Package leaflet: Information for the user

Diazepam Grindeks, 10 mg/2 mL, solution for injection
Diazepamum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Diazepam Grindeks is and what it is used for
What you need to know before using Diazepam Grindeks
How to use Diazepam Grindeks
Possible side effects
How to store Diazepam Grindeks
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. These have a calming, anxiolytic, anticonvulsant, and muscle relaxant effect on skeletal muscles, as well as a hypnotic effect.
Diazepam Grindeks is used:

for the treatment of moderate to severe states of agitation, anxiety and psychological tension;
as a primary sedative in patients experiencing anxiety or stress; for induction of anaesthesia and for sedation prior to diagnostic procedures, surgical procedures and endoscopic procedures (e.g. cardiac catheterization) (preoperative treatment);
to relieve agitation, panic, tremor and hallucinations (symptoms associated with acute alcohol withdrawal);
in the treatment of acute epileptic seizures, severe convulsions, tetanus and severe pregnancy-related conditions (pre-eclampsia or eclampsia);
in the treatment of reflex muscle spasms caused by local injury (wound, inflammatory condition); it may also be used to reduce spasticity due to spinal diseases and generalized rigidity.

2. Important information before using Diazepam Grindeks

When not to use Diazepam Grindeks:

if the patient is allergic to diazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
if the patient suffers from myasthenia gravis (a disease causing muscle weakness and excessive fatigue);
if the patient has problems with breathing or shortness of breath;
if the patient has severe liver disease;
if the patient has sleep apnoea (interruptions in breathing during sleep).

Warnings and precautions
Before starting treatment with Diazepam Grindeks, discuss with your doctor or
nurse:

if the patient has previously abused alcohol or has been addicted to drugs;
if the patient is taking medicines that depress (calm) the central nervous system (CNS);
if the patient is elderly, frail, or has heart or lung disease. In such cases, the doctor will adjust the dose;
if the patient has depression;
if the patient has impaired kidney or liver function.

Psychological and paradoxical reactions
While taking this medicine, paradoxical reactions may occur, such as: restlessness,
excitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis,
inappropriate behaviour, and other adverse effects on behaviour. Inform your
doctor if any of these symptoms occur; treatment should also be discontinued.
The likelihood of such symptoms is higher in children and elderly patients.
Dependence
Use of benzodiazepines may lead to psychological and physical dependence. The risk
increases in patients treated for a long time and/or those receiving high doses,
particularly in patients who previously abused alcohol or were addicted to drugs.
If physical dependence on benzodiazepines develops, stopping the medication may
lead to withdrawal symptoms. These may include: headache, 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 continued
for a prolonged period, the doctor will gradually reduce the dose.
Rebound insomnia and anxiety
After discontinuation of the medicine, a transient condition may occur in which the symptoms
that led to the need for benzodiazepine treatment return, even in an intensified form. This may
be accompanied by mood changes, anxiety, 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 increases with higher doses. Behavioural
disturbances may accompany amnesic effects.
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 unavailable.
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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use of diazepam with other medicines listed below may intensify sedative effects and affect the respiratory and cardiovascular systems. These include:

antipsychotics and antidepressants, e.g. fluvoxamine, fluoxetine (medicines used to treat depression and anxiety disorders);
anxiolytics and sedatives (medicines used to treat anxiety);
hypnotics (medicines used to treat insomnia);
anticonvulsants (medicines used to treat seizures);
anaesthetics (medicines used to treat pain and other sensations);
barbiturates (medicines used to treat seizures);
opioid analgesics (strong painkillers);
antihistamines (medicines used to treat allergies);
cimetidine, omeprazole (medicines used to treat ulcers);
ketoconazole (a medicine used to treat fungal infections);
alcohol. Medicines that inhibit the activity of certain liver enzymes may enhance the effects 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 may be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If your doctor has prescribed Diazepam Grindeks together with opioid medicines, your doctor should reduce the dose and recommend the shortest possible treatment duration.
Inform your doctor about all opioid medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the symptoms listed above. In emergency situations, all or part of this information may not apply.
Diazepam Grindeks and alcohol
The use of Diazepam Grindeks with alcohol is not recommended, as it may intensify the sedative effect.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
This medicine should not be used during pregnancy.
If Diazepam Grindeks must be used for medical reasons late in pregnancy or a high dose is administered during delivery, the newborn may experience symptoms such as low body temperature, reduced muscle tone, and moderate breathing difficulties.
Diazepam passes into human milk; therefore, this medicine should not be used during breastfeeding.
Driving and operating machinery
Diazepam Grindeks may cause sedation, amnesia, concentration difficulties,
and muscle function impairment; therefore, driving vehicles or operating machinery should be avoided while taking this medicine. The likelihood of impaired alertness may be increased if the patient has not had sufficient sleep. Alcohol consumption may intensify the above effects.
Diazepam Grindeks contains benzoic acid (E 210), sodium benzoate (E 211), propylene glycol,
benzyl alcohol, and 96% ethanol
This medicine contains 16 mg of benzoic acid and 196 mg of sodium benzoate in each 2 mL
ampoule, equivalent to 8 mg/1 mL benzoic acid and 98 mg/1 mL sodium benzoate. Benzoic acid and 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).
The medicine contains 900 mg of propylene glycol in each 2 mL ampoule, equivalent 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 the patient is pregnant or breastfeeding, she should not take this medicine unless advised by a doctor. The doctor may perform additional monitoring during treatment with this medicine.
If the patient has impaired liver or kidney function, he or she should not take this medicine without medical advice. The doctor may decide to perform additional tests during treatment.
The medicine contains 30 mg of benzyl alcohol in each 2 mL ampoule, equivalent to 15 mg/mL.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol is associated with a risk of serious adverse effects, including breathing difficulties (so-called "gasping syndrome"), in young children. Do not administer to newborns (up to 4 weeks of age) without medical advice. This medicine should not be given to children under 3 years of age for longer than one week without medical advice.
Pregnant or breastfeeding women, and patients with liver or kidney disease, should consult a doctor before using this medicine. This is because large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
This medicine contains up to 200 mg of 12% alcohol (ethanol) in each 2 mL ampoule, 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. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Diazepam Grindeks

This medicine will be administered by a doctor or nurse as an intravenous or intramuscular injection. If in doubt, consult a doctor or pharmacist.
Diazepam Grindeks dosages are individually determined for each patient, taking into account age and severity of the disease.
Recommended doses:
Adults
For moderate to severe anxiety states: the usual dose is 2–10 mg administered intramuscularly (im.) or intravenously (iv.). The dose may be repeated if necessary after 3–4 hours.
Premedication: the usual dose is 10–20 mg administered intramuscularly one hour before anesthesia begins.
In alcohol withdrawal syndrome: 10 mg administered intramuscularly or intravenously; if necessary, additional doses of 5–10 mg after 3–4 hours, or 0.1–2.0 mg/kg body weight intravenously, repeated cyclically every 8 hours until symptoms subside, followed by continuation of treatment with oral medications.
For induction of anesthesia: 0.2–0.5 mg/kg body weight administered intravenously.
For sedation prior to procedures: 10–20 mg intravenously (initial dose 5 mg, followed by 2.5 mg repeated every 30 seconds). In obese patients, the dose is 30 mg intravenously.
In epileptic seizures: 0.15–0.25 mg/kg body weight administered intravenously, repeated every 10–15 minutes if necessary, or administered as a continuous intravenous infusion (maximum dose 3 mg/kg body weight per 24 hours).
In tetanus: 0.1–0.3 mg/kg body weight administered intravenously every 1–4 hours, or alternatively as a continuous intravenous infusion or via gastric tube (3–4 mg/kg body weight per 24 hours).
In pre-eclampsia or eclampsia: 10–20 mg administered intravenously (additional doses may be required).
In muscle spasms: 5–10 mg administered intramuscularly or intravenously, repeated if necessary after 3–4 hours.
If necessary, after acute symptoms have subsided, the doctor will continue treatment with oral medications.
Elderly or debilitated patients
The doctor will adjust the dosage.
Patients with renal and/or hepatic impairment
The doctor will adjust the dosage.
Use in children
Premedication: the usual dose is 0.1–0.2 mg/kg body weight administered intramuscularly.
For sedation prior to procedures: the usual dose is 0.1–0.2 mg/kg body weight administered intravenously.
Administration of a higher than recommended dose of Diazepam Grindeks
Since this medicine is administered by a doctor or nurse, overdose is unlikely.
Overdose of Diazepam Grindeks may cause central nervous system depression of varying severity, ranging from drowsiness, through impaired motor coordination and speech disturbances, to coma. The depressant effect of benzodiazepines on the respiratory system is more pronounced in patients with respiratory disorders.
Inform the doctor immediately if the medicine is accidentally administered.
In case of overdose, vital signs will be monitored and appropriate treatment initiated, depending on the patient's clinical condition. Some patients may require symptomatic treatment for cardiovascular, respiratory, central nervous system, or circulatory complications.
In cases of severe central nervous system depression, administration of a drug called flumazenil (used to reverse the effects of this medicine) should be considered. In such cases, close monitoring of the patient's clinical condition is required.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The most commonly occurring adverse reactions are fatigue, drowsiness and muscle weakness,
and are usually dose-dependent. These effects usually occur at the beginning of treatment
and diminish with continued dosing.

Dependence
Prolonged use of this medicine (even at therapeutic doses) may lead to the development of physical and psychological dependence. Discontinuation of treatment may result in withdrawal symptoms or rebound effects.

Possible adverse reactions:

jaundice;
increased liver enzyme activity in blood tests;
disorientation, emotional blunting, reduced alertness, depression, increased or decreased libido;
uncoordinated movements, speech disorders, altered speech (slurred speech), headache, tremors, dizziness, anterograde amnesia (impaired ability to form new memories, leading to partial or complete inability to recall recent events);
double vision, blurred vision;
heart failure, including cardiac arrest;
low blood pressure, circulatory depression (marked slowing of heart rate);
respiratory depression (severe breathing difficulties), including respiratory failure;
nausea, dry mouth or excessive salivation, constipation and other gastrointestinal disturbances;
skin rash, urticaria, itching, erythema;
urinary incontinence, urinary retention;
irregular heartbeat;
venous thrombosis, phlebitis, irritation at injection site, local swelling or, less frequently, vascular changes, particularly after rapid intravenous administration;
falls and fractures. Intramuscular administration may cause pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Diazepam Grindeks

Store in a refrigerator (2°C – 8°C).
Keep the ampoule in the outer packaging to protect from light.
Do not freeze.
Keep the medicine out of the sight and reach of children.
After opening the ampoule, the injection solution should be used immediately.
The injection solution prepared for infusion administration should be used within 48 hours, stored during this time at room temperature of approximately 25°C.
Any unused portions should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Diazepam Grindeks contains

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

What Diazepam Grindeks looks like and contents of the pack
A clear solution, colourless to pale yellow with a greenish tint.
2 mL ampoules made of colourless glass, with a break ring or score mark.
5 ampoules packed in a PVC blister.
2 blisters (10 ampoules) or 10 blisters (50 ampoules) (hospital pack) placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Riga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]
For further information about this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Diazepam Grindeks
Portugal: Diazepam Grindeks 10 mg/2 ml, Solução injetável