Lexotan

LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION

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

Lexotan

6 mg, tablets

Bromazepamum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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. Contents of the package and other information

1. What is Lexotan and what is it used for

Lexotan contains bromazepam, which is an anxiolytic belonging to the group of benzodiazepines.
Lexotan is indicated for the treatment of anxiety disorders, including generalized anxiety disorders, and autonomic dysfunction, such as skin symptoms, gastrointestinal symptoms, cardiovascular symptoms, and genitourinary symptoms.
It is also used to treat anxiety states in patients with chronic organic brain diseases, post-traumatic stress disorders with anxiety symptoms, and adjustment disorders.

• generalized anxiety disorders
• autonomic dysfunction, such as skin symptoms, gastrointestinal symptoms, cardiovascular symptoms, and genitourinary symptoms
• anxiety states in patients 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 medicine (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 medical supervision throughout the treatment period - at the beginning of treatment to determine the minimum effective dose and the frequency of administration, and during treatment to prevent overdose.
Amnesia
Benzodiazepines may cause anterograde amnesia. This condition occurs most often a few hours after taking the medicine. 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.
Psychic reactions
When taking benzodiazepines, reactions such as anxiety, agitation, irritability, aggression, delusions, 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 are more likely to occur in children and the elderly.
Duration of treatment
The duration of treatment is limited (not exceeding 8-12 weeks), and the dose of the medicine should be gradually reduced under medical supervision. During the withdrawal of the medicine, a rebound phenomenon may occur (see section 3, "Discontinuation of Lexotan").
Consumption of alcohol or use of medicines that depress the activity of the central nervous system
During treatment with Lexotan, the patient should not drink alcohol or take medicines that depress the activity of 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 effectiveness of the medicine may decrease.
During treatment with benzodiazepines, if the medicine 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 disorders 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 treatment, due to the 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 narcotic abuse
The medicine should be used with special caution, strictly according to the doctor's instructions.
Dependence on the medicine
Taking benzodiazepines, including Lexotan, or similarly acting medicines may lead to physical and psychological dependence on these medicines. The risk of dependence increases with the dose and duration of treatment. The risk is also higher for patients who have abused alcohol, drugs, or narcotics, and for 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.
Patients with mild or moderate liver failure should be treated with caution.
Benzodiazepines should not be given to children without careful evaluation of the need for their use; the duration of treatment should be as short as possible, and the dose should be individualized for each patient.
Older adults should be given the medicine in reduced doses.

Pregnancy and breastfeeding

Before taking any medicine, the patient should consult their doctor or pharmacist.
Pregnancy
The safety of bromazepam during pregnancy has not been established. Although there are no clinical data on the occurrence of congenital malformations in the fetus due to the use of benzodiazepines during 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 dosage regimen.
The patient should contact their doctor about stopping treatment if they plan to become pregnant or suspect they are pregnant.
Administration of bromazepam during the third trimester of pregnancy and during childbirth is only allowed in exceptional cases, as it may cause adverse effects in newborns, such as hypothermia, reduced muscle tone, and moderate respiratory depression or apnea. Additionally, withdrawal symptoms have been observed in newborns, manifested by excessive irritability, anxiety, and tremors.
In children of mothers who have taken benzodiazepines for a long time during the last period of pregnancy, physical dependence on the medicine and the risk of withdrawal symptoms after birth may occur.
Breastfeeding
Benzodiazepines pass into breast milk, so breastfeeding women 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 medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking Lexotan with other medicines that depress the activity of the central nervous system (such as antidepressants, sedatives, narcotic analgesics, neuroleptics, anxiolytics, anticonvulsants, sedatives, antihistamines with sedative effects, and anesthetics) and alcohol may enhance the sedative effect of the medicine and increase its depressant 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 its stronger or prolonged effect.

Lexotan contains lactose monohydrate

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 medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
Lexotan is available in the following doses: 3 mg, 6 mg.
In each case, Lexotan should be taken under medical supervision.
Usually, the 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 consider the given dosage as general guidelines and individualize the dose for each patient. Outpatient treatment should be started with small doses, gradually increased to the optimal size. Treatment should be as short as possible.
The patient should regularly visit their doctor to assess the need for continued treatment, 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 medicine.
In some cases, therapy may last longer, provided that a specialized assessment of the patient's condition is performed by the doctor.
Older adults 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.

Taking a higher dose of Lexotan than recommended

In case of taking a higher dose of Lexotan than recommended, the patient should immediately consult 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 threatens life if the medicine 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 older adults. 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).

Missing a dose of Lexotan

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

Stopping treatment with Lexotan

In case of physical dependence, after stopping treatment, withdrawal symptoms (withdrawal syndrome) may occur.
These may include: headaches, diarrhea, muscle pain, increased anxiety, tension, anxiety, disorientation, and irritability. In severe cases, the following symptoms may occur: impaired perception of reality (derealization), impaired sense of one's own identity (depersonalization), hypersensitivity to sounds, feeling of numbness and tingling in the limbs, hypersensitivity to light, noise, and touch, hallucinations, or seizures.
After stopping the medicine, a rebound anxiety 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 disorders and anxiety, may also occur.
Since the risk of withdrawal syndrome and rebound phenomenon is higher in case of abrupt cessation of treatment, it is recommended to gradually reduce the dose of Lexotan.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Lexotan can cause side effects, although not everybody gets them.
The following side effects have been reported with an unknown frequency (cannot be estimated from the 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 - more likely to occur in children and older adults
• anterograde amnesia
• memory impairment
• drowsiness, headaches, dizziness, impaired alertness, coordination disorders, and balance disorders - 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
• reduced 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 older adults

Dependence:
Long-term use of the medicine (even in therapeutic doses) may lead to physical and psychological dependence on the medicine, and stopping treatment may cause withdrawal symptoms or rebound anxiety (exacerbation 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 tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 medicine.

5. How to store Lexotan

The medicine should be stored in a place inaccessible and invisible to children.
Do not store above 30°C.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Lexotan contains

• The active substance of the medicine is bromazepam (Bromazepamum). One tablet contains 6 mg of bromazepam.
• The other ingredients are: microcrystalline cellulose, magnesium stearate, talc, lactose monohydrate (90.85 mg in one tablet), aluminum lake of indigo carmine, yellow iron oxide.

What Lexotan looks like and what the package contains

Lexotan is available in the form of tablets.
The package contains 30 tablets of 6 mg, 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 Portugal, the country of export:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

Delpharm Milano S.r.l.
Via Carnevale, 1
20090, Segrate (MI)
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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorization number in Portugal, the country of export: 5470281
4576880
Parallel import authorization number: 249/19

Date of leaflet approval: 10.06.2024

[Information about the trademark]