Midazolam Eignapharma
ItalyTable of Contents
Patient Information Leaflet
Midazolam Eignapharma 5 mg/mL injection solution or infusion solution
midazolam
Equivalent medicine
Before administering this medicine, please read the entire leaflet carefully, as it contains important information for the patient.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.
Contents of this leaflet
- What Midazolam Eignapharma is and what it is used for
- What you need to know before using Midazolam Eignapharma
- How to use Midazolam Eignapharma
- Possible side effects
- How to store Midazolam Eignapharma
- Contents of the pack and other information
1. What Midazolam Eignapharma is and what it is used for
Midazolam Eignapharma is a short-acting medicine used to induce sedation (a state of calmness, drowsiness, or sleep) and to relieve anxiety and muscle tension. Its active substance, midazolam, belongs to a group of medicines called benzodiazepines.
This medicine is used in adults for:
Conscious sedation (a state of calmness or drowsiness during a medical examination or procedure) in adults and children.
Sedation of adults and children in intensive care units.
Anaesthesia in adults, used alone or in combination with other medicines.
Premedication (a medicine used to induce relaxation, calmness and drowsiness before anaesthesia) in adults and children.
2. What you need to know before using Midazolam Eignapharma
Do not use Midazolam Eignapharma
if you are hypersensitive (allergic) to midazolam or to any of the other ingredients of
this medicine (listed in section 6),
if you are allergic to benzodiazepine medicines, such as diazepam or nitrazepam,
if you have severe breathing problems and midazolam is required for conscious sedation.
Midazolam must not be administered if any of the above conditions apply. If you are unsure, discuss this with your doctor or nurse before receiving the medicine.
Warnings and precautions
Talk to your doctor or nurse before using Midazolam Eignapharma if
you are over 60 years of age,
you have a long-term illness, such as respiratory, kidney, liver, or heart problems,
you have an illness that makes you feel very weak, low in spirits, and lacking energy,
you suffer from a condition called "myasthenia gravis" (a neuromuscular disease causing muscle weakness),
you experience interrupted breathing during sleep (sleep apnea),
you regularly drink large amounts of alcohol or have previously had problems with alcohol use. Alcohol can increase the effects of midazolam, leading to profound sedation that could result in coma or death.
you regularly use recreational drugs (drugs taken for non-medical purposes) or have previously had substance dependence issues.
you are pregnant or think you might be pregnant (see "Pregnancy and breastfeeding").
If any of the above apply to you or if you are unsure, speak with your doctor or nurse before receiving the medicine.
Children
If this medicine is to be given to your child:
It is particularly important to inform the doctor or nurse if the child has cardiovascular diseases (heart problems). The child will be closely monitored and the dose will be specifically adjusted.
Children must be carefully monitored. For newborns and children under 6 months of age, this includes monitoring of breathing and oxygen levels.
Other medicines and Midazolam Eignapharma
Inform your doctor or nurse if you are taking, have recently taken, or might start taking any other medicines, including those obtained without a prescription and herbal medicines.
This is extremely important because Midazolam Eignapharma can affect the action of other medicines. Likewise, other medicines can affect the action of Midazolam Eignapharma.
In particular, inform your doctor if you are taking any of the following medicines:
tranquillizers (medicines used to treat anxiety, stress, and agitation)
hypnotics (medicines to help you sleep)
sedatives (medicines that make you feel calm or drowsy)
antidepressants (medicines used to treat depression)
very strong painkillers
antihistamines (medicines used to treat allergies)
azole antifungals (medicines used to treat fungal infections) such as ketoconazole,
voriconazole, fluconazole, itraconazol, or posaconazole
macrolide antibiotics (medicines used to treat bacterial infections) such as erythromycin,
clarithromycin, telithromycin, or roxithromycin
calcium channel blockers (medicines used to treat high blood pressure) such as diltiazem or
verapamil
protease inhibitors (medicines used to treat HIV or hepatitis C) such as boceprevir,
saquinavir, simeprevir, or telaprevir
medicines for hepatitis C (protease inhibitors such as boceprevir and telaprevir)
NK1 receptor antagonists (medicines used to treat nausea and vomiting) such as
aprepitant, netupitant, or casopitant
atorvastatin (a medicine used to treat high cholesterol)
rifampicin (a medicine used to treat mycobacterial infections, such as tuberculosis)
ticagrelor (a medicine used to prevent heart attacks)
carbamazepine or phenytoin (medicines used to treat epilepsy)
mitotane or enzalutamide (medicines used to treat certain types of cancer)
clobazam (a medicine used to treat epilepsy and anxiety)
efavirenz (a medicine used to treat HIV)
vemurafenib (a medicine used to treat melanoma)
St. John’s wort, quercetin, ginkgo biloba, or panax ginseng – valproic acid (a medicine
used to treat epilepsy).
If any of the above apply to you, or if you are unsure, discuss this with your doctor or nurse before receiving midazolam.
Surgery
If you are undergoing anesthesia for surgery or a dental procedure (including inhaled anesthetics), it is important to inform your doctor or dentist that you have been given midazolam.
Midazolam Eignapharma and alcohol
Do not drink alcohol when receiving midazolam, as alcohol can unpredictably enhance the effect of midazolam. This could lead to serious adverse effects on breathing, heart function, and circulation.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor, nurse, or pharmacist before taking this medicine.
During pregnancy, midazolam is administered only if the doctor considers it absolutely necessary for treatment.
If you are breastfeeding, stop breastfeeding for 24 hours after receiving midazolam. This is because midazolam can pass into breast milk.
Driving and using machines
Do not drive and do not operate tools or machinery until you have fully recovered from the effects of midazolam. Your doctor will inform you when you may resume these activities. This medicine may cause drowsiness, memory problems, or impair concentration and coordination. Ensure that someone accompanies you home after discharge.
Midazolam Eignapharma contains sodium
This medicine contains 5.88 mg of sodium per 3 mL vial, equivalent to 0.3% of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium for an adult.
This medicine contains 19.6 mg of sodium per 10 mL vial, equivalent to 0.98% of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium for an adult.
3. How to use Midazolam Eignapharma
The medicine will be administered by a doctor or nurse. It will be used in a facility equipped
for monitoring and treatment of any adverse effects that may occur. This may be a
hospital or an outpatient surgical unit. In particular, breathing, heart function, and circulation will be monitored.
The use of this medicine is not recommended in neonates and children under 6 months of age.
However, in intensive care situations, use in neonates and children under 6 months of age may
be considered if the doctor deems it necessary.
Midazolam Eignapharma is administered with a syringe (as an injection) into a vein (intravenously) or into a muscle (intramuscularly). It may also be given diluted in a larger volume of fluid through an intravenous infusion. If injection or infusion is not possible, rectal administration may also be used via a special applicator.
Dosage:
The doctor will determine the appropriate dose for you or your child, based on the treatment to be
received and the condition of your child.
If you receive more Midazolam Eignapharma than you should
The medicine is administered by a doctor. In case of accidental overdose of midazolam, the following effects may occur:
drowsiness and loss of normal muscle control (coordination) and reflexes,
speech disturbances and unusual eye movements,
low blood pressure. In this case, you may experience mental confusion or dizziness;
slowed or stopped breathing or heartbeat, and loss of consciousness (coma).
Treatment of overdose mainly consists of monitoring vital functions (heart function, circulation, and respiration). If necessary, the patient will receive adequate supportive care. In cases of severe poisoning, a specific antidote may be administered to counteract the effects of midazolam.
If you stop treatment with Midazolam Eignapharma
If treatment is stopped abruptly after prolonged use, for example in intensive care, withdrawal symptoms may occur such as:
headaches,
diarrhoea,
muscle pain,
feelings of anxiety, tension, restlessness, confusion or irritability,
sleep disturbances,
mood changes,
hallucinations (seeing or hearing things that are not there),
seizures (convulsions).
The doctor will gradually reduce the dose towards the end of midazolam treatment to avoid these effects.
If you have any further questions about the use of this medicine, please consult 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).
The following side effects can be life-threatening. If you experience any of the following,
tell your doctor immediately, who will stop administration of the medicine:
Anaphylactic shock (a potentially life-threatening allergic reaction). Signs may include sudden rash,
itching or lumpy rash (urticaria), and swelling of the face, lips, tongue or other parts of the body (angioedema).
You may also experience shortness of breath, wheezing or difficulty breathing (bronchospasm), or pale skin,
weak and rapid pulse, or feeling faint. You may also feel chest pain, a sign of a potentially serious allergic
reaction called Kounis syndrome.
Heart attack (cardiac arrest). Signs may include chest pain that may spread to the neck, shoulders,
and down the left arm.
Breathing problems or complications (which sometimes lead to respiratory arrest).
Choking and sudden blockage of the airways (laryngospasm).
Life-threatening side effects are more likely in adults over 60 years of age and in those who already have
respiratory difficulties or heart problems, particularly if the injection is administered too quickly or at high doses.
Other side effects:
Immune system problems:
General allergic reactions (skin reactions, heart and blood system reactions)
Effects on behaviour:
Agitation
Restlessness
Irritability
Nervousness, anxiety
Hostility, anger or aggression
Excitement
Hyperactivity
Changes in libido
Inappropriate behaviour and other negative behavioural effects
Muscle problems:
Muscle spasms and muscle tremors (involuntary shaking of muscles)
Mental and nervous system problems:
Confusion, disorientation
Psychosis (loss of contact with reality)
Emotional and mood disturbances
Hallucinations (seeing and possibly hearing things that are not there)
Drowsiness and prolonged sedation
Nightmares, abnormal dreams
Reduced alertness
Headache
Dizziness
Difficulty coordinating muscles
Seizures (convulsions), more frequent in premature infants and newborns
Temporary memory loss. The duration of this depends on the amount of midazolam received.
This may occur after treatment. In isolated cases, this phenomenon may persist.
Drug dependence, abuse
Heart and circulation problems:
Low blood pressure
Slow heart rate
Widening of blood vessels (vasodilation)
Breathing problems:
Slow breathing (respiratory depression)
Shortness of breath (dyspnea)
Breathing stops (apnea, respiratory arrest)
Hiccups
Stomach, intestinal and mouth problems:
Feeling or being sick (nausea)
Constipation
Dry mouth
Skin problems:
Rash
Urticaria (lumpy rash)
Itching
Effects at the site of administration:
Redness
Swelling of the skin
Blood clots or pain
General:
Tiredness (fatigue)
Injuries, poisonings and procedural complications:
Falling and breaking bones. This risk is increased in patients taking other sedatives (including alcohol) and in the elderly.
Elderly patients:
Life-threatening side effects are more likely in adults over 60 years of age and in those who already have respiratory difficulties or heart problems, particularly when the injection is administered too quickly or at high doses.
Patients with severe kidney disease:
Patients with severe kidney disease are more likely to experience side effects.
If any of these side effects become life-threatening or troublesome, or if you notice any side effect not listed in this leaflet, tell your doctor or nurse.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 Eignapharma
Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the vial and the outer carton.
The expiry date refers to the last day of the month.
Keep the vials in the outer packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Your doctor will dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Midazolam Eignapharma contains
The active substance is midazolam.
Each mL of Midazolam Eignapharma 5 mg/mL contains 5 mg of midazolam.
- 1 vial of 3 mL contains 15 mg of midazolam.
- 1 vial of 10 mL contains 50 mg of midazolam.
The other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide and water for
injections.
Description of the appearance of Midazolam Eignapharma and contents of the pack
Midazolam Eignapharma is a clear solution, colourless to slightly yellow.
Midazolam Eignapharma 5 mg/mL is available in:
- 3 mL colourless glass vial, pack of 5 vials
- 10 mL colourless glass vial, pack of 5 vials
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Eignapharma S.L.
Avda. Ernest Lluch 32,
TCM Tower 2, 6th Floor
08302 Mataró, Barcelona
Spain
Manufacturer:
Laboratori Fundació DAU
Calle Lletra C de la Zona Franca 12-14
Polígono Industrial de la Zona Franca de Barcelona
08040 Barcelona,
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Spain: Midazolam Eignapharma 5 mg/ml solución inyectable y para perfusión EFG
France: Midazolam Eignapharma 5 mg/mL, solution injectable/pour perfusion
Germany: Midazolam Eignapharma 5 mg/mL Injektions-/Infusionslösung
Poland: Midazolam Eignapharma
Slovenia: Midazolam Eignapharma 5 mg/mL raztopina za injiciranje/infundiranje
Italy: Midazolam Eignapharma
Other sources of information
The following information is intended exclusively for healthcare professionals:
Warnings
Preparation of infusion solution
The injectable solution of Midazolam Eignapharma may be diluted with 0.9% sodium chloride solution, 5% or 10% intravenous dextrose solution, compound sodium lactate injection/Ringer's lactate solution or Ringer's solution. In case of continuous intravenous infusion, the midazolam injectable solution may be diluted within a range of 0.015 to 0.15 mg per mL with one of the solutions listed above.
These solutions remain stable for 24 hours at room temperature (25 °C) and for 3 days at 5 °C. The midazolam injectable solution must not be mixed with solutions other than those listed above. In particular, the midazolam injectable solution must not be diluted with 6% p/v dextran (with 0.9% sodium chloride) in glucose or mixed with alkaline injectable solutions.
Midazolam precipitates in bicarbonate.
The injectable solution must be visually inspected before administration. Only solutions free from visible particles should be used.
Shelf life and storage
Midazolam vials for injectable solution are intended for single use only.
Vial before opening
Store in the original packaging to protect the medicine from light.
Handling
The medicine must be used immediately after opening.
Vial after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15–25 °C) or for 3 days at 5 °C.
From a microbiological standpoint, the product should be used immediately after preparation. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at 5 °C, unless dilution has been carried out under controlled and validated aseptic conditions.
The product is supplied in single-dose containers. Unused contents of opened containers must be immediately discarded. Use only if the solution is clear and colourless and if the container and closure are intact. For dilution instructions, incompatibilities and complete prescribing information, refer to the Summary of Product Characteristics.
Disposal of waste
Any unused product or waste material must be disposed of in accordance with local regulations.