Relsed

Package Leaflet: Information for the Patient

RELSED, 5 mg/2.5 ml rectal solution, microenema

RELSED, 10 mg/2.5 ml rectal solution, microenema

Diazepam

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Relsed and what is it used for
• 2. Important information before using Relsed
• 3. How to use Relsed
• 4. Possible side effects
• 5. How to store Relsed
• 6. Contents of the pack and other information

1. What is Relsed and what is it used for

Relsed contains the active substance diazepam. Diazepam belongs to a group of medicines called benzodiazepines. It has anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant properties.
Relsed is used rectally:

• in febrile seizures (seizures occurring during high fever);
• in prolonged or frequently recurring epileptic seizures (status epilepticus);
• in seizures occurring in eclampsia (called eclampsia);
• in anxiety attacks;
• in conditions characterized by increased muscle tone, including tetanus;
• in preparing the patient (premedication) before various procedures, e.g. before surgery, endoscopy;
• in the postoperative period to calm the patient.

2. Important information before using Relsed

When not to use Relsed

• if the patient is hypersensitive to diazepam or other benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has:
• myasthenia gravis (a chronic disease characterized by muscle weakness);
• severe respiratory failure (severe breathing difficulties);
• sleep apnea syndrome (characterized by short pauses in breathing during sleep);
• severe liver failure (severe liver dysfunction);
• phobias (fear of specific objects or situations) or obsessions (obsessive, recurring thoughts or behaviors).
• Relsed should not be used as the only medicine in the treatment of depression or anxiety associated with depression.

Warnings and precautions

Before starting treatment with Relsed, discuss it with your doctor.
Consult a doctor in the case of patients:

• of advanced age, weakened;
• with liver or kidney failure;
• with brain damage resulting from, for example, injury, atherosclerosis, stroke;
• with impaired motor function (called dyskinesia);
• with personality disorders;
• with chronic respiratory failure (even of moderate severity);
• with prostatic hyperplasia (with urinary retention);
• addicted to drugs or alcohol;
• suffering from glaucoma (increased eye pressure). Patients with the above diseases should inform their doctor.

It is recommended to follow the prescribed treatment time. The use of Relsed should be as short as possible.

Do not use the medicine for a long time, as this may increase the risk of dependence and the development of tolerance to the medicine. The development of tolerance means that the medicine becomes less effective over time, which may require an increase in the dose.

Children

• The medicine should not be used in newborns, especially in premature babies due to the presence of benzyl alcohol - see section 2. "Relsed contains benzyl alcohol, ethanol, sodium benzoate, propylene glycol, and sodium".
• In infants up to 6 months of age, the medicine can only be used in life-threatening conditions - in such cases, the medicine is administered by medical personnel.
• The medicine can be used in children from 7 months of age (see section 3. "How to use Relsed").
• During the use of Relsed in children, so-called paradoxical reactions (symptoms listed in section 4. "Possible side effects") may occur. If these symptoms occur, the use of the medicine should be discontinued.

Relsed and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Relsed and other medicines used at the same time may affect each other's action.
In particular, this applies to the following medicines listed below:

• strong painkillers (called opioid painkillers, e.g. morphine, buprenorphine); if diazepam is to be administered with opioid painkillers, diazepam should be administered last;
• medicines used in mental disorders (e.g. haloperidol);
• medicines used in the treatment of depression (fluoxetine, fluvoxamine);
• sedatives, anxiolytics, and hypnotics;
• antiepileptic drugs (e.g. phenobarbital);
• anesthetics and some medicines used in the treatment of allergies (with a sedative effect);
• cimetidine and omeprazole (medicines used in the treatment of peptic ulcer disease);
• disulfiram (a medicine used in the treatment of alcoholism);
• isoniazid (a medicine used in the treatment of tuberculosis);
• oral contraceptives;
• theophylline (a medicine used in the treatment of asthma);
• levodopa (a medicine used in the treatment of Parkinson's disease);
• muscle relaxants (e.g. baclofen);
• phenytoin (a medicine used in the treatment of epilepsy).

The concomitant use of Relsed and opioids (strong painkillers, drugs used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, the concomitant use of these medicines can only be considered if other treatment options are not possible.
If, however, the doctor has prescribed Relsed together with opioid medicines, the attending physician should reduce the dose and recommend the shortest possible treatment time.
Inform your doctor about all opioid medicines you are taking and strictly follow the dosage instructions. It may be helpful to inform friends or relatives about the risk, so they are aware of the above symptoms. If such symptoms occur, contact your doctor.

Relsed with alcohol (ethanol)

Alcohol (ethanol) enhances the sedative effect of diazepam. Do not drink alcohol while using Relsed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Relsed should not be used in pregnant women, especially during the first and third trimesters, and during breastfeeding, unless the doctor considers it necessary.

Driving and using machines

After using the medicine, drowsiness, concentration disorders, and other side effects may occur, which may adversely affect the performance of tasks requiring increased attention. Do not drive vehicles and operate machines for at least 24 hours after administering Relsed.

Relsed contains benzyl alcohol, ethanol, sodium benzoate, propylene glycol, and sodium

The medicine contains 15 mg of benzyl alcohol per 1 ml of solution. Benzyl alcohol may cause allergic reactions.
Administering benzyl alcohol to newborns is associated with the risk of severe side effects, including breathing disorders (so-called "gasping syndrome").
Do not give the medicine to newborns without a doctor's recommendation.
Do not give the medicine to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Patients with kidney or liver dysfunction, as well as pregnant or breastfeeding women, should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
The medicine contains 12.4% v/v ethanol (alcohol), i.e. up to 250 mg per microenema, which is equivalent to 5.94 ml of beer, 2.48 ml of wine per microenema.
Harmful to people with alcoholism.
This should be taken into account when using in pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy.
The medicine contains 48.8 mg of sodium benzoate per 1 ml of solution. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
The medicine contains 19.5 mg of sodium (the main component of table salt) per microenema (7.8 mg of sodium per 1 ml). This corresponds to 0.96% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 400 mg of propylene glycol in each 1 ml (1000 mg per microenema).
Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Pregnant or breastfeeding women, patients with kidney or liver dysfunction should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.

3. How to use Relsed

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.

• The medicine is for rectal use only.
• Relsed has a packaging designed for rectal administration, called a microenema. The microenema is a polyethylene tube with a rectal cannula, allowing for the administration of the medicine.
• Your doctor will determine the dosage and duration of treatment individually for each patient. Follow your doctor's instructions carefully.
• If the medicine is used at home, it should be administered to the patient by a responsible adult. Stay with the patient until the symptoms subside.
• The effect of the medicine is visible 5-10 minutes after administration.

A 2.5 ml microenema of Relsed (2 mg/ml) contains 5 mg of diazepam.
A 2.5 ml microenema of Relsed (4 mg/ml) contains 10 mg of diazepam.

Adults

Initially: 1 microenema of 5 mg of diazepam or 1 microenema of 10 mg of diazepam.
If symptoms do not subside, the dose can be repeated after about 10-15 minutes. If the patient's condition does not improve, call a doctor.
Before procedures and in the postoperative period:

• on the day before the procedure: 2 to 4 microenemas of 5 mg or 1 to 2 microenemas of 10 mg of diazepam;
• 30-60 minutes before surgery: 1 to 2 microenemas of 5 mg or 1 microenema of 10 mg of diazepam;
• after surgery: 1 to 2 microenemas of 5 mg or 1 microenema of 10 mg of diazepam.

Children

The doctor will inform the child's caregiver about the situations in which the medicine should be administered (type of seizure, duration) and determine the dose suitable for the child.
Usually used doses:

• infants from 7 months of age: up to 0.5 mg/kg body weight;
• children with a body weight of 10-15 kg: 1 microenema of 5 mg of diazepam;
• children with a body weight over 15 kg: 2 microenemas of 5 mg or 1 microenema of 10 mg of diazepam. If seizures do not subside, the dose can be repeated after 10-15 minutes. If the child's condition does not improve, call a doctor.

In the case of febrile seizures, children with a high risk of recurrence of seizures, the doctor may recommend administering the medicine in microenemas every 8 hours, if the fever persists above 38.5°C.
Always follow the doctor's instructions carefully.

Method of administration

During and for 15 minutes after administering the medicine, the patient should lie horizontally, on their stomach. A small child can be placed on the caregiver's lap.

• 1. Tear off the foil and remove the microenema.
• 2. Lubricate the cannula with a lubricating gel (available at the pharmacy), which will facilitate the introduction of the cannula into the rectum.
• 3. Open the microenema by twisting the end of the cannula.
• 4. Insert the cannula into the rectum (in the case of small children, insert the cannula only halfway, in the case of older children and adults, insert the entire cannula).
• 5. Empty the container by strong pressure with your thumb and index finger.
• 6. Remove the cannula from the rectum without releasing the pressure on the container.
• 7. Squeeze the buttocks for a few minutes to prevent the medicine from leaking out.

Using a higher dose of Relsed than recommended

After overdosing on diazepam, the following may occur: drowsiness, confusion (disorders of consciousness, disorientation, anxiety). In more severe cases, it may also cause impaired motor function, decreased blood pressure, muscle weakness, breathing difficulties, and coma. If a higher dose of the medicine is administered than recommended, seek medical attention immediately, and the doctor will provide appropriate treatment.

If you miss a dose of Relsed

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

Stopping the use of Relsed

After stopping the use of Relsed, symptoms of so-called withdrawal syndrome may occur, but its occurrence is unlikely, as the medicine is used on an as-needed basis. The symptoms of the syndrome include: headaches and muscle aches, anxiety, tension, restlessness, confusion, and in severe cases - loss of consciousness, depersonalization (feeling of uncertainty or unreality of one's own personality), increased sensitivity to sound, numbness and tingling of limbs, increased sensitivity to light, hallucinations, and epileptic seizures.
After stopping treatment, a so-called rebound phenomenon may occur (symptoms of the disease may return after stopping the medicine). Its symptoms are: mood changes, anxiety, difficulty falling asleep, restlessness.
Therefore, the medicine should be stopped gradually, reducing the doses. The doctor will inform the patient how to stop using Relsed to minimize the risk of these symptoms.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using the medicine, side effects are usually mild and rare.
The following may occur: sedation, drowsiness, impaired motor function, muscle weakness.
Rarely:

• pain and dizziness, vision disorders, disorientation, anterograde amnesia (the patient does not remember events that occurred in the short time after administering the medicine), speech disorders;
• breathing difficulties, laryngospasm, apnea, chest pain;
• decreased blood pressure, bradycardia, changes in blood count (visible in the so-called morphology test);
• gastrointestinal disorders (dry mouth, increased appetite, jaundice);
• changes in libido, menstrual disorders;
• urinary retention;
• skin allergic reactions;
• fatigue, tremors.

After using diazepam (especially in children and elderly patients), the following may occur: restlessness, excitement, hallucinations, changes in behavior, aggression, nightmares, psychoses (so-called paradoxical reactions).
In elderly and weakened patients, the side effects may be more pronounced.
After using diazepam, latent depression may be revealed.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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
Jerozolimskie Avenue 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 Relsed

Store in a temperature below 25°C.
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and microenema.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. 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 does Relsed 5 mg/2.5 ml contain, rectal solution, microenema

• The active substance of the medicine is diazepam. Each 1 ml of solution contains 2 mg of diazepam.
• The other ingredients are: ethanol 96%, benzyl alcohol (15 mg/ml), propylene glycol, sodium benzoate, glacial acetic acid, purified water. A 2.5 ml microenema contains 5 mg of diazepam.

What does Relsed 10 mg/2.5 ml contain, rectal solution, microenema

• The active substance of the medicine is diazepam. Each 1 ml of solution contains 4 mg of diazepam.
• The other ingredients are: ethanol 96%, benzyl alcohol (15 mg/ml), propylene glycol, sodium benzoate, glacial acetic acid, purified water. A 2.5 ml microenema contains 10 mg of diazepam.

What Relsed looks like and what the pack contains

Relsed is a clear, colorless to yellowish-green liquid.
The carton contains 5 microenemas (polyethylene tube with a rectal cannula) of 2.5 ml each.

Marketing authorization holder

Polpharma S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana Branch in Sieradz
Władysław Łokietek Street 10, 98-200 Sieradz
Date of last revision of the leaflet:December 2024