazolam is not predictable in the individual case.

04.6 Pregnancy and breastfeeding -

If the product is prescribed to a woman of childbearing age, the patient should contact her doctor, both if she intends to become pregnant, and if she suspects she is pregnant, regarding discontinuation of the medicine.

The product should not be used in the first trimester of pregnancy; subsequently it must be administered only in case of real need and under direct medical supervision. 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. After evening administration, particularly at the beginning of the treatment and with the increase of the dosage, the decrease of the alertness of the reflexes can persist until the following morning.

If sleep duration has been insufficient, the likelihood of impaired alertness may be increased (see 4.5 "Interactions with other medicinal products and other forms of interaction").

04.8 Undesirable effects -

Drowsiness, 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, skin reactions, accommodation disturbances, dysarthria, tremors, hypotension, jaundice, weight gain, increased appetite, dry mouth or hypersalivation, urinary incontinence or retention, changes in the blood count (neutropenia), menstrual disturbances, myalgias.

Amnesia

Anterograde amnesia can also occur at therapeutic dosages; the risk increases at higher dosages. Amnesic effects may be associated with behavioral changes (see 4.4. "Special warnings and precautions for" use ").

Depression

A pre-existing depressive state may be unmasked during the use of benzodiazepines.

Benzodiazepines or benzodiazepine-like compounds can cause reactions such as: restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, behavioral changes.

Such reactions can be quite severe. They are more likely in the elderly.

Dependence

The use of benzodiazepines (even at therapeutic doses) can lead to the development of physical dependence: discontinuation of therapy can cause rebound or withdrawal phenomena (see 4.4. "Special warnings and precautions for use"). Psychic dependence can occur. Abuse of benzodiazepines has been reported.

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 seen 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 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 -

ANSEREN contains, as active substance, ketazolam, a 1,4 benzodiazepine, which exerts prolonged anxiolytic and muscle relaxant actions. Doses up to 300 mg in humans did not induce significant changes in the cardiovascular and respiratory systems.

Studies carried out in the sleep laboratory have shown that ANSEREN reduces the latency time of sleep, prolongs its duration and reduces the number of nocturnal awakenings; ANSEREN caused slight decreases in the 3-4 and REM sleep stages.

05.2 "Pharmacokinetic properties -

After oral administration, ketazolam is rapidly absorbed; peak plasma concentrations are reached approximately 3 hours after administration and plasma levels are proportional to the administered dose over a range of 15 to 45 mg / day.

After repeated administration, steady-state is reached at 7-14 days. In vitro, 93% of ketazolam is bound to plasma proteins (up to concentrations of 3000 ng / ml).

The mean half-life of ketazolam is approximately 2 hours, that of its active metabolites is between 34 and 52 hours. The main active metabolites are diazepam, N-demethylketazolam and N-demethyldiazepam.

Ketazolam is extensively metabolised and eliminated mainly in the urine, in which the unchanged substance is found only in traces; the most important urinary metabolite is conjugated oxazepam.

17% of the total administered dose is eliminated via the faecal route.

05.3 Preclinical safety data -

The acute toxicity data, relating to the experimental animal, are as follows:

Animal species Route of administration LD50 (mg / kg) Mouse Intraperitoneal 2618 Mouse For os > 5000 Rat Intraperitoneal 3911 Rat For os > 5000

Single doses up to 1000 mg were relatively well tolerated in dogs and monkeys.

In chronic toxicity studies conducted in rats at doses of 10, 30 and 100 mg / kg / day for 15 months, signs of toxicity (ataxia) were observed only at the highest dose; dogs treated for 2 years with doses of 1.3 and 10 mg / kg / day showed no signs of toxicity.

Studies in mice, rats and rabbits indicated that ketazolam is not teratogenic; the tests for mutagenesis and carcinogenesis were also negative.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

ANSEREN 15 mg Capsules, hard

Calcium Carmellose; hydrogenated vegetable oil.

Constituents of the capsule: gelatin; titanium dioxide (E171).

ANSEREN 30 mg Capsules, hard

Calcium Carmellose; hydrogenated vegetable oil.

Constituents of the capsule: gelatin; titanium dioxide (E171); indigo carmine (E 132).

ANSEREN 45 mg Capsules, hard

Calcium Carmellose; hydrogenated vegetable oil.

Constituents of the capsule: gelatin; titanium dioxide (E171); indigo carmine (E 132).

06.2 Incompatibility "-

None known.

06.3 Period of validity "-

4 years.

06.4 Special precautions for storage -

Do not store at temperatures above 25 ° C.

06.5 Nature of the immediate packaging and contents of the package -

Blister material: opaque PVC.

ANSEREN 15 mg Hard capsules: box of 30 hard capsules of 15 mg.

ANSEREN 30 mg Hard capsules: box of 15 hard capsules of 30 mg.

ANSEREN 45 mg Hard Capsules: Box of 10 hard 45 mg capsules.

06.6 Instructions for use and handling -

None.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

PHOENIX LABS- Suite 12, Bunkilla Place, Bracetown Buusiness Park, Clonee Co Meath, Ireland

08.0 MARKETING AUTHORIZATION NUMBER -

ANSEREN 15 mg Hard capsules: AIC n. 026380030

ANSEREN 30 mg Hard capsules: AIC n. 026380028

ANSEREN 45 mg Hard capsules: AIC n. 026380016

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

Authorization: 10.02.1987

Renewal: 01.06.2010

10.0 DATE OF REVISION OF THE TEXT -

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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