Tranxene

Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
Tranxene
10 mg, hard capsules
Chlorazepate dipotassium
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• 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. It 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, skeletal 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, interfere with normal functioning, or are distressing 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,
• 10 mg capsules must not be used in children.

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 dependence on other drugs or substances.
In case of dependence, withdrawal symptoms may occur after treatment discontinuation: 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 dipotassium chlorazepate may lead to withdrawal symptoms, especially after long-term treatment or in case of suspected drug dependence.
During prolonged use, tolerance to the drug may develop (reduced drug efficacy).
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 continuous, uninterrupted 7–8 hour sleep.
During benzodiazepine use, 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 the above symptoms occur, the use of the medicine should be discontinued.
Concomitant use of benzodiazepines, including dipotassium chlorazepate, and opioids may cause sedation, respiratory depression, coma and death.
Due to these risks, the doctor will prescribe opioids and benzodiazepines together only to patients in whom other treatment options are insufficient.
If a decision is made to use dipotassium chlorazepate concomitantly 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.
Anxiolytic benzodiazepines 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 belong to the risk group for physical and psychological dependence.
Dosage adjustment of the medicine may be necessary in elderly patients and patients with renal insufficiency (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, the use of benzodiazepines may cause breathing problems (worsening hypoxia may lead to anxiety and may require admission to an intensive care unit).
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 medicine from the gastrointestinal tract.
Tranxene may be taken during meals or on an empty stomach.
Alcoholic beverages should not be consumed during treatment with dipotassium chlorazepate.

Pregnancy, breastfeeding and fertility
Data on the use of dipotassium chlorazepate 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 to become pregnant, she should consult her doctor to reassess the need for treatment.
If the patient takes high doses of dipotassium chlorazepate 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 dipotassium chlorazepate towards the end of pregnancy, the newborn may develop 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 treatment with dipotassium chlorazepate due to concentration disturbances, drowsiness and anterograde amnesia.
Concomitant use of other medicines may intensify the sedative effect of dipotassium chlorazepate (see section 2 "Tranxene with other medicines").

Tranxene with 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, 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.
Caution is required 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 (antiallergic medicines), non-benzodiazepine sedatives, clonidine and medicines with similar effects;
• cisapride (a prokinetic agent) due to the possibility of enhanced sedative effects of benzodiazepines;
• clozapine (a neuroleptic) due to increased risk of collapse with respiratory arrest 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 take Tranxene

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor.
Treatment should be started at the 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 by gradually reducing the daily dose.

Adults:
The therapeutic dose ranges from 5 to 30 mg per day.
Treatment should be initiated at a dose of 5 mg per day.
The daily dose may be taken once daily, in the evening.

Use in children and adolescents:
Tranxene 10 mg is intended for use in adults only.

Elderly patients:
The dose should be reduced by 50%. Treatment should be as short as possible.

Patients with renal impairment:
The dose should be reduced by 50%.

Patients with hepatic impairment:
Patients with impaired liver function must exercise caution when using this 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 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 physician, with due protection of the upper airways. If at least one hour has passed since overdose, activated charcoal may be administered to reduce absorption of the drug from the gastrointestinal tract.

After a minor overdose, symptoms include drowsiness, disorientation, and lethargy. After a more severe overdose, symptoms may include impaired body coordination, reduced muscle tone, hypotension, respiratory depression, coma (rarely), and death (very rarely).

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
• reduced muscle tone
• papular-rash and itchy skin eruptions

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 drug*
• cognitive disturbances such as memory impairment (retrograde amnesia*), attention deficits, and speech disturbances
• falls*

* see section 4.4 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,
• libido disorders,
• occurrence of memory loss (amnesia), which may be associated with unusual behaviour,
• psychiatric and paradoxical reactions with anxiety, delusions, anger outbursts, nightmares, psychoses, unusual behaviours, and other behavioural disturbances.

During benzodiazepine treatment, previously existing undiagnosed depression may become apparent.
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 this 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 pack and other information

What Tranxene contains
Each capsule contains the active substance chlordiazepoxide dipotassium 10 mg and 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 10 mg capsule is opaque, with a light pink cap and body, having a smooth, glossy surface, and contains a homogeneous powder white or yellowish in colour.
For further information, please contact the responsible party or the parallel importer.
Responsible entity 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Portugal marketing authorization number, country of export: 5842497
Parallel import authorization number: 443/22