MIDAZOLAM SALA 15mg/3ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Midazolam Sala 15 mg/3 ml Solution for Injection and Infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Midazolam Sala is and what it is used for
2. What you need to know before you use Midazolam Sala
3. How to use Midazolam Sala
4. Possible side effects
5. Storage of Midazolam Sala
6. Contents of the pack and other information

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

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

Midazolam Sala acts quickly and makes you feel sleepy or puts you to sleep. It will also calm and relax your muscles.

Midazolam Sala is used in adults:

• As an anaesthetic to induce sleep or to keep you 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 where 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 anaesthesia.

2. What you need to know before you use Midazolam Sala

Do not use Midazolam Sala

• if you are allergic to midazolam or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other benzodiazepines, such as diazepam or nitrazepam.
• if you have severe breathing difficulties and you are going to be given Midazolam Sala for “conscious sedation”.

Do not use Midazolam Sala if you are in one of these situations. If you are not sure, consult your doctor before using this medicine.

Warnings and precautions

Consult your doctor or nurse before using Midazolam Sala if:

• You are over 60 years old.
• • You have a chronic disease, such as respiratory, kidney, liver or heart problems.
• You have a disease that makes you feel very weak, exhausted and with little energy.
• You have “myasthenia gravis”, a disease that weakens your muscles.
• You have sleep apnoea.
• You have had problems with alcohol in the past.
• You have had problems with drugs in the past.

If you are in any of these situations (or are unsure), consult your doctor or nurse before using Midazolam Sala.

If your child is going to start using this medicine:

• Tell your doctor if your child is in any of the above situations.
• In particular, tell your doctor if your child has heart or respiratory problems.

Other medicines and Midazolam Sala

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal products.

This is very important because Midazolam Sala can affect the action of other medicines. Similarly, other medicines can affect the action of Midazolam Sala.

In particular, tell your doctor if you are taking any of the following medicines:

• Medicines for depression.
• Hypnotic medicines (help you sleep)
• Sedatives (make you feel calm or sleepy)
• Tranquilizers (to treat anxiety or to help you sleep).
• Carbamazepine or phenytoin (used to treat seizures or convulsions).
• Rifampicin (used to treat tuberculosis).
• Medicines used to treat HIV called “protease inhibitors” (such as saquinavir).
• Antibiotics called “macrolides” (such as erythromycin or clarithromycin).
• Medicines used to treat fungal infections (such as ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole).

• Strong painkillers.
• • Atorvastatin (used to treat high cholesterol).
  • Antihistamines (used to treat allergic reactions).
  • St. John's Wort (a herbal remedy used for depression).
  • Medicines used to treat high blood pressure called “calcium channel blockers” (such as diltiazem).

If you are in any of these situations (or are unsure), consult your doctor before using Midazolam Sala.

Using Midazolam Sala with alcohol

Do not drink alcohol if you have been given Midazolam Sala. This is because it can make you very sleepy and cause breathing problems.

Pregnancy and breast-feeding

• Before starting Midazolam Sala, tell your doctor if you are pregnant or think you may be pregnant. He will decide if this medicine is suitable for you.
• Midazolam may pass into breast milk, so if you have been given Midazolam Sala, do not breast-feed your baby for 24 hours.

Driving and using machines

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Midazolam Sala contains sodium

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

3. How to use Midazolam Sala

This medicine should only be administered by a doctor or nurse with experience in a properly equipped place for monitoring and treating side effects. This place may be a hospital, clinic or doctor's office. In particular, your breathing, heart and circulation will be monitored.

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

How Midazolam Sala will be administered to you

You will be given this medicine in one of the following ways:

• slow injection into a vein (intravenous injection),
• through a drip into 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 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 medicine, your response to treatment and whether you are being given other medicines at the same time.

After administration of Midazolam Sala

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

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

If you use more Midazolam Sala than you should

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

• You will feel sleepy 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 down or stopping of breathing or heartbeat and being unconscious (coma)

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken

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

If you are given this medicine for a long period, the following may happen:

• You may start to have less effect.
• You may become dependent on the medicine and have withdrawal symptoms when you stop using it (see “If you stop using Midazolam Sala”).

If you stop using Midazolam Sala

If you stop treatment suddenly after long-term use, you may experience withdrawal symptoms such as:

• mood changes,
• seizures,
• headaches,
• muscle pain,
• sleep problems (insomnia),
• feeling very worried (anxious), tense, restless, confused or irritable,
• seeing and possibly hearing things that do not exist (hallucinations).

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 medicine, ask your doctor or nurse.

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 (frequency not known, cannot be estimated from the available data) when using Midazolam Sala.

Seek medical attention immediately or call for an ambulance if you experience any of the following side effects:

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

Stop using Midazolam Sala and consult your doctor immediately if you experience any of the following side effects. They can be life-threatening and may require urgent medical treatment:

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

You may also have difficulty breathing, make breathing sounds or have difficulty breathing, or pale skin, weak and rapid pulse, or feeling of loss of consciousness.

• Heart attack (cardiac arrest). Symptoms may include chest pain that can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Breathing problems, sometimes causing respiratory arrest.
• Muscle spasm of the glottis, causing asphyxia.

Potentially 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 if the injection is given too quickly or in high doses.

Other side effects:

Nervous system disorders 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,
• seizures in premature and newborn babies,
• temporary loss of memory. The duration depends on the amount of Midazolam Sala administered. Occasionally it can last for a long time.
• agitation, restlessness, hostility, anger or aggression. You may also experience muscle spasms or uncontrolled tremors of your muscles. These effects have been observed more frequently when high doses of Midazolam Sala have been administered or when it has been administered quickly. These effects occur more frequently in children and the elderly.
• you should consult your doctor if you feel that you are becoming dependent on the medicine, or that you have become tolerant to its effects and need to increase the dose.

Heart and circulation disorders:

• fainting,
• decreased heart rate,
• flushing of the face and neck (flushing),
• low blood pressure. This can make you feel dizzy or lightheaded.

Respiratory disorders:

• hypo,
• shortness of breath.

Disorders of the mouth, stomach and intestine:

• dry mouth,
• constipation,
• feeling unwell (nausea), vomiting.

Skin disorders:

• itching,
• skin rash, including exanthema (hives),
• redness, pain, blood clots or inflammation of the skin at the injection site.

General disorders:

• allergic reactions including skin rash and breathing sounds,
• withdrawal symptoms (see section 3).
• falls and bone fractures: The risk is higher if you are also taking other sedative medicines (e.g. painkillers or sleeping pills), or if you drink alcohol.

Use in elderly patients:

• elderly patients taking benzodiazepine medicines, such as Midazolam Sala, have a higher risk of falls and bone fractures.
• potentially life-threatening side effects are more likely to occur in adults over 60 years old.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Midazolam Sala

Your doctor or pharmacist is responsible for storing this medicine. They are also responsible for disposing of any unused midazolam correctly.

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

Do not freeze. A precipitate may form which dissolves when the contents are shaken at room temperature.

6. Container Content and Additional Information

Composition of Midazolam Sala

• The active ingredient is midazolam (as midazolam hydrochloride). Each ml of Midazolam Sala 15 mg/3 ml contains 5 milligrams of midazolam.

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

• The other components (excipients) are: Sodium chloride, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Container Content

Midazolam Sala is a clear, colorless or slightly yellowish solution.

Midazolam Sala 15 mg/3 ml is presented as an injectable solution in two different package sizes, 5 ampoules or 50 ampoules of 3 ml.

Only one package size may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Leaflet:September 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

Midazolam Sala 15 mg/3 ml solution for injection and perfusion EFG

Preparation of the Solution for Perfusion

This medicinal product can be diluted with a 0.9% sodium chloride solution, 5% and 10% dextrose, 5% levulose, Ringer's solution, and Hartmann's solution with a mixing 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 the refrigerator at 2-8°C. Midazolam Sala should not be mixed with any solution other than those listed above. In particular, midazolam should not be diluted with 6% p/v dextran (with 0.9% sodium chloride) in glucose or mixed with an injection of an alkaline compound. Midazolam precipitates in hydrogen carbonate.

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

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

The dose of Midazolam Sala should be carefully calculated for each patient. Only a portion of the medicinal product 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 medicinal product injected requires adjustment based on the patient's body weight, use the pre-filled graduated syringe to reach the required volume, discarding any excess before injection in the case of intramuscular or intravenous bolus injection.

Validity Period and Storage

Midazolam Sala is designed for single use. Eliminate any excess content. The use of this medicinal product for multiple administrations in the same or different patients is not recommended.

Before Opening

Midazolam Sala ampoules should not be frozen, as they may burst. Additionally, a precipitate may form that dissolves when the contents are shaken at room temperature.

After Dilution

Physical-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 the refrigerator at 2-8°C.

Disposal of Waste Products

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.