Elenium

Package Leaflet: Information for the Patient

Elenium, 5 mg, scored tablets

Elenium, 10 mg, scored tablets

Elenium, 25 mg, scored tablets

Chlordiazepoxide

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

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

Contents of the Package 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 pack 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 you have:

• 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 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

Long-term use of Elenium may lead to psychological and physical dependence.

The risk of dependence increases with the dose and duration of treatment and is higher in patients who are dependent on drugs, alcohol, or have personality disorders.

Withdrawal symptoms

After sudden withdrawal of the medicine, the patient may experience withdrawal symptoms, such as: headaches, muscle pain, increased anxiety, tension, agitation, 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, behavioral disorders. If such symptoms occur, you should immediately contact your doctor.

Use in depression

Before taking Elenium, you should inform your 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 you have any of the following conditions, you should inform your doctor before taking the medicine:

• chronic respiratory failure;
• liver and/or kidney failure;
• alcohol, drug, or medication dependence. 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

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

This is especially important if you are 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 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 for substitution therapy [addiction treatment], some cough medicines) increases the risk of sedation, 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 your doctor prescribes Elenium with opioids, they should limit the dose and duration of concomitant treatment.

You should inform your doctor about all opioid medications you are taking and strictly follow the doctor's instructions regarding dosing. It may be helpful to inform friends or relatives to be aware of the possibility of these symptoms.

If such symptoms occur, you should contact your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice 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 using machines

During treatment with Elenium, you should not drive vehicles or operate machines.

The ability to drive vehicles and operate machines may be impaired due to sedation, 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 you have been diagnosed with intolerance to some sugars, you should contact your 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 exactly as directed by your doctor.

If you are unsure, ask your 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. Do not exceed the maximum daily dose of 100 mg.
• Anxiety states with associated insomnia - 10 mg to 30 mg in a single dose before bedtime.
• 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

Chlordiazepoxide is not recommended for use 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 you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Duration of treatment

The duration of treatment is determined by your 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, sedation, confusion, slurred speech. In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory disorders, coma, and even death.

If you have taken a higher dose of Elenium than recommended, you should immediately contact your doctor or go to the nearest emergency department in a hospital. You should take the medicine in its original packaging so that the medical staff can accurately check which medicine was taken.

Missing a dose of Elenium

If you forget to take a dose of the medicine, you should take the next dose as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose and take the next dose as directed. If you forget to take two or more doses, you should contact your doctor.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Elenium

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

If you have any doubts about taking the medicine, you should consult your doctor.

4. Possible side effects

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

Severe side effects

If you experience any of the following side effects, you should immediatelyinform your doctor or go to the nearest emergency department in a hospital:

• disorientation, excitement, and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses, 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 taking Elenium

The following side effects are common(less than 1 in 10 patients)

• feeling of sedation, 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 are rare(less than 1 in 1,000 patients)

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

The following side effects are very rare(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)
• bradycardia, 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 you experience any side effects, including those not listed in this package leaflet, you should inform your 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, you can help provide more information on the safety of the medicine.

5. How to store Elenium

Keep out of the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Elenium contains

The active substance of the medicine is chlordiazepoxide.

Elenium 5 mg

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

Elenium 10 mg

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

Elenium 25 mg

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

What Elenium looks like and contents of the pack

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 package leaflet: