Leaflet: information for the user

Midazolam B. Braun 5 mg/ml injectable solution and for infusion EFG

Read this leaflet carefully before you start 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 questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Midazolam B. Braun

3. How to use Midazolam B. Braun

4. Possible side effects

5. Storage of Midazolam B. Braun

6. Contents of the pack and additional information

Midazolam B. Braun is a short-acting medication used to induce sedation (a very relaxed state of calmness, drowsiness, or sleep) and alleviate anxiety and muscle tension. Its active ingredient, midazolam, belongs to a group of substances called benzodiazepines.

This medication is used in adults:

• as general anesthesia to induce sleep in the patient or to keep them asleep

This medication is also used in adults and children:

• to induce a feeling of relaxation or drowsiness in intensive care. This is known as “sedation”
• before and during a medical procedure or surgical intervention. In this case, patients remain awake but feel very calm and drowsy. This is known as “conscious sedation”.
• to induce a feeling of relaxation or drowsiness before administering an anesthetic.

Do not use Midazolam B. Braun:

• if you are hypersensitive (allergic) to midazolam, or to any of the other components of this medication (listed in section 6).
• if you are allergic to benzodiazepines, such as diazepam and nitrazepam
• if you have severe respiratory problems and need midazolam for conscious sedation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Midazolam B.Braun.

You will be closely monitored while receiving the medication. Your doctor will also ensure that the necessary equipment and medications are available for emergency treatment and resuscitation.

Your doctor will take extra precautions and may adjust the dose with special attention if:

• you are over 60 years old,
• you have a chronic illness, such as respiratory problems or kidney, liver, or heart disease,
• you have a condition that makes you feel weak, depressed, and lacking in energy.
• you have a condition called myasthenia gravis (a neuromuscular disease that causes muscle weakness),
• you have sleep apnea (your breathing stops during sleep),
• you have had alcohol addiction at any time,
• you have had addiction to any substance at any time.

If you receive this medication for a long period of time, it is possible that:

• you will develop tolerance to midazolam. The medication will lose its effectiveness and will not work as well for you,
• you will develop dependence on this medication and experience withdrawal symptoms (see "If you stop treatment with Midazolam B.Braun" in section3).

Midazolam will cause a memory gap that will start with administration. The duration will depend on the dose you receive. If you are discharged from the hospital or clinic after a surgical or diagnostic procedure, make sure someone accompanies you home.

Children

If your child is to receive this medication:

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

Other medications andMidazolam B. Braun

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications and herbal products.

This is extremely important, as Midazolam B. Braun may affect the effect of other medications. Similarly, other medications may affect the effect of Midazolam B. Braun.

In particular, inform your doctor if you are taking any of the following medications:

• tranquilizers (medications used to treat anxiety, stress, and nervousness or to help sleep)
• hypnotics (sleeping medications)
• sedatives (medications to feel calm or drowsy)
• antidepressants (medications used to treat depression)
• very potent analgesics (pain medications)
• antihistamines (medications to treat allergies)
• azole antifungals (medications to treat fungal infections) such as ketoconazole, voriconazole, fluconazole, itraconazole, or posaconazole
• macrolide antibiotics (medications to treat bacterial infections) such as erythromycin, clarithromycin, telithromycin, or roxithromycin
• calcium channel blockers (medications to treat high blood pressure) such as diltiazem or verapamil
• protease inhibitors (medications to treat HIV or hepatitis C infection) such as boceprevir, saquinavir, simeprevir, or telaprevir
• tyrosine kinase inhibitors (medications to treat certain cancers) such as idelalisib, imatinib, or lapatinib
• NK1 receptor antagonists (medications to treat nausea and vomiting) such as aprepitant, netupitant, or casopitant
• atorvastatin (medication to treat high cholesterol)
• rifampicin (medication to treat mycobacterial infections such as tuberculosis)
• ticagrelor (medication to prevent myocardial infarction)
• everolimus (medication used in transplants and to treat certain cancers)
• carbamazepine or phenytoin (medications to treat epilepsy)
• ciclosporin (medication used in transplants)
• propiverine (medication to treat overactive bladder)
• mitotane or enzalutamide (medications to treat certain cancers)
• clobazam (medication to treat epilepsy or anxiety)
• efavirenz (medication to treat HIV infection)
• vemurafenib (medication to treat melanoma)
• St. John's Wort, quercetin, Ginkgo biloba, or Panax ginseng (herbal products)
• valproic acid (medication to treat epilepsy)

Use of Midazolam B. Braun with alcohol

Do not consume alcoholic beverages while receiving midazolam, as alcohol will increase the potency of midazolam in an uncontrolled manner. This could cause severe adverse reactions in breathing, cardiac function, and circulation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, you will only receive midazolam if your doctor considers it absolutely necessary in the context of your treatment.

If you are breastfeeding, stop breastfeeding for 24 hours after midazolam administration, as it may pass into breast milk.

Driving and operating machinery

Do not drive or operate any tools or machinery until you have fully recovered from midazolam. Your doctor will indicate when you can resume this activity.

This medication may cause drowsiness and memory loss or affect your concentration and coordination. Make sure someone accompanies you home when you are discharged.

Midazolam B. Braun contains sodium

This medication contains 2.19 mg of sodium (main component of table salt/for cooking) in each 1 ml ampoule. This is equivalent to 0.11% of the maximum daily sodium intake recommended for an adult.

This medication contains 6.58 mg of sodium (main component of table salt/for cooking) in each 3 ml ampoule. This is equivalent to 0.33% of the maximum daily sodium intake recommended for an adult.

This medication contains 21.94 mg of sodium (main component of table salt/for cooking) in each 10 ml ampoule. This is equivalent to 1.01% of the maximum daily sodium intake recommended for an adult.

This medication will be administered by a doctor or nurse. It will be used in a place equipped to monitor you and treat any adverse effects that may occur. This place may be a hospital or an ambulatory surgery service. In particular, your breathing, cardiac function, and circulatory function will be closely monitored.

This medication is not recommended for newborns or children under 6 months of age. However, in intensive care situations, it may be used in newborns and children under 6 months of age if the doctor considers it necessary.

Midazolam will be administered with a syringe (as an injection) into a vein (intravenously) or into a muscle (intramuscularly). It may also be administered diluted in a larger amount of liquid, through a cannula placed in a vein (by infusion). It is also possible to administer it rectally with a special applicator if the injection or infusion is not feasible.

Dosage:

Your doctor will determine the correct dose for you or your child, depending on the treatment you or your child will receive and your or your child's condition.

If you use more Midazolam B. Braun than you should

This medication will be administered by a doctor. If you accidentally receive an excessive amount of midazolam, you may experience the following:

• drowsiness and loss of normal muscle control (coordination) and reflexes
• speech disturbances and unusual eye movements
• low blood pressure. In this case, you may feel dizzy or lightheaded
• slowing or stopping of breathing or heart rate and loss of consciousness (coma).

The treatment of overdose primarily involves monitoring your vital functions (cardiac function, circulation, and breathing). You will receive adequate support if necessary.

In cases of severe poisoning, you may receive a special antidote to counteract the effect of midazolam.

If you interrupt treatment with Midazolam B. Braun

If you suddenly interrupt treatment after prolonged use, you may experience withdrawal symptoms such as:

• headaches,
• diarrhea
• muscle pain,
• feeling anxious, tense, restless, confused, or irritable,
• sleep disturbances,
• mood changes,
• hallucinations (seeing and possibly hearing things that are not there),
• seizures.
• depersonalization,
• numbness and tingling in the extremities,
• hypersensitivity to light, sound, and physical contact.

Your doctor will gradually reduce your dose towards the end of treatment with midazolam to prevent these effects.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported (frequency unknown: cannot be estimated from available data).

The following side effects may be serious. If any of the following side effects occur, inform your doctor immediately, who will stop administering this medicine:

• Anaphylactic shock (a potentially fatal allergic reaction). Signs may include sudden onset of skin rash, itching, or skin rash with hives (urticaria) and swelling of the face, lips, tongue, or other parts of the body (angioedema). You may also experience shortness of breath, wheezing, or difficulty breathing (bronchospasm), or pale skin, weak and rapid pulse, or feeling of loss of consciousness. Additionally, you may experience chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Heart attack (cardiac arrest). Signs may include chest pain that may extend to the neck and shoulders and down the left arm, and respiratory problems (which may cause respiratory arrest on occasion).
• Asphyxia and sudden obstruction of the airway (laryngospasm).

Life-threatening side effects are more likely to occur in adults over 60years and in those who already have respiratory difficulties or heart problems, particularly if the injection is administered too quickly or with a high dose.

Other side effects:

Immune system problems:

• General allergic reactions (skin, cardiac, and blood reactions)

Effects on behavior:

• Agitation
• Anxiety
• Irritability
• Nervousness
• Hostility, anger, or aggression
• Excitement attacks (paroxysmal excitement)
• Hypervigilance
• Offensive behavior
• Changes in libido
• Inadequate behavior and other behavioral side effects

Muscle problems:

• Muscle spasms and tremors (muscle contractions that cannot be controlled)

Mental and nervous system problems:

• Confusion, disorientation
• Psychosis (loss of contact with reality)
• Mood and emotional disorders
• Hallucinations (seeing and possibly hearing things that are not there)
• Somnolence and prolonged sedation
• Nightmares, abnormal dreams
• Decreased alertness
• Headaches
• Dizziness
• Difficulty coordinating muscles
• Seizures, more frequently in premature infants and newborns
• Temporary loss of memory, the duration of which will depend on the amount of midazolam received. You may experience it after treatment. In isolated cases, this effect has had a long duration.
• Drug dependence, abuse
• Withdrawal symptoms, which may include seizures on occasion

Circulatory and cardiac problems:

• Low blood pressure
• Slow heart rate
• Widening of blood vessels (vasodilation)

Respiratory problems:

• Slow breathing (respiratory depression)
• Difficulty breathing (dyspnea)
• Respiratory arrest (apnea)
• Shortness of breath

Problems with the stomach, intestines, and mouth:

• Nausea
• Vomiting
• Constipation
• Dry mouth

Skin problems:

• Rash
• Urticaria (hives)
• Itching

Effects at the injection site:

• Redness
• Swelling of the skin
• Blood clots or pain

General disorders:

• Fatigue (fatigue)

Accidents, poisonings, and complications of therapeutic procedures:

• Falls and bone fractures. This risk is higher in patients taking other sedatives (including alcohol) and in the elderly.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Your doctor or pharmacist is responsible for the conservation of this medication. They are also responsible for properly disposing of unused midazolam.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Chemical and physical stability has been demonstrated during 24 hours at room temperature and during 3 days at 5 °C. From a microbiological standpoint, the dilutions should be used immediately after preparation. If not used immediately, the storage times in use and the conditions before use are the responsibility of the user and should normally not exceed 24 hours between 2 and 8orC, unless the dilution method excludes any risk of microbiological contamination.

Store the containers in the outer packaging to protect them from light.

Composition of Midazolam B. Braun

• The active ingredient is midazolam (as midazolam hydrochloride).

Each ml of Midazolam B. Braun 5 mg/ml contains 5 milligrams of midazolam.

- 1 vial of 1 ml contains 5 milligrams of midazolam,

- 1 vial of 10 ml contains 50 milligrams of midazolam,

• The other components are: sodium chloride, 10% hydrochloric acid and water for injection preparations.

Appearance of the product and contents of the package

Midazolam B. Braun is a transparent and colorless aqueous solution.

Midazolam B. Braun 5 mg/ml is presented in:

• Colorless glass vials, 1 ml, in packs of 10 vials.
• Colorless glass vials, 10 ml, in packs of 5 or 10 vials.
• Transparent polyethylene vials, 10 ml, in packs of 4, 10 and 20 vials.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

B. Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

Phone: +495661713383

Manufacturer responsible:

B. BRAUN MEDICAL, S.A.

Ctra. de Terrassa, 121.

Rubi (Barcelona) 08191B.

Braun Melsungen AG

Carl-Braun-Strasse 1

34212 Melsungen, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

B. Braun Medical, S.A.

Carretera de Terrassa 121,

Rubí,

08191, Barcelona, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:October 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

Warnings

Paradoxical reactions

Midazolam has been reported to cause paradoxical reactions, such as restlessness, agitation, irritability, involuntary movements (including tonic-clonic seizures and muscle tremors), hyperactivity, hostility, delirium, anger, aggression, anxiety, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior, paroxysmal excitement, and attacks. These reactions can occur with high doses and/or if the injection is administered rapidly. The highest incidence of such reactions has been described in children and the elderly. If these reactions occur, consider interrupting the administration of the medication.

Sleep apnea

Midazolam should be used with extreme caution in patients with sleep apnea and should be monitored periodically in patients

Handling

The medication should be used immediately after opening.

Shelf life after dilution according to instructions:

Chemical and physical stability has been demonstrated in use for 24hours at room temperature and for 3days at 5°C.

From a microbiological point of view, the dilutions should be used immediately after preparation. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not normally exceed 24hours between 2 and 8°C, unless the dilution has been prepared in controlled and validated aseptic conditions.

The productis supplied in single-use containers.The contents of opened containers should be eliminated immediately.

Only use if the solution is transparent and colorless and the container and its safety closure are not damaged.

See the technical data sheet or summary of product characteristics for instructions for dilution, incompatibilities, and complete prescribing information.