Midazolam B. Braun

Leaflet attached to the packaging: information for the user

Midazolam B. Braun, 5 mg/mL, solution for injection/infusion

Midazolam

You should carefully 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.
• If you have any further questions, you should ask your doctor or pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Midazolam B. Braun is a short-acting medicine used for the induction of sedation (a state of significant relaxation, drowsiness, or sleep) and to reduce the feeling of anxiety and muscle tension. The active substance contained 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 operation. In this case, patients are conscious but feel very calm and sleepy. This is called "shallow sedation";
• to induce a feeling of relaxation or drowsiness before the administration of an anesthetic.

2. Important information before using Midazolam B. Braun

When not to use Midazolam B. Braun:

• if the patient is hypersensitive (allergic) to midazolam or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to benzodiazepine medicines, such as diazepam or nitrazepam,
• if the patient has significant breathing problems and requires the use of midazolam for shallow sedation.

Warnings and precautions

Before starting treatment with Midazolam B. Braun, the patient should discuss it with their 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.

Long-term use of this medicine may 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 starts after administration. The duration depends on the dose received. If the patient is to be discharged from the hospital or surgical ward after the procedure, 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, the doctor or nurse should be informed.
• This is especially important if the child has heart disease or breathing problems.

Midazolam B. Braun and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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.

The patient should tell their doctor if they are taking any of the following medicines:

• anxiolytic medicines (medicines used to treat anxiety, stress, and excitement),
• sleeping medicines (medicines used to treat insomnia),
• sedative medicines (medicines that cause a feeling of calm or drowsiness),
• antidepressant medicines (medicines used to treat depression),
• 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 heart attack),
• 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),
• 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, the patient should not consume alcoholic beverages, as alcohol enhances the effect of midazolam in an uncontrolled manner. This may lead to severe side effects related to the respiratory system, heart function, and circulation.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
If the patient is pregnant, they will receive midazolam only if the doctor considers it absolutely necessary for treatment.
If the patient is breastfeeding, they 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 or operate machinery until the effects of midazolam have worn off completely. The doctor will inform them when they can 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 2.19 mg of sodium (the main component of common salt) per 1 mL ampoule. This corresponds to 0.11% of the maximum recommended daily intake of sodium in the diet for adults.
The medicine contains 21.94 mg of sodium (the main component of common salt) per 10 mL ampoule. This corresponds to 1.01% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Midazolam B. Braun

This medicine will be administered to the patient by a doctor or nurse. It will be used 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 ward. In particular, the patient's breathing, heart function, and circulation 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, based on the treatment they are to receive and their 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, they may experience 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, circulation, and breathing). The patient will receive appropriate treatment if necessary.
In case of acute poisoning, the patient may receive an antidote to counteract the effects 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 side effects.
If the patient has any further questions about the use of this medicine, they should ask their 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 the patient experiences any of the following side effects, they should immediately inform their doctor. The doctor will stop 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 problems (bronchospasm), or pale skin, weak and rapid pulse, or feeling of loss of consciousness. Additionally, it may cause chest pain, which can be a sign of a serious allergic reaction called Kounis syndrome.
• Heart attack (cardiac arrest). Symptoms include: chest pain, which may radiate to the neck and arms and down the left arm, breathing problems, 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 problems 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 disorders:

• 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 frequently in premature infants and newborns,
• temporary memory loss. The duration depends on the dose of midazolam received. It may occur after the end of treatment. In individual cases, it persisted for a longer period.
• dependence on the medicine, abuse of the medicine,
• withdrawal symptoms, sometimes including seizures (convulsions).

Heart and circulation problems:

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

Breathing problems:

• slow 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.

Administration site reactions:

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

General:

• fatigue (weakness).

Injuries, poisonings, 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 side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. 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 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 usually should not 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 5 mg/mL contains 5 milligrams of midazolam.
• One 1 mL ampoule contains 5 milligrams of midazolam.
• One 10 mL ampoule contains 50 milligrams of midazolam.
• The other ingredients are: sodium chloride, 10% hydrochloric acid, and water for injections

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

Midazolam B. Braun is a clear, colorless aqueous solution.
Midazolam B. Braun 5 mg/mL is available in:

• 1 mL colorless glass ampoules in cardboard boxes containing 10 ampoules,
• 10 mL colorless glass ampoules in cardboard boxes containing 5 or 10 ampoules,
• 10 mL transparent LDPE ampoules in cardboard boxes containing 4, 10, or 20 ampoules.

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

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

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

Belgium
Midazolam B. Braun 5 mg/mL
Cyprus
Midazolam B. Braun 5 mg/mL
Denmark
Midazolam B. Braun 5 mg/mL
Estonia
Midazolam B. Braun 5 mg/mL
France
Midazolam B. Braun 5 mg/mL
Germany
Midazolam B. Braun 5 mg/mL
Greece
Midazolam B. Braun 5 mg/mL
Italy
Midazolam B. Braun 5 mg/mL
Latvia
Midazolam B. Braun 5 mg/mL
Lithuania
Midazolam B. Braun 5 mg/mL
Luxembourg
Midazolam B. Braun 5 mg/mL
Malta
Midazolam B. Braun 5 mg/mL
Norway
Midazolam B. Braun 5 mg/mL
Poland
Midazolam B. Braun
Slovenia
Midazolam B. Braun 5 mg/mL solution for injection/infusion
Spain
Midazolam B. Braun 5 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, excitement, irritability, involuntary movements (including tonic-clonic seizures and muscle tremors), excessive activity, hostility, anger, or aggression, seizures of excitement (seizure-like activity), excessive activity, offensive behavior, changes in libido, inappropriate behavior, and other behavioral side effects, seizures of excitement, and acts of violence. 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 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 usually should not 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.