NEORELIUM

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer 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 using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine 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 or pharmacist. See section 4.

Table of contents:

1. What Neorelium is and what it is used for
2. What you need to know 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 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, anticonvulsant properties. It also has hypnotic 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 a premedication agent (preparation for certain surgical and diagnostic procedures);
• As an adjunctive anticonvulsant in the treatment of 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 of the medicine (listed in section 6);
• Severe respiratory insufficiency, regardless of cause;
• Severe liver or kidney impairment;
• Myasthenia gravis (a disease causing muscle weakness and excessive fatigue).

Warnings and precautions
General information regarding effects observed during treatment 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 medicine may decrease.
• Dependence: Prolonged use of Neorelium may lead to psychological and physical dependence. The risk of dependence increases with higher doses and longer duration of treatment, and is greater in patients with a history of drug or alcohol dependence, or in patients with personality disorders.
• Withdrawal symptoms: If Neorelium is stopped abruptly, withdrawal symptoms may occur, such as: headache, muscle pain, increased anxiety, tension, restlessness, disorientation, sleep disturbances, irritability. In more severe cases, the following may occur: loss of reality perception, personality disturbances, hypersensitivity to sound, touch, light, noise, tingling and numbness in limbs, hallucinations and delusions, epileptic seizures.
• Rebound phenomenon and anxiety: During discontinuation of Neorelium, a temporary return of intensified symptoms that were the reason for starting treatment may occur (so-called "rebound" phenomenon). These symptoms are often accompanied by mood changes, anxiety, sleep disturbances, and insomnia. To minimize the risk of such effects, gradual dose reduction is recommended.
• Anterograde amnesia (inability to remember events after taking the medicine): Neorelium may cause anterograde amnesia (difficulty in learning and remembering new information – new data are not permanently stored). This usually occurs within a few hours after administration of the medicine, 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 medicine half an hour before going to bed and ensure appropriate conditions for uninterrupted sleep lasting 7–8 hours.
• Psychological and paradoxical reactions: In children and elderly patients, the risk of abnormal psychological and paradoxical (opposite to expected) reactions is increased, such as: anxiety, agitation, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, behavioral disturbances. If such symptoms occur, contact the physician immediately.

Special patient groups

• Neorelium may be used in children only after careful dose adjustment by the 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 the safety and efficacy of the medicine 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 liver or kidney impairment or chronic respiratory insufficiency should inform the physician about these conditions before taking Neorelium.
• 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 treatment with benzodiazepines, underlying masked depression may become apparent.
• Patients with alcohol, drug, or medication dependence should inform the 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 loved one or during bereavement does not improve well-being.

Neorelium and other medicines
Inform the physician about all medicines currently used or recently taken, as well as any medicines the patient plans to take.
This is particularly important if the patient is using 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: Consumption of alcohol during treatment with Neorelium may enhance its effects and lead to paradoxical reactions such as psychomotor agitation and aggressive behavior (see section 2; Warnings and precautions).
• Opioids: Concurrent 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 even be life-threatening. Therefore, concurrent 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 concomitant 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 such symptoms occurring. If such symptoms occur, contact the physician immediately.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning 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.

Driving and operating machinery
During treatment with Neorelium and for 24 hours after completion of therapy, 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 the medicine.
Neorelium contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Neorelium

Neorelium should always be taken as directed by the physician.
In case of doubt, consult your doctor.

Recommended dosage
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 spasticity – 5 to 15 mg per day in divided doses; in severe cases, the daily dose may be increased to 60 mg.
• Prior to certain surgical and diagnostic procedures – 5 mg to 20 mg.
• As an anticonvulsant – 2 mg to 10 mg, 2 to 4 times daily.

Children over 3 years of age
For anxiety states, increased muscle tension, or as an anticonvulsant –
1 mg to 2.5 mg, 3 to 4 times daily, 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 the severity of adverse effects.

Patients with impaired renal and/or hepatic function
The physician will determine the dosage individually based 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 of the recommended adult dose.

If during treatment the patient feels that the effect of the medicine is too strong or too weak,
he/she should consult the doctor.

Duration of treatment
The duration of treatment is determined by the physician.

Administration method
Neorelium tablets should be taken orally, swallowed with a small amount of water.
The physician will initiate 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, and 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 attention or go to the nearest hospital emergency department. Bring the medicine in its original packaging so that the medical staff can identify exactly 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 remembered. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken as scheduled. If the patient forgets two or more doses, he/she should contact the doctor.
Do not take a double dose to make up for a missed dose.

Discontinuation of Neorelium
Do not stop taking the medicine unless instructed by the doctor. Symptoms of the disease may recur. If the doctor decides to discontinue treatment, the dose should be gradually reduced over several days.

In case of any doubts regarding the use of the medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, Neorelium may cause adverse reactions, although not everyone experiences them.

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

• Severe allergic reaction presenting as itching, swelling of the lips or tongue, wheezing, or difficulty breathing. These symptoms have been reported very rarely.
• Disorientation, states of excitement and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations (seeing or hearing things that do not exist), psychoses (loss of contact with reality), unusual behaviors. 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 tremors, seizures. Paradoxical reactions most commonly occur after alcohol consumption, in elderly patients, and in patients with psychiatric disorders.
• 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 reaction times 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.
• Decreased blood pressure.
• Gastrointestinal disturbances.
• Slight increase in liver enzyme activity, liver function disturbances with development of jaundice (yellowing of the skin and whites of the eyes).
• Muscle tremors, muscle weakness.
• Urinary retention, urinary incontinence.
• Menstrual disorders.
• General weakness, fainting.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician.

Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not mentioned in this leaflet, inform your doctor or pharmacist. 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 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Neorelium

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Neorelium contains
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, monohydrate lactose; coating:
hypromellose, polyethylene glycol 6000.
What Neorelium looks like and contents of the pack
Yellow, round, biconvex coated tablets.
The pack contains 20 coated tablets in a PVC/Aluminum blister pack within a cardboard box.
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:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Latvia, country of export: 96-0160
Parallel import authorisation number: 37/23