Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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 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. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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 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 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 treatment of patients with severe liver impairment 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 ongoing 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 unusual 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").
Consumption of alcohol 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 enhance 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, withdrawal symptoms may develop if the medicine used is replaced with a benzodiazepine having a significantly shorter half-life.
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 medication 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 increased in patients with a history of alcohol, drug or medication 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 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 in exceptional, strictly justified cases and with strict adherence to the prescribed dosage regimen.
The patient should contact her 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. In addition, withdrawal symptoms in the newborn, manifesting as excessive excitability, restlessness and tremor, have been observed.
In infants of mothers who have taken benzodiazepines long-term during late pregnancy, physical dependence on the medicine 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 or operate machinery, as Lexotan may cause excessive sedation and amnesia, impair concentration and muscle function. The likelihood of reduced alertness may increase if the patient is sleep-deprived. 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, opioid analgesics, neuroleptics, anxiolytics and sedatives, anticonvulsants, sedating antihistamines, anaesthetics) and alcohol may enhance the sedative effect of the medicine and increase its suppressive effects on the respiratory and circulatory systems.
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 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 as directed by the physician. In case of 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.
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 prescribed dosage should be considered by the physician as general guidelines, and the dose should be individually adjusted for each patient. Outpatient treatment should begin with low doses, gradually increasing them to the optimal level. Treatment should be as short as possible.
The patient should regularly visit the doctor to assess the need for continued use of the medicine, especially in situations where no symptoms of illness are observed. Total treatment duration should not exceed 8 to 12 weeks, including the period of gradual discontinuation of the medicine.
In some 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.
Use of a higher than recommended dose of Lexotan
If a higher than recommended dose is taken, contact your doctor immediately.
The doctor will decide on further management.
Common symptoms of benzodiazepine overdose include: drowsiness, impaired motor coordination, speech disturbances, and nystagmus.
Overdose of Lexotan rarely threatens life when the drug is taken alone. However, it may lead to loss of reflexes, respiratory arrest, drop in arterial blood pressure, cardiorespiratory depression, and coma. Coma, if it occurs, usually lasts several hours but may recur and worsen, especially in elderly individuals. 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.
Discontinuation of Lexotan
If physical dependence has developed, withdrawal symptoms (withdrawal syndrome) will occur after stopping 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 the sense of self-identity (depersonalization), hypersensitivity to sounds, 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 greater following abrupt discontinuation of treatment, gradual reduction of the Lexotan dose is recommended.
In case of any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, Lexotan may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below occurred with 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, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, unusual behaviour, restlessness, anxiety, abnormal dreams, excessive activity and other behavioural disturbances – these types of reactions are more likely 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
muscle weakness – 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 any 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 to provide more information on the safety of using this 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. This will 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.
Other components of the medicine are: microcrystalline cellulose, magnesium stearate, talc, and: monohydrate lactose (90.85 mg in 1 tablet), indigo carmine aluminium lake (E 132), yellow iron oxide (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 PVC/Al 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:
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 number in Portugal, country of export: 4576880
Parallel import authorisation number: 432/17