MIDAZOLAM 2 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Midazolam Hameln, 1 mg/ml, solution for injection/infusion
3. Midazolam Hameln, 2 mg/ml, solution for injection/infusion
4. Midazolam Hameln, 5 mg/ml, solution for injection/infusion
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Midazolam Hameln and what is it used for
   1. This medicine is used in adults for:
   2. This medicine is used in adults and children:
6. Important information before using Midazolam Hameln
   1. When not to use Midazolam Hameln
   2. Warnings and precautions
   3. Children
   4. Midazolam Hameln and other medicines
   5. Using Midazolam Hameln with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Midazolam Hameln contains sodium
7. How to use Midazolam Hameln
   1. Route and method of administration of Midazolam Hameln
   2. Dosage of Midazolam Hameln
   3. After administration of Midazolam Hameln
   4. Using a higher dose of Midazolam Hameln than recommended
   5. Long-term use of Midazolam Hameln for sedation in the intensive care unit
   6. Stopping Midazolam Hameln
8. Possible side effects
   1. If the patient experiences any of the following side effects, they should stop using Midazolam Hameln and tell their doctor immediately. These may be
   2. Other side effects
   3. Nervous system disorders and psychiatric disorders
   4. Cardiovascular disorders
   5. Respiratory disorders
   6. Gastrointestinal disorders
   7. Skin and subcutaneous tissue disorders
   8. General disorders and administration site conditions
   9. Elderly
   10. Reporting side effects
9. How to store Midazolam Hameln
10. Contents of the packaging and other information
    1. What Midazolam Hameln contains
    2. What Midazolam Hameln looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer/Importer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. Date of last revision of the leaflet: 2024-07-05
    7. The following information is intended for healthcare professionals only: Midazolam Hameln, 1 mg/ml, 2 mg/ml, 5 mg/ml, solution for injection/infusion
11. Pack size:
12. Preparation:
    1. Dilution of the solution

Leaflet attached to the packaging: information for the user

Midazolam Hameln, 1 mg/ml, solution for injection/infusion

Midazolam Hameln, 2 mg/ml, solution for injection/infusion

Midazolam Hameln, 5 mg/ml, solution for injection/infusion

Midazolam

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Midazolam Hameln and what is it used for
• 2. Important information before using Midazolam Hameln
• 3. How to use Midazolam Hameln
• 4. Possible side effects
• 5. How to store Midazolam Hameln
• 6. Contents of the packaging and other information

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

Midazolam belongs to a group of medicines called "benzodiazepines". It is a fast-acting medicine, used to induce drowsiness or sleep. It also has a calming effect and reduces muscle tension.

This medicine is used in adults for:

• general anesthesia, to induce a state of sleep and maintain sleep.

This medicine is used in adults and children:

• to make them feel calm and sleepy in the intensive care unit, this is called "sedation".
• before and during a medical examination or procedure, during which they cannot sleep. This makes them feel calm and sleepy. This is called conscious sedation.
• to make them feel calm and sleepy before administering an anesthetic.

2. Important information before using Midazolam Hameln

When not to use Midazolam Hameln

If any of the above applies to the patient, do not give Midazolam Hameln. If the patient is unsure, they should tell their doctor or nurse before taking the medicine.

Warnings and precautions

Before giving the medicine, the doctor or nurse should be informed if:

• the patient is over 60 years old,
• the patient has chronic diseases, such as respiratory, kidney, liver, or heart diseases,
• the patient feels very weak, exhausted, and lacking energy,
• the patient has muscle weakness (a disease characterized by muscle weakness),
• the patient has a condition called "sleep apnea syndrome" (in which breathing stops during sleep),
• the patient has ever abused alcohol,
• the patient has ever abused drugs.

If any of the above applies to the patient (or the patient is unsure), they should inform their doctor or nurse before taking Midazolam Hameln.

Children

• The doctor or nurse should be informed if any of the above applies to the child.
• In particular, the doctor or nurse should be informed if the child has heart or breathing problems.

Midazolam Hameln and other medicines

The doctor or nurse should be told about all medicines the patient is taking, or has recently taken, and about medicines they plan to take. This includes medicines available without a prescription and herbal medicines. This is because Midazolam Hameln may affect the way some medicines work. Also, some medicines may affect the way Midazolam Hameln works.

• antidepressant medicines (used to treat depression),
• sleeping medicines (that help with sleep),
• sedative medicines (used to calm and induce sleep),
• calming medicines (used to treat anxiety and help with sleep),
• carbamazepine or phenytoin (used to treat seizures),
• rifampicin (used to treat tuberculosis),
• medicines used to treat HIV infection, called protease inhibitors (such as saquinavir, boceprevir, telaprevir),
• macrolide antibiotics (such as erythromycin or clarithromycin),
• medicines used to treat fungal infections (such as ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole),
• narcotic pain relievers,
• atorvastatin (used to treat high cholesterol),
• antihistamine medicines (used to treat allergies),
• St. John's Wort (a herbal medicine used to treat depression),
• medicines used to treat high blood pressure, called "calcium channel blockers" (such as diltiazem).

If any of the above applies to the patient (or the patient is unsure), they should inform their doctor or nurse before taking Midazolam Hameln.

Using Midazolam Hameln with food, drink, and alcohol

While taking midazolam, the patient should not drink alcohol. Because it can significantly increase the sedative effect of midazolam (increase sleepiness) and cause breathing problems.

Pregnancy and breastfeeding

If the patient is pregnant or thinks she may be pregnant, she should consult her doctor before using this medicine. The doctor will decide if the medicine is suitable for the patient.

Midazolam may pass into breast milk. Therefore, women should not breastfeed for 24 hours after taking the medicine.

Driving and using machines

After taking Midazolam Hameln, the patient should not drive or operate machinery until their doctor decides it is safe to do so.

The medicine may cause sleepiness and memory problems. It may also affect concentration and coordination. These effects may affect the ability to drive and operate machinery. After taking this medicine, the patient should always be accompanied by a responsible adult on the way home.

Midazolam Hameln contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of solution, which means the medicine is considered "sodium-free".

3. How to use Midazolam Hameln

This medicine should only be given by an experienced doctor or nurse. It should be given in a place that has the necessary equipment to monitor and treat any side effects. This may be a hospital, clinic, or surgical office, with the possibility of monitoring breathing, heart function, and circulation.

It is not recommended to use midazolam in newborns and children under 6 months old.

In infants and children under 6 months old, midazolam should only be used when the doctor considers it necessary, in the intensive care unit.

Route and method of administration of Midazolam Hameln

Midazolam Hameln can be given in the following ways:

• intravenous injection: slow injection into a vein
• intravenous infusion: drip into one of the veins
• intramuscular injection: injection into a muscle
• rectal administration: into the rectum

Dosage of Midazolam Hameln

The doses vary significantly and depend on the planned treatment and desired level of sedation.

The appropriate dose of the medicine for a given patient is determined by the doctor. The dose size in a specific case depends on the patient's weight, age, and overall health. It also depends on the purpose of using midazolam, the response to treatment, and whether the patient will require other medicines during administration.

After administration of Midazolam Hameln

After the procedure, the patient must go home accompanied by a responsible adult, as the medicine may cause sleepiness and memory problems. It may also affect concentration and coordination.

Using a higher dose of Midazolam Hameln than recommended

The medicine will be given by a doctor or nurse. It is therefore unlikely that the patient will receive too much medicine.

If the patient accidentally overdoses, it may lead to:

• Sleepiness, lack of coordination.
• Speech disorders and involuntary eye movements.
• Low blood pressure. This may cause dizziness or fainting.
• Slowing or stopping breathing or heartbeat and loss of consciousness (coma).

Long-term use of Midazolam Hameln for sedation in the intensive care unit

If Midazolam Hameln is used for a long time, the patient may develop:

• reduced effectiveness of the medicine;
• dependence on the medicine or withdrawal symptoms may occur when treatment is stopped (see "Stopping Midazolam Hameln" below).

Stopping Midazolam Hameln

If Midazolam Hameln was given to the patient for a long time, for example in the intensive care unit, when the treatment is stopped, the patient may experience withdrawal symptoms. These include:

• mood changes
• seizures (convulsions)
• headache
• diarrhea
• muscle pain
• sleep disorders (insomnia)
• feeling of anxiety, tension, restlessness, confusion, or bad mood (irritability)
• seeing and possibly hearing things that are not there (hallucinations). The doctor will gradually reduce the dose. This will help avoid withdrawal symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop using Midazolam Hameln and tell their doctor immediately. These may be

life-threatening and require urgent treatment.

• Severe allergic reaction (anaphylactic shock). Symptoms may include sudden rash, itching, or hives, and swelling of the face, lips, tongue, or other parts of the body. It may also cause difficulty breathing, wheezing, or shortness of breath, or pale skin, weak and rapid pulse, or feeling of loss of consciousness. Additionally, it may cause chest pain, which may be a sign of a serious allergic reaction called Kounis syndrome.
• Heart attack (myocardial infarction). The symptom may be chest pain.
• Breathing difficulties, sometimes causing breathing to stop.
• Laryngospasm leading to airway obstruction. Life-threatening incidents occur more frequently in people over 60 years old and in people with breathing or heart problems. The mentioned side effects are also more likely if the medicine is injected too quickly or in a large dose.

Other side effects

Nervous system disorders and psychiatric disorders

• reduced alertness,
• confusion,
• euphoria (excessive feeling of happiness or excitement),
• changes in libido,
• feeling of fatigue, sleepiness, or prolonged sedation,
• seeing and hearing things that do not exist (hallucinations),
• disorders of consciousness (delirium),
• headache,
• dizziness,
• difficulty coordinating muscle movements,
• seizures in premature infants and newborns,
• temporary memory loss. The duration of memory loss depends on the dose used. In individual cases, it may last for a long time
• feeling of agitation, anxiety, anger, or aggression, muscle spasms, or involuntary muscle twitching. These reactions are more likely after using large doses of midazolam or injecting too quickly. Such reactions are more common in children and the elderly.

Cardiovascular disorders

• fainting,
• slow heart rate,
• flushing of the face and neck,
• low blood pressure. This may cause dizziness or fainting.

Respiratory disorders

• hiccups,
• shortness of breath, lack of breath.

Gastrointestinal disorders

• dry mouth,
• constipation,
• nausea, vomiting.

Skin and subcutaneous tissue disorders

• feeling of itching,
• rash, including hives,
• redness, pain, thrombophlebitis, or swelling of the skin at the injection site.

General disorders and administration site conditions

• allergic reactions, including rash and wheezing,
• angioedema (swelling of the skin and mucous membranes),
• the risk of falls and fractures is increased in people taking sedative medicines (including alcoholic beverages),
• withdrawal symptoms (see "Stopping Midazolam Hameln" above),
• drug abuse.

Elderly

The risk of falls and fractures is greater in elderly people who take benzodiazepines, such as Midazolam Hameln.

In people over 60 years old, there is a greater likelihood of life-threatening side effects.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist.

5. How to store Midazolam Hameln

• The doctor or pharmacist is responsible for storing midazolam. They are also responsible for the proper disposal of unused medicine.
• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the ampoule/vial and carton after "EXP". The expiry date refers to the last day of the month stated.
• Do not use this medicine if the glass packaging (ampoule/vial) or cardboard packaging is damaged.
• Store in the original packaging to protect from light.
• Store at a temperature below 25°C. Do not freeze.

6. Contents of the packaging and other information

What Midazolam Hameln contains

The active substance of the medicine is midazolam (in the form of midazolam hydrochloride).

Midazolam Hameln 1 mg/ml

Each 1 ml of solution contains 1 mg of midazolam (in the form of midazolam hydrochloride).

Midazolam Hameln 2 mg/ml

Each 1 ml of solution contains 2 mg of midazolam (in the form of midazolam hydrochloride).

Midazolam Hameln 5 mg/ml

Each 1 ml of solution contains 5 mg of midazolam (in the form of midazolam hydrochloride).

The other ingredients are sodium chloride, hydrochloric acid, and water for injections.

What Midazolam Hameln looks like and contents of the pack

This medicine is a clear, colorless solution in clear glass ampoules/vials (type I glass).

Midazolam Hameln, 1 mg/ml, solution for injection/infusion is available in:

• glass ampoule of 5 ml: in packs of 10 ampoules
• glass vial of 50 ml closed with a bromobutyl rubber stopper: in packs of 1 vial

Midazolam Hameln, 2 mg/ml, solution for injection/infusion is available in:

• glass vial of 50 ml: in packs of 1 vial

Midazolam Hameln, 5 mg/ml, solution for injection/infusion is available in:

• glass ampoule of 3 ml: in packs of 10 ampoules
• glass ampoule of 10 ml: in packs of 10 ampoules

Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma gmbh

Inselstraße 1

31787 Hameln

Germany

Manufacturer/Importer

Siegfried Hameln GmbH

Langes Feld 13

31789 Hameln

Germany

HBM Pharma s.r.o.

Sklabinská 30

03680 Martin

Slovakia

hameln rds s.r.o.

Horná 36

900 01 Modra

Slovakia

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19

83-200 Starogard Gdański

Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 2024-07-05

The following information is intended for healthcare professionals only: Midazolam Hameln, 1 mg/ml, 2 mg/ml, 5 mg/ml, solution for injection/infusion

This is a summary of the preparation of Midazolam Hameln, 1 mg/ml, 2 mg/ml, 5 mg/ml, solution for injection/infusion.

Before preparing this medicine, the entire contents of this guide should be read.

Full information on dosing and other information can be found in the Summary of Product Characteristics.

1. Pack size:

Midazolam Hameln, 1 mg/ml comes as a clear, colorless solution in clear glass ampoules (type I glass) containing 2, 5, or 10 ml of solution or glass vials containing 50 ml of solution.

Midazolam Hameln, 2 mg/ml comes as a clear, colorless solution in clear glass ampoules (type I glass) containing 5 or 25 ml of solution or glass vials containing 50 ml of solution.

Midazolam Hameln, 5 mg/ml comes as a clear, colorless solution in clear glass ampoules (type I glass) containing 1, 2, 3, 5, 10, or 18 ml of solution.

2. Preparation:

Dilution of the solution

This medicine should not be diluted with other solutions for parenteral use except those listed below.

In the case of continuous intravenous infusion, the midazolam solution can be diluted in a ratio of 15 mg of midazolam per 100-1000 ml of one of the following infusion solutions: 0.9% NaCl, 5% and 10% dextrose, and Ringer's solution.

The solution remains chemically and physically stable after dilution for 3 days at room temperature.

From a microbiological point of view, the product should be used immediately, unless it can be excluded that there is a risk of microbial contamination during opening/dilution.

3.

If the solution is not used immediately, the user is responsible for the storage conditions and storage time.

Pharmaceutical incompatibilities

Compatibility should be checked before administration if it is to be mixed with other medicines.

Midazolam precipitates in solutions containing bicarbonate. Theoretically, the midazolam injection solution may be unstable in solutions with a neutral or alkaline pH.

When midazolam is mixed with albumin, amoxicillin sodium, ampicillin sodium, bumetanide, dexamethasone sodium phosphate, dimenhydrinate, flucloxacillin sodium, furosemide, hydrocortisone sodium succinate, pentobarbital sodium, perphenazine, prochlorperazine edisylate, ranitidine, or thiopental sodium, or trimethoprim-sulfamethoxazole, a white precipitate forms immediately.

With nafcillin sodium, a cloudiness forms immediately, from which a white precipitate forms.

Also, with ceftazidime, a cloudiness forms.

With methotrexate sodium, a yellow precipitate forms.

With clonidine hydrochloride, an orange discoloration forms.

With omeprazole sodium, a brown discoloration forms, from which a brown precipitate forms later.

With fosphenytoin sodium, a gas forms.

Additionally, midazolam should not be mixed with acyclovir, albumin, alteplase, diclofenac sodium, diazepam, enoximone, flecainide acetate, fluorouracil, imipenem, mezlocillin sodium, phenobarbital sodium, phenytoin sodium, potassium canrenoate, sulbactam sodium, theophylline, tromethamine, or urokinase.