Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Lexotan (Lexotanil), 3 mg, tablets
Bromazepam
Lexotan and Lexotanil are different brand names for the same medicine.
Please read this leaflet carefully before taking 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 questions, 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 the same.
If you experience any adverse effects, 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 group of benzodiazepines.
Lexotan is indicated for pharmacological treatment of:

generalized anxiety disorders
autonomic dysfunctions presenting in somatic form, including skin, gastrointestinal, cardiovascular, and urogenital 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 to 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 entire duration of treatment – at the beginning of treatment to determine the minimum effective dose and dosing frequency, and during treatment to prevent drug overdose.
Amnesia
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. Anterograde amnesia may be associated with abnormal behaviour.
Psychological reactions
When using benzodiazepines, reactions such as anxiety, agitation, irritability, aggression, anxiety, delusions about 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, "Stopping Lexotan").
Alcohol consumption or use of medicines that suppress the central nervous system
During treatment with Lexotan, alcohol should not be consumed and medicines that suppress the central nervous system should not be taken.
Alcohol may intensify the effect of Lexotan and cause severe sedative symptoms and may lead to respiratory or circulatory depression, which may result in 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 treatment for psychotic disorders.
During treatment, due to the muscle-relaxant effect, there is a risk of falls and hip fractures, especially in elderly patients when getting 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.
Drug 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 increased in patients with a history of alcohol, drug or substance abuse and in patients with personality disorders.
Warnings regarding specific patient groups
Particular 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 insufficiency.
Benzodiazepines should not be given 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.
The medicine should be administered in reduced doses to elderly patients.
Pregnancy and breastfeeding
Before taking 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 foetus due to benzodiazepine use 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 circumstances and with strict adherence to the dosing regimen.
The patient should contact the doctor about discontinuing treatment if she plans to become pregnant or suspects she is pregnant.
Administration of bromazepam in the third trimester of pregnancy and during delivery is permitted only in cases of absolute medical 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. In addition, withdrawal symptoms in the newborn, such as excessive irritability, restlessness and tremors, have been observed.
In infants whose mothers took benzodiazepines long-term during the last stage 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 vehicles or operate machinery, as Lexotan may cause excessive sedation and amnesia, impair concentration and muscle function. In case of sleep deprivation, the likelihood of reduced alertness may increase. This effect may be particularly intensified if the patient additionally consumes alcohol.
Lexotan and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as about medicines the patient plans to use.
Concomitant use of Lexotan with any medicines that suppress the central nervous system (e.g. antidepressants, hypnotics, opioid analgesics, neuroleptics, anxiolytics and sedatives, anticonvulsants, sedative antihistamines, anaesthetics) and alcohol may intensify the sedative effect of the medicine and increase its suppressive effect on the respiratory and circulatory systems.
When opioid analgesics are used, 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 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 as directed by the physician. In case of doubt, consult your doctor.
Lexotan is available in 3 mg and 6 mg strengths.
In all cases, Lexotan should be used under medical supervision.
Typical dosage:
Average doses for outpatients: 1.5 mg to 3 mg 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.

The patient should visit the doctor regularly to evaluate the need for continued treatment, especially when disease symptoms are no longer present. Total treatment duration should not exceed 8 to 12 weeks, including the tapering-off period.
In some cases, treatment may last longer, provided a specialist evaluation of the patient's condition is 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 than the recommended dose of Lexotan
In case of taking more than the recommended dose, contact your doctor immediately. The doctor will decide on further management.

Common symptoms of benzodiazepine overdose include: drowsiness, impaired coordination, slurred speech, 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 deepen, 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).

Missed dose of Lexotan
Do not take a double dose to make up for a missed dose.

Stopping Lexotan treatment
If physical dependence has developed, withdrawal symptoms (withdrawal syndrome) may occur after discontinuation of treatment.

These may include: headache, diarrhoea, 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 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 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.

Since the risk of withdrawal syndrome and rebound phenomena is higher with abrupt discontinuation of treatment, gradual reduction of the Lexotan dose is recommended.

If you have any further questions about 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 have occurred with an unknown 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
decreased libido
drug dependence, drug abuse, withdrawal syndrome
depression
paradoxical reactions such as anxiety, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, unusual behavior, restlessness, anxiety, unusual dreams, excessive activity, and other behavioral disturbances – these types of reactions are more likely in children and elderly patients
anterograde amnesia
impaired memory
drowsiness, headache, dizziness, reduced alertness, problems with 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
reduced depth and frequency of breathing
nausea, vomiting – mainly at the beginning of treatment and usually subsiding during treatment
constipation
rash, itching, urticaria
decreased muscle strength – 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, 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 any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 helps provide more information on the safety of the medicine.

5. How to store Lexotan

Keep this medicine out of sight and reach of children.
Do not store at temperatures 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lexotan contains

The active substance is bromazepam (Bromazepamum). One tablet contains 3 mg of bromazepam.
The other ingredients are: microcrystalline cellulose, magnesium stearate, talc, lactose monohydrate, and iron oxide red (E 172).

What Lexotan looks like and contents of the pack
Lexotan is available 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 exporting country:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Delpharm Milano S.r.l.
Via Carnevale, 1
20054, Segrate (MI)
Italy
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation numbers in Greece, the exporting country: 15801/15-03-2010
24191/29-06-2017
119950/13-11-2020
Parallel Import Licence number: 86/20