Tranxene

Package Leaflet: Information for the Patient

TRANXENE, 5 mg, capsules

TRANXENE, 10 mg, capsules

Dipotassium clorazepate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack and other information

1. What is Tranxene and what is it used for

Tranxene is available in capsule form 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 an adjunct in the treatment of neurosis,
• for alcohol withdrawal syndrome (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 you are allergic to the active substance or any of the other ingredients of the medicine (listed in section 6),
• if you have severe respiratory failure,
• if you have sleep apnea syndrome,
• if you have myasthenia gravis (a disease characterized by rapid fatigue and muscle weakness),
• if you have 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, concomitant use of other medicines: psychotropic, anxiolytic or hypnotic, concomitant use of alcohol, 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, 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 treatment, 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 benzodiazepine treatment, 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 concurrently only to patients for whom other treatment options are insufficient. If the decision is made to use clorazepate concomitantly 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, suicide attempts, and suicides in patients taking certain sedative and hypnotic medicines, including this medicine. However, it has not been determined whether this is caused by taking this medicine or if there are other reasons. 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 caution in patients with a history of alcohol or 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 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 use in 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 drowsiness (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

During treatment, you should not drive vehicles or operate machines. The ability to drive vehicles and operate machines may be impaired during clorazepate treatment 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

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you 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, you should avoid consuming alcohol and taking medicines containing alcohol. Alcohol enhances the sedative effect of benzodiazepines. You should be cautious when taking Tranxene concomitantly with:

• medicines with a depressant effect on the central nervous system, such as: opioids, morphine derivatives, including buprenorphine (pain relievers, 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;

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. You should avoid concomitant use of benzodiazepines and sodium oxybate 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. If you have any doubts, consult your doctor. Treatment should be started with an initial dose, gradually increasing the dose to avoid adverse reactions. Do not exceed the maximum dose of 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 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 this medicine 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 taking the medicine; in patients with liver failure, encephalopathy may occur. If you feel that the effect of Tranxene is too strong or too weak, consult your doctor.

Overdose of Tranxene

The main symptom of severe overdose is deep sleep, which, depending on the dose taken, may lead 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, consult your doctor immediately.

Missed dose of Tranxene

If you miss a dose, take it as soon as possible, unless it is close to the time of the next dose. Do not take a double dose to make up for the missed dose. If you have any doubts, consult your 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 individual patient sensitivity and the dose of the medicine. The following side effects may occur:

• Very common(may occur in more than 1 in 10 patients):

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

• drowsiness (especially in elderly 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 the one that was the indication for treatment
• 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 Additionally, the following side effects have been reported during benzodiazepine treatment:

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

During benzodiazepine treatment, previously undiagnosed depression may be revealed. Psychic dependence may occur. Cases of benzodiazepine abuse have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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. Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tranxene

There are no special precautions. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

6. Contents of the pack and other information

What Tranxene contains

Each capsule contains the active substance dipotassium clorazepate 5 mg or 10 mg, depending on the strength indicated on the blister and carton, and the following excipients: potassium carbonate, talc. Capsule shell: gelatin, titanium dioxide, erythrosine.

What Tranxene looks like and contents of the pack

The pack contains 30 capsules. The 5 mg capsule is opaque, with a light pink cap and a white body, with a smooth, shiny surface, containing a uniform white or yellowish powder. The 10 mg capsule is opaque, with a light pink cap and a white body, with a smooth, shiny surface, containing a uniform white or yellowish powder.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert Str. 23, 40764 Langenfeld, Germany

Manufacturer

Sanofi-Winthrop Industrie, 1, rue de la Vierge, Ambares et Lagrave, 33565 Carbon Blanc Cedex, France, sanofi-aventis, S.A., Carretera de la Batlloria a Hostalric km. 63.09, 17404 Riells i Viabrea (Girona), Spain

Date of last revision of the leaflet: 01/2024