Tranxene

Patient Information Leaflet

Warning! Keep this leaflet – the packaging information is in a foreign language!
Tranxene
5 mg, hard capsules
Chlorazepate dipotassium
Please read this leaflet carefully before taking this 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, 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.

Table of contents

1. What Tranxene is and what it is 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 Tranxene is and what it is used for

Tranxene is available in the form of capsules and contains the active substance chlorazepate dipotassium.
Chlorazepate dipotassium belongs to a group of medicines called benzodiazepines. It has anxiolytic, muscle relaxant, sedative, hypnotic, and anticonvulsant properties.
Tranxene is used:

• in short-term anxiety and nervousness, particularly as temporary supportive treatment in neuroses;
• in alcohol withdrawal syndrome (alcohol hallucinosis, states preceding delirium tremens). Pharmacological treatment is indicated only when symptoms are severe, interfere with normal functioning, or cause significant distress to the patient.

2. Important information before using Tranxene

When not to use Tranxene:

• if the patient is allergic to the active substance or to any of the other ingredients of the medicine (listed in section 6),
• if the patient has severe respiratory insufficiency,
• if the patient has sleep apnoea syndrome,
• if the patient suffers from myasthenia gravis (a disease characterised by rapid muscle fatigue and weakness),
• if the patient suffers from severe hepatic insufficiency,
• in children:
• 5 mg capsules must not be used in children under 9 years of age

Warnings and precautions

Any treatment with benzodiazepines may lead to the development of psychological and physical dependence. Factors predisposing to dependence include: duration of treatment, dosage, concomitant use of other medicines such as psychotropic drugs, anxiolytics or hypnotics, concurrent alcohol consumption, and history of dependence on other medicines or substances.

Following discontinuation of treatment, withdrawal symptoms may occur, such as insomnia, headache, increased anxiety, muscle pain, increased muscle tension, and very rarely irritability, restlessness, and even confusion. In exceptional cases, tremors, hallucinations and seizures may occur.

The duration of treatment should be as short as possible and should not exceed 4 to 12 weeks. Your doctor will advise you on how to discontinue therapy (gradual dose reduction over several days to several weeks).

Discontinuation of treatment: abrupt discontinuation of dipotassium clorazepate may lead to withdrawal symptoms, particularly after prolonged treatment or if drug dependence is suspected.

With long-term use, tolerance to the medicine may develop (reduced effectiveness of the drug).

Amnesia may occur during treatment, particularly when benzodiazepines are taken immediately before going to bed and sleep duration is short (early awakenings caused by external factors).

To minimise the risk of amnesia, it is recommended to ensure conditions for uninterrupted, continuous 7–8 hour sleep.

During treatment with benzodiazepines, the following may occur: anxiety, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychoses, unusual behaviour and other behavioural disturbances. These symptoms occur more frequently in children and elderly patients. If any of these symptoms occur, treatment should be discontinued.

Concomitant use of benzodiazepines, including dipotassium clorazepate, and opioids may cause sedation, respiratory depression, coma and death.

Due to these risks, your doctor will prescribe opioids and benzodiazepines together only for patients in whom other treatment options are insufficient.

If a decision is made to use dipotassium clorazepate together with opioids, the medicines will be prescribed at the lowest effective dose and for the shortest possible duration 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 established whether this is caused by taking this medicine or whether there are other causes. If the patient has suicidal thoughts, they should contact their doctor as soon as possible to obtain further medical advice.

Benzodiazepines with anxiolytic properties should not be used in the treatment of depression and psychiatric disorders.

Benzodiazepines may mask symptoms of depression and should not be used as the sole treatment for depression (antidepressants 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 or other drug (including narcotics) dependence, as they are at increased risk of developing physical and psychological dependence.

Dosage adjustment of the medicine may be necessary in elderly patients and patients with renal impairment (see section 3. How to use Tranxene).

Extreme caution is required when using the medicine in patients with impaired liver function; hepatic encephalopathy may occur in patients with hepatic insufficiency.

In patients with respiratory insufficiency, the use of benzodiazepines may cause breathing problems (worsening hypoxia may lead to anxiety and may require admission to intensive care).

Concomitant use of multiple 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 effects such as drowsiness, dizziness and muscle weakness, which may lead to falls and consequently to serious injuries.

Dose reduction is recommended.

Tranxene with food, drink and alcohol

Food does not affect absorption of the medicine from the gastrointestinal tract.

Tranxene may be taken during meals or on an empty stomach.

Consumption of alcoholic beverages is not recommended during treatment with dipotassium clorazepate.

Pregnancy, breastfeeding and fertility

Data on the use of dipotassium clorazepate in pregnant women are limited.

Therefore, use of this medicine is not recommended during pregnancy or in women of childbearing potential who are not using contraception.

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor to reassess the need for treatment.

If the patient takes dipotassium clorazepate in high doses during the last three months of pregnancy or during delivery, the newborn may experience drowsiness (sedation), breathing difficulties (respiratory depression), muscle weakness (hypotonia), low body temperature (hypothermia) and feeding difficulties (sucking problems leading to poor weight gain).

If the patient regularly takes dipotassium clorazepate towards the end of pregnancy, withdrawal syndrome may occur in the newborn. In such cases, the newborn should be closely monitored during the postnatal period.

Tranxene should not be used during breastfeeding.

Driving and operating machinery

Patients should not drive or operate machinery while taking this medicine. The ability to drive and operate machinery may be impaired during treatment with dipotassium clorazepate due to the occurrence of concentration disturbances, drowsiness and anterograde amnesia.

Concomitant use of other medicines may enhance the sedative effect of dipotassium clorazepate (see section 2 "Tranxene with other medicines").

Tranxene with other medicines

Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

The risk of withdrawal symptoms increases with concomitant use of other anxiolytic and hypnotic benzodiazepines.

Alcohol consumption and use of medicines containing alcohol should be avoided during treatment. Alcohol enhances the sedative effect of benzodiazepines.

Exercise caution when using Tranxene concomitantly with:

• medicines with central nervous system depressant effects, such as: opioids, morphine derivatives including buprenorphine (analgesics, antitussives and medicines used in other therapies), neuroleptics, barbiturates, certain antidepressants, sedating antihistamines (antiallergic medicines), non-benzodiazepine sedatives, clonidine and medicines with similar effects;
• cisapride (a prokinetic agent) due to the possibility of increased sedative effect of benzodiazepines;
• clozapine (a neuroleptic medicine) due to increased risk of collapse with respiratory and (or) cardiac arrest;
• curare and its derivatives (muscle relaxants reducing skeletal muscle tone) due to additive effects.

Concomitant use of benzodiazepines and opioids increases the risk of sedation, respiratory depression, coma and death due to enhanced central nervous system depression.

Concomitant use of benzodiazepines and sodium oxybate should be avoided due to increased risk of respiratory depression.

3. How to use Tranxene

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor.
Treatment should begin with an initial dose, gradually increasing the dose to avoid adverse effects.
Do not exceed the maximum dose of 30 mg per day. The duration of treatment should be as short as
possible and should not exceed 8 to 12 weeks, including the tapering period. During treatment, the
patient should be monitored regularly so that the dose or frequency of administration can be reduced
if necessary. Due to the risk of withdrawal symptoms, the medicine should be discontinued
cautiously, gradually reducing the daily dose.
Adults:
The therapeutic dose ranges from 5 to 30 mg per day.
Treatment should be initiated with a dose of 5 mg per day.
The daily dose may be taken once daily, in the evening.
Use in children and adolescents:
Tranxene 5 mg: due to limited data on use in children and adolescents for the treatment of anxiety,
the use of Tranxene is not recommended in this age group.
Only in exceptional cases, a specialist physician may administer this medicine to children over 9
years of age at a dose of 0.5 mg/kg body weight per day in divided doses.
Elderly patients should have their dose reduced by 50%; treatment should be as short as possible.
Patients with impaired renal function should have their dose reduced by 50%.
Patients with impaired liver function must exercise caution when using this medicine; hepatic
encephalopathy (neurological dysfunction due to toxins accumulating in the body as a result of liver
damage) may occur in patients with liver failure.
If you feel that the effect of Tranxene is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Tranxene
The main symptom of severe overdose is deep sleep, which may progress to coma depending on the
amount ingested.
The prognosis is favorable if the patient has not taken other psychotropic drugs simultaneously and
receives appropriate treatment.
The patient should be admitted to hospital in an intensive care unit where respiratory and
cardiovascular functions will be monitored.
If less than one hour has passed since ingestion and the patient is conscious, vomiting should be
induced. If the patient is unconscious, the physician should perform gastric lavage, remembering to
secure the upper airway. If more than one hour has passed since overdose, activated charcoal may
be administered to reduce drug absorption from the gastrointestinal tract.
After a minor overdose, symptoms include drowsiness, disorientation, and lethargy; after a more
severe overdose: impaired body coordination, decreased muscle tone, hypotension, respiratory
disturbances, rarely coma, and very rarely death.
The physician may administer flumazenil to diagnose and/or treat benzodiazepine overdose.
In case of overdose, contact a doctor immediately.
Missed dose of Tranxene
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. Do not take
a double dose to make up for a missed dose. If in doubt, consult your doctor.

4. Possible adverse reactions

Like any medicine, Tranxene may cause adverse reactions, although not everyone experiences them.
The frequency and severity of adverse reactions depend on the individual patient's sensitivity and the dose administered.
The following adverse reactions 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):

• hypersensitivity reactions
• irritability, restlessness, confusion
• decreased muscle tone
• maculopapular and itchy skin rashes

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

• slowing of mental processes
• paradoxical reactions (especially in children and elderly patients)
• aggression, hallucinations
• so-called rebound syndrome with increased anxiety compared to the condition that led to treatment initiation
• physical dependence with long-term treatment (especially at high doses), and withdrawal symptoms after discontinuation*
• cognitive disturbances, such as memory impairment (retrograde amnesia*), attention deficits, and speech disturbances
• falls*

* see section Warnings and precautions
Additionally, the following adverse reactions have been reported during benzodiazepine use:

• emotional blunting, reduced alertness, headache,
• impaired coordination of body movements,
• double vision,
• gastrointestinal disturbances,
• decreased libido,
• occurrence of memory loss (amnesia), which may be associated with abnormal behavior.
• psychiatric and paradoxical reactions with anxiety, delusions, anger outbursts, nightmares, psychoses, abnormal behavior, and other behavioral disturbances.

Benzodiazepine use may unmask previously existing, undiagnosed depression.
Psychological dependence may occur. Cases of benzodiazepine abuse have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tranxene

No special storage instructions required.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 5 mg and the following excipients:
potassium carbonate, talc.
Capsule shell composition: erythrosine, titanium dioxide (E 171), gelatin.

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, having a smooth, glossy surface, and contains a homogeneous powder white or slightly yellowish in colour.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Neuraxpharm Portugal, Unipessoal Lda.
Avenida Dom João II, nº 35
Edifício Infante, nº 6 I
1990-083 Lisbon
Portugal

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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland

Portugal Marketing Authorisation Number (country of export): 5842398
Parallel Import Authorisation Number: 444/22