Package leaflet: information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Lexotan (Lexotanil)
6 mg, tablets
Bromazepam
Lexotan and Lexotanil are different brand names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Lexotan is and what it is used for
What you need to know 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 group of benzodiazepines.
Lexotan is indicated for pharmacological treatment of:

generalized anxiety disorders
autonomic dysfunctions presenting in somatic form, 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 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 the treatment of patients with severe liver failure due to the risk of brain damage)
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 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 usually occurs several hours after taking the medicine. To reduce the risk of anterograde amnesia, the patient should have uninterrupted sleep for several hours. Amnesic effects may be associated with abnormal behaviour.
Psychological reactions
When using benzodiazepines, reactions such as anxiety, agitation, irritability, aggression, anxiety, delusions regarding the external environment or one's own condition, outbursts of anger, nightmares, hallucinations, psychoses, unusual behaviour and other undesirable behaviours may occur.
If such symptoms occur, contact a 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 (should 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 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, long-term use of Lexotan may lead to reduced effectiveness of the medicine.
During benzodiazepine treatment, if the medicine used is replaced by a benzodiazepine with 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 these conditions, suicidal tendencies may be increased).
Benzodiazepines should not be used as first-line therapy for psychotic disorders.
Due to the muscle-relaxant effect of the medicine, there is a risk of falls and hip fractures, especially 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 physical and psychological dependence. The risk of dependence increases with dose and duration of treatment. The risk is also increased in patients with a history of alcohol, drug or substance abuse, and in patients with personality disorders.
Warnings regarding specific patient groups
Patients with chronic respiratory insufficiency should be closely monitored due to the risk of respiratory disturbances.
Particular caution is required in patients with mild or moderate liver insufficiency.
Benzodiazepines should not be administered to children without careful assessment of the justification for their use; treatment duration should be as short as possible, and the dose should be individually adjusted for each patient.
Elderly patients should be given 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 cleft palate.
Therefore, bromazepam should not be used during pregnancy unless strictly indicated and under close adherence to the dosing regimen.
The patient should contact a doctor about discontinuing treatment if she plans to become pregnant or suspects she is pregnant.
Administration of bromazepam during the third trimester of pregnancy and during delivery 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 leading to sucking difficulties (resulting in poor weight gain), and moderate respiratory depression or apnoea. Additionally, withdrawal symptoms in the newborn, manifested as excessive irritability, restlessness and tremors, have been observed.
In children of mothers who have taken benzodiazepines long-term during the late stages of pregnancy, physical dependence on the drug and risk of withdrawal symptoms after birth may occur.
Breastfeeding
Benzodiazepines pass into breast milk; therefore, women who are breastfeeding should not use Lexotan.
Driving and operating machinery
Do not drive motor vehicles or operate machinery, as Lexotan may cause excessive sedation and amnesia, impair concentration and muscle function. The likelihood of reduced alertness may increase in case of sleep deprivation. This effect may be particularly intensified if the patient has additionally consumed alcohol.
Lexotan with other medicines
Inform the doctor about all medicines currently 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, opioid analgesics, neuroleptics, anxiolytics and sedatives, anticonvulsants, sedative antihistamines, anaesthetics) and alcohol may enhance the sedative effect of the medicine and increase its respiratory and circulatory depressant effects.
When opioid analgesics are used concomitantly, a state of euphoria may occur, increasing the risk of psychological dependence.
Substances that inhibit the activity of certain liver enzymes may affect benzodiazepines metabolized by these enzymes. Concomitant administration of Lexotan with cimetidine, fluvoxamine, or (probably) propranolol may result in stronger or prolonged effects.
Lexotan contains 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 taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
Lexotan is available in doses of 3 mg and 6 mg.
In all cases, Lexotan should be used under medical supervision.
Typical dosage
Average 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 doctor should treat these dosage recommendations as general guidelines and adjust the dose
individually for each patient. Outpatient treatment should begin with low doses, gradually increasing
to the optimal dose. Treatment should last as short a time as possible.
The patient should visit the doctor regularly to assess the continued need for the medicine, especially
when disease symptoms are no longer present. The total duration of therapy should not exceed 8 to 12
weeks, including the tapering-off period.
In certain cases, therapy may last longer, provided a specialist evaluation of the patient's condition
has been carried out by the doctor.
Elderly patients and patients with impaired liver function require lower doses.
If the patient feels that the effect of Lexotan is too strong or too weak, they should contact the doctor.
Taking more than the recommended dose of Lexotan
If more than the recommended dose has been taken, contact a 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, apnea, decreased blood pressure, respiratory and circulatory depression, and
coma. Coma, if it occurs, usually lasts several hours but may recur and deepen, especially in elderly
patients. Symptoms of respiratory depression are more severe in patients with pre-existing
respiratory disorders.
Benzodiazepines enhance the effects of other central nervous system depressants (including alcohol).
Missed dose of Lexotan
Do not take a double dose to make up for a missed dose.
Stopping treatment with 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 the surrounding reality (derealization), disturbances in self-awareness
(depersonalization), hypersensitivity to sound, numbness and tingling sensations in the limbs,
hypersensitivity to light, noise, and touch, hallucinations, or seizures.
After discontinuation of the drug, "rebound anxiety" may occur—a transient syndrome in which the
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, it is recommended to gradually reduce the dose of Lexotan.
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 everybody 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 resolving during treatment
libido disorders
drug dependence, drug abuse, withdrawal syndrome
depression
paradoxical reactions such as anxiety, restlessness, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, unusual behavior, nervousness, anxiety, abnormal dreams, excessive activity, and other behavioral disturbances – higher probability 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 resolving during treatment
double vision – mainly at the beginning of treatment and usually resolving during treatment
heart failure, including cardiac arrest
reduced depth and frequency of respiration
nausea, vomiting – mainly at the beginning of treatment and usually resolving during treatment
constipation
rash, itching, urticaria
decreased muscle strength – mainly at the beginning of treatment and usually resolving during treatment
urinary retention
fatigue – mainly at the beginning of treatment and usually resolving 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, and 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 those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions allows the collection of additional 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. Contents of the packaging and other information

What Lexotan contains

The active substance is bromazepam (Bromazepamum). 1 tablet contains 6 mg of bromazepam.
The other ingredients are: microcrystalline cellulose, magnesium stearate, talc, lactose monohydrate, indigo carmine aluminium lake (E 132), yellow iron oxide (E 172).

What Lexotan looks like and contents of the pack
Lexotan is in the form of tablets.
The pack contains 30 tablets 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 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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Greece, the country of export: 119951/13-11-2020
Parallel import licence number: 235/24