Midazolam hameln

Package Leaflet: 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

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What Midazolam Hameln is and what it is 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 pack and other information

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

Midazolam belongs to a group of medicines called "benzodiazepines". It is a fast-acting medicine used to induce sleepiness or sedation. 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 the patient is allergic to midazolam or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to other benzodiazepine medicines, such as diazepam or nitrazepam.
• if the patient has severe breathing problems, and is to be given Midazolam Hameln for conscious sedation.

If any of the above applies to the patient, do not give Midazolam Hameln. If the patient is not sure, tell the doctor or pharmacist before giving the medicine.

Warnings and precautions

Before giving the medicine, tell the doctor or pharmacist if:

• the patient is over 60 years old,
• the patient has chronic diseases, such as respiratory, kidney, liver, or heart disease,
• the patient feels very weak, tired, and has no 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 not sure), tell the doctor or pharmacist before giving Midazolam Hameln.

Children

• Tell the doctor or pharmacist if any of the above applies to the child.
• In particular, tell the doctor or pharmacist if the child has heart or breathing problems.

Midazolam Hameln and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained 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 (that induce a state of calm and sleepiness),
• calming medicines (used to treat anxiety and to 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-relieving medicines,
• 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 not sure), tell the doctor or pharmacist before giving Midazolam Hameln.

Using Midazolam Hameln with food, drink, and alcohol

While using midazolam, the patient must 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 receiving the medicine.

Driving and using machines

After receiving Midazolam Hameln, the patient should not drive or operate machinery until the 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 or operate machinery. After receiving this medicine, the patient must 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 it is essentially "sodium-free".

3. How to use Midazolam Hameln

This medicine should only be given by a 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 ability to monitor breathing, heart rate, 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 an 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 the desired level of sedation.

The doctor will determine the appropriate dose of the medicine for the patient. The dose 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 need to receive other medicines during its administration.

After receiving 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 more than the recommended dose of Midazolam Hameln

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

If the patient accidentally receives too much, 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 heart rate and loss of consciousness (coma).

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

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 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 an 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 irritability
• seeing or hearing things that are not there (hallucinations). The doctor will gradually reduce the dose. This will help prevent withdrawal symptoms.

4. Possible side effects

Like all medicines, Midazolam Hameln 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 can 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 rapid heartbeat, 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 leading to respiratory arrest.
• Laryngospasm resulting in airway obstruction. Life-threatening incidents occur more frequently in people over 60 years old and in people with breathing or heart problems. These side effects are also more likely if the medicine is injected too quickly or in large doses.

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 or 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, restlessness, anger, or aggression, muscle spasms, or involuntary muscle twitching. These reactions are more likely after using large doses of midazolam or injecting it too quickly. Such reactions have been reported more frequently 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),
• increased risk of falls and fractures 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 higher in elderly people who receive benzodiazepines, such as Midazolam Hameln.

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

Reporting side effects

If side effects occur, tell the doctor or pharmacist. Side effects can be reported directly to the regulatory authority or to the Department of Adverse Reaction Monitoring 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

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 container (ampoule/vial) or carton is damaged.
• Store in the original package to protect from light.
• Store at a temperature below 25°C. Do not freeze.

6. Contents of the pack and other information

What Midazolam Hameln contains

The active substance is midazolam (as midazolam hydrochloride).

Midazolam Hameln 1 mg/ml

Each 1 ml of solution contains 1 mg of midazolam (as midazolam hydrochloride).

Midazolam Hameln 2 mg/ml

Each 1 ml of solution contains 2 mg of midazolam (as midazolam hydrochloride).

Midazolam Hameln 5 mg/ml

Each 1 ml of solution contains 5 mg of midazolam (as 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 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 package 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, read the entire contents of this guide.

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

1. Pack sizes:

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

2. Preparation:

Dilution of the solution

This medicine must 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 the method of opening/ dilution precludes the risk of microbial contamination.

3.

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

Incompatibilities

Check compatibility 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 neutral or alkaline pH. When midazolam is mixed with albumin, sodium amoxicillin, sodium ampicylin, bumetanide, dexamethasone sodium phosphate, dimenhydrinate, sodium floxacylin, furosemide, hydrocortisone sodium succinate, pentobarbital sodium, perphenazine, prochlorperazine edisylate, ranitidine, or thiopental sodium or trimethoprim-sulfamethoxazole, a white precipitate forms immediately.

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

With methotrexate sodium, a yellow precipitate forms. In the case of clonidine hydrochloride, an orange discoloration forms. In the case of omeprazole sodium, a brown discoloration forms, from which a brown precipitate forms later. With foskarnet sodium, gas forms.

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