Tranxen

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
TRANXENE, 5 mg, hard capsules
Chlordiazepoxide dihydrate
Please read the entire leaflet carefully before using the 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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 hard capsules and contains the active substance chlordiazepoxide. Chlordiazepoxide belongs to a group of medicines called benzodiazepines. It has anxiolytic, muscle relaxant, sedative, hypnotic, and anticonvulsant properties. Tranxene is used:

• for short-term anxiety and nervousness, especially as temporary supportive treatment in neurosis;
• in alcohol withdrawal syndrome (alcoholic hallucinosis, states preceding delirium tremens). Pharmacological treatment is indicated only when symptoms are severe, impair normal functioning, or cause significant discomfort 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 characterized by rapid muscle fatigue and weakness),
• if the patient has severe hepatic insufficiency,
• in children:
• 5 mg capsules must not be used in children under 9 years of age.

Warnings and precautions
Treatment with benzodiazepines may lead to the development of psychological and physical dependence. Factors predisposing to dependence include: duration of treatment, dose of the medicine, concomitant use of other psychotropic drugs, anxiolytics or hypnotics, concurrent alcohol consumption, and history of drug or substance dependence.
In case of dependence, withdrawal symptoms may occur after discontinuation of treatment: insomnia, headache, 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 should not exceed 4 to 12 weeks. The doctor will inform the patient how to discontinue therapy (gradual dose reduction over several days to several weeks).
Discontinuation of treatment: abrupt discontinuation of chlordiazepoxide may lead to withdrawal symptoms, especially after prolonged treatment or if drug dependence is suspected.
Tolerance to the medicine (reduced effectiveness) may develop during long-term use.
Transient anterograde amnesia may occur during treatment, especially when benzodiazepines are taken immediately before going to bed and sleep duration is short (early awakenings caused by external factors). To minimize the risk of amnesia, it is recommended to ensure conditions for uninterrupted, continuous 7–8 hour sleep.
During benzodiazepine treatment, the following may occur: anxiety, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychoses, unusual behavior, and other behavioral disturbances. These symptoms occur more frequently in children and elderly patients. If any of these symptoms occur, the medicine should be discontinued.
Concomitant use of benzodiazepines, including chlordiazepoxide, and opioids may cause sedation, respiratory depression, coma, and death. Due to these risks, the doctor will prescribe opioids and benzodiazepines together only if other treatment options are insufficient.
If a decision is made to use chlordiazepoxide together with opioids, both 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 suicide in patients taking certain sedative and hypnotic medicines, including this one. However, it has not been established whether this is due to taking this medicine or whether other causes exist. If the patient experiences suicidal thoughts, they should contact their doctor as soon as possible to obtain further medical advice.
Anxiolytic benzodiazepines should not be used to treat depression or 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 drug dependence (including narcotics), 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 liver insufficiency.
In patients with respiratory insufficiency, benzodiazepines may cause breathing problems (worsening of 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 psychosis.
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 the 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 chlordiazepoxide.

Pregnancy, breastfeeding, and fertility
Data on the use of chlordiazepoxide in pregnant women are limited. Therefore, the 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 a pregnancy, she should consult her doctor to reassess the need for treatment.
If the patient takes chlordiazepoxide in high doses during the last three months of pregnancy or during delivery, the newborn may experience drowsiness (sedation), breathing problems (respiratory depression), muscle weakness (hypotonia), decreased body temperature (hypothermia), and feeding difficulties (sucking problems leading to poor weight gain).
If the patient regularly takes chlordiazepoxide towards the end of pregnancy, the newborn may develop a withdrawal syndrome. 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 chlordiazepoxide treatment due to concentration disturbances, drowsiness, and anterograde amnesia. Concomitant use of other medicines may enhance the sedative effect of chlordiazepoxide (see section 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 when other anxiolytic and hypnotic benzodiazepines are used concomitantly.
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, sedative antihistamines, non-benzodiazepine sedatives, clonidine, and medicines with similar effects;
• cisapride (a prokinetic agent) due to the potential for increased sedative effect of benzodiazepines;
• clozapine (a neuroleptic) due to increased risk of respiratory and/or cardiac arrest;
• curare and its derivatives (medicines 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 exactly as prescribed by the doctor. In case of doubts, consult your doctor.
Treatment should begin with an initial dose, gradually increasing the dose to avoid unwanted effects. The maximum daily dose of 30 mg must not be exceeded. The duration of treatment should be as short as possible and should not exceed 8 to 12 weeks, including the tapering-off period. During treatment, the patient should be monitored regularly so that the dose or frequency of administration may 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 is not recommended for use in children and adolescents due to limited data on its use in the treatment of anxiety in this age group.
Only in exceptional cases may a specialist doctor administer this medicine to children over 9 years of age at a dose of 0.5 mg/kg body weight per day, given in divided doses.

Elderly patients: the dose should be reduced by 50%; treatment should last as short a time as possible.
Patients with renal impairment: the dose should be reduced by 50%.
Patients with hepatic impairment: caution is required when using the medicine; in patients with liver failure, encephalopathy (neurological dysfunction due to toxins accumulating in the body as a result of liver damage) may occur.

If you feel that the effect of Tranxene is too strong or too weak, consult your doctor.

Taking more Tranxene than prescribed
The main symptom of severe overdose is deep sleep, which may progress to coma depending on the amount ingested.
The prognosis is favorable provided 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 doctor should perform gastric lavage, ensuring protection of the upper airways. If more than one hour has passed since overdose, activated charcoal may be administered to reduce drug absorption from the gastrointestinal tract.
After minor overdose, symptoms include drowsiness, disorientation, and lethargy; after more severe overdose: impaired body coordination, reduced muscle tone, hypotension, respiratory disturbances, rarely coma, and very rarely death.
The doctor may administer flumazenil to diagnose and/or treat benzodiazepine overdose.
In case of overdose, seek immediate medical help.

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. In case of 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 (particularly 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 (particularly in children and elderly patients)
• aggression, hallucinations
• so-called rebound syndrome with increased anxiety compared to the level that was the indication for treatment
• physical dependence with long-term treatment (especially at high doses), and withdrawal symptoms after discontinuation of the medicine*
• cognitive disturbances such as memory impairment (anterograde amnesia*), attention disturbances and speech disturbances
• falls* * see section Warnings and precautions

Additionally, the following adverse reactions have been reported during benzodiazepine use in general:

• emotional blunting, reduced alertness, headache,
• disturbances in body movement coordination,
• double vision,
• gastrointestinal disturbances,
• disturbances in libido,
• occurrence of memory loss (amnesia), which may be associated with abnormal behaviour.
• psychiatric and paradoxical reactions with anxiety, delusions, rage attacks, nightmares, psychoses, abnormal behaviours and other behavioural disturbances.

During benzodiazepine treatment, previously existing undiagnosed depression may emerge.
Psychological dependence may occur. Cases of benzodiazepine abuse have been reported.

Reporting of adverse reactions

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

5. How to store Tranxene

Keep the medicine out of the sight and reach of children.
There are no special storage instructions.
Do not use the 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 required. 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: gelatin, titanium dioxide, erythrosine.
What Tranxene looks like and contents of the pack
The pack contains 30 hard capsules.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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. (Riells), 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 in:
Polfarmex S.A., ul. Józefów 9, 99-300 Kutno
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Portugal (country of export) marketing authorisation number: 5842398
Parallel import authorisation number: 30/15