Neorelium

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! 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 medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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. Neorelium 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 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 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 after treatment with benzodiazepines and other medicines with similar effects to benzodiazepines, which should be taken into account when taking Neorelium.

• Tolerance: After taking Neorelium for several weeks, the effectiveness of the medicine may decrease.
• Dependence: Taking Neorelium for a longer period may lead to psychological and physical dependence. The risk of developing 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 medicine, the patient may experience withdrawal symptoms, such as headaches, muscle pain, increased anxiety, tension, excitement, restlessness, disorientation, sleep disturbances, and 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 Neorelium, a transient recurrence of intensified symptoms, which 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): 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 medicine, especially in high doses. If the doctor has prescribed Neorelium 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 ensuring 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, excitement, irritability, aggression, anger, rage, delusions, nightmares, hallucinations, psychoses, and behavioral disorders. If such symptoms occur, the patient should immediately contact their doctor.

Special patient groups

• In children, Neorelium can be used after careful dose adjustment by the doctor and for the shortest possible treatment period. In children under 6 months, the medicine should be used with special caution and only when it is impossible to use other treatment methods, as the safety and efficacy of the medicine in this age group have not been established.
• Elderly and debilitated patients should receive lower doses of Neorelium (see section 3), due to the possibility of increased side effects, mainly orientation and motor coordination disorders (falls, injuries).
• Patients with liver or kidney failure or chronic respiratory failure should inform their doctor about these conditions before taking Neorelium.
• Before taking Neorelium, patients should inform their doctor about any mental health conditions. Patients with symptoms of depression or anxiety associated with depression should take several medicines at the same time. Administering Neorelium alone to patients with depression may worsen depressive symptoms, including suicidal thoughts.
• During treatment with benzodiazepines, masked depression may be revealed.
• Patients with a history of alcohol, drug, or medicine 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 take Neorelium only under strict medical supervision.
• Taking Neorelium after the loss of loved ones or during bereavement does not improve well-being.

Neorelium and other medicines

Patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important if the patient is taking any of the following medicines:

• Fluvoxamine, fluoxetine, and other medicines used to treat mental health conditions.
• Medicines used to treat insomnia.
• Medicines used to treat allergic conditions that may cause drowsiness.
• Medicines used to treat epilepsy (e.g., carbamazepine, phenytoin, hydantoin).
• Medicines used to treat stomach 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 excitement, aggressive behavior (see section 2; Warnings and precautions).
• Opioids: concomitant use of Neorelium and opioids (strong painkillers, substitution therapy, some cough medicines) increases the risk of sedation, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines 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 opioid medicines they 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, 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 taking this medicine. 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 up to 24 hours after the end of therapy, the patient should not drive vehicles or operate machines. The ability to drive vehicles and operate machinery may be impaired due to the possibility of sedation, 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 medicine. Neorelium contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Neorelium

Neorelium should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor. The 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, 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 medicines 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 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, if necessary, will gradually increase it.

Taking a higher dose of Neorelium than recommended

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

Missing a dose of Neorelium

If the patient forgets to take a dose of Neorelium, 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 as recommended. 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.

Stopping treatment with Neorelium

The patient should not stop taking Neorelium unless it is in accordance with their doctor's instructions. It is possible that the symptoms of the disease will recur. If the doctor decides to discontinue treatment, the dose of Neorelium should be gradually reduced over several days. In case of doubts related to the use of the medicine, the patient should consult their doctor.

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 patient should immediatelyinform their doctor or go to the nearest emergency department in a hospital:

• Severe allergic reaction, such as 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, and behavioral disorders. 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.
• Rashes, itching, hives.
• Lack of appetite.
• Paradoxical reactions - psychomotor excitement, insomnia, increased excitability, and aggression, muscle tremors, seizures. Paradoxical reactions most often occur after consuming alcohol, in elderly patients, and in patients with mental health conditions.
• 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 medicines 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 sex drive.
• Visual disturbances (blurred, double vision).
• Slow heart rate, chest pain.
• Low blood pressure.
• Gastrointestinal disorders.
• Slightly elevated liver enzyme activity, 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 patient should consult their doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Neorelium

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to 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 specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. 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 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 pack contains

Yellow, round, biconvex coated tablets. The packaging contains 20 coated tablets in a PVC/Aluminum blister pack in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or the 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:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw Marketing authorization number in Latvia, the country of export:96-0160

Parallel import authorization number: 37/23 Date of leaflet approval: 07.03.2023

[Information about the trademark]