Midazolam eignapharma

Package leaflet: Information for the user

Midazolam Eignapharma, 5 mg/mL, solution for injection / for infusion
Midazolamum
Please read this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet:

1. What Midazolam Eignapharma is and what it is used for
2. Important information before using Midazolam Eignapharma
3. How to use Midazolam Eignapharma
4. Possible side effects
5. How to store Midazolam Eignapharma
6. 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 deep state of calmness, drowsiness or sleep) and to relieve anxiety symptoms and reduce muscle tension.
Midazolam Eignapharma contains midazolam, which belongs to a group of medicines called benzodiazepines.
This medicine is used in adults for:

• inducing light sedation (a state of deep calmness or drowsiness with preserved consciousness during medical examinations and procedures) in adults and children,
• inducing sedation in adults and children in intensive care units,
• anaesthesia in adults, used alone or in combination with other anaesthetic agents,
• premedication to induce relaxation, calmness and drowsiness before anaesthesia induction in adults and children.

2. Important information before using Midazolam Eignapharma
When not to give Midazolam Eignapharma to the patient

• if the patient has a known allergy (hypersensitivity) to midazolam or to any of the other ingredients of this medicine listed in section 6,
• if the patient has an allergy to benzodiazepines such as diazepam or nitrazepam,
• if the patient has severe breathing problems and is to undergo light sedation.

Do not administer midazolam if any of the above apply to the patient. If you are unsure, inform your doctor or nurse before the medicine is given.
Warnings and precautions
Before receiving this medicine, inform your doctor or nurse if:

• the patient is over 60 years old,
• the patient has chronic illness (e.g. chronic respiratory, kidney, liver or heart disease),
• the patient has a condition causing extreme weakness, exhaustion and lack of energy,
• the patient has muscle fatigue (a neuromuscular disorder characterized by reduced muscle strength),
• the patient has experienced sleep apnoea (cessation of breathing during sleep),
• the patient currently misuses or has previously misused alcohol. Alcohol may significantly enhance the clinical effects of midazolam, including deep sedation, which may result in coma or death,
• the patient regularly uses recreational drugs (drugs used for non-medical purposes) or has a history of drug abuse,
• the patient is pregnant or suspects she may be pregnant (see section "Pregnancy and breastfeeding").

If any of the above apply to the patient or if you have any doubts, consult your doctor or nurse before administration of the medicine.
Children
If this medicine is to be given to a child:
It is particularly important to inform your doctor or nurse if the child has cardiovascular disease. The child will be closely monitored and the dose adjusted accordingly.
Children should be closely monitored; in infants and children under 6 months of age, monitoring should include respiratory rate and haemoglobin oxygen saturation.
Midazolam Eignapharma with other medicines
Tell your doctor or nurse about all medicines the patient is currently taking or plans to take, including herbal medicines.
This is extremely important because Midazolam Eignapharma may affect the action of other medicines. Similarly, some other medicines may affect the action of Midazolam Eignapharma.
In particular, inform your doctor or nurse if the patient is taking any of the following medicines:

• sedatives (used to treat anxiety, stress and agitation),
• hypnotics (medicines that help with falling asleep),
• tranquilizers (medicines inducing calmness or drowsiness),
• antidepressants (medicines used to treat depression),
• very strong opioid analgesics,
• antihistamines (medicines used to treat allergies),
• azole antifungals (medicines used to treat fungal infections), such as ketoconazole, voriconazole, fluconazole, itraconazole or posaconazole,
• macrolide antibiotics (medicines used to treat bacterial infections), such as erythromycin, clarithromycin, telithromycin or roxithromycin,
• calcium channel antagonists (medicines used to treat high blood pressure), such as diltiazem or verapamil,
• protease inhibitors (medicines used to treat HIV or hepatitis C virus), such as boceprevir, saquinavir, simeprevir or telaprevir,
• medicines used to treat 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 levels),
• rifampicin (a medicine used to treat mycobacterial infections such as tuberculosis),
• ticagrelor (a medicine to prevent heart attack),
• carbamazepine or phenytoin (medicines used to treat epilepsy),
• mitotane or enzalutamide (medicines used to treat certain cancers),
• clobazam (a medicine used to treat epilepsy or anxiety),
• efavirenz (a medicine used to treat HIV),
• vemurafenib (a medicine used to treat melanoma),
• herbal medicines: St. John's wort, quercetin, Ginkgo biloba or Panax ginseng,
• valproic acid (a medicine used to treat epilepsy).

If any of the above situations apply to the patient or if you have any doubts, inform your doctor or pharmacist before taking midazolam.
Surgical procedures
If the patient is to receive an anaesthetic before surgery or dental treatment (including inhaled anaesthetics), it is important to inform the doctor or dentist that the patient has taken midazolam.
Midazolam Eignapharma and alcohol
The patient must not drink alcohol while taking midazolam, as alcohol may significantly enhance the sedative effect of Midazolam and cause serious adverse effects on breathing, heart function and circulation.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to become pregnant, she should consult her doctor, nurse or pharmacist before taking this medicine.
If the patient is pregnant, midazolam will only be administered if the doctor considers it absolutely necessary for treatment.
Midazolam may pass into human milk; therefore, women must not breastfeed for 24 hours after administration of the medicine.
Driving and operating machinery
Do not drive or operate any tools or machinery until the effects of midazolam have completely worn off. Your doctor will advise when this is safe. This medicine may cause drowsiness, memory impairment or affect concentration and coordination. Ensure that someone accompanies the patient home after hospital discharge.
Midazolam Eignapharma contains sodium
The medicinal product contains 5.88 mg of sodium per 3 mL ampoule, equivalent to 0.3% of the WHO recommended maximum daily intake of 2 g sodium for adults.
The medicinal product contains 19.6 mg of sodium per 10 mL ampoule, equivalent to 0.98% of the WHO recommended maximum daily intake of 2 g sodium for adults.

3. How to use Midazolam Eignapharma

This medicine will be administered by doctors or nurses. It should be given in a healthcare facility equipped with equipment to monitor the patient and manage any possible adverse effects. This may be a hospital or an outpatient surgical unit. In particular, breathing, heart function and circulation will be monitored.
This medicine is not recommended for use in children and infants under 6 months of age.
However, in intensive care situations, administration in children and infants under 6 months of age may occur if the doctor considers it necessary.
Midazolam Eignapharma is administered using 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 catheter (infusion). Rectal administration using a special applicator is also possible if injection or infusion is not feasible.
Dosing:
The appropriate dose for each patient will be determined by the doctor. Doses vary significantly and depend on the planned treatment and the patient's health status.
Taking more than the recommended dose of Midazolam Eignapharma
The medicine will be administered by a doctor. If accidental overdose occurs, it may lead to:

• drowsiness and ataxia (lack of coordination) and loss of reflexes,
• dysarthria (speech disturbances) and abnormal eye movements,
• low blood pressure (hypotension). This may cause dizziness or lightheadedness,
• slower breathing or respiratory arrest and slower heart rate, or cardiac arrest and loss of consciousness (coma).

Treatment of overdose mainly involves monitoring vital functions (heart, circulation and breathing). If necessary, the patient will receive appropriate supportive care. In cases of severe intoxication, the patient may receive a specific antidote to counteract the effects of midazolam.
Stopping Midazolam Eignapharma treatment
If treatment is abruptly discontinued after prolonged use, e.g. in intensive care, withdrawal symptoms may occur, such as:

• headache,
• diarrhoea,
• muscle pain,
• feelings of anxiety, tension, restlessness, disorientation or low mood (irritability),
• sleep disturbances,
• mood changes,
• hallucinations (seeing and possibly hearing things that are not there),
• seizures.

The doctor will gradually reduce the dose towards the end of midazolam treatment to avoid these symptoms.
If you have any further questions about the use of this medicine, please ask your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below occurred with unknown frequency (frequency cannot be determined
from the available data).
If any of the adverse reactions listed below occur in a patient, Midazolam Eignapharma must be discontinued
and a doctor must be informed immediately. These may be life-threatening reactions requiring urgent treatment:

• Anaphylactic shock (a life-threatening allergic reaction). Symptoms include sudden rash, itching or hives; swelling of the face, lips, tongue or other parts of the body. Breathing difficulties, wheezing or trouble breathing may also occur, as well as pale skin, weak and rapid pulse, or feeling faint. Additionally, chest pain may occur, which could be a symptom of a serious allergic reaction called Kounis syndrome.
• Myocardial infarction. Symptoms include chest pain which may radiate to the neck and shoulders, and then down the left arm.
• Breathing difficulties or complications (sometimes leading to respiratory arrest)
• Choking and sudden airway obstruction (laryngospasm)

Life-threatening events occur more frequently in adults over 60 years of age and in individuals
with respiratory insufficiency or impaired cardiac function, particularly if the medicine is administered too rapidly
or if the dose administered is too high.
Other adverse reactions.
Immune system disorders

• General allergic reactions (skin reactions, cardiac and cardiovascular reactions)

Effects on behaviour:

• Agitation
• Psychomotor restlessness
• Irritability
• Nervousness, anxiety
• Hostility, anger or aggression
• Excitement
• Hyperactivity
• Changes in libido
• Inappropriate behaviour and other unfavourable effects on behaviour

Muscle disorders

• Muscle spasms and tremors (involuntary muscle movements)

Psychiatric and nervous system disorders

• Confusion, disorientation
• Psychoses (loss of contact with reality)
• Emotional and mood disturbances
• Hallucinations (seeing or hearing things that do not exist)
• Drowsiness and prolonged sedation
• Nightmares, unusual dreams
• Impaired alertness
• Headache
• Dizziness
• Difficulty coordinating muscle movements
• Seizures (convulsions), more frequently in premature infants and newborns
• Transient memory loss. The duration of memory loss depends on the length of treatment and the dose used. Amnesia may occur after completion of treatment. In isolated cases, it may persist for a long time.
• Drug dependence, abuse

Cardiovascular disorders

• Low blood pressure
• Slowed heart rate
• Vasodilation

Respiratory disorders

• Slow breathing (respiratory depression)
• Shallow breathing (dyspnoea)
• Respiratory arrest (apnoea, cessation of breathing)
• Hiccups

Gastrointestinal disorders

• Nausea or vomiting
• Constipation
• Dry mouth

Skin and subcutaneous tissue disorders

• Skin redness (rash)
• Urticaria (hives)
• Itching of the skin

Local reactions at the site of administration

• Redness
• Swelling of the skin
• Blood clots or pain

General disorders

• Fatigue

Injury, poisoning and complications

• Risk of falls and bone fractures. This risk is higher in elderly individuals and in those taking other sedative agents (including alcohol).

Elderly patients:
The likelihood of life-threatening adverse reactions increases in patients over 60 years of age and in those
with respiratory insufficiency or impaired cardiac function, particularly if the medicine is administered too rapidly
or in high doses.
Patients with severe kidney disease:
In patients with severe kidney disease, there is an increased likelihood of adverse reactions occurring.
If any adverse reaction becomes severe, worsens, or if an adverse reaction not listed in this leaflet occurs,
a doctor or nurse must be informed.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, a doctor, pharmacist,
or nurse should be informed. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Midazolam Eignapharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule following the word EXP. The expiry date refers to the last day of the specified month.
Store the ampoules in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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, concentrated hydrochloric acid, sodium hydroxide, and water for injections.

What Midazolam Eignapharma looks like and contents of the pack
Midazolam Eignapharma is a clear, colourless to pale yellow solution.
Midazolam Eignapharma 5 mg/mL is available as:

• 3 mL vials made of colourless glass, in packs of 5 vials
• 10 mL vials made of colourless glass, in packs of 5 vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Eignapharma S.L.
Avda. Ernest Lluch, 32, TecnoCampus Torre TCM2, 6th Floor
08302 Mataro, Barcelona
Spain
Email: [email protected]

Importer:
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 authorised in the European Economic Area countries 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

Information intended exclusively for medical professionals:

Warnings
Preparation of infusion solution
Midazolam Eignapharma for injection can be diluted in 0.9% sodium chloride solution, 5% or 10% dextrose solution for intravenous administration, compound sodium lactate injection solution/Ringer's lactate solution, or Ringer's solution. For continuous intravenous infusion, midazolam solution may be diluted within the range of 0.015 to 0.15 mg per mL using 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. Midazolam for injection must not be mixed with any solution other than those specified, and must especially not be diluted in 6% dextran w/v (with 0.9% sodium chloride solution) in glucose or mixed with alkaline injection solutions. Midazolam precipitates in sodium bicarbonate solutions.
The solution should be inspected visually before administration. Only solutions free from visible solid particles may be used.

Shelf life and storage
Midazolam ampoules are intended for single use only.
Ampoules before opening
Store in the original packaging to protect from light.
Handling
The medicinal product should be used immediately after opening.
Diluted ampoules
After dilution, the solution maintains chemical and physical stability for 24 hours at room temperature (15–25°C) or for 3 days at 5°C.
From a microbiological standpoint, the diluted product should be used immediately. If this is not possible, the responsibility for storage conditions and duration prior to use lies with the person administering the drug, provided that storage does not exceed 24 hours at 5°C, unless dilution was carried out under controlled and validated aseptic conditions.
The product is supplied in single-dose containers. Any unused content of an opened container must be immediately discarded. The product should only be used if the solution is clear and colourless and the container and closure are undamaged. Guidelines for dilution, incompatibilities, and full prescribing information are provided in the Summary of Product Characteristics.

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