Lexotan

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Lexotan(Lexotanil)

6 mg, tablets

Bromazepamum
Lexotan and Lexotanil are different trade names for the same drug.

It is essential to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Lexotan and what is it used for
• 2. Important information before taking Lexotan
• 3. How to take Lexotan
• 4. Possible side effects
• 5. How to store Lexotan
• 6. Package contents and other information

1. What is Lexotan and what is it used for

Lexotan contains bromazepam, which is an anxiolytic drug belonging to the benzodiazepine group.
Lexotan is indicated for the treatment of anxiety disorders, including generalized anxiety disorders, autonomic dysfunction, and anxiety states associated with chronic organic brain diseases.

• Generalized anxiety disorders
• Autonomic dysfunction, including somatic symptoms such as skin symptoms, gastrointestinal symptoms, cardiovascular symptoms, and genitourinary symptoms
• Anxiety states associated with chronic organic brain diseases
• Post-traumatic stress disorders with anxiety symptoms
• Adjustment disorders

2. Important information before taking Lexotan

When not to take Lexotan

• If the patient is allergic to benzodiazepines or any other component of the drug (listed in section 6)
• If the patient has severe respiratory failure
• If the patient has severe liver failure (benzodiazepines are not recommended for patients with severe liver failure due to the risk of brain damage)
• If the patient has myasthenia gravis
• If the patient has sleep apnea syndrome

Warnings and precautions

The patient should be under the doctor's supervision throughout the treatment period, initially to determine the minimum effective dose and the frequency of administration, and during the treatment period to prevent overdose.
Amnesia
Benzodiazepines may cause anterograde amnesia. This condition usually occurs a few hours after taking the drug. To reduce the risk of anterograde amnesia, the patient should have uninterrupted sleep for several hours. The effect of anterograde amnesia may be associated with abnormal behavior.
Psychological reactions
When taking benzodiazepines, reactions such as anxiety, agitation, irritability, aggression, fear, false beliefs about the environment or one's own state, outbursts of anger, nightmares, hallucinations, psychosis, abnormal behavior, and other adverse behaviors may occur. If such symptoms occur, the patient should immediately contact their doctor.
These symptoms may occur with greater probability in children and the elderly.
Duration of treatment
The duration of treatment is limited (not exceeding 8-12 weeks), and the dose of the drug should be gradually reduced under the doctor's supervision. During the withdrawal of the drug, a rebound phenomenon may occur (see section 3, "Discontinuation of Lexotan").
Consumption of alcohol or use of drugs that depress the central nervous system
During the use of Lexotan, the patient should not drink alcohol or take drugs that depress the central nervous system.
Alcohol may enhance the effect of Lexotan and cause severe sedation, as well as respiratory or circulatory depression, which may lead to coma or death.
Tolerance
In the case of repeated administration of Lexotan for a longer period, the drug's effectiveness may decrease.
During treatment with benzodiazepines, if the administered drug is replaced with a benzodiazepine with a significantly shorter half-life, withdrawal symptoms may develop.
Benzodiazepines should not be used as the only treatment for depression or anxiety associated with depression (as these conditions may be associated with increased suicidal tendencies).
Benzodiazepines should not be used as the first-line treatment for psychotic disorders.
During the use of the drug, due to its muscle relaxant effect, there is a risk of falls and hip fractures, especially in older patients when getting up at night.
History of alcohol, drug, or substance abuseThe drug should be used with particular caution, strictly according to the doctor's instructions.
Drug dependence
Taking benzodiazepine drugs, including Lexotan, or similarly acting drugs, may lead to the development of physical and psychological dependence on these drugs. The risk of dependence increases with the dose and duration of treatment. The increased risk also applies to patients who have abused alcohol, drugs, or substances, and patients with personality disorders.
Special warnings for certain patient groups
Patients with chronic respiratory failure should be monitored closely due to the risk of respiratory depression.
Particular caution should be exercised in patients with mild or moderate liver failure.
Benzodiazepines should not be given to children without careful evaluation of the justification for their use; the duration of treatment should be as short as possible, and the dose should be individually tailored for each patient.
For elderly patients, the drug should be administered in a reduced dose.

Pregnancy and breastfeeding

Before taking any medication, the patient should consult their doctor or pharmacist.
Pregnancy
The safety of bromazepam use in pregnant women has not been established. Although there are no clinical data on the occurrence of significant congenital malformations in the fetus due to the use of benzodiazepines in the first trimester of pregnancy, some epidemiological studies have shown an increased risk of cleft palate.
Therefore, bromazepam should not be used during pregnancy, unless in exceptional cases and with strict adherence to the dosing schedule.
The patient should contact their doctor regarding the discontinuation of treatment if they plan to become pregnant or suspect they are pregnant.
The administration of bromazepam in the third trimester of pregnancy and during childbirth is only allowed in cases of absolute indication, as adverse reactions may occur in newborns, such as hypothermia, decreased muscle tone, which may manifest as feeding problems (resulting in poor weight gain), and moderate respiratory depression or apnea. Additionally, withdrawal symptoms have been observed in newborns, characterized by excessive excitability, anxiety, and tremors.
In children of mothers who have taken benzodiazepines for a prolonged period in the last trimester of pregnancy, physical dependence on the drug and the risk of withdrawal symptoms after birth may occur.
Breastfeeding
Benzodiazepines pass into breast milk; therefore, women who are breastfeeding should not take Lexotan.

Driving and operating machinery

The patient should not drive vehicles or operate machinery, as Lexotan may cause excessive sedation and amnesia, disrupt concentration, and impair muscle function. In case of sleep deprivation, the likelihood of decreased alertness may increase. This effect may be enhanced, especially if the patient has consumed alcohol.

Lexotan and other medications

The patient should inform their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Taking Lexotan with other medications that depress the central nervous system (such as antidepressants, sedatives, narcotic analgesics, neuroleptics, anxiolytics, anticonvulsants, sedatives, antihistamines with a sedative effect, and anesthetics) and alcohol may enhance the sedative effect of the drug and increase its inhibitory effect on the respiratory and circulatory systems.
In the case of narcotic analgesics, a state of euphoria may occur, leading to an increased risk of psychological dependence.
Substances that inhibit the activity of certain liver enzymes may affect benzodiazepines that are metabolized by these enzymes. Concurrent administration of Lexotan with cimetidine, fluvoxamine, or (probably) propranolol may cause a stronger or prolonged effect of the drug.
Lexotan contains lactose.If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking Lexotan.

3. How to take Lexotan

This medication should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
Lexotan is available in 3 mg and 6 mg doses.
In each case, Lexotan should be taken under the doctor's supervision.
Typically, the administered dose is:
Average doses for outpatients: 1.5 mg to 3 mg, three times a day.
Severe cases, especially in hospital treatment: 6 mg to 12 mg, two or three times a day.
The doctor should treat the given dosing as general guidelines and adjust the dose individually for each patient. Outpatient treatment should begin with small doses, gradually increasing them to the optimal size. Treatment should be as short as possible.
The patient should regularly visit their doctor to assess the need for continued administration of the drug, especially in situations where no symptoms of the disease are observed. The total duration of therapy should not exceed 8 to 12 weeks, including the period of gradual withdrawal of the drug.
In some cases, therapy may last longer, provided that a specialized assessment of the patient's condition is performed by the doctor.
Elderly patients and patients with liver function disorders require smaller doses.
If the patient feels that the effect of Lexotan is too strong or too weak, they should consult their doctor.

Overdose of Lexotan

In case of taking a higher dose of Lexotan than recommended, the patient should immediately contact their doctor.
The doctor will decide on further action.
Common symptoms of benzodiazepine overdose include: drowsiness, coordination disorders, speech disorders, and nystagmus.
Overdose of Lexotan rarely poses a threat to life if the drug is taken alone. However, it may lead to loss of reflexes, apnea, decreased blood pressure, circulatory and respiratory depression, and coma. Coma, if it occurs, usually lasts several hours but may recur and worsen, especially in the elderly. Symptoms of respiratory depression are more severe in patients with underlying respiratory diseases.
Benzodiazepines enhance the effect of other central nervous system depressants (including alcohol).

Missed dose of Lexotan

The patient should not take a double dose to make up for a missed dose.

Discontinuation of Lexotan

In case of physical dependence, after discontinuation of treatment, withdrawal symptoms (withdrawal syndrome) may occur.
These symptoms may include: headaches, diarrhea, muscle pain, increased anxiety, tension, restlessness, disorientation, and irritability. In severe cases, the following symptoms may occur: distorted perception of reality (derealization), disturbances in the sense of one's own identity (depersonalization), increased sensitivity to sounds, feelings of numbness and tingling in the limbs, increased sensitivity to light, noise, and touch, hallucinations, or seizures.
After discontinuation of the drug, a rebound anxiety phenomenon may occur - a transient syndrome in which the symptoms that led to the use of Lexotan recur in an intensified form. Other reactions, such as mood changes, anxiety, or sleep disturbances and restlessness, may also occur.
Since the risk of withdrawal syndrome and rebound phenomenon is higher in case of abrupt discontinuation of treatment, it is recommended to gradually reduce the dose of Lexotan.
In case of any further doubts regarding the use of this medication, the patient should consult their doctor.

4. Possible side effects

Like all medications, Lexotan may cause side effects, although they may not occur in every patient.
The following side effects have been reported with an unknown frequency (which cannot be determined based on available data):

• Hypersensitivity (allergy), anaphylactic shock, angioedema
• Confusion, disorientation, emotional disturbances, and mood changes - mainly at the beginning and usually resolving during treatment
• Libido disorders
• Drug dependence, drug abuse, withdrawal syndrome
• Depression
• Paradoxical reactions such as anxiety, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, abnormal behavior, nervousness, anxiety, unusual dreams, excessive activity, and other behavioral disorders - with a higher probability of these reactions in children and the elderly
• Anterograde amnesia
• Impaired memory
• Drowsiness, headaches, dizziness, impaired alertness, coordination disorders, and balance problems - mainly at the beginning and usually resolving during treatment
• Double vision - mainly at the beginning and usually resolving during treatment
• Heart failure, including cardiac arrest
• Decreased depth and frequency of breathing
• Nausea, vomiting - mainly at the beginning and usually resolving during treatment
• Constipation
• Rash, itching, urticaria
• Muscle weakness - mainly at the beginning and usually resolving during treatment
• Urinary retention
• Fatigue - mainly at the beginning and usually resolving during treatment
• Falls, fractures - the risk increases in patients taking sedatives (including alcoholic beverages) and in the elderly.

Dependence:
Prolonged use of the drug (even in therapeutic doses) may lead to the development of physical and psychological dependence on the drug, and discontinuation of treatment may result in withdrawal symptoms or rebound anxiety (intensification of disease symptoms - see "Discontinuation of Lexotan").
There have been reports of benzodiazepine abuse .

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Lexotan

The medication should be stored in a place inaccessible and invisible to children.
Do not store above 30°C.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medications should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist what to do with unused medications. This will help protect the environment.

6. Package contents and other information

What Lexotan contains

• The active substance of the drug is bromazepam (Bromazepamum). One tablet contains 6 mg of bromazepam.
• Other ingredients are: microcrystalline cellulose, magnesium stearate, talc, lactose monohydrate, aluminum lake of indigo carmine (E 132), yellow iron oxide (E 172).

What Lexotan looks like and what the package contains

Lexotan is available in tablet form.
The package contains 30 tablets, in blisters, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

Delpharm Milano S.r.l.
Via Carnevale, 1
Segrate, 20054 Milan
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Greece, the country of export: 119951/13-11-2020
Parallel import authorization number: 235/24

Date of leaflet approval: 11.06.2024

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