Tranxene

Package leaflet: information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tranxene
5 mg, capsules, hard
Chlordiazepoxide dipotassium
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 as hard capsules and contains the active substance: dipotassium chlordiazepoxide.
Chlordiazepoxide belongs to a group of medicines called benzodiazepines. It has anxiolytic, muscle relaxant, sedative, hypnotic, and anticonvulsant properties.
Tranxene is indicated:

• for short-term treatment of anxiety and nervousness, particularly as temporary supportive therapy in neurosis;
• in alcohol withdrawal syndrome (alcoholic hallucinosis, states preceding delirium tremens). Pharmacological treatment is indicated only when symptoms are severe, interfere with 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: do not use 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 psychotropic drugs, anxiolytics or hypnotics, concurrent alcohol consumption, and history of substance or drug abuse.

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. Your doctor will inform you 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.

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

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 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 use of the drug should be discontinued.

Concomitant use of benzodiazepines, including chlordiazepoxide, and opioids may result in 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 chlordiazepoxide together with opioids, both drugs 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 medicine. However, it has not been established whether this is caused by taking this medicine or whether other factors are involved. If the patient experiences suicidal thoughts, they should contact their doctor as soon as possible for further medical advice.

Benzodiazepines with anxiolytic action 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 higher risk of developing physical and psychological dependence.

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

Extreme caution is required in patients with liver function disorders; hepatic encephalopathy may occur in patients with liver insufficiency.

In patients with respiratory insufficiency, the use of 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 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 the absorption of the drug from the gastrointestinal tract.

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

Alcoholic beverages should not be consumed 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 plans to become pregnant, 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), low 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 experience 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 vehicles 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 with concomitant use of other anxiolytic and hypnotic benzodiazepines.

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

Exercise caution when using Tranxene concomitantly with:

• central nervous system depressants such as: opioids, morphine derivatives including buprenorphine (analgesics, antitussives, and other therapies), neuroleptics, barbiturates, certain antidepressants, sedating antihistamines (antiallergic drugs), non-benzodiazepine sedatives, clonidine, and drugs with similar effects;
• cisapride (a gastrointestinal motility stimulant) 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 (drugs reducing skeletal muscle tension) 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 doubt, consult your doctor.
Tranxene is available in the following strengths: 5 mg, 10 mg.
Treatment should be initiated with a starting dose, gradually increasing the dose to avoid unwanted effects. The maximum dose of 30 mg per day 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 can be reduced if necessary. Due to the risk of withdrawal symptoms, the medicine should be discontinued cautiously by 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 can be taken once daily, in the evening.

Use in children and adolescents
Due to limited data on the use of Tranxene in children and adolescents for the treatment of anxiety, the use of this medicine is not recommended in this age group.
Only in exceptional cases, a specialist doctor may prescribe 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.

The dose should be reduced by 50% in elderly patients; treatment should be as short as possible.
The dose should be reduced by 50% in patients with impaired renal function.
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 insufficiency.

If the effect of Tranxene seems too strong or too weak, consult your doctor.

Taking more Tranxene than recommended

The main symptom of severe overdose is deep drowsiness, 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 to 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, gastric lavage should be performed by a doctor, with due protection of the upper airways. If more than one hour has passed since the overdose, activated charcoal may be administered to reduce absorption of the drug from the gastrointestinal tract.

After a mild overdose, symptoms include drowsiness, disorientation, and lethargy; after a 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, contact a doctor immediately.

Missed dose of Tranxene

If a dose is missed, take it as soon as possible, unless the next scheduled dose is approaching. 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 (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
• reduced 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 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 (retrograde amnesia*), attention disorders 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,
• impaired coordination of body movements,
• double vision,
• gastrointestinal disturbances,
• decreased libido,
• occurrence of memory loss (amnesia), which may be associated with unusual behaviour,
• psychiatric and paradoxical reactions including anxiety, delusions, rage attacks, nightmares, psychoses, unusual 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, phone: +48 22 4921301, fax: +48 22 4921309, 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 are required.
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 stated month.
Medicines must not be disposed of via the sewage system 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 hard capsule contains the active substance: chlordiazepoxide dipotassium 5 mg and the following excipients: potassium carbonate, talc.
Capsule shell composition: gelatin, titanium dioxide (E 171), erythrosine (E 127).
What Tranxene looks like and contents of the pack
The pack contains 30 hard capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Portugal, 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. (Riells)
Carretera de la Batlloria a Hostalric km. 63, 09
17404 Riells i Viabrea Girona, Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Portugal, country of export: 5842398
Parallel import authorisation number: 37/16