Leaflet: information for the user

Midazolam Solution for injection and infusion 15 mg/3 ml 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• 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 and what is it used for

2. What you need to know before you start using Midazolam

3. How to use Midazolam

4. Possible side effects

5. Storage of Midazolam

6. Contents of the pack and additional information

Midazolam Sala contains an active ingredient called midazolam. This belongs to a group of medicines called “benzodiazepines”.

Midazolam Sala acts quickly and makes you feel sleepy or fall asleep. It will also calm and relax your muscles.

Midazolam Sala is used in adults:

• As an anesthetic to induce sleep or to keep them asleep.
• Midazolam Sala is also used in adults and children:
• To calm them and make them feel sleepy if they are in the Intensive Care Unit. This is called “sedation”.
• Before and during a medical procedure in which they will be awake. Midazolam Sala calms them and makes them feel sleepy. This is called “conscious sedation”.
• To calm them and make them feel sleepy before anesthesia.

No use midazolam sala

• if you are allergic to midazolam or any of the other components of this medication (listed in section 6).
• if you are allergic to other benzodiazepines, such as diazepam or nitrazepam.
• if you have severe breathing difficulties and midazolam sala is to be administered for "conscious sedation".

Do not use midazolam sala if you are in one of these cases. If you are unsure, consult your doctor before starting to use this medication.

Warnings and precautions

Consult your doctor or nurse before starting to use midazolam sala if:

If you are in any of these cases (or are unsure), consult your doctor or nurse before starting to use midazolam sala.

If your child is to start taking this medication:

Other medications and midazolam sala

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

This is very important, as midazolam sala may affect the effect of other medications. Similarly, other medications may affect the effect of midazolam sala.

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

• Strong painkillers to treat pain.
• • Atorvastatin (used to treat high cholesterol).
  • Antihistamines (used to treat allergic reactions).
  • St. John's Wort (a medicinal plant used to treat depression).
  • Medications used to treat high blood pressure called "calcium channel blockers" (such as diltiazem).

If you are in any of these cases (or have doubts), consult your doctor before starting to use midazolam sala.

Use of midazolam sala with alcohol

Do not drink alcohol if you have been administered midazolam sala. This is because it may cause you to feel very sleepy and cause breathing problems.

Pregnancy and breastfeeding

• Before starting to take midazolam sala, inform your doctor if you are pregnant or think you may be pregnant. He will decide if this medication is suitable for you.
• Midazolam may pass into breast milk, so if you have been administered midazolam sala, do not breastfeed your baby for 24 hours.

Driving and operating machinery

-After being administered midazolam sala, do not drive vehicles or use tools or machinery until your doctor tells you when you can do so.

-This is because midazolam sala may make you feel sleepy or forgetful. It may also affect your concentration and coordination. This may affect your ability to drive or use tools and machinery.

-You should be accompanied home by an adult after treatment.

Midazolam sala contains sodium

This medication contains 6 mg of sodium (main component of table salt/for cooking) in each 3 ml ampoule. This is equivalent to 0.3% of the maximum daily sodium intake recommended for an adult.

This medication should only be administered by a doctor or nurse with experience in a properly equipped place for monitoring and treating adverse effects. This place can be a hospital, a clinic, or a doctor's office. Specifically, your breathing, heart, and circulation will be monitored.

This medication is not recommended for the treatment of newborns or babies under 6 months old. However, if the doctor considers it necessary, it can be administered to newborns or babies under 6 months old who are in intensive care.

How Midazolam Sala will be administered to you

You will be administered this medication in one of the following ways:

• slow injection into a vein (intravenous injection),
• through a drip in one of your veins (intravenous infusion),
• injection into a muscle (intramuscular injection),
• through the anus (rectal route).

Dosage:

The recommended dose varies from patient to patient. Your doctor will decide on the most suitable dose for you. It will depend on your age, weight, and physical condition. It will also depend on why you need the medication, your response to treatment, and if you will be administered other medications concurrently.

After the administration of Midazolam Sala

After treatment, you should go home accompanied by an adult who can take care of you. This is because this medication can make you feel drowsy or forget things. It can also affect your concentration and coordination.

If you have been treated with this medication for a long time, for example in intensive care, your body may start to get used to the medication. This means that the effect may not be the same.

If you take more Midazolam Sala than you should

This medication will be administered by a doctor or nurse. This means that it is unlikely that you will be given too much midazolam by mistake. However, if you are given too much by error, you will notice the following:

• You will feel drowsy and lose your coordination and reflexes.
• Speech problems and unusual eye movements (nystagmus).
• Low blood pressure. This can make you feel dizzy or lightheaded.
• Slowing or cessation of breathing or heart rate and being unconscious (coma)

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Long-term use of Midazolam Sala for sedation in intensive care

If you are administered this medication for a long period of time, the following may occur:

• You may start to have less effect.
• You may develop dependence on the medication and experience withdrawal symptoms when you stop using it (see "If you interrupt treatment with Midazolam Sala").

If you interrupt treatment with Midazolam Sala

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

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

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

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

The following side effects have been described (frequency not known, cannot be estimated from available data) when administering Midazolam Injection:

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 Injection and seek medical attention immediately if you experience any of the following side effects. They may be potentially life-threatening and may require urgent medical treatment:

• Severe allergic reaction (anaphylactic shock). Symptoms may include skin rash, itching, hives, or urticaria, swelling of the face, lips, tongue, or other parts of the body (angioedema).

You may also experience shortness of breath, making sounds while breathing, or difficulty breathing, or pale skin, weak pulse, and rapid heart rate, or feeling a loss of consciousness.

• Heart attack (cardiac arrest). Symptoms may include chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Respiratory problems, which may cause respiratory arrest.
• Spasm of the glottis muscles, causing asphyxia.

Life-threatening side effects are more likely to occur in adults over 60 years old and in people who already have respiratory or heart problems. These side effects are also more likely to occur if the injection is administered too quickly or at a high dose.

Other side effects:

Nervous system and mental problems:

• Decreased alertness,
• Confusion,
• Feeling excessively happy or excited (euphoria),
• Feeling tired, sleepy, or sedated for a long time,
• Seeing or possibly hearing things that do not exist (hallucinations),
• Headache,
• Feeling dizzy,
• Difficulty coordinating muscles,
• Convulsions in premature babies and newborns,
• Temporary loss of memory. The duration may depend on the amount of Midazolam Injection administered. Occasionally, it may last for a long period.
• Agitation, restlessness, hostility, anger, or aggression. You may also experience muscle spasms or uncontrollable muscle tremors. These effects have been observed more frequently when high doses of Midazolam Injection are administered or when it is administered quickly. These effects are more likely to occur in children and older adults.
• Seek medical attention if you feel you are becoming dependent on the medication, or if you feel you have become tolerant to its effects and need to increase the dose.

Heart and circulation problems:

• Fainting,
• Decreased heart rate,
• Redness of the face and neck (flushing),
• Low blood pressure. This may cause dizziness or vertigo.

Respiratory problems:

• Apnea,
• Shortness of breath.

Problems with the mouth, stomach, and intestines:

• Dry mouth,
• Constipation,
• Feeling unwell (nausea), vomiting.

Skin problems:

• Itching,
• Skin rash, including hives,
• Redness, pain, blood clots, or inflammation of the skin at the injection site.

General problems:

• Allergic reactions, including skin rash and breathing sounds,
• Withdrawal symptoms (see section 3).
• Falls and bone fractures: The risk is higher if you take other sedatives (e.g., tranquilizers or sleeping pills) at the same time, or if you drink alcohol.

Use in elderly patients:

• Elderly patients taking medications from the benzodiazepine group, such as Midazolam Injection, have a higher risk of falls and bone fractures.
• Life-threatening side effects are more likely to occur in adults over 60 years old.

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 leaflet. You can also report them directly through the Spanish 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 medication.

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

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 freeze. A precipitate may also form, which dissolves upon agitation of the contents at room temperature.

Midazolam Solution Composition

Each ampule of 3 ml contains 15 mg of midazolam as hydrochloride.

Product Appearance and Packaging Contents

Midazolam Solution is a transparent, colorless, or slightly yellowish solution.

Midazolam Solution 15 mg/3 ml is presented as an injectable solution in two different packaging sizes, 5 ampules or 50 ampules of 3 ml.

It may only be marketed in some packaging sizes.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this prospectus:September 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:

Midazolam Solution 15 mg/3 ml injectable solution and for perfusion EFG

Preparation of the perfusion solution

This medicine can be diluted with a sodium chloride 0.9% solution, dextrose 5% and 10%, levulose 5%, Ringer's solution, and Hartmann's solution in a ratio of 15 mg of midazolam per 100-1000 ml of solution.

These solutions remain stable for 24 hours at room temperature or 3 days in a refrigerator at 2-8°C. Midazolam Solution should not be mixed with any solution other than those listed above. In particular, midazolam should not be diluted with 6% dextran solution (with sodium chloride 0.9%) in glucose or mixed with an alkaline injection. Midazolam precipitates in hydrogen carbonate.

The injectable solution should be visually inspected before administration. Only solutions without visible particles should be used.

More concentrated midazolam solutions for infusion may cause midazolam precipitation, especially if the pH of the sample exceeds 4.5-5.

The dose of Midazolam Solution should be calculated carefully for each patient. Only a part of the medicine may be required. Please pay attention to the accuracy of the required dose for each patient based on their body weight.

When the amount of injected drug needs to be adjusted based on the patient's body weight, use the pre-loaded syringe graduated to achieve the required volume, discarding any excess before injection in case of intramuscular or intravenous bolus injection.

Shelf life and storage

Midazolam Solution has been designed for single use. Dispose of any excess content. The use of this medicine for multiple administrations in the same or different patients is not recommended.

Before opening

Midazolam Solution ampules should not be frozen, as they may burst. Additionally, a precipitate may form, which dissolves when the contents are agitated at room temperature.

After dilution

Physical and chemical stability has been demonstrated in use conditions for the dilutions for 24 hours at room temperature (15°C-25°C) or for 3 days in a refrigerator at 2-8°C.

Disposal of waste products

All unused medicine or waste material should be disposed of in accordance with local regulations.