Tranxene

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

TRANXENE

10 mg, hard capsules

Dipotassium clorazepate

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this patient. 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 inform 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 package and other information

1. What is Tranxene and what is it used for

Tranxene is available in the form of hard capsules and contains the active substance clorazepate. 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 anxiety disorders, especially as a temporary adjunct in the course of neurosis,
• for alcohol withdrawal syndrome (alcoholic hallucinations, 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 gravis (a disease characterized by rapid fatigue and muscle weakness),
• if the patient has severe liver failure,
• in children: Tranxene, hard capsules, 10 mg, 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, concomitant use of other psychotropic medicines, anxiolytics, or hypnotics, concomitant 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, and very rarely irritability, agitation, 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). Ending treatment: sudden ending of 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, agitation, 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 clorazepate simultaneously with opioids, the medicines will be prescribed in the smallest effective dose and for the shortest possible time of concomitant use. Some studies have shown an increased risk of suicidal thoughts, attempted suicide, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by taking this 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. Anxiolytic benzodiazepines should not be used to treat depression and mental disorders. Benzodiazepines may mask the symptoms of depression and should not be used as the only treatment for depression (antidepressants should be used). Treatment with benzodiazepines alone may exacerbate 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 developing 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 when using the medicine; 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 may 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 patients with psychoses. Elderly patients are more susceptible to adverse reactions, 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 clorazepate treatment, 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, suspects that she may be pregnant, or plans to have a child, she should consult her 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, resulting in 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

During the use of the medicine, the patient should not drive vehicles or operate machines. The ability to drive vehicles and operate machines may be limited during the use of clorazepate due to the occurrence of concentration disorders, drowsiness, and anterograde amnesia. Concomitant use of other medicines may enhance the sedative effect of clorazepate (see section Tranxene and other medicines).

Tranxene and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as medicines they plan to take, even 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. Caution should be exercised when using Tranxene 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, some antidepressants, antihistamines with a sedative effect, sedatives other than benzodiazepines, clonidine, and medicines with similar effects;

During the use of benzodiazepines, the following may occur: anxiety, agitation, 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 clorazepate simultaneously with opioids, the medicines will be prescribed in the smallest effective dose and for the shortest possible time of concomitant use.

• 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 (medicines that reduce skeletal muscle tension) due to the additive effect.

Concomitant use of benzodiazepines and opioids increases the risk of sedation, respiratory depression, coma, and death due to the 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 instructions. In case of doubts, the patient should consult their doctor. Tranxene is available in doses of 5 mg and 10 mg. Treatment should be started with an initial dose, gradually increasing the dose to avoid adverse reactions. The maximum dose should not exceed 30 mg per day. 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 if necessary. Due to the possibility of withdrawal symptoms, the medicine should be discontinued cautiously, gradually reducing the daily dose. Adults: The therapeutic dose is 5 to 30 mg per day. Treatment is recommended to start 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, 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.

Use of a higher than recommended dose of Tranxene

The main symptom of severe overdose 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 been less 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 consult their doctor.

Missing a dose of Tranxene

If a dose is missed, it should be taken 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 not everybody gets them. The frequency and severity of side effects depend on the individual patient's sensitivity 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, agitation, confusion
• decreased muscle tone
• maculopapular 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 discontinuation 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"

In addition, 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. Psychic 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 this 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 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 medicine.

5. How to store Tranxene

The medicine should be stored in a place that is invisible and inaccessible to children. There are no special recommendations for storage. This 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 package and other information

What Tranxene contains

Each hard capsule contains the active substance dipotassium clorazepate (10 mg) and the following excipients: potassium carbonate, talc. Shell:Body: gelatin, titanium dioxide (E 171), erythrosine (E 127). Cap: gelatin, titanium dioxide (E 171), erythrosine (E 127).

What Tranxene looks like and what the package contains

The package contains 30 hard capsules. The 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 parallel importer.

Marketing authorization holder in Portugal, the country of export:

Neuraxpharm Portugal, Unipessoal Lda. Avenida Dom João II, nº 35 Edifício Infante, 6º I 1990-083 Lisbon Portugal

Manufacturer:

Sanofi Aventis, S.A. Carretera de la Batlloria a Hostalric km. 63, 09 17404 Riells i Viabrea Girona Spain

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Authorization number in Portugal, the country of export: 5842497 4507885 4507984

Parallel import authorization number: 252/18

Date of leaflet approval: 04.09.2024

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