Midazolam Ibi

Package leaflet: Information for the user

MIDAZOLAM IBI 5 mg/ml injectable solution

Midazolam
Equivalent medicine
Please read all of this leaflet carefully before you use this medicine, because it contains important information for you

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Midazolam IBI 5 mg/ml is and what it is used for
2. What you need to know before using Midazolam IBI 5 mg/ml
3. How to use Midazolam IBI 5 mg/ml
4. Possible side effects
5. How to store Midazolam IBI 5 mg/ml
6. Contents of the pack and other information

1. What MIDAZOLAM IBI 5 mg/ml is and what it is used for

Midazolam belongs to a group of medicines known as benzodiazepines. It is a short-acting medicine used to induce sedation (a state of calmness, drowsiness or sleep) and to relieve anxiety and muscle tension.
This medicine is used for:

• conscious sedation (a state of calmness or drowsiness in which you remain awake) in adults and children
• sedation in intensive care in adults and children
• anesthesia in adults (premedication before induction, induction of anesthesia, as a sedative component with other medicines in anesthesia)
• premedication before induction of anesthesia in children

2. What you should know before using MIDAZOLAM IBI 5 mg/ml

Do not use MIDAZOLAM IBI 5 mg/ml

• if you are allergic to midazolam or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe breathing difficulties or very shortness of breath and are undergoing conscious sedation (a state of calmness or drowsiness in which you remain awake) before and during diagnostic procedures, with or without local anaesthesia.

Warnings and precautions
Be especially careful with MIDAZOLAM IBI 5 mg/ml

• if you have a history of alcohol or drug abuse. Midazolam should be administered with great caution
• if you are over 60 years of age
• if you have a disease causing muscle weakness (myasthenia gravis)
• if you regularly experience shortness of breath
• if you have problems with your kidneys, liver, or heart
• if you have a generally poor physical condition
• if midazolam is used in newborns or children. Inform your doctor if the child has a heart condition.

If any of these conditions apply to you, contact your doctor before proceeding with sedation. In all of the above cases, the doctor must reduce the dosage and/or the rate of administration.
Additionally, when reactions such as involuntary movements, hyperactivity, hostility, rage reactions, aggression, excitement, or periodic assaults occur during treatment with midazolam, you should consult your doctor. These reactions have been particularly observed in children and the elderly.
Furthermore, it is important to know the following

• When administered intravenously, midazolam may slow breathing and heart rate. Rarely, this has led to respiratory or cardiac arrest. To prevent this, doses are administered slowly and kept as low as possible. In addition, midazolam should only be used when resuscitation equipment is available
• Midazolam may become less effective after prolonged sedation in intensive care
• When midazolam is used for prolonged sedation in intensive care, it should be remembered that physical dependence on midazolam may develop. The risk of dependence increases with the dose and duration of treatment (see also section 3, if you stop using Midazolam IBI 5 mg/ml)
• After administration of midazolam, amnesia may occur. This is desirable in situations such as before and during surgical and diagnostic procedures. Prolonged amnesia may pose problems if discharge after the procedure is planned. In such cases, you must be accompanied by a responsible caregiver when leaving the hospital
• Special care must be taken when midazolam is administered to preterm neonates and infants up to 6 months of age.

Other medicines and MIDAZOLAM IBI 5 mg/ml
Inform your doctor if you are taking or have recently taken any other medicines, including those without a prescription.
Other medicines may be affected by midazolam. In turn, they may influence the effect of midazolam. Midazolam may interact with:

• ketoconazole, fluconazole, itraconazole, voriconazole and posaconazole (antifungals), diltiazem (for treatment of heart and vascular diseases), erythromycin, clarithromycin and telithromycin (antibiotics), medicines for treatment of HIV (saquinavir and other HIV protease inhibitors), a medicine to prevent nausea and vomiting after chemotherapy or surgery (aprepitant). The effects of midazolam may be intensified by these medicines
• alcohol, tranquillisers, hypnotics (medicines that induce sleep), narcotic analgesics (very strong painkillers), medicines for treatment of psychological disorders, such as neuroleptics for treatment of psychosis (severe mental illness), antidepressants, sedatives, phenobarbital (for treatment of epilepsy), other benzodiazepines (anaesthetics), some medicines for treating high blood pressure (hypertension) and some antihistamines (for treatment of allergies). The effects of midazolam may be intensified; in addition, some of these medicines may increase respiratory depression
• rifampicin (antibiotic) and use of St. John’s wort (hypericum) may weaken the therapeutic effect of midazolam.

MIDAZOLAM IBI 5 mg/ml with food, drinks and alcohol
Consumption of alcohol must be strongly avoided when midazolam is administered.
Alcohol may reduce or increase the effect of midazolam; furthermore, alcohol may increase respiratory depression. Therefore, caution is advised when using alcohol and midazolam simultaneously.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. You must inform your doctor if you are pregnant or think you might be. The doctor can then decide whether this medicine is suitable for you.
There are insufficient data available to assess the safety of midazolam during pregnancy. Midazolam must not be used during pregnancy unless strictly necessary. It is preferable to avoid using midazolam for caesarean section.
Administration of high doses of midazolam during the last 3 months of pregnancy, during labour, or when used as an induction agent for anaesthesia in caesarean section may cause adverse effects in the mother (inhalation problems), in the foetus (irregular heart rate), or in the newborn (decreased body temperature (hypothermia), muscle weakness (hypotonia), and breathing and feeding difficulties). In addition, there is a risk that the baby may develop physical dependence on midazolam before birth, and withdrawal symptoms may occur after birth. Therefore, midazolam must not be used during the late stages of pregnancy unless strictly necessary.
Midazolam may pass into breast milk; therefore, if you are breastfeeding, you must not do so for 24 hours
after administration of this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may cause drowsiness, amnesia, or affect your concentration and coordination.
This may impair performance in certain practical activities such as driving or operating machinery. Your doctor should advise you when you can resume these activities. Always have a responsible adult accompany you home after treatment.
Midazolam IBI 5 mg/ml contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use MIDAZOLAM IBI 5 mg/ml

Midazolam will be administered to you by a doctor. Midazolam can be injected into a muscle (intramuscular route) or into a vein (intravenous route). Administration may also be performed via infusion (drip). Children may receive midazolam administered rectally (through the anus).
Dosage
Your doctor will determine the appropriate dose for you. The dosage, route of administration, frequency and duration of midazolam treatment depend on your body weight, age, general health, response to the medication, required level of sedation, and whether you are taking other medicines at the same time.
If you feel that the effect of midazolam is too strong or too weak, consult your doctor.
If you use more Midazolam IBI 5 mg/ml than you should
This medicine will be given to you by a doctor. If you think you have been given too much, inform your doctor immediately.
If you have accidentally taken an overdose of midazolam, this could lead to drowsiness, incoordination of voluntary muscle movements (ataxia), speech disorders (dysarthria) and involuntary eye movements (nystagmus), loss of reflexes, cessation of breathing (apnea), low blood pressure (hypotension), loss of heart and/or lung function (cardiorespiratory depression), and coma. Overdose may require intensive monitoring of vital signs and treatment of cardiac and respiratory complications.
If you stop treatment with Midazolam IBI 5 mg/ml
Only your doctor can decide how long treatment should last. In general, treatment duration should be as short as possible.
Prolonged midazolam treatment in intensive care may lead to physical dependence. Therefore, midazolam treatment must not be stopped abruptly, as this may cause withdrawal symptoms. The following symptoms may occur: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, inability to sleep, mood changes, hallucinations, and seizures. Since the risk of withdrawal symptoms is higher after abrupt discontinuation of treatment, it is recommended to gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Midazolam IBI 5 mg/ml can cause side effects, although not everybody experiences them.
The following side effects have been reported (frequency not known, cannot be estimated from the available data).

Immune system

• Allergic reactions (skin reactions, reactions affecting the heart and blood circulation, wheezing)
• Anaphylactic shock (a life-threatening allergic reaction)

Skin

• Rash
• Allergic reactions
• Itching

Nervous system

• Drowsiness and prolonged sedation
• Reduced alertness
• Numbness
• Headache
• Dizziness
• Difficulty in muscle coordination (ataxia)
• The sedative effect may persist for some time after administration
• Uncontrolled muscle contractions (seizures) have been reported in premature neonates and newborn infants

Memory loss
Temporary memory loss has been reported. The duration of this effect depends on the amount of midazolam administered; you may experience this after your treatment. In isolated cases, this effect may persist.

Mental

• Confusion
• Excessive feeling of well-being (euphoria)
• Hallucinations
• Rapid decline in level of consciousness and general mental functioning (delirium)
• Agitation
• Muscle spasms and muscle tremors
• Restlessness
• Hostility
• Rage
• Aggression
• Excitation
• Assault

These reactions have been observed more frequently following administration of a high dose of midazolam, or when the administration is too rapid. Children and elderly patients are more sensitive to these reactions.

Dependence
Patients may develop dependence on midazolam, even at therapeutic doses. After prolonged use, it is important that discontinuation of midazolam treatment is gradual to avoid withdrawal symptoms, including seizures due to drug discontinuation.

Heart

• Serious events: Heart attack
• Low blood pressure
• Decreased heart rate
• Effects due to vasodilation (e.g., flushing, fainting, and headache)

Respiration

• Serious events: Breathing complications (sometimes with respiratory arrest)
• Shortness of breath
• Airway obstruction
• Hiccups

Potentially life-threatening events are more likely in patients over 60 years of age and in those who already have respiratory difficulties or heart problems.

Stomach and intestines

• Feeling unwell
• Vomiting
• Constipation
• Dry mouth

Systemic and injection site-related conditions

• Fatigue, pain at injection site, swelling and redness of the skin (erythema, thrombophlebitis)
• Blood clots (thrombosis)

Injuries
An increased risk of falls and fractures has been reported in elderly patients.

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MIDAZOLAM IBI 5 mg/ml

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Midazolam IBI 5 mg/ml contains

• The active substance is midazolam.
• The excipients are: sodium chloride, hydrochloric acid and/or sodium hydroxide, water for injections, and nitrogen.

Description of the appearance of Midazolam IBI 5 mg/ml and contents of the pack
Midazolam IBI 5 mg/ml is available in colorless glass vials containing 1, 3, 5 or 10 ml of
Midazolam 5 mg/ml solution for injection.
The vials are packed in cartons or polypropylene trays, containing 5 or 10 vials, inside lithographed cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.p.A.
Via Fossignano, 2 - 04011 Aprilia (LT)
e-mail: [email protected]

Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Marconi, 2
24069 Cenate Sotto (Bergamo)

This medicinal product has been authorised in the European Economic Area countries under the
following names:
Italy MIDAZOLAM IBI 5 mg/ml solution for injection