TRANSENE 5 mg Hard Capsule

Зміст інструкції

1. Transene 5 mg hard capsules, 10 mg hard capsules
   1. What is Transene and what is it used for
   2. What you need to know before taking Transene
2. Transene should not be used alone to treat depression or anxiety associated with
   1. How to take Transene
   2. Possible side effects
   3. How to store Transene
   4. Contents of the pack and other information

Transene 5 mg hard capsules, 10 mg hard capsules

Potassium clorazepate

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Transene is and what it is used for
• 2. What you need to know before you take Transene
• 3. How to take Transene
• 4. Possible side effects
• 5. How to store Transene
• 6. Contents of the pack and other information

1. What is Transene and what is it used for

Transene contains potassium clozepate, which belongs to a class of medicines called
benzodiazepines, used to reduce and treat some disorders of the nervous and mental system, including
states of anxiety and distress.
Transene is indicated for the treatment of:

• anxiety, a mental state characterized by a feeling of worry and fear of varying intensity and duration;
• tension, a mental state characterized by strong worry and agitation;
• other physical and mental disorders associated with a psychological state known as anxiety syndrome and characterized by intense and prolonged fear, worry and distress, not due to a precise and apparent reason or external stimulus. Transene is indicated only when the disorder is severe, disabling and causes significant discomfort.

2. What you need to know before taking Transene

Do not take Transene

• if you are allergic to clorazepate dipotassium or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other benzodiazepines or other similar-benzodiazepine substances;
• if you have a disease characterized by severe muscle weakness (myasthenia gravis);
• if you have severe breathing difficulties (severe respiratory failure);
• if you have severe problems with liver function (severe hepatic insufficiency);
• if you suffer from episodes of interruption or slowing of breathing during nighttime rest (sleep apnea syndrome);
• if you have an increase in pressure inside the eye (glaucoma);
• if you suffer from psychological states characterized by feelings of inadequacy and guilt, insecurity, discomfort in the work, social, family and interpersonal sphere, anger and loss of interest (depressive neuroses);
• if you suffer from mental disorders characterized by loss of contact with reality, altered reflection on oneself and one's experiences, altered awareness, unreal and non-concrete thoughts, altered ability to judge and bizarre and disorganized behavior (psychotic reactions);
• if you are a child or adolescent under the age of 18 (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Transene.

Psychiatric and paradoxical reactions
When using benzodiazepines and other similar-benzodiazepine substances, such as Transene,
strange reactions (paradoxical reactions) may occur, such as: restlessness, agitation,
irritability, aggression, delirium, outbursts of anger, nightmares, seeing or hearing things that do not
exist (hallucinations), severe mental disorders that alter the control of behavior and
actions (psychoses), changes in behavior. If this happens to you, you should
stop using Transene.
These reactions are more common in children and the elderly.

Patients with kidney problems
If you have kidney problems (renal insufficiency) your doctor will establish the appropriate dose.

Elderly or debilitated patients
If you are elderly or debilitated, your doctor will establish a lower initial dose and then evaluate
the opportunity to gradually increase the dose (see “How to take Transene”). If you are
elderly, you have a greater risk of experiencing undesirable effects such as drowsiness, reduced
reactivity (sedation), dizziness, muscle weakness that can lead to falls and consequently to serious injuries (see “Possible side effects”). If
this occurs, a dose reduction is necessary.

Patients with respiratory problems
If you have severe respiratory problems (respiratory failure) you should take a lower dose
because respiratory depression may occur, which may itself be the cause
of anxiety and may require hospitalization. Avoid the concurrent use
of Transene and sodium oxybate due to the increased risk of respiratory depression (see
“Other medicines and Transene”).

Patients with liver problems
If you have severe liver dysfunction problems (severe hepatic insufficiency) you should not
use Transene as it may worsen brain damage
(encephalopathy).

Suicidal tendency and patients with depression or anxiety associated with depression
Some studies have shown an increased risk of suicidal thoughts, suicide attempts and
suicide in patients, with or without depression, who were taking certain sedatives and hypnotics,
including this medicine. However, it has not been established whether this is caused by the medicine
or whether there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible
for further advice.

Transene should not be used alone to treat depression or anxiety associated with

depression, because there is an increased risk of suicide.

Patients with a history of alcohol and substance abuse
Transene must be used with particular caution if you have previously engaged in excessive use
(abuse) of drugs or alcohol.

Patients with myasthenia
If you suffer from a disease characterized by severe muscle weakness (myasthenia), treatment with
benzodiazepines and benzodiazepine-like agents will worsen your symptoms. You should
use Transene only in exceptional cases and under close medical supervision.

Tolerance
After repeated use for several weeks, the effectiveness of Transene may be reduced. This phenomenon
is known as "tolerance".

Dependence
The use of benzodiazepines and benzodiazepine-like agents can lead to the development of severe
physical disorders when administration is stopped (physical dependence) and the desire to no longer
interrupt taking the medicine (psychic dependence). The risk of
dependence increases with increasing dose and prolonged treatment duration and with
the combination with other medicines (e.g. psychotropic medicines, which act on psychological and
mental activity; anxiolytic medicines, used to alleviate and treat states of anxiety;
hypnotic medicines, which induce sleep, including benzodiazepines). The risk is greater
if you are or have been excessively using (abusing) medicines, drugs or alcohol.
Once physical dependence has developed, abrupt discontinuation of treatment can
lead to the appearance of withdrawal symptoms, such as headache, muscle pain, extreme anxiety,
tension, restlessness, confusion, irritability and, in exceptional cases, tremor. In severe
cases, the following symptoms may manifest: perceiving the surrounding reality as vague, distant
and alien (derealization), feeling your body as foreign and feeling like an external observer
of your body and your thoughts (depersonalization), auditory disturbance
characterized by discomfort with common sounds (hyperacusis), loss of sensitivity in a part of the
body (numbness), tingling and prickling sensation in the hands and feet (formication),
abnormal and exaggerated reaction (hypersensitivity) to light, noise and physical contact, seeing and
hearing things that do not exist (hallucinations) or seizures (convulsions).

Rebound insomnia and anxiety
When you stop treatment, you may develop a transient syndrome consisting of
the reappearance, in a more severe form, of the symptoms that led to treatment with
the medicine. It may also be accompanied by other reactions such as mood changes,
anxiety, restlessness or sleep disturbances. This syndrome is more likely to manifest if
the administration of the medicine is stopped abruptly and therefore you should discontinue
treatment with Transene gradually.

Duration of treatment
The duration of treatment should be as short as possible (see "How to take Transene")
and should not exceed 8-12 weeks, including the discontinuation phase of the medicine. The duration
of treatment should not be prolonged without the doctor's judgment. However, in case of
prolonged treatments, the doctor will subject you to periodic examinations of the liver, kidneys and
blood (blood count).
At the beginning of treatment, the doctor will explain to you that this treatment will be of limited duration and
how you will have to gradually reduce the dose.
It is important that you are aware of the possibility of the onset of the previously listed disorders:
insomnia, rebound anxiety and withdrawal. Do not change this
medicine, even with another benzodiazepine, without first consulting your doctor.

Memory disturbances
Benzodiazepines and benzodiazepine-like agents can cause memory disturbances
(anterograde amnesia). Most often this effect occurs several hours after taking
the medicine. To reduce the risk, make sure you can sleep uninterruptedly for 7-8 hours.
(see "Possible side effects").

Children and adolescents
This medicine should not be used in children and adolescents under the age of 18
years.

Other medicines and Transene
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine.
The effects of Transene may be influenced by or influence the following medicines:

• medicines with a depressing effect on the central nervous system (morphine derivatives such as buprenorphine (cough suppressants and painkillers), barbiturates, other benzodiazepines, antipsychotic neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, sedative antihistamines, clonidine and similar substances): the concomitant use of Transene with these medicines may increase the depressing effect on the central nervous system, with serious consequences especially for those who drive vehicles and use machinery;
• highly effective painkillers (narcotic analgesics): an increase in euphoria may occur, which may lead to an increase in psychic dependence (desire to no longer interrupt taking the medicine);
• medicines to obtain muscle relaxation (neuromuscular depressants, such as medicines with a curare-like effect and muscle relaxants): they can increase the muscle relaxation effect;
• other benzodiazepines used as anxiolytics (to reduce states of anxiety and distress) or hypnotics (to induce sleep): there is a risk of developing withdrawal symptoms when treatment is stopped abruptly;
• medicines that block the activity of specific substances found in liver cells (hepatic enzymes, especially cytochrome P450): the concomitant use of these medicines may increase the activity of Transene;
• cisapride (used to treat heartburn): increases the sedative effect of Transene. This may make driving and operating machinery dangerous;
• clozapine (for the treatment of mental illness): the association of clozapine and Transene increases the risk of a severe and sudden reduction in blood flow throughout the body (collapse) with respiratory arrest and/or cardiac arrest;
• sodium oxybate (used to stabilize nighttime sleep and reduce sleep attacks during waking hours): the concomitant use of Transene and sodium oxybate causes breathing problems, even serious ones. You should avoid the concomitant use of Transene and sodium oxybate.

The concomitant use of Transene and opioids (strong painkillers, medicines for the treatment of
dependence and some medicines for cough) increases the risk of drowsiness, difficulty in
breathing (respiratory depression), coma and can be life-threatening. For this
reason, concomitant use should only be considered when other treatment options
are not possible.
However, if your doctor prescribes Transene together with opioids, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all the opioid medicines you are taking and carefully follow
your doctor's dosage recommendations. It may be helpful to inform friends or relatives to pay
attention to the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.

Transene with alcohol
Do not take Transene together with alcohol.
The calming (sedative) effect may be increased if the medicine is taken together with
alcohol, with a negative influence on the ability to drive or operate machinery.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
Do not use Transene during the first three months of pregnancy.
There is limited data on the use of Transene in pregnant women. Therefore, the use of
this medicine is not recommended during pregnancy and in women of childbearing potential who do not
use contraception.
If you discover that you are pregnant or are planning to become pregnant, consult immediately
your doctor to reassess the need for treatment.
If you take Transene at high doses during the last three months of pregnancy or during childbirth,
your baby may experience drowsiness (sedation), breathing problems (respiratory depression), muscle weakness (hypotonia), a decrease in body temperature
(hypothermia) and difficulty feeding (feeding problems causing poor weight gain).
If taken regularly in the late stages of pregnancy, your baby may develop withdrawal symptoms. In this case, the newborn must be carefully monitored during the
postnatal period.

Breastfeeding
As Transene passes into breast milk, you should not take this medicine if you are breastfeeding
breastfeeding.

Driving and operating machinery
Transene impairs the ability to drive vehicles and operate machinery because it can make you
feel sleepy or confused and cause you to lose concentration and muscle function.
Therefore, you should not drive or operate machinery until you know what effects the medicine has on
you. Also, if you haven't slept enough, these effects may be increased.
The concomitant use of other medicines and alcohol may excessively increase the calming effect
(see "Other medicines and Transene").

3. How to take Transene

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The use of this medicine is reserved for adult patients only.
The duration of treatment should be as short as possible. Your doctor will monitor you
periodically, carefully evaluating the duration of treatment. Generally, the overall duration
of treatment should not exceed 8-12 weeks, including the gradual discontinuation phase of the medicine.
In certain cases, it may be necessary to prolong the maximum treatment period; in such
cases, this should only be done after consulting your doctor.
Treatment should be started with the lowest recommended dose. Do not exceed the
maximum dose.

Use in adults
The recommended dose is 10-30 mg per day orally, in 2-3 administrations.

Use in the elderly
If you are elderly, your doctor will carefully determine the dose, considering a reduction of the doses
above (see “Warnings and precautions”).
Your doctor will monitor you regularly at the beginning of treatment to assess the appropriateness of
using the lowest doses in order to prevent taking an excessive dose (overdose)
due to the accumulation of the medicine in your body.

If you take more Transene than you should
In case of accidental ingestion/intake of an excessive dose of Transene, immediately inform
your doctor or go to the nearest hospital.
Taking an excessive dose of this medicine usually manifests with
alterations of the central nervous system: from slowing down your abilities to loss of
consciousness (coma). In mild cases, the disorders are: slowing down (drowsiness), mental confusion
and sleepiness (lethargy). In more severe cases, the disorders may be: loss of
coordination of movements (ataxia), muscle weakness (hypotonia), low blood pressure
(hypotension), respiratory disorders, rarely coma and very rarely death.

If you forget to take Transene
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects depend on the dose taken and your response to the medicine.

Very common side effects (may affect more than 1 in 10 people)

• drowsiness (particularly in the elderly)*

Common side effects (may affect up to 1 in 10 people)

• weakness/physical fatigue (asthenia)
• dizziness (vertigo)*

Uncommon side effects (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity)
• irritability,
• agitation
• confusion*
• skin irritation with redness and swelling (maculopapular rash) and itching
• reduced muscle tone (muscle hypotonia)

Side effects with unknown frequency (frequency cannot be estimated on the basis of
available data)

• decreased emotions (emotional blunting)*
• reduced attention*
• fatigue*
• headache*
• muscle weakness*
• loss of movement coordination (ataxia)*
• double vision*
• stomach and intestinal disorders
• changes in sexual desire
• skin reactions
• dry mouth
• blurred vision
• changes in specific blood tests to monitor liver and kidney function
• reduction in the number of red blood cells in the blood (decreased hematocrit)
• recurrence of the same symptoms that led to treatment with the medicine (rebound symptoms) with worsening of the anxiety that required treatment
• memory loss (anterograde amnesia) which may be associated with inappropriate behavior (see “Warnings and precautions”). The risk increases with the use of higher doses
• depression: a pre-existing and previously unknown state of depression may manifest
• strange mental side effects (paradoxical reactions) such as: restlessness, agitation, irritability, aggression, delirium, outbursts of anger, nightmares, seeing or hearing things that do not exist (hallucinations), serious mental disorders that alter control of behavior and actions (psychosis), changes in behavior, slowing of mental functions. These side effects can be severe and are more frequent in children and the elderly
• violent physical disturbances when stopping administration (physical dependence)
• physical dependence, withdrawal symptoms after stopping treatment (see “Warnings and precautions”)
• a desire to no longer stop taking the medicine (psychological dependence)
• excessive use (abuse) of this medicine and other benzodiazepines
• falls (see “Warnings and precautions”)
• cognitive (learning) disorders such as: memory loss (anterograde amnesia), changes in attention and language.

*These side effects occur mainly at the beginning of treatment and usually
disappear with subsequent administrations.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Transene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Transene 5 mg hard capsules contain

• The active ingredient is potassium clorazepate. Each capsule contains 5 mg of potassium clorazepate.
• The other ingredients are potassium carbonate and talc.
• The capsule excipients are: erythrosine, titanium dioxide, gelatin.

What Transene 10 mg hard capsules contain

• The active ingredient is potassium clorazepate. Each capsule contains 10 mg of potassium clorazepate.
• The other ingredients are potassium carbonate and talc.
• The capsule excipients are: erythrosine, titanium dioxide, gelatin.

Description of the appearance of Transene and contents of the pack
Transene is presented in the form of hard capsules:

• pack of 30 hard capsules of 5 mg in blisters
• pack of 30 hard capsules of 10 mg in blisters

Marketing Authorisation Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47,

• 63100 - Ascoli Piceno (AP), Italy

Manufacturer
SANOFI WINTHROP INDUSTRIE - 1, rue de la Vierge - 33440 AMBARES – FRANCE
SANOFI-AVENTIS S.A. – ctra. la Batlloria a Holstalric – 17404 Riells I Viabrea – Gerona
SPAIN