Tranxene

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Tranxene

10 mg, hard capsules

Dipotassium clorazepate

You should carefully read the contents of the leaflet before using the medicine, 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 medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tranxene and what is it used for
• 2. Important information before taking Tranxene
• 3. How to take Tranxene
• 4. Possible side effects
• 5. How to store Tranxene
• 6. Contents of the packaging and other information

1. What is Tranxene and what is it used for

Tranxene is available in capsule form and contains the active substance dipotassium clorazepate.
Dipotassium clorazepate belongs to a group of medicines called benzodiazepines. It has anxiolytic, muscle relaxant, sedative, hypnotic, and anticonvulsant effects.
Tranxene is used:

• for short-term anxiety and restlessness, especially as an adjunct in the course of neurosis,
• for withdrawal syndrome in alcohol dependence (alcoholic hallucinosis, states preceding delirium tremens). Pharmacological treatment is indicated only in situations where symptoms are severe, disrupt normal functioning, or are bothersome to the patient.

2. Important information before taking Tranxene

When not to take Tranxene:

• if the patient is allergic to the active substance or any of the other ingredients of the medicine (listed in section 6),
• if the patient has severe respiratory failure,
• if the patient has sleep apnea syndrome,
• if the patient has myasthenia (a disease characterized by rapid fatigue and muscle weakness),
• if the patient has severe liver failure,
• in children:
• 5 mg capsules should not be used in children under 9 years of age
• 10 mg capsules should not be used in children

Warnings and precautions

Any benzodiazepine treatment may lead to the development of psychological and physical dependence. Factors predisposing to the development of dependence include: duration of treatment, dose of the medicine, concurrent use of other medicines: psychotropic, anxiolytic or hypnotic, concurrent alcohol consumption, dependence on other medicines or substances in the history.
In case of dependence, after the end of treatment, withdrawal symptoms may occur: insomnia, headaches, increased anxiety, muscle pain, increased muscle tension, very rarely irritability, excitement, and even confusion. In exceptional cases, tremors, hallucinations, and seizures may occur.
The duration of treatment should be as short as possible and not exceed 4 to 12 weeks. The doctor will inform the patient how to end the therapy (gradual reduction of the dose of the medicine - over several days to several weeks).
End of treatment: sudden end of dipotassium clorazepate treatment may lead to the occurrence of withdrawal symptoms, especially in the case of long-term treatment, as well as suspected dependence on the medicine.
During long-term use, tolerance to the medicine may occur (decreased efficacy of the medicine).
During the use of the medicine, anterograde amnesia may occur, especially when benzodiazepines are used directly before going to sleep, and the duration of sleep is short (early awakenings caused by external factors).
To minimize the risk of anterograde amnesia, it is recommended to ensure conditions for continuous, uninterrupted 7-8 hours of sleep.
During the use of benzodiazepines, the following may occur: anxiety, excitement, irritability, aggression, delusions, anger, nightmares, hallucinations, psychoses, atypical behavior, and other behavioral disorders. These symptoms occur more frequently in children and elderly patients. If the above symptoms occur, the use of the medicine should be discontinued.
Concomitant use of benzodiazepines and opioids may cause sedation, respiratory depression, coma, and death.
Due to these risks, the doctor will prescribe opioids and benzodiazepines simultaneously only to patients for whom other treatment options are insufficient.
If the decision is made to use dipotassium clorazepate simultaneously with opioids, the medicines will be prescribed in the smallest effective dose and for the shortest possible time of concurrent use.
Certain studies have shown an increased risk of suicidal thoughts, attempted suicide, and suicide in patients taking certain sedative and hypnotic medicines, including this medicine. However, it has not been determined whether this is caused by taking the medicine or if there are other causes. If the patient has suicidal thoughts, they should contact their doctor as soon as possible to receive further medical advice.
Benzodiazepines with anxiolytic effects should not be used to treat depression and mental disorders.
Benzodiazepines may mask symptoms of depression and should not be used as the only treatment for depression (antidepressant medicines should be used).
Treatment with benzodiazepines alone may increase suicidal tendencies.
Benzodiazepines should be used with great caution in patients with a history of alcohol and other drug (including narcotic) dependence, as they are at risk of physical and psychological dependence.
In elderly patients and patients with renal impairment, it may be necessary to adjust the dose of the medicine (see section 3. How to take Tranxene).
In patients with liver function disorders, caution should be exercised; in patients with liver failure, encephalopathy may occur.
In patients with respiratory failure, the use of benzodiazepines may cause breathing problems (worsening of hypoxia may be the cause of anxiety and require hospitalization in the intensive care unit).
Concomitant use of several benzodiazepines is not beneficial and may increase the risk of dependence.
Benzodiazepines are not recommended for use in patients with psychoses.
Elderly patients are more sensitive to the occurrence of side effects, such as drowsiness, dizziness, muscle weakness, which can lead to falls and, consequently, to serious injuries.
It is recommended to reduce the dose of the medicine.

Tranxene with food, drink, and alcohol

Food does not affect the absorption of the medicine from the gastrointestinal tract.
Tranxene can be taken during meals or on an empty stomach.
During treatment with clorazepate, it is not recommended to consume alcoholic beverages.

Pregnancy, breastfeeding, and fertility

Data on the use of clorazepate in pregnant women are limited.
Therefore, it is not recommended to use this medicine during pregnancy or in women of childbearing age who do not use contraception.
If the patient is pregnant or plans to have a child, they should consult their doctor to reassess the need for treatment.
If the patient takes clorazepate in high doses during the last three months of pregnancy or during childbirth, the child may experience sedation (sedation), breathing problems (respiratory depression), muscle weakness (hypotonia), decreased body temperature (hypothermia), and feeding difficulties (problems with sucking leading to poor weight gain).
If the patient regularly takes clorazepate at the end of pregnancy, the child may experience withdrawal syndrome. In such a case, the newborn should be closely monitored during the postpartum period.
Tranxene should not be used during breastfeeding.

Driving and using machines

The ability to drive vehicles and operate machinery may be impaired during the use of dipotassium clorazepate due to the occurrence of concentration disorders, drowsiness, and anterograde amnesia. Concomitant use of other medicines may enhance the sedative effect of dipotassium clorazepate (see section 2 "Tranxene and other medicines").

Tranxene and other medicines

The patient should inform their doctor about all medicines taken recently, including those that are available without a prescription.
The risk of withdrawal symptoms increases during concomitant use of other anxiolytic and hypnotic benzodiazepines.
During treatment, the patient should avoid consuming alcohol and taking medicines containing alcohol.
Alcohol enhances the sedative effect of benzodiazepines.
Cautious use of Tranxene is recommended with:

• medicines with a depressant effect on the central nervous system, such as: opioids, morphine derivatives, including buprenorphine (painkillers, antitussives, and used in other therapies), neuroleptics, barbiturates, certain antidepressants, antihistamines with a sedative effect, sedatives other than benzodiazepines, clonidine, and medicines with similar effects;
• cisapride (a medicine that stimulates gastrointestinal motility) due to the possibility of increased sedative effect of benzodiazepines;
• clozapine (a neuroleptic medicine) due to the increased risk of collapse with respiratory and/or cardiac arrest;
• curare and its derivatives (muscle relaxants) due to the additive effect.

Concomitant use of benzodiazepines and opioids increases the risk of sedation, respiratory depression, coma, and death due to enhanced depressant effect on the central nervous system.
Concomitant use of benzodiazepines and sodium oxybate should be avoided due to the increased risk of respiratory depression.

3. How to take Tranxene

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.
Treatment should be started with an initial dose, gradually increasing the dose to avoid the occurrence of side effects. The maximum dose of 30 mg per day should not be exceeded. The duration of treatment should be as short as possible and not exceed 8 to 12 weeks, including the period of dose reduction. During treatment, the patient should be regularly monitored to adjust the dose or frequency of administration of the medicine if necessary. Due to the possibility of withdrawal symptoms, the medicine should be discontinued carefully, gradually reducing the daily dose.
Adults:
The therapeutic dose is 5 to 30 mg per day.
Treatment is recommended to be started with a dose of 5 mg per day.
The daily dose can be taken once a day, in the evening.
Use in children and adolescents:
Tranxene 5 mg: due to limited data on the use of Tranxene in children and adolescents for the treatment of anxiety, it is not recommended to use Tranxene in this age group.
Only in exceptional cases, a specialist doctor may use this medicine in children over 9 years of age: at a dose of 0.5 mg/kg body weight per day in divided doses.
Tranxene 10 mg: Tranxene 10 mg is intended for use in adults.
Elderly patients should have their dose reduced by 50%; treatment should be as short as possible.
Patients with renal impairment should have their dose reduced by 50%.
Patients with liver function disorders should exercise caution when using the medicine; in patients with liver failure, encephalopathy may occur.
If the patient feels that the effect of Tranxene is too strong or too weak, they should consult their doctor.

Using a higher than recommended dose of Tranxene

The main symptom of severe overdose of the medicine is deep sleep, which, depending on the dose taken, may progress to coma.
The prognosis is favorable if the patient has not taken other psychotropic medicines and receives appropriate treatment.
The patient should be hospitalized in the intensive care unit, where their respiratory and cardiovascular systems will be monitored.
If it has not been more than an hour since the medicine was taken and the patient is conscious, vomiting should be induced, and if the patient is unconscious, the doctor will perform gastric lavage, ensuring the protection of the upper airways. If more than an hour has passed since the overdose, activated charcoal can be administered to reduce the absorption of the medicine from the gastrointestinal tract.
After a minor overdose, the following may occur: drowsiness, disorientation, lethargy; after a more severe overdose: coordination disorders, decreased muscle tone, hypotension, breathing disorders, rarely coma, and very rarely death.
The doctor may use flumazenil to diagnose and/or treat benzodiazepine overdose.
In case of overdose, the patient should immediately call their doctor.

Missing a dose of Tranxene

In case of missing a dose, the patient should take it as soon as possible, unless it is close to the time of the next dose. A double dose should not be taken to make up for the missed dose. In case of doubts, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Tranxene can cause side effects, although they may not occur in every patient.
The frequency and severity of side effects depend on the individual sensitivity of the patient and the dose of the medicine.
The following side effects may occur:
Very common(may occur in more than 1 in 10 patients):

• drowsiness (especially in elderly patients)

Common(may occur in up to 1 in 10 patients):

• dizziness
• weakness

Uncommon(may occur in up to 1 in 100 patients):

• allergic reactions
• irritability, excitement, confusion
• decreased muscle tone
• papular and pruritic skin rashes

Frequency not known(frequency cannot be estimated from the available data):

• slowing of mental processes
• paradoxical reactions (especially in children and elderly patients)
• aggression, hallucinations
• so-called rebound syndrome with more severe anxiety than that for which treatment was indicated
• physical dependence in case of long-term treatment (especially with high doses) and, after withdrawal of the medicine, withdrawal symptoms*
• cognitive function disorders, such as memory impairment (anterograde amnesia*), attention disorders, and speech disorders
• falls*

* see section Warnings and precautions
Additionally, during the use of benzodiazepines, the following side effects have been reported:

• emotional suppression, decreased alertness, headache,
• coordination disorders,
• double vision,
• gastrointestinal disorders,
• libido disorders,
• occurrence of amnesia (amnesia), which may be associated with atypical behavior.
• psychotic and paradoxical reactions with anxiety, delusions, fits of anger, nightmares, hallucinations, psychoses, atypical behavior, and other behavioral disorders.

During the use of benzodiazepines, previously undiagnosed depression may be revealed.
Psychological dependence may occur. Cases of benzodiazepine abuse have been reported.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Tranxene

No special storage precautions.
The medicine should be stored in a place that is invisible and inaccessible to children.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Tranxene contains

Each capsule contains the active substance dipotassium clorazepate 10 mgand the following excipients:
potassium carbonate, talc. Capsule shell: erythrosine, titanium dioxide (E 171), gelatin.

What Tranxene looks like and what the packaging contains

The packaging contains 30 capsules.
The 10 mg capsule is opaque, with a light pink cap and body, has a smooth, shiny surface, and contains a uniform white or yellowish powder.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Sanofi - Produtos Farmacêuticos, Lda.
Empreendimento Lagoas Park
Edifício 7, 3º Piso
2740-244 Porto Salvo, Portugal

Manufacturer:

Sanofi Aventis S.A. (Fab. Girona)
Ctra. C-35 - La Batlloria a Hostalric km. 63, 09
Riells i Viabrea, 17404 Girona
Spain

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

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 authorization number in Portugal, the country of export: 5842497
4507885
4507984

Parallel import authorization number: 443/22 Date of leaflet approval: 22.12.2022

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