Neorelium

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Neorelium (Relium)

5 mg, coated tablets

Diazepam
Neorelium and Relium are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• -The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Neorelium and what is it used for
• 2. Important information before using Neorelium
• 3. How to use Neorelium
• 4. Possible side effects
• 5. How to store Neorelium
• 6. Package contents and other information

1. What is Neorelium and what is it used for

Neorelium contains the active substance diazepam, which belongs to a group of drugs called benzodiazepines. Diazepam has anxiolytic, sedative, anticonvulsant, and muscle relaxant properties. It is used:

• short-term for the treatment of anxiety states (for 2 to 4 weeks), which may also be associated with insomnia;
• for the treatment of symptoms of acute alcohol withdrawal;
• for the treatment of muscle tension states;
• as a sedative and premedication (preparation for certain surgical and diagnostic procedures);
• as an adjunctive anticonvulsant in the treatment of certain types of epilepsy, such as clonic muscle seizures.

2. Important information before using Neorelium

When not to use Neorelium

If the patient has:

• hypersensitivity (allergy) to diazepam or other benzodiazepines or any of the excipients of the drug (listed in section 6);
• severe respiratory failure, regardless of the cause;
• severe liver or kidney failure;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue).

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Warnings and precautions

General information about the effects observed after treatment with benzodiazepines and other drugs with similar effects to benzodiazepines, which should be taken into account when using Neorelium.

Tolerance: After using Neorelium for several weeks, the effectiveness of the drug may decrease.

Dependence: Long-term use of Neorelium 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: In case of sudden withdrawal of the drug, 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 reality, personality disorders, hypersensitivity to sound, touch, light, noise, feeling of tingling and numbness of limbs, hallucinations, and delusions, seizures.

Rebound phenomenon and anxiety: During the withdrawal of Neorelium, a transient recurrence of intensified symptoms may occur, which were the reason for using the drug (so-called rebound phenomenon). 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 drug.

Anterograde amnesia (inability to remember events after taking the drug): Neorelium 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 drug, especially in high doses. If the doctor recommends taking Neorelium once a day, to reduce the risk of anterograde amnesia, it is recommended to take the drug 30 minutes before going to bed and ensuring adequate conditions for continuous, uninterrupted sleep lasting 7-8 hours.

Psychotic and paradoxical reactions: In children and the elderly, the risk of abnormal psychotic and paradoxical reactions (opposite to expected) increases, such as anxiety, excitement, irritability, aggression, anger, fury, delusions, nightmares, hallucinations, psychoses, behavioral disorders.

If such symptoms occur, you should immediately contact your doctor.

Special patient groups

Children: Neorelium can be used in children after careful dose adjustment by the doctor and for the shortest possible treatment period.

In children under 6 months of age, the drug should be used with special caution and only when it is not possible to use other treatment methods, as the safety and efficacy of the drug have not been established in this age group.

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

Patients with liver or kidney failure or chronic respiratory failure should inform their doctor about these conditions before taking Neorelium.

Use in depression: Before using Neorelium, patients should inform their doctor about any mental illnesses. Patients with symptoms of depression or anxiety associated with depression should use multiple drugs simultaneously. Administering Neorelium alone to patients with depression may exacerbate symptoms of depression, including suicidal thoughts.

During the use of benzodiazepines, masked depression may be revealed.

Patients with a history of alcohol, drug, or medication abuse should inform their doctor about these addictions before taking Neorelium.

These patients are at high risk of developing psychological and physical dependence. Therefore, this group of patients should use Neorelium only under the strict control of a doctor.

Use of Neorelium after the loss of loved ones or during bereavement does not improve well-being.

Neorelium and other drugs

Patient should tell their doctor about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.

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

• Fluvoxamine, fluoxetine, and other drugs used to treat mental illnesses.
• Drugs used to treat insomnia.
• Drugs used to treat allergic diseases that may cause drowsiness.
• Drugs used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin).
• Drugs used to treat stomach and duodenal ulcers (e.g., cimetidine, omeprazole, cisapride).
• Ketoconazole (an antifungal drug).
• Strong painkillers (e.g., morphine).
• Alcohol: consuming alcohol during treatment with Neorelium may enhance its effect and lead to paradoxical reactions, such as psychomotor excitement, aggressive behavior (see section 2; Warnings and precautions).
• Opioids: concomitant use of Neorelium and opioids (strong painkillers, drugs used in substitution therapy, some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these drugs can only be considered when other treatment options are not possible.

If the doctor prescribes Neorelium concomitantly with opioids, the dose and duration of concomitant treatment should be limited.

The patient should inform their doctor about all the opioid drugs they are taking and strictly follow the doctor's recommendations regarding dosing. It may be helpful to inform friends or relatives so that they are 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 or pharmacist before using this drug.

Neorelium should not be taken during pregnancy.

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

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Driving and operating machinery

During treatment with Neorelium and up to 24 hours after the end of therapy, the patient should not drive vehicles or operate machinery.

The ability to drive vehicles and mechanical devices may be impaired due to the possibility of drowsiness, concentration disorders, or other side effects that reduce concentration (see section 4. Possible side effects).

Neorelium contains lactose monohydrate

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

Neorelium contains less than 1 mmol (23 mg) of sodium per tablet, which means the drug is considered "sodium-free".

3. How to use Neorelium

Neorelium should always be taken according to the doctor's recommendations.

In case of doubts, the patient should contact their doctor.

Recommended dose

Adults

• Anxiety and restlessness - 5 to 10 mg per day in 1 to 2 divided doses.
• Alcohol withdrawal syndrome - up to 30 mg per day in divided doses, on average 10 mg 3 times a day. In justified cases, especially in alcoholic psychoses, the dose can be increased to 60 mg per day (it is necessary to monitor possible respiratory disorders).
• Insomnia - 5 to 10 mg 30 minutes before bedtime.
• Muscle spasticity - 5 to 15 mg per day in divided doses, in severe cases, the daily dose can be increased to 60 mg.
• Before certain surgical and diagnostic procedures - 5 mg to 20 mg.
• As an anticonvulsant - 2 mg to 10 mg, 2 to 4 times a day.

Children over 3 years

In anxiety states, muscle tension states, or as an anticonvulsant - 1 mg to 2.5 mg 3 to 4 times a day or 0.12 mg to 0.8 mg/kg body weight or 3.5 mg to 24 mg/m2 body surface area per day in 3 to 4 divided doses, then the dose can be gradually increased depending on efficacy and severity of side effects.

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 drugs that act on the central nervous system. When using Neorelium 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 drug is too strong or too weak during treatment, they should consult their doctor.

Treatment duration

The treatment duration is determined by the doctor.

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Method of administration

Neorelium tablets should be taken orally, with a small amount of water.

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

Use of a higher than recommended dose of Neorelium

Symptoms of diazepam 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.

In case of use of a higher than recommended dose of Neorelium, the patient should immediately contact their doctor or go to the nearest emergency department in a hospital. The patient should take the drug in its original packaging so that the medical staff can accurately check which drug was used.

Missed dose of Neorelium

If the patient forgets to take a dose of the drug, 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 recommendation. 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 the missed dose.

Discontinuation of Neorelium

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

In case of doubts about the use of the drug, the patient should consult their doctor.

4. Possible side effects

Like all drugs, Neorelium can cause side effects, although they do not occur in everyone.

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:

• Severe allergic reaction in the form of itching, swelling of the lips or tongue, or wheezing, or shortness of breath. These symptoms are very rare.
• Disorientation, excitement, and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses, abnormal behavior. These disorders most often occur in children and the elderly.

Other side effects that may occur after treatment with Neorelium

• Changes in blood cell count and type.
• Rashes, itching, hives.
• Lack of appetite.
• Paradoxical reactions - psychomotor anxiety, insomnia, increased excitability and aggression, muscle tremors, seizures. Paradoxical reactions most often occur after consuming alcohol, in elderly patients, and in patients with mental illnesses.

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• Psychological and physical dependence may develop during treatment with diazepam in therapeutic doses. Sudden discontinuation of treatment may cause withdrawal syndrome. Patients who abuse alcohol or drugs are more prone to developing dependence. During treatment with diazepam, previously undiagnosed depression may be revealed.
• Feeling of drowsiness, dizziness, slowed reactions may occur during the first few days of treatment.
• Drowsiness, memory disorders, coordination disorders, speech disorders, changes in libido.
• Visual disturbances (blurred, double vision).
• Slow heart rate, chest pain.
• Low blood pressure.
• Gastrointestinal disorders.
• Slight increase in liver enzyme activity, liver dysfunction with jaundice (yellowing of the skin, whites of the eyes).
• Muscle tremors, muscle weakness.
• Urinary retention, incontinence.
• Menstrual disorders.
• General weakness, fainting.

If any side effects occur, including any side effects not listed in the leaflet, the patient should consult their doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in the 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to store Neorelium

The drug should be stored in a place that is invisible and inaccessible to children.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month.

Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Neorelium contains

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The active substance of the drug is diazepam. One coated tablet contains 5 mg of diazepam.

Other ingredients are: potato starch, sodium carboxymethyl starch (type A), gelatin, polysorbate 80, quinoline yellow (E 104), talc, magnesium stearate, lactose monohydrate; coating: hypromellose, macrogol 6000.

What Neorelium looks like and what the package contains

Yellow, round, biconvex coated tablets.

Packaging: 20 coated tablets.

To obtain more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Poland

Manufacturer:

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Poland

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing authorization number in Latvia, the country of export: 96-0160

Parallel import authorization number: 297/22 Date of leaflet approval: 03.08.2022

[Information about the trademark]

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