MIDAZOLAM SALA 50mg/10ml INJECTABLE SOLUTION

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

Talk to your doctor or nurse before using Midazolam Sala if:

• You are over 60 years old.
• • You have a long-term illness, such as breathing, kidney, liver or heart problems.
• You have an illness that makes you feel very weak, tired and lacking in energy.
• You have “myasthenia gravis”, an illness 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 be given 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 breathing 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 way other medicines work. Also, other medicines can affect the way Midazolam Sala works.

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

• Medicines for depression.
• Sleeping medicines (hypnotics)
• Sedatives (make you feel calm or sleepy)
• Tranquillisers (for anxiety or to help you sleep).
• Carbamazepine or phenytoin (used to treat fits 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 you start taking Midazolam Sala, tell your doctor if you are pregnant or think you might be. He will decide if this medicine is suitable for you.
• Midazolam can 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 20 mg of sodium (a major component of cooking/table salt) in each 10 ml ampoule. This is equivalent to 1.0% of the maximum recommended daily intake of sodium for an adult.

3. How to use Midazolam Sala

This medicine must be given only by a doctor or nurse who has experience in a place that is properly equipped for monitoring and treating side effects. This place may be a hospital, clinic or doctor's surgery. In particular, your breathing, heart and circulation will be monitored.

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

How Midazolam Sala will be given 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 back passage (rectal route).

Dose:

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 given other medicines at the same time.

After you have been given 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 given 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.
• Problems with speaking and unusual eye movements (nystagmus).
• Low blood pressure. This can make you feel dizzy or faint.
• Slowing down or stopping of breathing or heartbeat and being unconscious (coma)

If you have taken too much or if someone else has taken your medicine, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Take this leaflet and any remaining medicine with you.

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

If you are given this medicine for a long time, 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 a long time, you may get withdrawal symptoms such as:

• mood changes,
• convulsions,
• headaches,
• muscle pain,
• sleep problems (insomnia),
• feeling anxious, tense, restless, confused or irritable,
• seeing or possibly hearing things that are not there (hallucinations).

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

If you have any further 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 Midazolam Sala is given.

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 which makes it difficult to swallow or breathe.

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

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

You may also feel short of breath, wheeze or have difficulty breathing or pale skin, weak and fast pulse, or feeling of loss of consciousness.

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

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

Other side effects:

Nervous system disorders and mental problems:

• reduced alertness,
• confusion,
• feeling excessively happy or excited (euphoria),
• feeling tired, sleepy or sedated for a long time,
• seeing or possibly hearing things that are not there (hallucinations),
• headache,
• feeling dizzy,
• difficulty coordinating your muscles,
• convulsions in premature and newborn babies,
• temporary loss of memory. The length of time this can last depends on the amount of Midazolam Sala given. Occasionally it can last a long time.
• agitation, restlessness, hostility, anger or aggression. You may also get muscle spasms or uncontrolled shaking of your muscles. These effects have been seen more often when high doses of Midazolam Sala have been given or when it has been given quickly. These effects are more likely to happen in children and elderly people.
• you should see 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,
• slow heart rate,
• flushing of the face and neck (rubor),
• low blood pressure. This can make you feel dizzy or faint.

Respiratory disorders:

• hiccups,
• shortness of breath.

Disorders of the mouth, stomach and intestines:

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

Skin disorders:

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

General disorders:

• allergic reactions including skin rash and wheezing,
• withdrawal symptoms (see section 3).
• falls and bone fractures: The risk is greater if you are also taking other medicines that cause sedation (e.g. painkillers or sleeping medicines), or if you drink alcohol.

Use in elderly patients:

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. Storing 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 refers to 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 50 mg/10 ml contains 5 milligrams of midazolam.

Each 10 ml ampoule contains 50 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 50 mg/10 ml is presented as an injectable solution in two different package sizes, 10 ampoules or 50 ampoules of 10 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 thisProspectus: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 50 mg/10 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% dextran (with 0.9% sodium chloride) in glucose or mixed with an alkaline compound injection. 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 injected drug 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 intended 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.