Lexotan

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lexotan (Lexotanil), 3 mg, tablets

Bromazepamum
Lexotan and Lexotanil are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, 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 drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform 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 using Lexotan
• 3. How to use Lexotan
• 4. Possible side effects
• 5. How to store Lexotan
• 6. Contents of the packaging and other information

1. What is Lexotan and what is it used for

Lexotan contains bromazepam, which is an anxiolytic drug belonging to the benzodiazepine group.
Lexotan is indicated for the treatment of anxiety disorders, including generalized anxiety disorders, autonomic dysfunction, and anxiety states associated with chronic organic brain diseases.

• generalized anxiety disorders
• autonomic dysfunction, including somatic symptoms such as skin symptoms, gastrointestinal symptoms, cardiovascular symptoms, and genitourinary symptoms
• anxiety states associated with chronic organic brain diseases
• post-traumatic stress disorders with anxiety symptoms
• adjustment disorders

2. Important information before using Lexotan

When not to use Lexotan:

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 frequency of administration, and during treatment to prevent overdose.
Amnesia
Benzodiazepines can cause anterograde amnesia. This condition occurs most often a few hours after taking the drug. 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.
Psychological reactions
When using benzodiazepines, reactions such as anxiety, agitation, irritability, aggression, anxiety, false beliefs about the external environment or one's own state, outbursts of anger, nightmares, hallucinations, psychosis, abnormal behavior, and other adverse behaviors may occur.
If such symptoms occur, the patient should immediately contact their doctor.
The above-mentioned 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 drug should be gradually reduced under medical supervision. During the withdrawal of the drug, a rebound phenomenon may occur (see section 3, "Discontinuation of Lexotan").
Consumption of alcohol or use of drugs that depress the central nervous system
During the use of Lexotan, the patient should not drink alcohol or take drugs that depress the central nervous system.
Alcohol may enhance the effect of Lexotan and cause severe sedation symptoms, as well as respiratory or circulatory depression, which can lead to coma or death.
Tolerance
In the case of repeated use of Lexotan for a longer period, the drug's effectiveness may decrease.
During benzodiazepine treatment, if the used drug 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 (in the case of these diseases, there may be a greater tendency to commit suicide).
Benzodiazepines should not be used as the first-line treatment for psychotic disorders.
During the use of the drug, due to its muscle relaxant effect, there is a risk of falls and hip fractures, especially in older patients, when getting up at night.
Past abuse of alcohol, drugs, or narcotics
The drug should be used with special caution, strictly according to the doctor's recommendations.
Drug dependence
Taking benzodiazepine drugs, including Lexotan, or similarly acting drugs, can lead to the development of physical and psychological dependence on these drugs. The risk of dependence increases with the dose and duration of treatment. The increased risk also applies to patients who have abused alcohol, drugs, or narcotics, and patients with personality disorders.
Warnings for specific 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 justification 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 drug in reduced doses.

Pregnancy and breastfeeding

Before using any drug, the patient should consult a doctor or pharmacist.
Pregnancy
The safety of using bromazepam in pregnant women has not been established. Although there are no clinical data on the occurrence of significant congenital malformations in the fetus due to the use of benzodiazepines 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 cases and with strict adherence to the dosing schedule.
The patient should contact their doctor about stopping treatment if they plan to become pregnant or suspect they are pregnant.
Administration of bromazepam in the third trimester of pregnancy and during childbirth is allowed only in cases of absolute indication, as adverse reactions may occur in newborns, such as hypothermia, decreased muscle tone, which may manifest as problems with sucking (leading to poor weight gain) and moderate respiratory depression or apnea. Additionally, withdrawal symptoms have been observed in newborns, manifested as excessive irritability, anxiety, and tremors.
In children of mothers who have taken benzodiazepines for a long time in the last period of pregnancy, physical dependence on the drug and the risk of withdrawal symptoms after birth may occur.
Breastfeeding
Benzodiazepines pass into breast milk, so breastfeeding women should not use 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 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 drugs

The patient should tell their doctor about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Concomitant use of Lexotan with any drugs that depress the central nervous system (such as antidepressants, sedatives, narcotic analgesics, neuroleptics, anxiolytics, anticonvulsants, sedatives, antihistamines with a sedative effect, and anesthetics) and alcohol may enhance the sedative effect of the drug and increase its inhibitory effect on the respiratory and circulatory systems.
In the case of the use 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. Concomitant 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 some sugars, they should consult their doctor before taking Lexotan.

3. How to use Lexotan

This drug should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Lexotan is available in doses of 3 mg and 6 mg.
In each case, Lexotan should be used 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 treat the given dosing as general guidelines and individualize the dose for each patient. Outpatient treatment should be started with small doses, gradually increasing them to the optimal size. Treatment should be as short as possible.
The patient should regularly visit their doctor to assess the need for continued use of the drug, 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 drug.
In some cases, therapy may last longer, provided that a specialized assessment of the patient's condition is carried out 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.

Use of 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 poses a threat to life if the drug 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.

Discontinuation of 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), increased sensitivity to sounds, feelings of numbness and tingling in the limbs, increased sensitivity to light, noise, and touch, hallucinations, or seizures.
After stopping the drug, a rebound anxiety phenomenon may occur - a transient syndrome in which the symptoms that were the reason for using 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 sudden discontinuation of treatment, it is recommended to gradually reduce the dose of Lexotan.
In case of any further doubts related to the use of this drug, the patient should consult their doctor.

4. Possible side effects

Like any drug, Lexotan can cause side effects, although not everyone will experience them.
The following side effects have been reported with an unknown frequency (cannot be estimated based on available data):

• hypersensitivity (allergy), anaphylactic shock, angioedema
• confusion, disorientation, emotional disturbances, and mood disorders - 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, abnormal 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
• decreased 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 people using sedatives (including alcoholic beverages) and in older adults

Dependence:
Long-term use of the drug (even in therapeutic doses) may lead to the development of physical and psychological dependence on the drug, and discontinuation of 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 inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects can help gather more information on the safety of the drug.

5. How to store Lexotan

The drug should be stored in a place invisible and inaccessible to children.
Do not store above 30°C.
Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist what to do with unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Lexotan contains

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

What Lexotan looks like and what the packaging contains

Lexotan is available in tablet form.
The packaging contains 30 tablets, in blisters placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:15801/15-03-2010
24191/29-06-2017
119950/13-11-2020
Parallel import authorization number:86/20

Date of leaflet approval: 18.12.2024

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