Patient Information Leaflet

Midazolam Serraclinics1 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.
• 1. If you have any questions, consult yourdoctor, pharmacistor nurse.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you, as it may harm them.

• If you experience any side effects,consult your doctor,pharmacistor nurse,even if they are not listed in this leaflet. See section 4.

Contents of theleaflet

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

2.What you need to knowbeforestarting touseMidazolam Serraclinics

3.How to use Midazolam Serraclinics

4.Possible side effects

1. Storage of Midazolam Serraclinics
2. Contents of the container and additional information

The active ingredient of Midazolam Serraclinics is midazolam; it belongs to the group of benzodiazepines, drugs known as hypnotics (sleep inducers) and sedatives (drugs that decrease nervous excitement).

Midazolam Serraclinics is indicated for:

In adults for:

?Conscious Sedationbefore and during diagnostic or therapeutic procedures with or without local anesthesia.

?Anesthesia

-Premedication before anesthetics induction.

-Anesthesia induction.

-As a sedative component in combined anesthesia.

?Sedation in Intensive Care Units (ICU).

?Conscious Sedationbefore and during diagnostic or therapeutic procedures with or without local anesthesia

?Anesthesia

-Premedication before anesthetics induction

?Sedation in Intensive Care Units (ICU)

This medication should only be used when there are adequate resuscitation facilities available for each type of patient, as the intravenous administration ofMidazolam Serraclinicsmay depress myocardial contractility (decrease in heart contractions) and cause apnea (pause in breathing).

Do not use Midazolam Serraclinics

• If you are allergic to midazolam,benzodiazepinesor any of the other components ofthis medication (listed in section 6).
• In conscious sedation if the patient has severe respiratory insufficiency or acute respiratory depression.

Warnings and precautions

Consult your doctor,pharmacistor nurse before starting to use Midazolam Serraclinics.

• If administered in:

• Adults over 60 years old.

• Pediatric patients, especially those with cardiovascular instability.
• Patients with chronic diseases or debilitated patients such as:

• Patients with chronic respiratory insufficiency.

• Patients with chronic renal insufficiency.

• Patients with altered cardiac function.
• Patients with altered liver function.

• Patients with myasthenia gravis (severe muscle weakness).

These high-risk patients require lower doses, and they should be continuously monitored for early signs of vital function alterations.

• Patients with a history of alcohol or drug abuse.

• Patients for premedication, it is mandatory to observe the patient carefully after administration because individual sensitivity is variable and symptoms of overdose may occur.

• Similarly, the following aspects should be taken into account while on treatment with this medication:

• Tolerance

Certain decrease in efficacy has been described whenMidazolam Serraclinicsis used for prolonged sedation in intensive care units (ICUs).

• Dependence

WhenMidazolam Serraclinicsis used for prolonged sedation in the ICU, it should be taken into account that it may produce physical dependence. The risk of dependence increases with dose and treatment duration.

• Withdrawal symptoms

During prolonged treatment withMidazolam Serraclinicsin the ICU, physical dependence may occur. Therefore, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms. The following symptoms may occur: headache, myalgias (muscle pain), anxiety, tension, restlessness, confusion, irritability, rebound insomnia, mood alterations, hallucinations, and seizures. As the risk of withdrawal symptoms is higher after abrupt discontinuation of treatment, it is recommended to gradually reduce doses (see how they will administerMidazolam Serraclinics).

• Amnesia

Midazolam Serraclinics causesanterograde amnesia (partial or total loss of memory of events that occurred just after recovery of consciousness; often this effect is very desirable in situations such as before and during surgical interventions and diagnostic procedures), whose duration is directly related to the dose administered. Prolonged amnesia may pose problems in the case of ambulatory patients, for whom discharge is planned after the intervention. After receiving midazolam parenterally, patients may leave the hospital or clinic only if accompanied by another person.

• Paradoxical reactions

Paradoxical reactions have been described withMidazolam Serraclinicssuch as agitation, involuntary movements (tonic-clonic seizures and muscle tremors), hyperactivity, hostility, anger reaction, aggression, paroxysmal excitement (excitement attacks) and threats and insults. These reactions may occur with high doses or when the injection is administered quickly. These reactions are characterized by a maximum incidence in children and the elderly.

Children and adolescents

It is not recommended for use in children under 6 months for conscious sedation and anesthesia.

Other medications and Midazolam Serraclinics

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Certain medications may interact with Midazolam Serraclinics; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Itraconazole, Fluconazole, and Ketoconazole (antifungal medications)
• Verapamil and Diltiazem (calcium channel blockers)
• Erythromycin and Clarithromycin (macrolide antibiotics)
• Cimetidine and Ranitidine (ulcer treatment medication)
• Saquinavir and other protease inhibitors (HIV/AIDS treatment medications)
• Central nervous system depressants (opioids, antipsychotics, and other benzodiazepines)
• Opioids, phenobarbital, and benzodiazepines.Particular attention should be paid to an additional increase in respiratory depression when these medications are used with Midazolam Serraclinics.

It should be taken into account that sedation is added whenMidazolam Serraclinicsis combined with sedative medications.

The intravenous administration ofMidazolam Serraclinicsdecreases the alveolar concentration of anesthetics in inhalation required for general anesthesia.

Use of Midazolam Serraclinics with food, drinks, and alcohol

Alcohol may significantly potentiate the sedative effect ofMidazolam Serraclinics.It is essential to avoid alcohol consumption when administeringMidazolam Serraclinics.

Pregnancy, lactation, and fertility

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

Midazolam Serraclinics should not be used during pregnancy unless absolutely necessary. It is preferable not to use it for cesarean section.

The risk to the fetus should be taken into account when administeringMidazolam Serraclinicsfor any surgical intervention near the end of pregnancy.

It is recommended that breastfeeding mothers suspend treatment until 24 hours after administration ofMidazolam Serraclinics.

Driving and operating machinery

Midazolam Serraclinics is a medication that causes sleep. Do not drive or operate machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Midazolam Serraclinics contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially “sodium-free”

Follow exactly the administration instructionsfor this medicationindicated byyour doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Midazolam Serraclinics

Dosage and administration forms

Midazolam Serraclinicsis a potent sedative that requires dose adjustment and slow administration. Your doctor will adapt the dose according to clinical needs, physical condition, age, weight, and concomitant medications.

Midazolam Serraclinics can be administered as an intravenous bolus, intravenous infusion, intramuscular injection, and rectal administration.

If you have been administered more Midazolam Serraclinics than you should

Symptoms:

The symptoms of overdose are: drowsiness, mental confusion, lethargy, and muscle relaxation or paradoxical excitement. The most severe symptoms would consist of areflexia (absence of normal reflexes), hypotension, cardiopulmonary depression, apnea (pause in breathing), and coma.

If you have been administered more Midazolam Serraclinics than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone (91) 562 04 20.

Treatment in case of overdose

In most cases, only controlling vital functions is necessary. In the treatment of overdose, special attention should be paid to respiratory and cardiovascular functions in the intensive care unit (ICU).

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

Side effects can occur at certain frequencies, which are defined as follows:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

Frequency not known (cannot be estimated from available data)

The following adverse reactions have been described (very rarely) when administering Midazolam Serraclinics:Midazolam Serraclinics

Dermatological and subcutaneous tissue disorders: skin rash (redness of the skin), urticaria (allergy), pruritus.

Central and peripheral nervous system, psychiatric disorders: prolonged somnolence and sedation, decreased alertness, confusion, euphoria, hallucinations, fatigue, headache, dizziness, ataxia (discoordination of movements), postoperative sedation and anterograde amnesia (whose duration is directly related to the administered dose). Anterograde amnesia may persist at the end of the procedure and in isolated cases, prolonged amnesia has been described.

Paradoxical reactions have been described, such as agitation, involuntary movements (tonic/clonic movements and muscular tremors), hyperactivity, hostility, anger reaction, aggression, paroxysmal excitement, and threats and insults, particularly in the case of children and the elderly.

Convulsions have been registered more frequently in the case of newborns and premature infants.

The useof Midazolam Serraclinics,even at therapeutic doses, may favor the development of physical dependence after prolonged intravenous administration; abrupt discontinuation of the drug may be accompanied by withdrawal symptoms, such as convulsions.

Gastrointestinal disorders: nausea, vomiting, hiccups, constipation, and dry mouth.

Cardiovascular and respiratory disorders: severe cardiorespiratory adverse events: respiratory depression, apnea (pause in breathing), respiratory arrest or cardiac arrest, hypotension, alteration of heart rate, vasodilatory effects, dyspnea (sensation of lack of air), and laryngospasm.

Life-threatening incidents are more likely to occur in adults over 60 years old and in patients with pre-existing respiratory insufficiency or cardiac function alteration, particularly when the injection is administered too quickly or when a high dose is applied.

General disorders: generalized allergic reactions: skin reactions, cardiovascular reactions, bronchospasm, anaphylactic shock (severe allergic reaction).

Injection site disorders: erythema (redness) and pain at the injection site, circulatory alterations (thrombophlebitis and thrombosis).

Seek immediate medical attention or call for an ambulance if the patient experiences the following side effects:

• Swelling of the face, lips, tongue, or throat that makes it difficult to swallow or breathe.

Stop taking Midazolam Serraclinics and seek medical attention immediately if you notice any of the following side effects. They may be life-threatening and may require urgent medical treatment:

• Anaphylactic shock (a potentially life-threatening allergic reaction). Signs may include a sudden rash, itching, or hives (urticaria) and swelling of the face, lips, tongue, or other parts of the body. You may also experience shortness of breath, wheezing, or difficulty breathing, or pale skin, weak pulse, and rapid heart rate, 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.

If any other reaction is observed that is not described in this leaflet, consult your doctor or pharmacist.

Reporting of adverse reactions

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter CAD The expiration date is the last day of the month indicated.

Do not freeze. A precipitate may also form, which dissolves upon agitation of the contents at room temperature.

Do not store at a temperature above 25°C.

Your doctor or pharmacist is responsible for the conservation of midazolam. They are also responsible for the proper disposal of the medication that remains after administration.

• The active principle is midazolam. Each ampoule of 5 ml contains 5 mg of midazolam.
• The other components (excipients) are: sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injectable preparations.

Aspect of the product and content of the packaging

Midazolam Serraclinics is presented as an injectable solution in ampoules of 5 ml.The solution is transparent, colorless or slightly yellow.Each package contains 10 or 50 ampoules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorizationand responsible for manufacturing:

Laboratorios Serra Pamies, S.A.

Ctra.Castellvell, 24

43206REUS (Tarragona)

Date of the last review of thisleaflet: August 2023

The detailed information of this medicine 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:

For conscious sedation before a diagnostic or surgical procedure, midazolam will be administered IV. The dose must be individualized and adapted, and should not be administered in a single rapid injection. The onset of sedation may vary individually depending on the patient's physical condition and the specific circumstances of the dosage. If necessary, subsequent doses may be administered in accordance with individual needs. The medication begins to act approximately 2 minutes after injection. A maximum effect is obtained within 5 to 10 minutes.

Compatibility with infusion solutions

The Midazolam Serraclinics ampoule solution can be diluted with sodium chloride 0.9%, dextrose 5%, and 10%, levulose5%, Ringer's solution and Hartmann's solution in a mixing ratio of 15mg of midazolam per 100-1000ml of solution. These solutions remain stable for 24 hours at room temperature, or 3 days at 5°C. The Midazolam Serraclinics ampoule solution cannot be diluted with Macrodex 6%, in dextrose or mixed with alkaline injections.

Adults

Midazolam IV injection should be administered slowly at a rate of approximately 1 mg in 30 seconds.

Children

The use is not recommended for children under 6 months in conscious sedation and anesthesia, as there is little data available for this population.

• IV administration: the midazolam dose should be adjusted slowly to achieve the desired clinical effect. The initial dose of midazolam should be administered over 2 or 3 minutes. Allow 2 to 5 minutes to accurately assess the sedative effect before initiating the procedure or repeating the dose. If additional sedation is needed, continue adjusting the dosage with small increments to achieve the appropriate level of sedation.

• Rectal administration: the total dose of midazolam usually varies between 0.3 and 0.5 mg/kg. Rectal administration of the ampoule solution is performed using a plastic applicator attached to the end of the syringe. If the volume to be administered is too small, water can be added to a total volume of 10 ml. The total dose should be administered at once, and repeated rectal administration should be avoided.

• IM administration: This route should only be used in exceptional cases. Rectal administration is preferred, as IM injection is painful.

Treatment in case of overdose

In most cases, only monitoring of vital functions is necessary. In the treatment of overdose, special attention should be paid to respiratory and cardiovascular functions in the intensive care unit (ICU). Flumazenil, a benzodiazepine antagonist, is indicated in cases of severe intoxication accompanied by coma or respiratory depression. Flumazenil should be used with caution in cases of mixed pharmacological overdose and in patients with epilepsy already treated with benzodiazepines. Flumazenil should not be used in patients treated with tricyclic antidepressants or epileptogenic drugs, or in patients with electrocardiogram abnormalities (prolongation of QRS or QT).