Diazepam Grindeks

Package Leaflet: Information for the Patient

Diazepam Grindeks, 10 mg/2 mL, Solution for Injection

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, pharmacist, 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, please inform your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

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

1. What Diazepam Grindeks is and what it is used for

Diazepam Grindeks contains diazepam, which belongs to a group of medicines called benzodiazepines, characterized by a calming, anxiolytic, anticonvulsant, muscle relaxant, and sedative effect.

Diazepam Grindeks is used:

• to treat moderate to severe anxiety, agitation, and tension;
• as a primary sedative in patients with anxiety or stress; for induction of anesthesia and to sedate before diagnostic procedures, surgical procedures, and endoscopic procedures (heart catheterization) (preoperative treatment);
• to alleviate agitation, panic, tremors, and hallucinations (symptoms associated with sudden alcohol withdrawal);
• to treat acute seizure disorders, severe convulsions, tetanus, and severe pregnancy complications (pre-eclampsia or eclampsia);
• to treat reflex muscle spasms caused by local injury (injury, inflammation); it may also be used to suppress spasticity caused by spinal cord diseases and stiff person syndrome.

2. Important information before using Diazepam Grindeks

When not to use Diazepam Grindeks:

• if you are allergic to diazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have myasthenia gravis (a disease that causes muscle weakness and excessive fatigue);

and

• if you have breathing or respiratory problems;
• if you have severe liver disease;
• if you have sleep apnea (pauses in breathing during sleep).

Warnings and precautions

Before starting treatment with Diazepam Grindeks, discuss it with your doctor or nurse:

• if you have a history of alcohol or drug abuse;
• if you are taking medicines that act depressively on the central nervous system (CNS);
• if you are elderly, weakened, or have heart or lung disease. Your doctor will adjust the dose in such cases;
• if you have depression;
• if you have kidney or liver function disorders.

Psychological and paradoxical reactions
During treatment with this medicine, paradoxical reactions such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other undesirable effects on behavior may occur. Inform your doctor if you experience any of these symptoms; you should also stop treatment.
The likelihood of such symptoms is higher in children and the elderly.
Dependence
Taking benzodiazepines can lead to psychological and physical dependence. The risk increases in patients treated for a long time and (or) with high doses, especially in patients who have previously abused alcohol or been dependent on drugs. If physical dependence on benzodiazepines develops, stopping the medicine may cause withdrawal symptoms. These may include symptoms such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability. In more severe cases, the following symptoms may occur: loss of reality, depersonalization, numbness of limbs, hypersensitivity to light, sound, and touch, hallucinations, or seizures. If intravenous administration of the medicine is prolonged, the doctor will gradually reduce the dose.
Insomnia and rebound anxiety
After stopping the medicine, a transient state may occur in which the symptoms that necessitated benzodiazepine treatment return, even in an intensified form. This may be accompanied by mood changes, anxiety, or sleep disturbances and restlessness. To minimize the risk of this syndrome, the doctor will gradually reduce the dose.
Amnesia (anterograde amnesia)
This medicine may cause amnesia, and the risk is higher when high doses are used. The effect of amnesia may be accompanied by behavioral disturbances.

Children

Diazepam Grindeks should not be given to children under 6 months of age, as it is not safe. The doctor may prescribe it only when other treatment methods are not available.
The duration of treatment in children over 6 months should be as short as possible.

Diazepam Grindeks and other medicines

Tell your doctor about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Concomitant use of diazepam with other medicines listed below may enhance the sedative effect and affect the respiratory and cardiovascular systems.
These medicines include:

• antipsychotic and antidepressant medicines, e.g., fluvoxamine, fluoxetine (medicines used to treat depression and anxiety disorders);
• anxiolytic and sedative medicines (medicines used to treat anxiety);
• sleeping medicines (medicines used to treat insomnia);
• anticonvulsant medicines (medicines used to treat seizures);
• anesthetics (medicines used to treat pain and other sensations);
• barbiturates (medicines used to treat seizures);
• opioid analgesics (strong painkillers);
• antihistamine medicines (medicines used to treat allergies);
• cimetidine, omeprazole (medicines used to treat ulcers);
• ketokonazole (a medicine used to treat fungal infections);
• alcohol. Medicines that inhibit the activity of certain liver enzymes may enhance the effect of Diazepam Grindeks.

Diazepam Grindeks affects the elimination of phenytoin (a medicine used to treat epilepsy) from the body.
Concomitant use of Diazepam Grindeks and opioids (strong painkillers, medicines 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. Therefore, concomitant use of these medicines should only be considered when other treatment methods are not possible.
If the doctor prescribes Diazepam Grindeks with opioid medicines, the doctor 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 doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, contact your doctor. In emergency situations, part or all of this information may not apply.

Diazepam Grindeks with alcohol

It is not recommended to use Diazepam Grindeks with alcohol, as it may enhance the sedative effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
This medicine should not be used during pregnancy.
If it is necessary to use Diazepam Grindeks for medical reasons and it is used in late pregnancy or a high dose is used during delivery, the newborn may experience symptoms such as low body temperature, muscle weakness, and moderate breathing difficulties.
Diazepam passes into breast milk, so this medicine should not be used during breastfeeding.

Driving and using machines

Diazepam Grindeks can cause sedation, amnesia, impaired concentration, and impaired muscle function, so you should not drive or operate machinery while using this medicine. If you have insufficient sleep, the risk of impaired alertness may be increased. Consuming alcohol may enhance these effects.

Diazepam Grindeks contains

This medicine contains benzoesic acid (E 210), sodium benzoate (E 211), propylene glycol, benzyl alcohol, and 96% ethanol.
This medicine contains 16 mg of benzoesic acid and 196 mg of sodium benzoate in each 2 mL ampoule, which corresponds to 8 mg/1 mL of benzoesic acid and 98 mg/1 mL of sodium benzoate. Benzoesic acid and sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
The medicine contains 900 mg of propylene glycol in each 2 mL ampoule, which corresponds to 450 mg/mL. 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.
If you are pregnant or breastfeeding, do not take this medicine unless your doctor advises you to do so. Your doctor may perform additional checks while you are taking this medicine.
If you have liver or kidney function disorders, do not take this medicine without consulting your doctor. Your doctor may decide to perform additional tests while you are taking this medicine.
The medicine contains 30 mg of benzyl alcohol in each 2 mL ampoule, which corresponds to 15 mg/mL. Benzyl alcohol may cause allergic reactions.
Benzyl alcohol is associated with a risk of severe side effects, including breathing difficulties (so-called "gasping syndrome") in small children. Do not give to newborns (up to 4 weeks of age) without consulting a doctor. Do not give to children under 3 years of age for more than a week without consulting a doctor.
Pregnant or breastfeeding women, patients with liver or kidney disease should consult their doctor before using this medicine. This is because a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
This medicine contains up to 200 mg of 12% ethanol (alcohol) in each 2 mL ampoule, which is equivalent to 100 mg/1 mL. The amount of alcohol in 2 mL of this medicine is equivalent to 5 mL of beer or 2 mL of wine. A small amount of alcohol in this medicine will not have noticeable effects.

3. How to use Diazepam Grindeks

This medicine will be administered by a doctor or nurse by intravenous or intramuscular injection. In case of doubts, consult a doctor or pharmacist.
The doses of Diazepam Grindeks are determined individually for each patient, taking into account their age and the severity of the disease.
The recommended dose is:

• Adults

Anxiety of moderate to severe degree: the usual dose is 2-10 mg intramuscularly (im) or intravenously (iv). If necessary, the dose can be repeated after 3-4 hours.

• Premedication: the usual dose is 10-20 mg intramuscularly one hour before the start of anesthesia.

In alcohol withdrawal syndrome: 10 mg intramuscularly or intravenously, if necessary, after 3-4 hours, an additional 5-10 mg (or 0.1-2.0 mg/kg body weight intravenously, repeated cyclically every 8 hours, until symptoms subside), and then treatment will be continued with oral medicines.

For induction of anesthesia: 0.2-0.5 mg/kg body weight intravenously.
For sedation before procedures: 10-20 mg intravenously (initial dose 5 mg, then 2.5 mg, repeated every 30 seconds). In patients with obesity, the dose is 30 mg intravenously.
In seizure disorders: 0.15-0.25 mg/kg body weight intravenously, repeated every 10-15 minutes if necessary, or in continuous intravenous infusion (at a maximum dose of 3 mg/kg body weight per 24 hours).
In tetanus: 0.1-0.3 mg/kg body weight intravenously every 1-4 hours, or alternatively in continuous intravenous infusion or through a gastric tube (3-4 mg/kg body weight per 24 hours).
In pre-eclampsia or eclampsia: 10-20 mg intravenously (additional doses may be required).
In muscle spasms: 5-10 mg intramuscularly or intravenously, if necessary, repeated after 3-4 hours.
If necessary, after the acute symptoms have subsided, the doctor will continue treatment with oral medicines.
Elderly and weakened patients
The doctor will adjust the dose of the medicine.
Patients with kidney and (or) liver disorders
The doctor will adjust the dose of the medicine.

Use in children

Premedication: the usual dose is 0.1-0.2 mg/kg body weight intramuscularly.
For sedation before procedures: the usual dose is 0.1-0.2 mg/kg body weight intravenously.

Using a higher than recommended dose of Diazepam Grindeks

The medicine is administered by a doctor or nurse, so overdose is unlikely.
Overdose of Diazepam Grindeks may cause slowing of the central nervous system activity of varying severity, from drowsiness, through lack of coordination, speech disturbances, to coma. The depressant effect of benzodiazepines on the respiratory system is more pronounced in patients with respiratory disease.
Inform your doctor immediately if the medicine is administered accidentally.
In case of overdose, the patient's vital signs will be monitored, and depending on the patient's clinical condition, appropriate treatment will be initiated. In some patients, it may be necessary to treat symptoms from the heart, circulatory system, respiratory system, or central nervous system.
In case of severe central nervous system depression, consider administering a medicine called flumazenil (used to reverse the effects of this medicine). In such cases, it is necessary to monitor the patient's clinical condition.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Diazepam Grindeks can cause side effects, although not everybody gets them.
The most common side effects are fatigue, drowsiness, and muscle weakness, and are usually dose-dependent. These effects usually occur at the beginning of treatment and subside after subsequent doses.
Dependence
Long-term use of the medicine (even in therapeutic doses) may lead to the development of physical and psychological dependence, and stopping treatment may cause withdrawal symptoms or rebound effects.
Possible side effects:

• jaundice;
• increased liver enzyme activity in blood tests;
• disorientation, emotional indifference, decreased alertness, depression, increased or decreased libido;
• uncoordinated movements, speech disturbances, changed speech (slurred speech), headaches, tremors, dizziness, anterograde amnesia (loss of ability to memorize, leading to partial or complete inability to recall recent past);
• double vision, blurred vision;
• heart failure, including cardiac arrest;
• low blood pressure, circulatory depression (significant slowing of heart rate);
• respiratory depression (severe breathing difficulties), including respiratory failure;
• nausea, dry mouth or excessive saliva production, constipation, and other gastrointestinal disorders;
• skin rash, urticaria, itching, flushing;
• urinary incontinence, urinary retention;
• irregular heartbeat;
• venous thrombosis, phlebitis, irritation at the injection site, local swelling, or less frequently, vascular changes, especially after rapid intravenous administration;
• falls and fractures. Intramuscular administration may cause pain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 this medicine.

5. How to store Diazepam Grindeks

Store in a refrigerator (2°C – 8°C).
Store the ampoule in the outer packaging to protect it from light.
Do not freeze.
Keep the medicine out of the sight and reach of children.
After opening the ampoule, the solution for injection should be used immediately.
The solution for injection prepared for administration as an infusion should be used within 48 hours, stored at room temperature (about 25°C) during this time.
Unused residues should be disposed of.
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 Diazepam Grindeks contains

• The active substance is diazepam. 1 mL of the solution contains 5 mg of diazepam. One ampoule (2 mL) contains 10 mg of diazepam.
• The other ingredients are benzoesic acid (E 210), sodium benzoate (E 211), propylene glycol, benzyl alcohol, 96% ethanol, and water for injections.

What Diazepam Grindeks looks like and contents of the pack

A clear solution, colorless to light yellow with a greenish tint.
2 mL ampoules made of colorless glass, with a break line or break point.
5 ampoules packed in a PVC blister pack.
2 blister packs (10 ampoules) or 10 blister packs (50 ampoules) (hospital packaging) placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53, Riga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
Email: [email protected]
For more detailed information on this medicine, please contact the marketing authorization holder.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
Diazepam Grindeks
Portugal:
Diazepam Grindeks 10 mg/2 mL, Solução injetável
Date of last revision of the leaflet:10/2024