PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet – the packaging information in a foreign language!
Lexotan
6 mg, tablets
Bromazepam
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Lexotan is and what it is used for
Important information before taking Lexotan
How to take Lexotan
Possible side effects
How to store Lexotan
Contents of the pack and other information

1. What Lexotan is and what it is used for

Lexotan contains bromazepam, which is an anxiolytic medicine belonging to the benzodiazepine group.
Lexotan is indicated for pharmacological treatment of:

generalized anxiety disorders
autonomic dysfunctions presenting somatically, including skin symptoms, gastrointestinal, cardiovascular, and urogenital system symptoms
anxiety states occurring in the course of chronic organic diseases of the central nervous system
post-traumatic stress disorders with anxiety symptoms
adjustment disorders.

2. Important information before using the medicine Lexotan

When not to use Lexotan

if the patient is allergic to benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
if the patient has severe respiratory insufficiency
if the patient has severe hepatic insufficiency (benzodiazepines are not indicated for treatment of patients with severe liver impairment due to the risk of developing encephalopathy)
if the patient has muscle weakness (myasthenia gravis)
if the patient has sleep apnoea syndrome.

Warnings and precautions
The patient should remain under medical supervision throughout the entire duration of treatment – at the beginning of treatment to determine the minimum effective dose and dosing frequency, and during treatment to prevent overdose.
Memory impairment
Benzodiazepines may cause anterograde amnesia. This condition most commonly occurs several hours after taking the medicine. To reduce the risk of anterograde amnesia, the patient should ensure uninterrupted sleep for several hours. The amnesic effect may be associated with abnormal behaviour.
Psychological reactions
When using benzodiazepines, reactions such as anxiety, agitation, irritability, aggression, delusions regarding the external environment or one's own condition, rage outbursts, nightmares, hallucinations, psychoses, abnormal behaviour, and other undesirable behaviours may occur. If such symptoms occur, contact the doctor immediately.
The above-mentioned symptoms are more likely to occur in children and elderly patients.
Duration of treatment
The duration of treatment is limited (does not exceed 8–12 weeks), and the dose should be gradually reduced under medical supervision. During discontinuation of the medicine, a rebound phenomenon may occur (see section 3, "Discontinuing treatment with Lexotan").
Alcohol consumption or use of medicines that depress central nervous system function
During treatment with Lexotan, alcohol should not be consumed and medicines that depress central nervous system function should not be taken.
Alcohol may intensify the effect of Lexotan and cause severe sedation, as well as respiratory or circulatory depression, which may lead to coma or death.
Tolerance
Repeated administration of Lexotan over a prolonged period may lead to reduced effectiveness of the medicine.
During benzodiazepine treatment, if the medicine used is replaced with a benzodiazepine having a significantly shorter half-life, withdrawal symptoms may develop.
Benzodiazepines should not be used as the sole treatment for depression or anxiety states associated with depression (in such conditions, suicidal tendencies may be increased).
Benzodiazepines should not be used as first-line treatment for psychotic disorders.
Due to the muscle-relaxant effect of the medicine, there is a risk of falls and hip fractures, particularly in elderly patients who get up at night.
History of alcohol, drug or substance abuse
The medicine should be used with particular caution and strictly according to the doctor's instructions.
Medication dependence
Taking medicines from the benzodiazepine group, including Lexotan, or similarly acting medicines, may lead to the development of both physical and psychological dependence on these medicines. The risk of dependence increases with dose and duration of treatment. The risk is also higher in patients with a history of alcohol, drug or substance abuse and in patients with personality disorders.
Warnings regarding specific patient groups
Special care should be taken in patients with chronic respiratory insufficiency due to the risk of respiratory disturbances.
Particular caution is required in patients with mild or moderate hepatic impairment.
Benzodiazepines should not be administered to children without careful assessment of the justification for their use; the duration of treatment should be as short as possible, and the dose should be individually adjusted for each patient.
Elderly patients should receive a reduced dose.
Pregnancy and breastfeeding
Before using any medicine, consult a doctor or pharmacist.
Pregnancy
The safety of bromazepam use in pregnant women has not been definitively established. Although there are no clinical data indicating significant congenital malformations in the fetus due to benzodiazepine use during the first trimester of pregnancy, some epidemiological studies have shown an increased risk of oral clefts.
Therefore, bromazepam should not be used during pregnancy unless strictly indicated and only under strict adherence to the dosing regimen.
The patient should contact the doctor regarding discontinuation of treatment if she plans to become pregnant or suspects she is pregnant.
Administration of bromazepam during the third trimester of pregnancy and during labour is permitted only in cases of absolute necessity, as adverse effects in newborns may be expected, such as hypothermia (lowered body temperature), reduced muscle tone, which may manifest as sucking difficulties (leading to poor weight gain), and moderate respiratory depression or apnoea. Additionally, withdrawal symptoms in the newborn, such as excessive excitability, restlessness, and tremor, have been observed.
In infants whose mothers have taken benzodiazepines long-term during the late stages of pregnancy, physical dependence on the drug may occur, along with a risk of withdrawal symptoms after birth.
Breastfeeding
Benzodiazepines pass into breast milk; therefore, women who are breastfeeding should not use Lexotan.
Driving and operating machinery
Do not drive vehicles or operate machinery, as Lexotan may cause excessive sedation and amnesia, impair concentration and muscle function. In cases of sleep deprivation, the likelihood of reduced alertness may increase. This effect may be particularly intensified if the patient has also consumed alcohol.
Lexotan and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Concomitant use of Lexotan with any medicines that depress the central nervous system (e.g. antidepressants, hypnotics, narcotic analgesics, neuroleptics, anxiolytics and sedatives, anticonvulsants, sedating antihistamines, anaesthetics) and alcohol may enhance the sedative effect of the medicine and increase its depressant effects on the respiratory and circulatory systems.
When narcotic analgesics are used, a state of euphoria may occur, increasing the risk of psychological dependence.
Substances that inhibit the activity of certain liver enzymes may affect benzodiazepines that are metabolized by these enzymes. Concomitant administration of Lexotan with cimetidine, fluvoxamine, or (probably) propranolol may result in stronger or prolonged effects.
Lexotan contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Lexotan.

3. How to use Lexotan

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor.
Lexotan is available in the following doses: 3 mg, 6 mg.
In all cases, Lexotan should be used under medical supervision.
Recommended dosage
Usual doses for outpatients: 1.5 mg to 3 mg up to three times daily.
Severe cases, especially in hospital treatment: 6 mg to 12 mg two or three times daily.
The physician should consider these dosage recommendations as general guidelines and should adjust the dose individually for each patient. Outpatient treatment should begin with low doses, gradually increasing to the optimal dose. Treatment should be as short as possible.
Patients should visit their doctor regularly to assess the continued need for the medicine, especially when disease symptoms are not apparent. Total treatment duration should not exceed 8 to 12 weeks, including the tapering-off period.
In certain cases, treatment may last longer, provided a specialist evaluation of the patient's condition has been performed by the physician.
Elderly patients and patients with impaired liver function require lower doses.
If the effect of Lexotan seems too strong or too weak, consult your doctor.
Taking more Lexotan than prescribed
If you take more Lexotan than prescribed, contact your doctor immediately. The doctor will decide on further management.
Common symptoms of benzodiazepine overdose include: drowsiness, impaired coordination, speech disturbances, and nystagmus.
Overdose with Lexotan is rarely life-threatening when the drug is taken alone. However, it may lead to loss of reflexes, respiratory arrest, hypotension, cardiorespiratory depression, and coma. Coma, if it occurs, usually lasts several hours but may recur and worsen, especially in elderly patients. Respiratory depression symptoms are more severe in patients with pre-existing respiratory disorders.
Benzodiazepines enhance the effects of other central nervous system depressants (including alcohol).
Missing a dose of Lexotan
Do not take a double dose to make up for a missed dose.
Stopping Lexotan
If physical dependence has developed, withdrawal symptoms (withdrawal syndrome) may occur after discontinuation of treatment.
These may include: headache, diarrhea, muscle pain, increased anxiety, tension, restlessness, disorientation, and irritability. In severe cases, the following symptoms may occur: distorted perception of surroundings (derealization), disturbances in self-awareness (depersonalization), hypersensitivity to sounds, numbness and tingling sensations in the limbs, hypersensitivity to light, noise, and touch, hallucinations, or seizures.
After stopping the medicine, rebound anxiety may occur—a transient syndrome in which symptoms that led to the use of Lexotan return in an intensified form. Other reactions may also occur, such as: mood changes, anxiety, sleep disturbances, and restlessness.
Because the risk of withdrawal syndrome and rebound phenomena is greater following abrupt discontinuation of treatment, gradual reduction of the Lexotan dose is recommended.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, Lexotan may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below occurred at an unknown frequency (frequency cannot be estimated from the available data):

hypersensitivity (allergy), anaphylactic shock, angioedema
confusion, disorientation, emotional disturbances and mood disturbances – mainly at the beginning of treatment and usually subsiding during treatment
libido disorders
drug dependence, drug abuse, withdrawal syndrome
depression
paradoxical reactions such as anxiety, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, unusual behaviour, restlessness, fear, unusual dreams, excessive activity and other behavioural disturbances – higher likelihood of such reactions in children and elderly patients
anterograde amnesia
memory impairment
drowsiness, headache, dizziness, reduced alertness, problems with motor coordination and balance – mainly at the beginning of treatment and usually subsiding during treatment
double vision – mainly at the beginning of treatment and usually subsiding during treatment
heart failure, including cardiac arrest
decreased depth and rate of breathing
nausea, vomiting – mainly at the beginning of treatment and usually subsiding during treatment
constipation
rash, itching, urticaria
muscle weakness – mainly at the beginning of treatment and usually subsiding during treatment
urinary retention
fatigue – mainly at the beginning of treatment and usually subsiding during treatment
falls, fractures – risk is increased in patients concurrently using sedatives (including alcoholic beverages) and in elderly patients.

Dependence:
Prolonged use of the medicine (even at therapeutic doses) may lead to the development of psychological and physical dependence. Discontinuation of treatment may result in withdrawal symptoms or "rebound" anxiety (worsening of disease symptoms – see "Discontinuation of Lexotan treatment").
Cases of benzodiazepine abuse have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Lexotan

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Lexotan contains

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

What Lexotan looks like and contents of the pack
Lexotan is available in the form of tablets.
The pack contains 30 tablets of 6 mg, in blisters, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, 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 in:
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 authorisation number in Portugal, country of export: 5470281
Parallel import licence number: 249/19