TRANXENE 20 mg /2 Ml Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. TRANXENE 20, 20 mg, powder and solvent for solution for injection
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Tranxene 20 and what is it used for
4. Important information before using Tranxene 20
   1. When not to use Tranxene 20
   2. Warnings and precautions
   3. Tranxene 20 with food, drink, and alcohol
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Tranxene 20 and other medicines
5. How to use Tranxene 20
   1. Use in children and adolescents
   2. Using a higher dose of Tranxene 20 than recommended
   3. Missing a dose of Tranxene 20
6. Possible side effects
   1. Reporting side effects
7. How to store Tranxene 20
8. Contents of the packaging and other information
   1. What Tranxene 20 contains
   2. What Tranxene 20 looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last update of the leaflet:

Leaflet attached to the packaging: patient information

TRANXENE 20, 20 mg, powder and solvent for solution for injection

Dikalii clorazepas

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tranxene 20 and what is it used for
• 2. Important information before using Tranxene 20
• 3. How to use Tranxene 20
• 4. Possible side effects
• 5. How to store Tranxene 20
• 6. Contents of the packaging and other information

1. What is Tranxene 20 and what is it used for

Tranxene 20 comes in the form of a powder with a solvent for solution for intramuscular and intravenous injection.
Tranxene 20 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 20 is indicated for:

• treatment of anxiety and restlessness attacks,
• treatment of motor excitement and aggression attacks,
• prevention and/or treatment of delirium tremens and other symptoms of alcohol withdrawal syndrome.

This medicine is also used as an adjunctive treatment for tetanus.

2. Important information before using Tranxene 20

When not to use Tranxene 20

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe respiratory failure
• if the patient has sleep apnea syndrome
• if the patient has severe, acute or chronic liver dysfunction (risk of encephalopathy)
• if the patient has myasthenia (a disease characterized by rapid fatigue and muscle weakness)
• the use of Tranxene 20 in children is contraindicated

Warnings and precautions

Particular caution should be exercised when using Tranxene 20
The effectiveness of benzodiazepines may change during long-term administration of the medicine, due to the possibility of tolerance.
Similarly, as with other benzodiazepines, especially during long-term use, physical and psychological dependence on this medicine may develop.
Certain factors, such as the duration of treatment, the dose used, dependence on other medicines or alcohol in the history, may contribute to the development of dependence.
Dependence may also occur after withdrawal of the medicine. Often, the following symptoms may occur: insomnia, headache, increased anxiety, muscle pain, muscle tension, irritability. Other symptoms occur less frequently: excitement, or even episodes of confusion, increased sensitivity to various stimuli (noise, light), depersonalization, loss of sense of reality, hallucinations, seizures.
Disorders after withdrawal of the medicine may occur after a few days of discontinuing its use.
The use of several benzodiazepines, regardless of the indications for use (anxiety relief or hypnotic effect), may increase the risk of developing dependence on the medicine.
A temporary increase in anxiety disorders, which were the indication for benzodiazepine treatment (so-called rebound phenomenon), may occur.
Within a few hours of administering a dose of the medicine, memory disorders may occur. This may happen when a medicine containing a benzodiazepine is used before going to bed and when sleep is interrupted too early. To minimize the risk of memory disorders, it is recommended to ensure conditions for continuous, uninterrupted 7-8 hours of sleep.
In some people, benzodiazepines and similar medicines may cause paradoxical reactions, such as:

• increased insomnia, nightmares;
• excitement, nervousness, irritability, outbursts of anger, manifestation of aggressive behavior;
• hallucinations, a state resembling sleep, symptoms of psychosis, abnormal behavior, and other behavioral disorders.

Concomitant use of benzodiazepines, including clorazepate, and opioids may cause sedation, respiratory depression, coma, and death. Due to these risks, the doctor will prescribe opioids and benzodiazepines concomitantly 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 duration of concomitant use.
Some caution should be exercised when using Tranxene 20 concomitantly with:

• medicines with a depressant effect on the central nervous system, such as: opioids, morphine derivatives, including buprenorphine (painkillers, antitussives, and used in other therapies), neuroleptics, barbiturates, sedatives other than benzodiazepines, some antidepressants, antihistamines with a sedative effect, clonidine, and medicines with a similar effect;
• cisapride (a medicine that stimulates gastrointestinal motility) due to the possibility of increased sedative effect of benzodiazepines;
• clozapine (a neuroleptic) due to the increased risk of respiratory and/or cardiac arrest;
• curare and its derivatives (medicines that reduce muscle tone) due to the additive effect).

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.
Concomitant use of benzodiazepines and sodium oxybate should be avoided due to the increased risk of respiratory depression.
The medicine should be used with great caution in patients with alcoholism or other addictions.
In elderly patients, with renal or hepatic impairment, it is recommended to reduce the dose, for example, by half.
In patients with respiratory failure, the use of benzodiazepines may cause breathing problems.
Elderly patients are more susceptible to the occurrence of side effects, 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 20 with food, drink, and alcohol

The medicine is for intravenous and intramuscular use.
During treatment with Tranxene 20, you should avoid drinking alcohol and using medicines that contain alcohol.
After consuming alcohol, an increase in the sedative effect of benzodiazepines is observed, which may affect the ability to drive vehicles and operate machines.

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 a doctor to reassess the need for treatment.
If the patient takes clorazepate in large 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 in the postpartum period.
Tranxene 20 should not be used during breastfeeding.

Driving and using machines

While using the medicine, you should not drive vehicles or operate machines. Tranxene 20 may cause drowsiness, dizziness, and decreased concentration, which may affect the ability to drive vehicles and operate machines during treatment. Concomitant use of other medicines may enhance the sedative effect of clorazepate (see section Tranxene 20 and other medicines).

Tranxene 20 and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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 that contain alcohol.
Alcohol enhances the sedative effect of benzodiazepines.
Some caution should be exercised when using Tranxene 20 concomitantly with:

• medicines with a depressant effect on the central nervous system, such as: opioids, morphine derivatives, including buprenorphine (painkillers, antitussives, and used in other therapies), neuroleptics, barbiturates, sedatives other than benzodiazepines, some antidepressants, antihistamines with a sedative effect, clonidine, and medicines with a similar effect;
• cisapride (a medicine that stimulates gastrointestinal motility) due to the possibility of increased sedative effect of benzodiazepines;
• clozapine (a neuroleptic) due to the increased risk of respiratory and/or cardiac arrest;
• curare and its derivatives (medicines that reduce muscle tone) due to the additive effect).

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

3. How to use Tranxene 20

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor.
The recommended dose is:
In acute anxiety and psychomotor excitement or aggression attacks, doses of 20 to 200 mg per day are recommended, intramuscularly or intravenously, after which, if necessary, the medicine should be continued in oral form.
In alcohol withdrawal syndrome: 50 to 100 mg per day, intramuscularly or intravenously. If there is a need for further use in injections, the doctor will reduce the dose by half after 2-3 days; any further use of the medicine may be continued in oral form.
In tetanus: in cases not requiring tracheotomy - 120 to 500 mg per day in intravenous infusions; in severe tetanus, with assisted breathing - 500 to 2000 mg per day in intravenous infusion.
In elderly patients and in patients with impaired renal or hepatic function, the dose should be reduced. Sometimes, a dose half the size of the average dose is sufficient.

Use in children and adolescents

The use of Tranxene 20 in children is contraindicated.
Method of administration
The medicine can be administered intramuscularly or in slow intravenous injection or slow intravenous infusion.
Due to the risk of apnea with rapid intravenous injection, the medicine should be administered in slow intravenous injection, into a large vein (see section 4. Possible side effects).
When administered intramuscularly, the medicine should be injected deeply into the muscle.
The facility where the medicine is administered should be equipped with equipment for intensive respiratory therapy.
You should avoid mixing medicines in the same syringe.
You should only use the solvent provided with the medicine packaging.
Duration of treatment
Treatment should last as short as possible. In case of switching to oral form, the presence of indications for its use should be regularly verified.
If you feel that the effect of Tranxene 20 is too strong or too weak, you should consult a doctor.

Using a higher dose of Tranxene 20 than recommended

The symptom of overdose is mainly deep sleep, which can turn into coma, depending on the dose of the medicine used. In mild cases, symptoms such as confusion and lethargy are observed.
In more severe cases, there is clumsiness, decreased muscle tone, decreased blood pressure, and respiratory depression. In rare cases, death may occur.
The prognosis is favorable if the patient has not taken other psychotropic medicines and has been properly treated.
In the diagnosis and/or treatment of intentional or accidental benzodiazepine overdose, the administration of flumazenil may be useful.
In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Tranxene 20

In case of missing a dose of the medicine, you should take it as soon as possible, except when the next dose is approaching. You should not take a double dose to make up for the missed dose. In case of doubts, you should consult a doctor.

4. Possible side effects

Like all medicines, Tranxene 20 can cause side effects, although not everybody gets them.
The frequency and severity of side effects depend on the individual patient's sensitivity and the dose of the medicine used.
The following side effects 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):

• allergic reactions
• irritability, excitement, confusion
• decreased muscle tone
• papular 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 phenomenon 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 withdrawal 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, during the use of benzodiazepines, the following side effects have been reported:

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

During the use of benzodiazepines, previously undiagnosed depression may be revealed.
Psychological dependence may occur. Cases of benzodiazepine abuse have been reported.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 gather more information on the safety of the medicine.

5. How to store Tranxene 20

Store in a temperature below 25°C.
The medicine should be stored in a place that is 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 stated.

6. Contents of the packaging and other information

What Tranxene 20 contains

• The active substance of the medicine isdipotassium clorazepate. 1 vial of powder contains 20 mg of dipotassium clorazepate.
• The excipients are: powder: mannitol, potassium carbonate; solvent: potassium dihydrogen phosphate, potassium hydrogen phosphate, water for injections

What Tranxene 20 looks like and what the packaging contains

Brown glass vials with a stopper and cap, and ampoules with a solvent made of colorless glass, in a cardboard box.
The packaging contains:
5 vials of powder + 5 ampoules with solvent 2 ml

Marketing authorization holder

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

Manufacturer

Sanofi S.r.l.
Via Valcanello 4
03012 Anagni (FR)
Italy
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Neuraxpharm Polska Sp. z o.o.
Poleczki 35
02-822 Warsaw
[email protected]

Date of last update of the leaflet: