Neorelium

Package Leaflet: Information for the Patient

NEORELIUM, 5 mg/ml, Solution for Injection

Diazepam

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

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or nurse. See section 4.

• 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:

• states of severe nervous excitement and anxiety;
• treatment of severe symptoms of alcohol withdrawal (delirium tremens);
• treatment of states of increased muscle tone (tetanus, spastic states of various etiologies);
• seizure states, convulsions in the course of poisoning, and febrile convulsions;
• as a sedative in preparation for surgical procedures and unpleasant diagnostic tests (e.g., endoscopy).

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 medicine (listed in section 6);
• severe respiratory failure, regardless of the cause;
• sleep apnea syndrome (frequent, short pauses in breathing during sleep);
• severe liver failure;
• myasthenia gravis (a disease that causes muscle weakness and excessive fatigue);
• phobias and obsessions;
• chronic psychoses.

Warnings and precautions

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

• Tolerance After using Neorelium for several weeks, its effectiveness may decrease.
• Dependence Long-term use of Neorelium may lead to psychological and physical dependence. The risk of dependence increases with increasing dose and duration of treatment and is higher in patients dependent on alcohol or drugs, as well as in patients with 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, 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 During withdrawal of Neorelium, a transient recurrence of intensified symptoms, which were the reason for using 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 administration of 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 half an hour 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, rage, delusions, nightmares, hallucinations, psychoses, behavioral disorders. If such symptoms occur, you should immediately contact your doctor.

Specific patient groups

• Elderly and debilitated patients should receive smaller doses of Neorelium, due to the possibility of increased side effects, mainly orientation and coordination disorders (falls, injuries).
• Patients with liver or kidney failure or with chronic respiratory failure should inform their doctor about these conditions before taking Neorelium.
• Use in depression. Before using Neorelium, you should inform your doctor about any mental illnesses. Patients with symptoms of depression or anxiety associated with depression should use several medicines at the same time. Administering Neorelium to patients with depression alone may exacerbate symptoms of depression, including suicidal thoughts.
• Patients with porphyria (a blood disease), myasthenia gravis (a disease that causes muscle weakness and excessive fatigue), atherosclerosis should inform their doctor about these conditions before taking the medicine.
• In patients in whom a decrease in blood pressure may lead to cardiovascular disorders, the medicine is administered very slowly, with great caution.
• Patients addicted to alcohol, drugs, or medicines should inform their doctor about these addictions before taking Neorelium. In these patients, there is a high risk of developing psychological and physical dependence. Therefore, this group of patients should use Neorelium only under strict medical supervision.

Neorelium and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as about medicines you plan to take.
This is especially important if you are taking any of the following medicines or drinking alcohol:

• 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);
• muscle relaxants (e.g., baclofen);
• levodopa (a medicine used to treat Parkinson's disease);
• medicines used to treat stomach and duodenal ulcers (e.g., cimetidine, omeprazole, cisapride);
• ketokonazole (an antifungal medicine);
• strong painkillers (e.g., morphine);
• alcohol: drinking alcohol while taking Neorelium may enhance its effect and lead to paradoxical reactions, such as: psychomotor excitement, aggressive behavior (see section 2, Warnings and precautions).

Concomitant use of Neorelium and opioids (strong painkillers, medicines used to treat addiction, some cough medicines) increases the risk of somnolence, respiratory depression, coma, and can be life-threatening.
Therefore, concomitant use of these medicines can only be considered if other treatment options are not possible.
If, however, the doctor prescribes Neorelium concomitantly 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 strictly follow the doctor's instructions. It may be helpful to inform friends or relatives to be aware of the possibility of these symptoms. If such symptoms occur, you should contact your doctor.

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before using this medicine.
If you are pregnant or think you may be pregnant
If you suspect you are pregnant or plan to become pregnant, you should inform your doctor.
Neorelium should not be used during pregnancy.
If you are breastfeeding
Neorelium passes into breast milk. If it is necessary to administer the medicine, breastfeeding should be discontinued.

Driving and using machines

During treatment with Neorelium, you should not drive vehicles or operate machines.
Ability to drive vehicles and operate machinery may be impaired due to the possibility of somnolence, impaired concentration, or other side effects that reduce concentration (see section 4, Possible side effects).
Neorelium contains benzyl alcohol(15.5 mg/ml).
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to small children is associated with a risk of serious side effects, including respiratory depression (so-called "gasping syndrome").
Do not administer to newborns (up to 4 weeks of age) without a doctor's recommendation.
Do not administer to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Women who are pregnant or breastfeeding should contact their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should contact their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Neorelium contains ethanol12.5% v/v ethanol, i.e., 100 mg/ml, which is equivalent to 2.5 ml of beer or 1 ml of wine.
This should be taken into account when using in pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.
The alcohol in the medicine may alter the effect of other medicines.
Harmful to people with alcoholism.
Neorelium contains propylene glycol (E 1520)(455 mg/ml)
Within the recommended diazepam dose range of 0.1 to 10 mg/kg body weight per day, the propylene glycol content is 54.6 mg to 910 mg/kg body weight per day, respectively.
Before administering the medicine to a child under 5 years of age, you should consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Women who are pregnant or breastfeeding should not take this medicine without a doctor's recommendation.
The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.
Propylene glycol in this medicine may cause symptoms similar to those after alcohol consumption and increase the likelihood of side effects.
Neorelium should not be used in children under 5 years of age in doses that contain more than 500 mg/kg body weight per day of propylene glycol.
The medicine should only be used on a doctor's prescription.
The doctor may decide to perform additional tests on the patient taking this medicine.
Neorelium contains sodium benzoate (E 211)(49 mg/ml) and benzoic acid (E 210)
Benzoic acid/sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

3. How to use Neorelium

Neorelium should always be used in accordance with the doctor's instructions.
In case of doubts, you should contact your doctor.
The medicine should be administered under medical supervision. It can be administered intramuscularly or intravenously.
Except in emergency situations, during intravenous administration of the medicine, a second person should always be present; a resuscitation kit should also be available.
It is recommended that patients remain under medical supervision for at least one hour after administration of the medicine. At home, the patient should always be accompanied by a responsible adult.

Adults

• In states of severe psychotic excitement and anxiety, occurring in psycho-organic syndromes and psychoses: 5 to 10 mg intramuscularly or intravenously. The dose can be repeated after 4 hours.
• In acute alcohol withdrawal syndrome: initially 10 mg, intramuscularly or intravenously, and then 5 to 10 mg after 3 to 4 hours.
• In acute spastic states of muscles: 5 to 10 mg, intramuscularly or intravenously. The dose can be repeated after 4 hours.
• In tetanus: 0.1 to 0.3 mg/kg body weight every 4 hours, intravenously or intramuscularly, or 3 to 10 mg/kg body weight in intravenous infusion every 24 hours. The number of doses depends on the patient's response to the medicine.
• In seizure states, during convulsions in the course of poisoning, and febrile convulsions: 0.15 to 0.25 mg/kg body weight (usually 10 to 20 mg) intravenously or intramuscularly. If necessary, the dose can be repeated after 30 to 60 minutes. After controlling the attacks, to prevent recurrence, diazepam can be administered in intravenous infusion at a maximum dose of 3 mg/kg body weight per day.
• In premedication (preparation for surgical procedures and unpleasant diagnostic tests, e.g., endoscopy): 0.1 to 0.2 mg/kg body weight.

Children

In seizure states, during convulsions in the course of poisoning, and febrile convulsions:
0.2 to 0.3 mg/kg body weight intravenously or intramuscularly, or 1 mg per year of age. If there is no improvement after 5 minutes, the dose can be repeated.
Due to the content of benzyl alcohol, the medicine should not be administered to premature infants and newborns (see section 2).

Duration of treatment

The duration of treatment is determined by the doctor.

Using a higher dose of Neorelium than recommended

The medicine is administered by a doctor or nurse, so it is unlikely that the patient will receive a higher dose than recommended. However, if the patient suspects they have received a higher dose of the medicine, they 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 used.
Symptoms of diazepam overdose are impaired consciousness, somnolence, confusion, slurred speech. In severe cases of poisoning, the following may occur: ataxia, hypotension, muscle weakness, respiratory depression, coma, and even death.

Missing a dose of Neorelium Do not take a double dose to make up for a missed dose.

Stopping treatment with Neorelium

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

4. Possible side effects

Like all medicines, Neorelium can cause side effects, although not everybody gets them.
The frequency of side effects occurring after use of the medicine is defined as follows:
very common– occurs in more than 1 in 10 people;
common– occurs in less than 1 in 10 people;
uncommon– occurs in less than 1 in 100 people;
rare– occurs in less than 1 in 1,000 people;
very rare– occurs in less than 1 in 10,000 people;
frequency not known- cannot be estimated from the available data.

Severe side effects

If you experience any of the following side effects, you should immediatelyinform your doctor or go to the nearest emergency department in a hospital:
Occurring very rarely:

• severe allergic reaction in the form of itching, swelling of the lips or tongue, or wheezing, or shortness of breath

Occurring with unknown frequency:

• disorientation, states of excitement and agitation, depression with suicidal tendencies, anxiety, irritability, delusions, nightmares, hallucinations, psychoses, behavioral disorders. These disorders occur most often in children and the elderly. The frequency of these symptoms cannot be estimated from the available data.

Other side effects that may occur after treatment with Neorelium

The following side effects occur rarely:

• nausea, stomach upset, dry mouth.

The following side effects occur with unknown frequency:

• changes in the number of some blood cells;
• rash, itching, urticaria;
• loss of appetite;
• paradoxical reactions - anxiety, insomnia, increased excitability, and aggression, muscle tremors, seizures. Paradoxical reactions occur most often after alcohol consumption, in the elderly, and in patients with mental illnesses.
• psychological and physical dependence may develop during treatment with diazepam at 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 somnolence, dizziness, slowed reactions may occur during the first few days of treatment;
• somnolence, memory disturbances, coordination disorders, speech disturbances, changes in libido;
• visual disturbances (blurred, double vision);
• bradycardia, chest pain;
• hypotension;
• mild increase in liver enzyme activity, liver function disorders with jaundice (yellowing of the skin and whites of the eyes);
• muscle tremors, muscle weakness;
• urinary retention, incontinence;
• menstrual disorders;
• general weakness, fainting;
• respiratory and circulatory depression have been observed after rapid intravenous administration. Keeping the patient in a supine position during the injection or infusion and following the recommended rate of administration of diazepam almost completely eliminates these complications.
• phlebitis may occasionally occur at the injection site;
• pain, and sometimes redness at the injection site, may occur during intramuscular injections.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Neorelium

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist 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 the medicine is diazepam. 1 ml of the solution contains 5 mg of diazepam.
The other ingredients are: propylene glycol (E 1520), ethanol 96%, benzyl alcohol, sodium benzoate (E 211), benzoic acid (E 210), water for injections.

What Neorelium looks like and contents of the pack

Clear, colorless to yellow solution.
Packaging:50 ampoules (orange glass) of 10 mg diazepam in 2 ml solution (5 mg/ml) in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder and manufacturer
Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information, you should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Except in emergency situations, during intravenous administration of the medicine, a second person should always be present; a resuscitation kit should also be available. It is recommended that patients remain under medical supervision for at least one hour after administration of the medicine. At home, the patient should always be accompanied by a responsible adult; the patient should be informed about the prohibition of driving vehicles and operating machinery for 24 hours after administration of the medicine.

Method of administration and preparation of solutions

Intramuscular injections
The Neorelium solution should be injected slowly, deeply, into large muscle groups (the medicine is absorbed relatively slowly).
Intravenous injections
The Neorelium solution should be administered slowly.
The contents of the ampoule should be injected slowly at a rate of 0.5 to 1 ml (2.5 to 5 mg) per minute (maximum 1 ml per minute) into a large vein in the elbow.
Intravenous infusion
As a rule, the product should not be diluted. An exception is the administration of the product in slow intravenous infusion in a large volume of 0.9% sodium chloride solution or glucose solution in the treatment of tetanus and seizure states.
The contents of the ampoule (10 mg/2 ml) should be diluted in at least 50 ml of 0.9% sodium chloride solution or 5% glucose solution. Do not dilute more than 40 mg (8 ml solution - 4 ampoules) in 500 ml of 0.9% sodium chloride solution or 5% glucose solution.
The solution should be prepared immediately before administration and used within 6 hours.
The prepared Neorelium solution should be administered slowly.
Too rapid intravenous administration of the medicine may cause respiratory depression and hypotension.
For preparation of solutions, glass bottlesshould be used.
More than 50% of diazepam from the solution may be adsorbed onto the walls of plastic containers with the solution for infusion. Adsorption onto plastic tubes of the infusion set may cause a significant initial decrease in the concentration of diazepam administered, which then slowly increases over several hours. The infusion rate should be frequently adjusted according to the patient's condition.
Sometimes, during dilution of the medicine, turbidity may occur, which disappears after a few minutes.
If the turbidity does not disappear, the medicine should not be administered.

Incompatibilities

Neorelium should not be mixed with other medicines in the same syringe or infusion bottle.