Midazolam Sandoz

Leaflet accompanying the packaging: patient information

Midazolam Sandoz, 1 mg/ml, solution for injection or infusion

Midazolam Sandoz, 5 mg/ml, solution for injection or infusion

Midazolam

You should read the contents 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.
In case of any doubts, you should consult a doctor, pharmacist, or nurse.
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 not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
See section 4.

Table of contents of the leaflet:

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

1. What is Midazolam Sandoz and what is it used for

Midazolam Sandoz contains the active substance midazolam and belongs to a group of medicines called benzodiazepines. Midazolam is a short-acting medicine that causes sedation (a state of calm, drowsiness, or sleep) and relieves anxiety and muscle tension. It has anticonvulsant properties and causes amnesia for recent events.

Midazolam Sandoz is used:

• to induce sedationin adults and children during diagnostic or therapeutic procedures
• to induce sedation in adults and children being treated in intensive care units
• in anesthesiain adults (as the only medicine or in combination with other anesthetics)
• to induce sedation before introducing adults and children to anesthesia

2. Important information before using Midazolam Sandoz

When not to use Midazolam Sandoz

If:
the patient is allergicto:

• midazolam or any of the other ingredients of this medicine (listed in section 6)
• other benzodiazepine medicines. The names of their active substances end in "azepam" (e.g., diazepam, nitrazepam) the patient has acuteor severe breathing difficulties, and is to receive Midazolam Sandoz for shallow sedation In case of doubt, the patient should consult a doctor or nurse before receiving this medicine.

Warnings and precautions

Midazolam Sandoz should only be used when appropriate resuscitation equipment is available, tailored to the patient's age and size, due to the possibility of life-threatening side effects, see also section 4. Administration of Midazolam Sandoz may inhibit cardiac muscle contractions and cause apnea (a pause in breathing). Severe cardiovascular and respiratory side effects are possible. These include respiratory depression, apnea, respiratory arrest, and (or) cardiac arrest. To avoid such events, the medicine should be administered slowly and in the smallest possible dose.
If Midazolam Sandoz is used for premedication, the doctor will carefully monitor the patient's reaction to ensure the correct dose is administered, as sensitivity to the medicine varies between patients.
During the use of Midazolam Sandoz, paradoxical reactions and anterograde amnesia (loss of memory of recent events) have been reported, see section 4.
Long-term use
If Midazolam Sandoz is used for a long time, the patient may develop tolerance (reduced effectiveness of the medicine) or dependence on the medicine.
After long-term treatment (e.g., in an intensive care unit), the patient may experience withdrawal symptoms. To avoid them, the doctor will gradually reduce the dose of the medicine. Further information can be found in section 3: "Discontinuation of Midazolam Sandoz".
Before using Midazolam Sandoz, the patient should talk to their doctor or nurse if they:

• are over 60 years oldPatients of this age require smaller doses and close monitoring of vital functions.
• have chronic diseaseor are malnourishedand have, for example:
• breathing difficulties Note: Midazolam Sandoz should not be used in patients with the above-mentioned breathing difficulties (see "When not to use Midazolam Sandoz").
• kidney failure
• liver or heart function disorders Patients who are malnourished or have chronic diseases require smaller doses and close monitoring of vital functions.
• have a certain type of muscle weaknesscalled myasthenia
• have a history of alcohol or drug abuseMidazolam Sandoz should not be used in patients with such addiction in their history.
• are taking any other medicines, including those prescribed by a doctor (more information can be found in the section "Midazolam Sandoz and other medicines")
• have periodic breathing pauses during sleep(sleep apnea)
• are pregnant or think they may be pregnant.

Children

The use of Midazolam Sandoz in infants or children requires special caution.
The patient should talk to their doctor or nurse if their child is to receive this medicine and:

• has heart or breathing disorders The child's condition will be closely monitored, and the dose of the medicine will be adjusted accordingly.
• is less than 6 months old or is premature
• the use of Midazolam Sandoz in children under 6 months is indicated only for sedation in an intensive care unit
• it is necessary to administer the dose gradually and closely monitor breathing and blood oxygen saturation, as patients of this age are more prone to breathing disorders.

Midazolam Sandoz and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken.
The patient should inform their doctor or nurseif they are taking any of the following medicines, as they may enhance the effect of Midazolam Sandoz:
sedatives, sleeping pills, muscle relaxants, or medicines used to treat anxiety or mental disorders
medicines that facilitate sleep or are used in anesthesia, such as etomidate, ketamine, propofol
medicines used to treat mental disorders or anxiety, with a sedative effect
medicines used to treat depression
carbamazepine or phenytoin (medicines that may be administered in case of seizures or epilepsy)
medicines used to treat severe pain or cough, or used in substitution therapy
medicines used to treat allergies and sleep disorders (so-called antihistamines)
medicines used to treat fungal infections, with active substance names ending in "azol", such as ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole
medicines used to treat bacterial infections, with active substance names ending in "mycin", such as erythromycin, clarithromycin
diltiazem: a medicine used to treat high blood pressure and heart disorders
medicines used to treat high blood pressure, acting on the brain
medicines used to treat HIV infections, with active substance names ending in "nawir", such as saquinavir
medicines used to treat hepatitis C, with names ending in "previr", such as boceprevir, telaprevir
atorvastatin: a medicine used to reduce cholesterol levels
rifampicin: a medicine used to treat tuberculosis
St. John's Wort: a herbal medicine used to treat depression
inhalation anesthetics

Midazolam Sandoz with food, drink, and alcohol

While using Midazolam Sandoz, the patient must not drink alcohol. Alcohol may significantly enhance the sedative effect of this medicine and cause breathing difficulties.

Pregnancy, breastfeeding, and fertility

• PregnancyIf the patient is pregnant or thinks she may be pregnant, she should inform her doctor. The doctor will decide whether this medicine is suitable for her. If the doctor decides to use this medicine in late pregnancy, during childbirth, or cesarean section, there is a risk of maternal aspiration and irregular heart rhythm of the newborn, its hypotonia (decreased muscle tone), difficulty sucking, low body temperature, and respiratory depression. In children of mothers who received this medicine for a long time in the last phase of pregnancy, physical dependence and the risk of withdrawal symptoms after birth may occur.
• BreastfeedingThe patient should not breastfeed for 24 hours after receiving Midazolam Sandoz, as it may pass into breast milk.
• FertilityAs the current data indicate, Midazolam Sandoz does not affect fertility.

Driving and using machines

• The patient should not drive or operate machinesuntil the effect of the medicine has completely worn off. The doctor should advise the patient when they can resume these activities.
• After using this medicine, the patient should always be accompanied by another person on the way home. Midazolam Sandoz may cause drowsiness and memory loss or impair concentration and coordination, affecting the ability to perform tasks such as driving or operating machines.

Midazolam Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".

3. How to use Midazolam Sandoz

This medicine should only be administered by an experienced doctor or nurse. It is administered in a hospital, clinic, or surgical office, with the possibility of:

• monitoring and supporting breathing, heart function, and circulation
• diagnosing and properly treating expected side effects.

Recommended dose:

The doctor determines the dose individually for the patient, depending on:

• the indication for treatment
• the type of sedation required
• the patient's age, weight, and overall condition
• concomitant treatment
• the patient's reaction to Midazolam Sandoz
• the need to use other medicines at the same time If the patient needs to receive strong painkillers, they will be administered first, and then Midazolam Sandoz in an individually selected dose.

Route and method of administration

• intravenous administration: slow injection into a vein
• infusion: in a drip into one of the veins
• intramuscular administration: injection into a muscle
• rectal administration: into the rectum

Children over 12 years old usually receive the medicine intravenously. Rectal administration is also possible if the goal is to sedate before anesthesia. The patient should read the information in section 2 under the title "Children".

Instructions for proper use

Midazolam Sandoz is compatiblewith the following infusion solutions:

• 0.9% (9 mg/ml) sodium chloride solution,
• 5% (50 mg/ml) glucose solution,
• 10% (100 mg/ml) glucose solution,
• Ringer's solution,
• Hartmann's solution.

Midazolam Sandoz is not compatiblewith the following infusion solutions:

• 6% (w/v) dextran solution (with 0.9% sodium chloride solution) in dextrose
• alkaline injection solutions. Midazolam precipitates in a solution containing sodium bicarbonate.

To avoid possible incompatibility, Midazolam Sandoz should not be mixed with other solutions, except for those listed above.
Ampoules of Midazolam Sandoz are for single use. Any unused product should be discarded.
Before administration, the ampoule and solution should be inspected. Only undamaged ampoules and clear solutions without solid particles and without color change should be used.

Administration of a higher dose of Midazolam Sandoz than recommended

If the patient experiences any of the following symptoms of overdose, they should inform their doctor, who will provide appropriate treatment:

• drowsiness
• difficulty controlling movements or speech
• loss of reflexes
• involuntary eye movements
• low blood pressure (may cause dizziness or fainting)
• slow or stopped breathing or heart rate
• loss of consciousness (coma)

Overdose may require close monitoring of vital functions, symptomatic treatment of cardiovascular and respiratory effects, and the use of a benzodiazepine antagonist.

Discontinuation of Midazolam Sandoz

If Midazolam Sandoz has been used for a long time:

• it may become less effective and not work as expected
• the patient may become dependent on it and experience withdrawal symptoms

If the treatment is stopped suddenly or the dose is reduced too quickly, the patient may experience the following withdrawal symptoms:

• headache
• muscle pain
• anxiety
• tension
• restlessness
• confusion
• irritability
• difficulty sleeping
• mood changes
• hallucinations (seeing or hearing things that do not exist)
• seizures

The doctor will gradually reduce the dose of the medicine to avoid these symptoms.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during the use of this medicine. Their frequency is unknown (cannot be estimated from the available data).

If the patient experiences any of the side effects listed in bold, they should STOP USINGMidazolam Sandoz and immediately tell their doctor. These may be life-threatening and require urgent treatment.

• severe allergic reaction (anaphylactic shock)Symptoms are sudden rash, itching, or hives; swelling of the face, lips, tongue, or other parts of the body. It is also possible to experience difficulty breathing, wheezing, or shortness of breath, or pallor, weak and rapid pulse, or a feeling of loss of consciousness. Additionally, there may be chest pain, which can be a symptom of a serious allergic reaction called Kounis syndrome.
• heart attackSymptoms are chest pain, which may radiate to the neck and arms, and then down to the left arm.
• breathing difficultiesor complications
• laryngospasmThe occurrence of these life-threatening side effects is more likely in patients over 60 years old or patients with breathing or heart function disorders. This usually happens after too rapid administration of the medicine or in high doses.

The patient may experience any of the following side effects

Nervous system disorders and mental disorders

reduced alertness
confusion
excessive feeling of happiness or excitement (euphoria)
changes in sex drive
fatigue, drowsiness, and prolonged sedation
seeing or hearing things that do not exist (hallucinations)
headache
dizziness
coordination disorders
seizures in premature infants and newborns
temporary memory loss. The duration of memory loss depends on the duration of treatment and the dose administered. It may persist after the end of treatment, in individual cases for a long time.
anxiety, hostility, anger, or aggression. Uncontrolled muscle spasms or muscle tremors may also occur. The likelihood of their occurrence is higher if the patient receives a high dose of Midazolam Sandoz or if the medicine is administered too quickly, as well as in children and the elderly.
If the patient notices that they are becoming dependent on the medicine or the medicine is becoming less effective and the dose needs to be increased, they should tell their doctor.

Cardiovascular disorders

slow heart rate
cardiac arrest
flushing of the face and neck
fainting
low blood pressure (may cause dizziness or fainting)
formation of a blood clot or vein inflammation (thrombophlebitis)

Respiratory disorders

hiccups
shortness of breath, difficulty breathing

Gastrointestinal disorders

dry mouth
constipation
nausea, vomiting

Skin and subcutaneous tissue disorders

itching
rash, hives
redness of the skin and pain at the injection site

General disorders and administration site conditions

allergic reactions, including rash and wheezing
withdrawal symptoms (see "Discontinuation of Midazolam Sandoz" in section 3)
falls and bone fractures. The risk of their occurrence is higher if the patient is taking other medicines that cause drowsiness (e.g., sedatives or sleeping pills) or if the patient is also drinking alcohol.

Elderly

The risk of falls and bone fractures is higher in the elderly who receive benzodiazepines, such as Midazolam Sandoz.
In people over 60 years old, the likelihood of life-threatening side effects is higher.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 the medicine.

5. How to store Midazolam Sandoz

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
After opening the ampoule
For microbiological reasons, the medicine should be used immediately. If not, the user is responsible for the storage time and conditions before use.
After dilution
Chemical and physical stability of the diluted solutions has been demonstrated for 24 hours at room temperature (15-25°C) and for 3 days at a temperature of +2°C to +8°C.
From a microbiological point of view, the medicine should be used immediately after dilution. If not, the user is responsible for the storage time and conditions before use, but this time should not exceed 24 hours, and the temperature should be between +2°C and +8°C, unless the dilution was performed under controlled and validated aseptic conditions.
Ampoules of Midazolam Sandoz are for single use. Any unused product should be discarded.
Do not use this medicine if the ampoule is not intact or the solution is not free from solid particles or has changed color.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Midazolam Sandoz contains

The active substance of the medicine is midazolam.
Midazolam Sandoz1 mg/ml
Each 5 ml ampoule of solution for injection or infusion contains 5 mg of midazolam (as midazolam hydrochloride).
Midazolam Sandoz5 mg/ml
Each 1 ml ampoule of solution for injection or infusion contains 5 mg of midazolam (as midazolam hydrochloride).
Each 3 ml ampoule of solution for injection or infusion contains 15 mg of midazolam (as midazolam hydrochloride).
Each 10 ml ampoule of solution for injection or infusion contains 50 mg of midazolam (as midazolam hydrochloride).
The other ingredients are:
Midazolam Sandoz 1 mg/ml: sodium chloride, hydrochloric acid, water for injections.
Midazolam Sandoz 5 mg/ml: sodium chloride, hydrochloric acid, sodium hydroxide, water for injections.

What Midazolam Sandoz looks like and contents of the pack

This medicine is a clear, light yellow solution in a clear glass ampoule.
Pack sizes:
Midazolam Sandoz 1 mg/ml
5 x 5 ml
Midazolam Sandoz 5 mg/ml
5 x 1 ml
5 x 3 ml
5 x 10 ml

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
EVER Pharma Jena GmbH
Otto-Schott-Straße 15
7745 Jena
Germany

To obtain more detailed information about the medicine and its names in other European Economic Area member states, the patient should contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
Date of last revision of the leaflet:08/2023
Sandoz logo

Information intended only for healthcare professionals

Preparation of the infusion solution
Midazolam Sandoz can be diluted with 0.9% sodium chloride solution, 5% (50 mg/ml) glucose solution, or 10% (100 mg/ml) glucose solution, Ringer's solution, or Hartmann's solution in a ratio of 15 mg of midazolam per 100 to 1000 ml of infusion solution. These solutions remain stable for 24 hours at room temperature and for 3 days at a temperature of +2°C to +8°C.
Midazolam Sandoz should not be mixed with other solutions except for those listed above.
In particular, Midazolam Sandoz should not be mixed with 6% (w/v) dextran solution (with 0.9% sodium chloride solution) in dextrose or with alkaline injection solutions. Midazolam precipitates in a solution containing sodium bicarbonate.
Ampoules and solution should be inspected before administration. Only undamaged ampoules and clear solutions without solid particles and without color change should be used.
Shelf life and storage
Ampoules of Midazolam Sandoz are for single use.
Ampoules before opening
Store in the outer packaging to protect from light.
Ampoules after dilution
Chemical and physical stability of the diluted solutions has been demonstrated for 24 hours at room temperature (15-25°C) and for 3 days at a temperature of +2°C to +8°C.
From a microbiological point of view, the medicine should be used immediately after dilution. If not, the user is responsible for the storage time and conditions before use, but this time should not exceed 24 hours, and the temperature should be between +2°C and +8°C, unless the dilution was performed under controlled and validated aseptic conditions.
In case of continuous intravenous infusion, the solution can be diluted with one of the above-mentioned solutions to achieve a final concentration in the range of 0.015 to 0.15 mg.
Disposal of waste
Any unused product or waste should be disposed of in accordance with local regulations.