Midazolam B. Braun

Leaflet accompanying the packaging: information for the user

Midazolam B. Braun, 1 mg/mL, solution for injection/infusion

Midazolam

You should carefully read the contents of this 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, ask your doctor or pharmacist.
• 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 Midazolam B. Braun is and what it is used for
• 2. Important information before using Midazolam B. Braun
• 3. How to use Midazolam B. Braun
• 4. Possible side effects
• 5. How to store Midazolam B. Braun
• 6. Contents of the packaging and other information

1. What Midazolam B. Braun is and what it is used for

Midazolam B. Braun is a short-acting medicine used for the induction of sedation (a state of significant calmness, drowsiness, or sleep) and reducing the feeling of anxiety and muscle tension. The active substance in it belongs to a group of substances called benzodiazepines.
The medicine is used in adults:

• as general anesthesia to put the patient to sleep or maintain the patient in a state of sleep.

The medicine is also used in adults and children:

• to induce a feeling of muscle relaxation or drowsiness in intensive care units. This is called "sedation";
• before and during a medical procedure or surgical procedure. In this case, patients are conscious but feel very calm and sleepy. This is called "light sedation";
• to induce a feeling of relaxation or drowsiness before administering an anesthetic.

2. Important information before using Midazolam B. Braun

When not to use Midazolam B. Braun:

Warnings and precautions

Before starting treatment with Midazolam B. Braun, you should discuss it with your doctor or pharmacist.
The patient will be closely monitored while receiving this medicine. The doctor will also ensure that the necessary equipment and medicines for emergency treatment and resuscitation are available.
The doctor will exercise particular caution and may carefully adjust the dose in the following cases:

• in patients over 60 years of age,
• in patients with chronic diseases, such as breathing problems or kidney, liver, or heart disease,
• in patients who have a disease that makes them very weak, exhausted, or lacking energy,
• in patients who have a disease called "myasthenia" (a nerve-muscle disease that causes muscle weakness),
• in patients who have breathing pauses during sleep (sleep apnea),
• in patients who have been dependent on alcohol,
• in patients who have been dependent on drugs or narcotics.

Using this medicine for a long time can lead to:

• the development of tolerance to midazolam. The medicine will become less effective and will not have the desired effect.
• dependence on the medicine and the occurrence of withdrawal symptoms (see "Discontinuation of Midazolam B. Braun" in section 3).

Midazolam causes memory loss, which begins after administration. The duration of this effect depends on the dose received. If after surgery or a diagnostic procedure the patient is to be discharged from the hospital or treatment room, the patient should be accompanied by a caregiver on the way home.

Children

If it is planned to give this medicine to a child:

• If any of the above situations apply to the child, you should inform the doctor or nurse.
• This is especially important if the child has heart disease or breathing problems.

Midazolam B. Braun and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take, including those available without a prescription and herbal medicines.
This is extremely important because Midazolam B. Braun may affect the action of other medicines. Similarly, some other medicines may affect the action of Midazolam B. Braun.

• B. Braun.

You should tell your doctor if the patient is taking any of the following medicines:

• anxiolytic medicines (medicines used to treat anxiety, stress, and excitement),
• sleeping medicines (medicines used to treat insomnia),
• calming medicines (medicines that cause a feeling of calm or drowsiness),
• antidepressant medicines (medicines used to treat depression),
• very strong painkillers,
• antihistamine medicines (medicines used to treat allergies),
• azole antifungal medicines (medicines used to treat fungal infections), such as ketoconazole, voriconazole, fluconazole, itraconazole, or posaconazole,
• macrolide antibiotics (medicines used to treat bacterial infections), such as erythromycin, clarithromycin, telithromycin, or roxithromycin,
• calcium channel blockers (medicines used to treat high blood pressure), such as diltiazem or verapamil,
• protease inhibitors (medicines used to treat HIV or hepatitis C virus infection), such as boceprevir, saquinavir, simeprevir, or telaprevir,

inhibitors of tyrosine kinase (medicines used to treat certain cancers), such as idelalisib, imatinib, or lapatinib,

• NK1 receptor antagonists (medicines used to treat nausea and vomiting), such as aprepitant, netupitant, or casoprepitant,
• atorvastatin (a medicine used to treat high cholesterol),
• rifampicin (a medicine used to treat infections caused by mycobacteria, such as tuberculosis),
• tikagrelor (a medicine used to prevent myocardial infarction),
• everolimus (a medicine used in transplants and to treat certain cancers),
• carbamazepine or phenytoin (medicines used to treat epilepsy),
• cyclosporin (a medicine used in transplants),
• propiverine (a medicine used to treat overactive bladder syndrome),
• mitotane or enzalutamide (medicines used to treat certain cancers),
• clobazam (a medicine used to treat epilepsy or anxiety),
• efavirenz (a medicine used to treat HIV infection),
• vemurafenib (a medicine used to treat melanoma),
• herbal medicines: St. John's Wort, quercetin, Ginkgo biloba, or ginseng (Panax ginseng),
• valproic acid (a medicine used to treat epilepsy).

Midazolam B. Braun with alcohol

After receiving midazolam, you should not consume alcoholic beverages, as alcohol enhances the effect of midazolam in an uncontrolled manner. This can lead to severe side effects related to the respiratory system, heart function, and circulatory system.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, she will receive midazolam only if the doctor considers it absolutely necessary in the context of treatment.
If the patient is breastfeeding, she should stop breastfeeding for 24 hours after receiving midazolam.
This is because midazolam may pass into human milk.

Driving and using machines

The patient should not drive vehicles or operate machines until the effect of midazolam has completely disappeared. The doctor will inform when it is possible to resume these activities.
The medicine may cause drowsiness, forgetfulness, or affect concentration and coordination.
The patient should ensure that they are accompanied by another person on the way home after discharge.

Midazolam B. Braun contains sodium

The medicine contains 17.63 mg of sodium (the main component of common salt) per 5 mL ampoule. This corresponds to 0.88% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 176.33 mg of sodium (the main component of common salt) per 50 mL bottle. This corresponds to 8.81% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 352.65 mg of sodium (the main component of common salt) per 100 mL bottle. This corresponds to 17.63% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Midazolam B. Braun

This medicine will be given to the patient by a doctor or nurse. It will be administered in a place equipped with equipment to monitor the patient's condition and treat any side effects that may occur. This may be a hospital or surgical clinic. In particular, the patient's breathing, heart function, and circulatory system will be monitored.
This medicine is not recommended for use in children and infants under 6 months of age. Nevertheless, in cases that occur in intensive care units, its use in children and infants under 6 months of age may be justified if the doctor considers it necessary.
Midazolam B. Braun is administered by injection (intravenously) or into a muscle (intramuscularly). It can also be administered in a diluted form in a large amount of fluid through a cannula placed in a vein (as an infusion). It can also be administered rectally using a special applicator if injection or infusion is not possible.
Dosage:
The doctor will determine the correct dose for the patient or child, depending on the treatment the patient or child is to receive, and based on the patient's or child's state of health.

Using a higher dose of Midazolam B. Braun than recommended

The medicine is administered to the patient by a doctor. If the patient accidentally receives too much midazolam, the patient may notice the following symptoms:

• drowsiness and lack of proper muscle control (coordination) and reflexes,
• speech disorders and abnormal eye movements,
• low blood pressure. In this case, the patient may feel lightheaded or dizzy,
• slower breathing or cessation of breathing and slower heart rate, or cessation of heart rate and loss of consciousness (coma).

Treatment of overdose is based mainly on monitoring vital functions (heart function, circulatory system, and breathing). The patient will receive appropriate treatment if necessary.
In case of acute poisoning, the patient may receive an antidote to counteract the effect of midazolam.

Discontinuation of Midazolam B. Braun

If the patient suddenly stops treatment after long-term use, they may experience withdrawal symptoms, such as:

• headaches,
• diarrhea,
• muscle pain,
• feeling of anxiety, tension, restlessness, confusion, or irritability (irritability),
• sleep disorders,
• mood changes,
• hallucinations (seeing and possibly hearing things that are not really there),
• seizures (convulsions),
• depersonalization,
• numbness and tingling of limbs,
• hypersensitivity to light, noise, and physical contact.

At the end of midazolam treatment, the doctor will gradually reduce the dose to avoid the occurrence of the above-mentioned effects.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported (with unknown frequency: frequency cannot be estimated from the available data).

The following side effects may be serious. If you experience any of the following side effects, tell your doctor immediately. The doctor will discontinue the administration of the medicine:

• Anaphylactic shock (a life-threatening allergic reaction). Symptoms include: rash, itching, or hives and swelling of the face, lips, tongue, or other parts of the body (angioedema). It may also cause difficulty breathing, wheezing, or breathing difficulties (bronchospasm), or pale skin, weak and rapid pulse, or feeling of loss of consciousness. Additionally, it may cause chest pain, which can be a symptom of a serious allergic reaction called Kounis syndrome.
• Myocardial infarction (heart attack). Symptoms include: chest pain, which may radiate to the neck and arms and down the left arm, breathing difficulties or complications (sometimes leading to cessation of breathing).
• Choking and sudden blockage of the airways (laryngospasm).

Life-threatening side effects occur more frequently in adults over 60 years of age and in patients with breathing difficulties or heart disease, especially if the injection is given too quickly or in too high a dose.

Other side effects: Immune system disorders:

• general allergic reactions (skin reactions, cardiovascular and vascular reactions)

Effects on behavior:

• agitation,
• restlessness,
• irritability,
• nervousness, anxiety,
• hostility, anger, or aggression,
• seizures of excitement (seizure-like activity),
• excessive activity,
• offensive behavior,
• changes in libido,
• inappropriate behavior and other behavioral side effects.

Muscle problems:

• muscle spasms or muscle tremors (muscle tremors that the patient cannot control).

Psychiatric and nervous system problems:

• confusion, disorientation,
• psychosis (loss of contact with reality),
• emotional and mood disorders,
• hallucinations (seeing and possibly hearing things that are not really there),
• drowsiness and prolonged sedation,
• nightmares, unusual dreams,
• reduced level of consciousness,
• headache,
• dizziness,
• difficulty with muscle coordination,
• seizures (convulsions), more often in premature infants and newborns,
• temporary memory loss. The duration of this effect depends on the dose of midazolam received. It may occur after the end of treatment. In individual cases, it lasted for a longer time.
• dependence on the medicine, abuse of the medicine,
• withdrawal symptoms, sometimes including seizures (convulsions).

Heart and circulatory system problems:

• low blood pressure,
• slow heart rate,
• vasodilation.

Breathing problems:

• slowed breathing (respiratory depression),
• shortness of breath (dyspnea),
• cessation of breathing (apnea, respiratory arrest),
• hiccups.

Stomach, intestine, and mouth problems:

• nausea,
• vomiting,
• constipation,
• dry mouth.

Skin problems:

• rash,
• hives (urticaria),
• itching.

Effects at the injection site:

• redness,
• swelling of the skin,
• blood clots or pain.

General:

• fatigue (weakness).

Injuries, poisoning, and complications after procedures:

• falls and bone fractures. This risk is higher in patients taking other sedative medicines (including alcohol) and in elderly patients.

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 Adverse Reaction Monitoring of Medicinal Products 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Midazolam B. Braun

The doctor or pharmacist is responsible for storing this medicine. They are also responsible for the proper disposal of any unused midazolam.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Do not store above 25°C.
Chemical and physical stability during use has been demonstrated for 24 hours at room temperature and 3 days at 5°C.
From a microbiological point of view, the diluted medicinal product should be used immediately after preparation. If the solution is not used immediately, the user is responsible for the storage time and conditions, which should not normally exceed 24 hours at a temperature of 2 to 8°C, unless the dilution was performed under controlled and approved aseptic conditions.
Store the containers in the outer packaging to protect from light.

6. Contents of the packaging and other information

What Midazolam B. Braun contains

• The active substance of the medicine is midazolam (in the form of midazolam hydrochloride). Each 1 mL of Midazolam B. Braun 1 mg/mL contains 1 milligram of midazolam.
• One 5 mL ampoule contains 5 milligrams of midazolam.
• One 50 mL bottle contains 50 milligrams of midazolam.
• One 100 mL bottle contains 100 milligrams of midazolam.
• The other ingredients are: sodium chloride, hydrochloric acid 10%, and water for injection

What Midazolam B. Braun looks like and what the packaging contains

Midazolam B. Braun is a clear, colorless aqueous solution.
Midazolam B. Braun 1 mg/mL is available in:

• 5 mL ampoules made of colorless glass in cardboard boxes containing 10 ampoules,
• 5 mL transparent ampoules made of LDPE in cardboard boxes containing 4, 10, or 20 ampoules,
• 50 mL and 100 mL transparent bottles made of LDPE in cardboard boxes containing 10 bottles.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany

Mailing address:
34209 Melsungen, Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-4567
Manufacturer

• B. Braun Melsungen AG Mistelweg 2 12357 Berlin Germany
• B. Braun Medical, S.A. Carretera de Terrassa 121 Rubi, 08191 Barcelona, Spain

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

Belgium
Midazolam B. Braun 1 mg/mL
Cyprus
Midazolam B. Braun 1 mg/mL
Denmark
Midazolam B. Braun 1 mg/mL
Estonia
Midazolam B. Braun 1 mg/mL
France
Midazolam B. Braun 1 mg/mL
Germany
Midazolam B. Braun 1 mg/mL
Greece
Midazolam B. Braun 1 mg/mL
Italy
Midazolam B. Braun 1 mg/mL
Latvia
Midazolam B. Braun 1 mg/mL
Lithuania
Midazolam B. Braun 1 mg/mL
Luxembourg
Midazolam B. Braun 1 mg/mL
Malta
Midazolam B. Braun 1 mg/mL
Norway
Midazolam B. Braun 1 mg/mL
Poland
Midazolam B. Braun
Slovenia
Midazolam B. Braun 1 mg/mL solution for injection/infusion
Spain
Midazolam B. Braun 1 mg/mL

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Warnings

Paradoxical reactions
Paradoxical reactions have been reported after the administration of midazolam, such as restlessness, agitation, irritability, involuntary movements (including tonic-clonic seizures and muscle tremors), excessive activity, hostility, anger, or aggression, seizures of excitement, hyperactivity, offensive behavior, changes in libido, inappropriate behavior, and other behavioral side effects, seizure-like activity.
Such reactions may occur after the use of high doses and (or) rapid injection. These reactions most often occurred in children and the elderly. If they occur, consideration should be given to discontinuing the medicinal product.
Sleep apnea
Midazolam should be used with caution in patients with sleep apnea syndrome and their condition should be regularly monitored.

Procedure

The medicinal product should be used immediately after opening.
Shelf life after dilution in accordance with the instructions:
Chemical and physical stability during use has been demonstrated for 24 hours at room temperature and 3 days at 5°C.
From a microbiological point of view, the diluted medicinal product should be used immediately after preparation. If the solution is not used immediately, the user is responsible for the storage time and conditions, which should not normally exceed 24 hours at a temperature of 2 to 8°C, unless the dilution was performed under controlled and approved aseptic conditions.
The product is supplied in single-dose containers. Unused contents of opened containers should be discarded immediately.
Use only if the solution is clear and colorless and the container and its closure are undamaged.
Instructions for dilution, incompatibilities, and detailed information on prescribing, see Summary of Product Characteristics.