Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Neorelium (Relium)
5 mg, coated tablets
Diazepamum
Neorelium and Relium are different brand names for the same medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Neorelium is and what it is used for
What you need to know before taking Neorelium
How to take Neorelium
Possible side effects
How to store Neorelium
Contents of the pack and other information

1. What Neorelium is and what it is used for

Neorelium contains diazepam as the active substance, which belongs to a group of medicines called benzodiazepines. Diazepam has anxiolytic, sedative, and anticonvulsant properties. It also has sleep-inducing effects and reduces skeletal muscle tension. Neorelium is used:

Short-term treatment of anxiety states (for 2 to 4 weeks), which may also be associated with insomnia;
Treatment of symptoms of acute alcohol withdrawal;
Treatment of conditions with increased skeletal muscle tension;
As a sedative and premedication (preparation for certain surgical and diagnostic procedures);
As an adjunctive anticonvulsant treatment in certain types of epilepsy, e.g. clonic muscle seizures.

2. Important information before using Neorelium

When not to use Neorelium
Do not use Neorelium if the patient has:

Hypersensitivity (allergy) to diazepam or other benzodiazepines or to any of the excipients listed in section 6;
Severe respiratory insufficiency, regardless of cause;
Severe hepatic or renal insufficiency;
Myasthenia gravis (a disease causing muscle weakness and excessive fatigue).

Page 1 of 7
Warnings and precautions
General information regarding effects observed with benzodiazepines and other drugs with similar action, which should be considered when using Neorelium.
➢ Tolerance
After several weeks of treatment with Neorelium, the effectiveness of the drug may decrease.
➢ Dependence
Prolonged use of Neorelium may lead to psychological and physical dependence. The risk of developing dependence increases with higher doses and longer duration of treatment, and is greater in patients with a history of drug or alcohol dependence or those with personality disorders.
➢ Withdrawal symptoms
If Neorelium is discontinued abruptly, withdrawal symptoms may occur, such as:
headache, muscle pain, increased anxiety, tension, agitation, motor restlessness, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of sense of reality, personality disturbances, hypersensitivity to sound, touch, light, noise, tingling and numbness in the extremities, hallucinations and delusions, epileptic seizures.
➢ Rebound phenomenon and anxiety
During discontinuation of Neorelium, a temporary recurrence of intensified symptoms that led to treatment initiation may occur (so-called "rebound" phenomenon). These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of these effects, gradual dose reduction is recommended.
➢ Anterograde amnesia (inability to remember events after drug administration)
Neorelium may cause anterograde amnesia (difficulty in learning and remembering new information – new data are not permanently stored). This condition most commonly occurs within a few hours after drug administration, especially at higher doses. If the physician has prescribed Neorelium once daily, to reduce the risk of anterograde amnesia it is recommended to take the medication half an hour before going to bed and ensure appropriate conditions for uninterrupted sleep lasting 7–8 hours.
➢ Psychiatric and paradoxical reactions
In children and elderly patients, the risk of psychiatric and paradoxical (opposite to expected) reactions is increased, such as: anxiety, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disturbances.
If such symptoms occur, contact a physician immediately.
Special patient groups
➢ Neorelium may be used in children only after careful dose adjustment by a physician and for the shortest possible duration.
In children under 6 months of age, Neorelium should be used with particular caution and only when other treatment methods are not feasible, as safety and efficacy have not been established in this age group.
➢ Elderly and debilitated patients should receive lower doses of Neorelium (see section 3), due to the increased risk of adverse effects, particularly disturbances in orientation and motor coordination (falls, injuries).
➢ Patients with hepatic or renal insufficiency or chronic respiratory insufficiency should inform their physician about these conditions before taking Neorelium.
Page 2 of 7
➢ Use in depression. Before using Neorelium, inform the physician about any psychiatric disorders. Patients with symptoms of depression or anxiety associated with depression should be treated with multiple medications. Administering Neorelium alone to patients with depression may worsen depressive symptoms, including suicidal thoughts.
➢ During benzodiazepine treatment, previously masked depression may emerge.
➢ Patients with alcohol, narcotic, or drug dependence should inform their physician about such habits 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 strict medical supervision.
➢ Use of Neorelium after the loss of a close person or during bereavement does not improve well-being.
Neorelium and other medicines
Inform your physician about all medicines currently used, recently used, or planned for use.
This is particularly important if the patient is taking any of the following medicines:

Fluvoxamine, fluoxetine, and other medicines used in the treatment of psychiatric disorders.
Medicines used for insomnia.
Medicines used for allergic conditions that may cause drowsiness.
Medicines used for epilepsy (e.g., carbamazepine, phenytoin, hydantoin).
Medicines used for peptic ulcer disease (e.g., cimetidine, omeprazole, cisapride).
Ketoconazole (an antifungal medicine).
Strong analgesics (e.g., morphine).
Alcohol: consuming alcohol during treatment with Neorelium may enhance its effects and lead to paradoxical reactions such as psychomotor excitation and aggressive behavior (see section 2; Warnings and precautions).
Opioids: concomitant use of Neorelium and opioids (strong analgesics, medicines used in substitution therapy [addiction treatment], some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when no other treatment options are available.

If the physician prescribes Neorelium together with opioids, the dose and duration of concurrent treatment should be minimized.
The patient should inform the physician about all opioid medicines being taken and strictly follow the physician's dosing instructions. It may be helpful to inform friends or family members about the possibility of these symptoms occurring. If such symptoms occur, contact the physician immediately.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a physician or pharmacist before using this medicine.
Neorelium should not be used during pregnancy.
Neorelium passes into breast milk. If treatment is necessary, breastfeeding should be discontinued.
Page 3 of 7
Driving and operating machinery
During treatment with Neorelium and for 24 hours after therapy ends, patients should not drive or operate machinery.
The ability to drive and operate mechanical equipment may be impaired due to possible drowsiness, concentration disturbances, or other adverse effects that reduce concentration (see section 4. Possible adverse effects).
Neorelium contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicine.
Neorelium contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Neorelium

Neorelium must always be taken as prescribed by the physician.
In case of doubts, consult your doctor.
Recommended dose
Adults

Anxiety and nervousness - 5 to 10 mg per day in 1 to 2 divided doses.
Symptoms of alcohol withdrawal syndrome - up to 30 mg per day in divided doses, typically 10 mg three times daily. In justified cases, especially in alcoholic psychoses, the dose may be increased to 60 mg per day (respiratory function must be monitored).
Insomnia - 5 to 10 mg taken 0.5 hours before bedtime.
Muscle spastic states - 5 to 15 mg per day in divided doses; in severe cases, the daily dose may 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 per day.

Children over 3 years of age
For anxiety states, increased muscular tension, or as an anticonvulsant –
1 mg to 2.5 mg 3 to 4 times per 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 3–4 divided doses; the dose may then be gradually increased depending on efficacy and severity of adverse effects.
Patients with impaired renal and/or hepatic function
The physician determines the dosage individually for each patient, depending on the degree of organ dysfunction.
Elderly patients
Elderly patients are more sensitive to drugs acting on the central nervous system.
When using Neorelium in this population, it is recommended to administer the lowest effective dose.
The dose should not exceed half the dose recommended for adults.
If during treatment the patient feels that the effect of the drug is too strong or too weak,
he/she should consult the physician.
Duration of treatment
The duration of treatment is determined by the physician.
Page 4 of 7
Method of administration
Neorelium tablets should be taken orally, swallowed with a small amount of water.
The physician will start treatment with the lowest effective dose and, if necessary, gradually increase it.
Use of a higher than recommended dose of Neorelium
Symptoms of diazepam overdose include disturbances of consciousness, drowsiness, confusion, slurred speech. In severe cases of poisoning, the following may occur: motor incoordination, hypotension, muscle weakness, respiratory depression, coma, and even death.
In case of ingestion of a higher than recommended dose of Neorelium, seek immediate medical advice or go to the nearest hospital emergency department. Bring the medication in its original packaging so that medical staff can clearly identify which drug was taken.
Missed dose of Neorelium
If the patient forgets to take a dose, he/she should take the next dose as soon as he/she remembers. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the next dose taken as prescribed. If the patient forgets two or more doses, he/she should contact the physician.
Do not take a double dose to make up for a missed dose.
Stopping Neorelium treatment
Do not discontinue treatment unless advised by the physician. Reappearance of disease symptoms is possible. If the physician decides to discontinue the drug, the dose should be gradually reduced over several days.
In case of any doubts regarding the use of the medication, consult your doctor.

4. Possible adverse reactions

Like all medicines, Neorelium may cause adverse reactions, although not everyone experiences them.

Serious adverse reactions
If any of the following adverse symptoms occur, immediately contact your doctor or go to the nearest hospital emergency department:

Severe allergic reaction presenting as itching, swelling of lips or tongue, wheezing, or difficulty breathing. These symptoms have been reported very rarely.
Disorientation, excitement and agitation, depression with suicidal tendencies, anxiety, irritability, hallucinations, nightmares, illusions (seeing or hearing things that do not exist), psychoses (loss of contact with reality), unusual behaviour. These disorders most commonly occur in children and elderly patients.

Other adverse reactions that may occur during treatment with Neorelium

Changes in number and type of blood cells.
Skin rashes, itching, urticaria.
Loss of appetite.
Paradoxical reactions – psychomotor agitation, insomnia, increased excitability and aggressiveness, muscle tremor, seizures. Paradoxical reactions most commonly occur after alcohol consumption, in elderly patients, and in patients with psychiatric disorders.

Page 5 of 7

Psychological and physical dependence may develop during treatment with diazepam at therapeutic doses. Abrupt discontinuation of treatment may lead to withdrawal syndrome. Patients who abuse alcohol or drugs are more susceptible to developing dependence. Treatment with diazepam may unmask previously existing, undiagnosed depression.
Drowsiness, dizziness, slowed reactions may occur during the first few days of treatment.
Drowsiness, memory disturbances, impaired motor coordination, speech disturbances, changes in libido.
Visual disturbances (blurred or double vision).
Slowed heart rate, chest pain.
Low blood pressure.
Gastrointestinal discomfort.
Slight increase in liver enzyme activity, liver function disturbances with jaundice (yellowing of the skin and whites of the eyes).
Muscle tremor, muscle weakness.
Urinary retention, urinary incontinence.
Menstrual disorders.
General weakness, fainting.

If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, consult a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 (22) 49 21 301
Fax: + 48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Neorelium

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Neorelium contains
Page 6 of 7
The active substance is diazepam. One coated tablet contains 5 mg of diazepam.
The 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 contents of the pack
Yellow, round, biconvex coated tablets.
Pack: 20 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Latvia, country of export:
Tarchomin Pharmaceutical Works "Polfa" S.A., A. Fleminga 2,
03-176 Warsaw, Poland
Manufacturer:
Tarchomin Pharmaceutical Works "Polfa" S.A., A. Fleminga 2,
03-176 Warsaw, Poland
Parallel importer:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Latvia, country of export: 96-0160
Parallel import authorisation number: 297/22
Page 7 of 7