ELENIUM 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Elenium, 5 mg, scored tablets
3. Elenium, 10 mg, scored tablets
4. Elenium, 25 mg, scored 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:
5. What is Elenium and what is it used for
6. Important information before taking Elenium
   1. When not to take Elenium
   2. Warnings and precautions
   3. Elenium and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and operating machinery
   6. Elenium contains sodium
   7. Elenium 25 mg contains orange yellow S (E110)
7. How to take Elenium
   1. Recommended dose
   2. Adults
   3. Children
   4. Patients with impaired renal and/or hepatic function
   5. Elderly patients
   6. Duration of treatment
   7. Method of administration
   8. Taking a higher dose of Elenium than recommended
   9. Missing a dose of Elenium
   10. Stopping treatment with Elenium
8. Possible side effects
   1. Severe side effects
   2. Other side effects that may occur after treatment with Elenium
   3. Reporting side effects
9. How to store Elenium
10. Contents of the packaging and other information
    1. What Elenium contains
    2. Elenium 5 mg
    3. Elenium 10 mg
    4. Elenium 25 mg
    5. What Elenium looks like and contents of the packaging
    6. Marketing authorization holder and manufacturer
    7. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Elenium, 5 mg, scored tablets

Elenium, 10 mg, scored tablets

Elenium, 25 mg, scored tablets

Chlordiazepoxide

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 nurse.
• 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 any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Elenium and what is it used for

Elenium contains the active substance chlordiazepoxide, which belongs to a group of medicines called benzodiazepines. Chlordiazepoxide has anxiolytic, sedative, moderately hypnotic, and muscle relaxant properties. Elenium is used for a short period (2 to 4 weeks) in the treatment of:

• anxiety states of various origins;
• anxiety states associated with insomnia;
• acute alcohol withdrawal syndrome;
• states of increased muscle tension.

2. Important information before taking Elenium

When not to take Elenium

If the patient has:

• hypersensitivity (allergy) to chlordiazepoxide or other benzodiazepines or any of the excipients of the medicine (listed in section 6);
• severe respiratory failure, regardless of the cause;
• sleep apnea syndrome (frequent, short pauses in breathing during sleep);
• severe liver failure;
• phobias, obsessions (anxiety disorders due to unjustified fears and thoughts [obsessive states]);
• chronic psychoses;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue).

Warnings and precautions

General information about the effects observed after treatment with benzodiazepines and other medicines with similar effects to benzodiazepines, which should be taken into account when taking Elenium.

Tolerance

After taking Elenium for several weeks, its effectiveness may decrease.

Dependence

Taking Elenium for a longer period may lead to psychological and physical dependence.

The risk of developing dependence increases with the increase in dose and treatment time and is higher in patients addicted to drugs, alcohol, or narcotics, or in patients with personality disorders.

Withdrawal symptoms

After sudden withdrawal of the medicine, the patient may experience withdrawal symptoms, such as headaches, muscle pain, increased anxiety, tension, excitement, restlessness, disorientation, sleep disturbances, irritability.

In severe cases, the following may occur: loss of sense of reality, personality disorders, hypersensitivity to sound, touch, light, noise, feeling of tingling and numbness of limbs, hallucinations, and delusions, epileptic seizures.

Rebound phenomenon and anxiety

When discontinuing Elenium, a transient recurrence of intensified symptoms that were the reason for taking the medicine (so-called rebound phenomenon) may occur.

These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia.

To minimize the risk of these symptoms, it is recommended to gradually reduce the dose of the medicine.

Anterograde amnesia (inability to remember events after taking the medicine)

Elenium may cause anterograde amnesia (difficulty learning and remembering new information - new data is not permanently stored).

This condition usually occurs within a few hours of taking the medicine, especially in high doses.

If the doctor has prescribed Elenium to be taken once a day, to reduce the risk of anterograde amnesia, it is recommended to take the medicine 30 minutes before going to bed and ensure adequate conditions for continuous, uninterrupted sleep lasting 7-8 hours.

Psychological and paradoxical reactions

In children and the elderly, the risk of abnormal psychological and paradoxical reactions (opposite to expected) increases, such as anxiety, agitation, irritability, aggression, outbursts of anger, delusions, nightmares, hallucinations, psychoses, and behavioral disorders.

If such symptoms occur, the patient should immediately contact their doctor.

Use in depression

Before taking Elenium, the patient should inform their doctor about any mental illnesses and any attempted suicides.

Administering Elenium to such patients may exacerbate symptoms of depression, including suicidal thoughts.

Specific patient groups

Elderly patients should receive lower doses of Elenium (see section 3), due to the possibility of increased side effects, mainly orientation and motor coordination disorders (falls, injuries).

Children and adolescents - the safety and efficacy of the medicine have not been established in children and adolescents under 18 years of age, therefore, the use of the medicine in this age group is not recommended.

If the patient has any of the following conditions, they should inform their doctor before taking the medicine:

• chronic respiratory failure;
• liver and/or kidney failure;
• alcohol, drug, or medication addiction. In this group of patients, there is a high probability of developing habituation and psychological and physical dependence. Therefore, such patients should take Elenium only under strict medical supervision.

Elenium and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

This is especially important if the patient is taking any of the following medicines:

• fluvoxamine, fluoxetine, and other medicines used to treat mental illnesses;
• medicines used to treat insomnia;
• medicines used to treat allergic diseases that may cause drowsiness;
• medicines used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin);
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine, omeprazole, cisapride);
• rifampicin (a medicine used to treat tuberculosis);
• erythromycin (an antibiotic);
• ketoconazole (an antifungal medicine);
• medicines used for general anesthesia;
• narcotic painkillers (e.g., morphine, codeine);
• muscle relaxants (e.g., baclofen);
• medicines used to treat Parkinson's disease (e.g., levodopa);
• disulfiram (used to treat alcoholism);
• alcohol: consuming alcohol during treatment with Elenium may enhance its effect and lead to the occurrence of paradoxical reactions, such as psychomotor agitation, aggressive behavior (see section 2; Warnings and precautions).
• opioids: concomitant use of Elenium and opioids (strong painkillers, medicines used in substitution therapy [addiction treatment], some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered when other treatment options are not possible.

If the doctor prescribes Elenium concomitantly 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 doctor's instructions regarding dosage.

It may be helpful to inform friends or relatives to be aware of the possibility of these symptoms.

If such symptoms occur, the patient should contact their doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Elenium should not be taken during pregnancy.

Chlordiazepoxide passes into breast milk. If administration is necessary, breastfeeding should be discontinued.

Driving and operating machinery

During treatment with Elenium, the patient should not drive vehicles or operate machinery.

The ability to drive vehicles and operate machinery may be impaired due to drowsiness, impaired concentration, or other side effects that reduce concentration (see section 4. Possible side effects).

Elenium contains lactose monohydrate and sucrose.

Elenium 5 mg or 10 mg or 25 mg contains lactose monohydrate and sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Elenium contains sodium

Elenium 5 mg or 10 mg or 25 mg contains less than 1 mmol (23 mg) of sodium per scored tablet, which means the medicine is considered "sodium-free".

Elenium 25 mg contains orange yellow S (E110)

Elenium 25 mg contains orange yellow S (E110), which may cause allergic reactions.

3. How to take Elenium

This medicine should always be taken according to the doctor's instructions.

In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Adults

• Anxiety states - usually 30 mg per day in divided doses, every 6 to 8 hours. In special situations, the doctor may increase the dose. The maximum daily dose should not be exceeded.
• Anxiety states with associated insomnia - 10 mg to 30 mg in a single dose before sleep.
• In states of agitation in acute alcohol withdrawal syndrome - 25 mg to 100 mg. If necessary, the dose can be repeated after 2 to 4 hours, not exceeding 200 mg per day. Then, the dose is reduced to a maintenance dose, the lowest sufficient to control the symptoms of agitation.
• In states of increased muscle tension - 10 mg to 30 mg per day in divided doses.

Children

It is not recommended to use chlordiazepoxide in children.

Patients with impaired renal and/or hepatic function

The doctor determines the dosage individually for each patient, depending on the degree of dysfunction of the given organ.

Elderly patients

Elderly patients are more sensitive to medicines that act on the central nervous system.

When taking Elenium in this population, it is recommended to administer the smallest effective dose. The dose should not exceed half of the recommended dose for adults.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Duration of treatment

The duration of treatment is determined by the doctor.

Method of administration

Elenium tablets should be swallowed, washed down with a small amount of water.

The doctor will start treatment with the smallest effective dose and, if necessary, will gradually increase it.

Taking a higher dose of Elenium than recommended

Symptoms of overdose are impaired consciousness, drowsiness, confusion, slurred speech. In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory disorders, coma, and even death.

If a higher dose of Elenium than recommended is taken, the patient should immediately contact their doctor or go to the nearest emergency department in a hospital. The patient should take the medicine in its original packaging so that the medical staff can precisely check which medicine was taken.

Missing a dose of Elenium

If the patient forgets to take a dose of the medicine, they should take the next dose as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose according to the recommended schedule. If the patient forgets to take two or more doses, they should contact their doctor.

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Elenium

The patient should not stop taking Elenium unless it is in accordance with their doctor's instructions. It is possible that the symptoms of the disease will recur. If the doctor decides to discontinue treatment with Elenium, the dose of the medicine should be gradually reduced over several days.

In case of doubts related to the use of the medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Elenium can cause side effects, although not everybody gets them.

Severe side effects

If any of the following side effects occur, the patient should immediatelyinform their doctor or go to the nearest emergency department in a hospital:

• disorientation, excitement, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses, and abnormal behavior. These disorders usually occur after consuming alcohol, in elderly patients, or in patients with mental illnesses. The frequency of these symptoms cannot be determined based on available data.

Other side effects that may occur after treatment with Elenium

The following side effects occur frequently(less than 1 in 10 patients)

• feeling of drowsiness, dizziness, slowed reactions - may occur during the first few days of treatment in elderly patients and usually disappear during further treatment.

The following side effects occur rarely(less than 1 in 1,000 patients)

• nausea, stomach upset, dry mouth, constipation
• speech disorders, changes in sex drive - mainly affect patients taking high doses of the medicine
• memory disorders

The following side effects occur very rarely(less than 1 in 10,000 patients)

• anaphylactic reactions

Frequency not known (cannot be estimated from the available data)

• changes in the number of certain types of blood cells
• rash, itching, urticaria (allergic reactions)
• loss of appetite
• paradoxical reactions - psychomotor agitation, insomnia, increased excitability and aggression, muscle tremors, seizures. Paradoxical reactions usually occur after consuming alcohol, in elderly patients, and in patients with mental illnesses.
• psychological and physical dependence (even at therapeutic doses of chlordiazepoxide) - patients who abuse alcohol or medicines are more susceptible. Sudden discontinuation of treatment may cause withdrawal syndrome.
• depression (may reveal previously undiagnosed depression)
• visual disturbances (blurred, double vision)
• slow heart rate, chest pain
• mild decrease in blood pressure
• mild increase in liver enzyme activity, liver dysfunction with jaundice (yellowing of the skin, whites of the eyes)
• muscle tremors, muscle weakness, seizures
• urinary retention, incontinence
• menstrual disorders
• general weakness, fainting, falls.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. 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 Elenium

Keep out of sight and reach of children.

Store in a temperature below 25°C. Protect from light and moisture.

Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the given month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Elenium contains

The active substance of the medicine is chlordiazepoxide.

Elenium 5 mg

One tablet contains 5 mg of chlordiazepoxide.

Other ingredients are: potato starch, sodium carboxymethyl starch (type A), gelatin, polysorbate 80, talc, magnesium stearate, lactose monohydrate.

Coating ingredients: polyvinyl alcohol, talc, maltodextrin, quinoline yellow (E104), titanium dioxide, opaglos 6000, sucrose.

Elenium 10 mg

One tablet contains 10 mg of chlordiazepoxide.

Other ingredients are: potato starch, sodium carboxymethyl starch (type A), gelatin, polysorbate 80, talc, magnesium stearate, lactose monohydrate.

Coating ingredients: polyvinyl alcohol, talc, maltodextrin, indigo carmine (E132) + quinoline yellow (E104), titanium dioxide, opaglos 6000, sucrose.

Elenium 25 mg

One tablet contains 25 mg of chlordiazepoxide.

Other ingredients are: potato starch, sodium carboxymethyl starch (type A), gelatin, polysorbate 80, talc, magnesium stearate, lactose monohydrate.

Coating ingredients: polyvinyl alcohol, talc, maltodextrin, orange yellow S (E110), titanium dioxide, opaglos 6000, sucrose.

What Elenium looks like and contents of the packaging

Elenium, 5 mg: yellow scored tablets, round, biconvex.

Elenium, 10 mg: green scored tablets, round, biconvex.

Elenium, 25 mg: orange scored tablets, round, biconvex.

Packaging:20 scored tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, phone: 22 811-18-14. For more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: