Neorelium

Package Leaflet: Information for the Patient

Neorelium, 5 mg, Coated Tablets

Diazepam

Please read carefully the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine 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, the doctor or pharmacist should be informed. See section 4.

Table of Contents of the Leaflet:

• 1. What is Neorelium and what is it used for
• 2. Important information before taking Neorelium
• 3. How to take Neorelium
• 4. Possible side effects
• 5. How to store Neorelium
• 6. Contents of the pack 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 medicines called benzodiazepines. Diazepam has anxiolytic, sedative, anticonvulsant, and muscle relaxant properties. It is used:

• for a short period in the treatment of anxiety states (for 2 to 4 weeks), which may also be associated with insomnia;
• in the treatment of symptoms of acute alcohol withdrawal;
• in the treatment of increased muscle tone;
• 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 taking Neorelium

When not to take Neorelium

If the patient has:

• hypersensitivity (allergy) to diazepam or other benzodiazepines or any of the excipients of the medicine (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).

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 Neorelium.

Tolerance may develop after taking Neorelium for several weeks, reducing its effectiveness.

Dependence may occur with long-term use of Neorelium, leading to psychological and physical dependence. The risk of dependence increases with the dose and duration of treatment and is higher in patients with a history of substance abuse or personality disorders.

Withdrawal symptoms may occur when Neorelium is stopped abruptly, such as headaches, muscle pain, increased anxiety, tension, agitation, restlessness, disorientation, sleep disturbances, and irritability. In severe cases, more serious symptoms may occur, including loss of reality, personality disorders, hypersensitivity to sound, touch, light, noise, tingling, and numbness of limbs, hallucinations, and delusions.

A rebound effect and anxiety may occur when Neorelium is discontinued, with a transient recurrence of the symptoms that led to its use. 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 Neorelium.

Anterograde amnesia (inability to remember events after taking the medicine) may occur, especially when Neorelium is taken in high doses. This condition usually occurs within a few hours of taking the medicine.

Psychological and paradoxical reactions, such as anxiety, agitation, irritability, aggression, anger, and rage, may occur, especially in children and the elderly.

In case of such symptoms, the doctor should be contacted immediately.

Special patient groups:

Children: Neorelium should be used with caution in children and only for a short period, as the safety and efficacy of the medicine have not been established in this age group.

Elderly patients: Neorelium should be used with caution in elderly patients, as they may be more sensitive to the medicine. The dose should be reduced, and the patient should be monitored closely for signs of dependence or withdrawal symptoms.

Patients with liver or kidney impairment: Neorelium should be used with caution in patients with liver or kidney impairment, as the medicine may accumulate in the body and increase the risk of side effects.

Patients with depression: Neorelium should be used with caution in patients with depression, as it may worsen the symptoms of depression.

Patients with a history of substance abuse: Neorelium should be used with caution in patients with a history of substance abuse, as they may be more likely to develop dependence on the medicine.

Neorelium and other medicines

The doctor should be informed about all medicines being taken, including those that are about to be taken.

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).
• Ketoconazole (an antifungal medicine).
• Strong painkillers (e.g., morphine).
• Alcohol: consuming alcohol during treatment with Neorelium may enhance its effects and lead to paradoxical reactions, such as psychomotor agitation, aggressive behavior (see section 2; Warnings and precautions).
• Opioids: concomitant use of Neorelium and opioids (strong painkillers, medicines used to treat addiction, some cough medicines) increases the risk of sedation, respiratory depression, coma, and even death. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.

If the doctor prescribes Neorelium with opioids, the dose and duration of concomitant treatment should be limited. The patient should inform the doctor about all opioid medicines being taken and follow the doctor's instructions for dosing. It may be helpful to inform friends or family members to be aware of the possibility of these symptoms. If such symptoms occur, the doctor should be contacted.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or planning to become pregnant, they should consult their doctor or pharmacist before taking Neorelium.

Neorelium should not be taken during pregnancy.

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

Driving and using machines

During treatment with Neorelium and for 24 hours after stopping treatment, the patient should not drive or operate machinery.

The ability to drive or operate machinery may be impaired due to the possibility of sedation, impaired concentration, or other side effects that may 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 consult their doctor before taking Neorelium.

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

3. How to take Neorelium

Neorelium should always be taken as directed by the doctor.

In case of doubts, the doctor should be consulted.

Recommended dose:

Adults

• Anxiety and restlessness - 5 to 10 mg per day in 1 to 2 divided doses.
• Alcohol withdrawal symptoms - up to 30 mg per day in divided doses, usually 10 mg 3 times a day. In justified cases, especially in alcoholic psychosis, the dose can be increased to 60 mg per day (with necessary monitoring for respiratory depression).
• Insomnia - 5 to 10 mg 0.5 hours before bedtime.
• Muscle spasms - 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

For anxiety, increased muscle tone, 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 side effects.

Patients with impaired renal and/or hepatic function

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

Elderly patients

Elderly patients are more sensitive to medicines that act on the central nervous system. When taking Neorelium in this population, the smallest effective dose should be used. 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

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

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

Overdose of Neorelium

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

In case of overdose, the doctor or the nearest emergency department should be contacted immediately. The patient should take the medicine in its original packaging so that the medical staff can accurately determine which medicine was taken.

Missed dose of Neorelium

If the patient forgets to take a dose, they should take the next dose as soon as possible. However, if it is close to the time of the next dose, the missed dose should be skipped and the next dose taken as directed. If the patient forgets to take two or more doses, they should consult their doctor.

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

Stopping treatment with Neorelium

Treatment with Neorelium should not be stopped unless advised by the doctor. It is possible that the symptoms of the disease will recur. If the doctor decides to stop treatment, the dose of Neorelium should be gradually reduced over several days.

In case of doubts about taking the medicine, the doctor should be consulted.

4. Possible side effects

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

Severe side effects

If any of the following side effects occur, the doctor should be informed immediatelyor the patient should go to the nearest emergency department:

• Severe allergic reaction with symptoms such as itching, swelling of the lips or tongue, or wheezing.
• Disorientation, excitement, and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychosis (loss of contact with reality), abnormal behavior. These disorders usually occur in children and the elderly.

Other side effects that may occur with Neorelium

• Changes in blood cell count.
• Rashes, itching, hives.
• Lack 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 may develop during treatment with diazepam. Sudden withdrawal of the medicine may lead to a withdrawal syndrome. Patients who abuse alcohol or drugs are more prone to developing dependence. During treatment with diazepam, previously undiagnosed depression may be revealed.
• Drowsiness, dizziness, slowed reactions may occur during the first few days of treatment.
• Sedation, memory disturbances, coordination disorders, speech disturbances, changes in libido.
• Visual disturbances (blurred or double vision).
• Slow heart rate, chest pain.
• Low blood pressure.
• Gastrointestinal disorders.
• Mild elevation of liver enzymes, liver dysfunction with jaundice (yellowing of the skin and 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 this leaflet, the doctor should be consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to store Neorelium

The medicine should be stored 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 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 pharmacist should be asked 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 Neorelium contains

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

The other ingredients are: potato starch, sodium carboxymethylcellulose (type A), gelatin, polysorbate 80, quinoline yellow (E 104), talc, magnesium stearate, lactose monohydrate, hypromellose, macrogol 6000.

What Neorelium looks like and contents of the pack

Yellow, round, biconvex coated tablets.

Packaging:20 coated tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna

ul. A. Fleminga 2

03-176 Warszawa

Phone: 22 811-18-14

To obtain more detailed information, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: