CLORANXEN 10 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. CLORANXEN, 10 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient
   2. Table of contents of the leaflet:
3. What is Cloranxen and what is it used for
4. Important information before taking Cloranxen
   1. When not to take Cloranxen
   2. Warnings and precautions
   3. Cloranxen and other medicines
   4. Cloranxen with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Pregnancy
   7. Breastfeeding
   8. Driving and using machines
   9. Cloranxen contains lactose
5. How to take Cloranxen
   1. Overdose of Cloranxen
   2. Missed dose of Cloranxen
6. Possible side effects
   1. Reporting side effects
7. How to store Cloranxen
8. Contents of the pack and other information
   1. What Cloranxen contains
   2. What Cloranxen looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of leaflet approval:

Leaflet accompanying the packaging: information for the user

CLORANXEN, 10 mg, tablets

(Dipotassium clorazepate)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 their symptoms are the same.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Cloranxen and what is it used for

Cloranxen contains the active substance dipotassium clorazepate. Clorazepate belongs to a group of medicines called benzodiazepines. It has anxiolytic, sedative, and hypnotic effects.
The indications for the use of Cloranxen are:

• short-term treatment of anxiety and restlessness, as an adjunct in the course of neurosis
• alcohol withdrawal syndrome (delirium tremens, pre-delirium states).

Cloranxen is indicated only when the symptoms are significantly severe, disrupt normal functioning, or are very troublesome for the patient.

2. Important information before taking Cloranxen

When not to take Cloranxen

• 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 muscle weakness (myasthenia gravis)
• severe respiratory failure
• sleep apnea syndrome
• severe liver failure
• narrow-angle glaucoma

The medicine is contraindicated in children under 12 years of age.

Warnings and precautions

Before starting treatment with Cloranxen, the patient should discuss it with their doctor or pharmacist.
The medicine may cause psychological and physical dependence, and its use should be under close medical supervision and, in most cases, limited in time. The risk of dependence increases with the dose and duration of treatment, and is higher in patients with a history of alcohol, drug, or substance abuse, as well as those taking other psychotropic, anxiolytic, or sedative medicines. Particular caution should be exercised when administering the medicine to patients suspected of having a tendency to abuse medicines or alcohol.
The duration of treatment should be limited and not exceed 4 weeks. The doctor will inform the patient how to stop the therapy (gradually reducing the dose of the medicine).
Sudden withdrawal may cause withdrawal syndrome, characterized by muscle tremors, agitation, insomnia, hallucinations, disorientation, derealization (feeling of change in the surrounding world), depersonalization (feeling of change in one's own image), headaches, muscle pain, anxiety, irritability, seizures, hypersensitivity to light, sound, and physical contact. These symptoms may occur 4-8 days after stopping the medicine.
Stopping treatment, especially suddenly, may cause rebound insomnia and anxiety. Gradual withdrawal of the medicine is recommended.
During long-term use, tolerance to the medicine (reduced efficacy) may develop.
During treatment with the medicine, anterograde amnesia may occur, especially when taking benzodiazepines directly before going to sleep and in cases of short sleep duration (early awakening caused by external factors).
Benzodiazepines should not be used as the only treatment for depression or anxiety associated with depression (in these patients, the risk of suicidal attempts may occur).
The medicine should not be used to treat mental disorders.
Paradoxical reactions are occasionally observed: anxiety, irritability, aggression, euphoria, agitation, hallucinations, insomnia, psychoses, inappropriate behavior. These reactions occur especially in children and the elderly.
During treatment with clorazepate, it is not recommended to consume alcoholic beverages.
In elderly patients and patients with kidney disease, it may be necessary to adjust the dose of the medicine.
The medicine should be used with caution in patients with liver failure and in patients with respiratory failure.
Concomitant use of several benzodiazepines is not beneficial and may increase the risk of dependence.

Cloranxen and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The risk of withdrawal symptoms increases when other benzodiazepines with anxiolytic and sedative effects are used concomitantly.
Concomitant use of Cloranxen and opioids (strong painkillers, substitution therapy for addiction, and some antitussive medicines) increases the risk of sedation, respiratory difficulties (respiratory failure), coma, and can be life-threatening. For this reason, concomitant use of these medicines can only be considered when other treatment options are not possible.
If the doctor prescribes Cloranxen with opioids, they should limit the dose and duration of concomitant treatment.
The patient should inform their doctor about all opioid medicines they are taking and strictly follow the dosage recommended by the doctor. It may be helpful to inform friends or relatives about these symptoms. In case of such symptoms, the patient should contact their doctor.
Alcohol
During treatment, the patient should avoid consuming alcohol and taking medicines containing alcohol.
Alcohol enhances the sedative effect of benzodiazepines. This can lead to reduced concentration and impaired ability to drive vehicles and operate machinery.
The medicine acts synergistically with muscle relaxants (curare and its derivatives, drugs reducing skeletal muscle tone).
It enhances the effect of other medicines acting on the central nervous system (psychotropic medicines, opioid analgesics, barbiturates, some antidepressants, sedatives, antihistamines with sedative effects, other sedatives, neuroleptics, anesthetics, antiepileptics, anxiolytics). Increased inhibitory effect on the central nervous system may cause impaired ability to drive vehicles and operate machinery.
In the case of concomitant use of opioid analgesics with clorazepate, euphoria may be enhanced, leading to psychological dependence.
Cisapride (a medicine stimulating intestinal motility) temporarily enhances the sedative effect of benzodiazepines due to increased absorption. Cimetidine enhances sedation after clorazepate.
It is difficult to predict interactions with phenytoin. An increase in its serum concentration and enhancement of side effects may occur. It is also possible that the concentration of phenytoin may decrease or there may be no interaction. Clorazepate weakens the effect of levodopa.
The metabolism of clorazepate is generally accelerated in smokers and people taking anticonvulsant medicines. Antacids (aluminum and magnesium hydroxide and salts) may sometimes significantly delay the absorption of clorazepate, but usually without changing its absolute bioavailability.

Cloranxen with food and drink

The medicine can be taken regardless of meal times.

Pregnancy, breastfeeding, and fertility

Pregnancy

Before taking any medicine, the patient should consult their doctor or pharmacist.
The medicine should not be used during pregnancy, especially in the first and third trimesters.
The doctor should inform women of childbearing age about the potential risks. If a woman plans to become pregnant, treatment should be stopped in advance. If the medicine is administered at the end of the third trimester of pregnancy or during delivery, the newborn may experience: hypothermia (low body temperature), hypotonia (low muscle tone), respiratory depression. In newborns of mothers taking clorazepate in the last period of pregnancy, physical dependence may develop, and there is a risk of withdrawal symptoms.

Breastfeeding

Before taking any medicine, the patient should consult their doctor or pharmacist.
The medicine and its metabolites pass into breast milk. Clorazepate should not be used in breastfeeding mothers.

Driving and using machines

The medicine may impair psychophysical fitness, the ability to drive vehicles, and perform other complex tasks requiring concentration.

Cloranxen contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Cloranxen

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Treatment should be started with an initial dose, gradually increasing the dose to avoid side effects. The maximum dose of 30 mg per day should not be exceeded. The duration of treatment should be as short as possible and not exceed 4 weeks, including the period of dose reduction. During treatment, the patient should be regularly monitored to potentially reduce the dose or frequency of administration. Due to the possibility of withdrawal symptoms, the medicine should be withdrawn carefully, gradually reducing the daily dose.
Adults
Therapeutic dose: 5 mg to 30 mg per day.
Treatment is recommended to be started with a dose of 5 mg per day.
The daily dose can be taken once a day, in the evening.
Use in children and adolescents
Cloranxen is not recommended for use in children and adolescents (see also section 2).
Only in exceptional cases, justified by a specialist doctor, can the medicine be used in children over 12 years of age: at a dose of 0.5 mg/kg body weight per day in divided doses.
Use in elderly patients or patients with kidney disease
The dose of the medicine should be reduced by half, and treatment should be as short as possible.

Overdose of Cloranxen

Overdose is characterized by varying degrees of inhibition of central nervous system activity: from moderate sedation to coma.
In the case of minor overdose, the following symptoms occur: sedation, disorientation, lethargy; in severe overdose: ataxia, muscle hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death. In addition to general principles of treatment for oral poisoning (removal of stomach contents depending on the patient's condition - inducing vomiting or gastric lavage, administration of activated charcoal, maintenance of respiratory and cardiovascular function), in the case of severe poisoning with coma or respiratory failure, the benzodiazepine receptor antagonist flumazenil can be administered intravenously as an antidote.
The use of flumazenil as an antidote is contraindicated in the case of: tricyclic antidepressant use, concomitant administration of drugs lowering the seizure threshold, ECG abnormalities in the form of QT or QRS prolongation (suggesting concomitant use of tricyclic antidepressants).
Although benzodiazepine overdose is rarely life-threatening, one should never forget that the patient may have taken the medicine with alcohol or other substances acting on the central nervous system.

Missed dose of Cloranxen

In case of a missed dose, the patient should take the next dose at the usual time.
A double dose should not be taken to make up for a missed dose.
In case of doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cloranxen can cause side effects, although not everybody gets them.
Nervous system disorders:
Sedation, headaches, dizziness, fatigue, irritability, ataxia, double vision, slurred speech, depression, disturbances of consciousness may occur.
General disorders:
Weight gain, changes in libido may occur. Additionally, hypotension may occur.
Reproductive system and breast disorders:
Menstrual disorders and ovulation inhibition.
Gastrointestinal disorders:
Dryness of the mucous membranes of the mouth, feeling of fullness in the epigastrium, constipation.
Psychiatric disorders:
Anxiety, irritability, aggression, euphoria, agitation, hallucinations, insomnia, nightmares, psychoses, inappropriate behavior. These reactions occur especially in children and the elderly. Anterograde amnesia may occur.
Skin and subcutaneous tissue disorders:
Rarely, skin rashes may occur.
Even therapeutic doses of the medicine may lead to physical dependence; stopping treatment may cause withdrawal symptoms or rebound insomnia and anxiety.
Psychological dependence may occur.
There have been reports of benzodiazepine abuse.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Cloranxen

Store in a temperature below 25°C. Store the container tightly closed to protect from light and moisture.
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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cloranxen contains

• The active substance of the medicine is dipotassium clorazepate.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, potassium chloride, anhydrous potassium carbonate, magnesium stearate, talc, quinoline yellow lake (E104).

What Cloranxen looks like and contents of the pack

Tablets.
HDPE bottle with an aluminum membrane, closed with a PP cap and an HDPE container with a desiccant, in a cardboard box. The membrane should be removed after the first opening of the bottle. The bottle contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

Date of leaflet approval: