Midazolam Hameln - Midazolam uses, dose and side effects

Midazolam Hameln belongs to the group of drugs benzodiazepines . Midazolam Hameln is a fast-acting agent with a calming and soothing effect. It also has a calming and muscle relaxing effect.

Midazolam Hameln is used in adults:

• as an anesthetic to induce or maintain sleep.

Midazolam Hameln is used in adults and children:

• as a sedative and sleep-inducing agent in intensive care. This is called “sedation”.

• before and during medical tests or examinations performed while awake. The drug has a calming and soothing effect. This is called “awake sedation”.

• as a sedative or hypnotic before anesthesia.

Midazolam contained in Midazolam Hameln may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you are given Midazolam Hameln

You should not be given Midazolam Hameln

• if you are allergic to midazolam or any of the other ingredients of this medicine (listed in section 6: Other information).

• if you are allergic to other benzodiazepines such as diazepam or nitrazepam.

• if you have severe breathing difficulties and should receive Midazolam Hameln for “awake sedation”.

You must not be given Midazolam Hameln if any of the above apply to you. If you are not sure, talk to your doctor or nurse before taking this medicine.

Warnings and cautions

Talk to your doctor or nurse before giving Midazolam Hameln:

• if you are over 60 years old

• if you have a chronic illness such as breathing difficulties or any liver, kidney, or heart disease

• if you have an illness that makes you feel very weak, down or weak

• if you have myasthenia gravis, which is characterized by muscle weakness

• if you have a condition called “sleep apnea syndrome” (when you have a pause in breathing while sleeping)

• if you have ever had alcohol problems

• if you have ever had problems with drugs

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before taking Midazolam Hameln.

Children

• Talk to your doctor or nurse if any of the above apply to your child.

• It is especially important that you tell your doctor or nurse if your child has any heart disease or difficulty breathing.

Other medicines and Midazolam Hameln

Tell your doctor or nurse if you are taking or have recently taken any other medicines. This also applies to over-the-counter medicines and herbal medicines. This is important because midazolam may affect the way some other medicines work. Conversely, some medicines may affect the way midazolam works.

You must tell your doctor or nurse if you are taking any of the following medicines:

• Antidepressants (antidepressants)

• Sleeping pills

• Sedatives (which make you feel calm and sleepy)

• Sedatives (for anxiety or to help you sleep)

• Carbamazepine or phenytoin (can be used for epileptic seizures or seizures)

• Rifampicin (for tuberculosis )

• Protease inhibitors against HIV infection and hepatitis C (eg saquinavir , boceprevir, telaprevir)

Macrolide antibiotics (eg erythromycin or clarithromycin)

• Medicines for fungal infections (eg ketoconazole , voriconazole, fluconazole , itraconazole, posaconazole)

• Strong painkillers

• Atorvastatin (for high cholesterol )

• Antihistamines (for allergic reactions)

St. John’s wort (a natural remedy for depression)

Calcium channel blockers are used to treat high blood pressure (eg diltiazem )

If any of the above applies to you (or you do not know), talk to your doctor or nurse before receiving Midazolam Hameln.

Concomitant use of Midazolam Hameln with opioid medicines (strong painkillers, opioid-dependent medicines, and certain cough medicines) increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

If your doctor prescribes Midazolam Hameln at the same time as opioid medicines, the dose and treatment time should be limited by your doctor.

Tell your doctor if you are taking any opioid medication and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

Midazolam Hameln with drink

You should not drink alcohol after receiving Midazolam Hameln, as this may make you very sleepy and cause breathing difficulties.

Pregnancy and breastfeeding

Talk to your doctor before receiving Midazolam Hameln if you are pregnant or think you may be pregnant. Your doctor can then decide if this medicine is right for you.

You should not breastfeed within 24 hours of receiving Midazolam Hameln, as this medicine may pass into breast milk.

Driving and using machines

Once you have received Midazolam Hameln, do not drive or use any tools or tools until your doctor tells you that it is OK. This is because Midazolam Hameln can make you tired or forgetful. The drug can also affect your ability to concentrate and coordinate, which in turn can affect your ability to drive and the ability to use tools and machines. After the treatment, you must be accompanied by an adult who can look after you.

Midazolam Hameln contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.

How to take Midazolam Hameln

Midazolam Hameln is given by a doctor or nurse. It is given in a place that has the equipment needed to monitor you and to treat any side effects. This can be at a hospital, a clinic, or at a doctor’s surgery. Breathing, heart activity, and blood circulation will be monitored particularly closely.

The use of Midazolam Hameln is not recommended for infants under 6 months of age. If the doctor deems it necessary, however, the drug can be given to infants under 6 months who receive intensive care.

How to get Midazolam Hameln

You can get Midazolam Hameln in one of the following ways:

• As a slow injection into a vein ( intravenous injection ).

• As a drip into a vein ( intravenous infusion ).

• As an injection into a muscle ( intramuscular injection ).

• Via the rectum.

How much Midazolam Hameln you will get

Dose one of Midazolam Hameln varies between patients. Your doctor will calculate the dose that is right for you. Dose one is determined by age, weight, and general condition. The size of the dose also depends on the purpose for which you are receiving the medicine, how you respond to the treatment, and whether other medicines should be given at the same time.

Once you have received Midazolam Hameln

After the treatment, you must be accompanied by an adult who can look after you. This is important because Midazolam Hameln may make you tired or forgetful. The medicine may also affect your ability to concentrate and coordinate.

If you receive Midazolam Hameln for a long time, as in intensive care, you may develop tolerance to the drug. This means that the drug does not work as well.

If you have been given too much Midazolam Hameln

Midazolam Hameln is given by a doctor or nurse. This means that you are unlikely to get too much medicine. However, if you have made too many mistakes, you may notice the following symptoms:

• Drowsiness, coordination difficulties, and reflex loss.

• Speech difficulties and unusual eye movements.

• Low blood pressure. This can make you dizzy or faint.

• Slow or stopped breathing or pulse and unconsciousness ( coma ).

Long-term use of Midazolam Hameln in connection with sedation in intensive care

If you are taking Midazolam Hameln for a long time, the following may occur:

• The drug may be less effective.

• You may develop drug dependence and experience withdrawal symptoms when treatment is stopped (see “When medication is discontinued” below).

If you stop using Midazolam Hameln

If you receive Midazolam Hameln for a long time, such as in intensive care, you may experience withdrawal symptoms when treatment is stopped. Symptoms include:

• Mood swings

• Seizures (muscle twitching)

• Headache

• Diarrhea

• Muscle pain

• Difficulty sleeping

• Strong anxiety (anxiety), tension, restlessness, confusion, or bad mood (irritability)

• To see and possibly hear things that do not exist (hallucinations)

The doctor gradually reduces the dose. This will prevent you from getting withdrawal symptoms.

Possible side effects

Like all medicines, Midazolam Hameln can cause side effects, although not everybody gets them. The following adverse reactions have been reported but their frequency is unknown and cannot be calculated from the available data.

Contact a doctor immediately if you notice any of the following side effects, as treatment with Midazolam Hameln may need to be stopped. The following side effects can be life-threatening and you may need urgent medical attention.

• A severe allergic reaction (anaphylactic shock ). Symptoms may include sudden rash, itching or raised rash ( hives ), and swelling of the face, lips, tongue, and other parts of the body. You may also be short of breath, have wheezing, or difficulty breathing.

• Heart attack (cardiac arrest). Symptoms may include chest pain.

• Breathing difficulties, which can sometimes cause breathing to stop.

• Muscle spasm around the larynx, which can cause suffocation.

Life-threatening side effects are more likely to occur in people over 60 years of age and in people who already have breathing or heart problems. The risk of these side effects is also higher if the injection is given too quickly or in a high dose.

Other possible side effects are

Nervous system and mental disorders

• Decreased attention

• Confusion

• Strong feeling of happiness or excitement ( euphoria )

• Changes in libido

Persistent tiredness, drowsiness, or drowsiness

• To see or possibly hear things that do not exist (hallucinations)

• Consciousness disorder ( delirium )

• Headache

• Dizziness

• Difficulty coordinating muscle movements

• Seizures (muscle twitching) in premature and newborn babies

• Temporary memory loss. How long this lasts depends on how much midazolam you have been given. In some cases, the memory loss persists for a long time.

Upset, restlessness, anger, or aggression. You may also have muscle spasms or muscle tremors that you cannot control ( tremor ). These effects are more likely to occur if you have been given a high dose or if the medicine has been given too quickly. It is also more common in children and the elderly.

Heart and blood circulation

• Fainting

• Slow heartbeat

• Redness of the face and neck (hot flashes)

• Low blood pressure. This can make you dizzy or faint.

Breath

• Hiccups

• Shortness of breath

Mouth, stomach, and intestines

• Dry mouth

• Constipation

• Nausea or vomiting

Skin

Itching _

• Rash, including raised rash ( hives )

Redness, pain , blood clots, or swelling of the skin where an injection was given

Generally

• Allergic reactions including rash and wheezing

• Swelling of the skin / mucous membranes ( angioedema )

• The risk of falls and fractures increases in those who also use sedatives (including alcoholic beverages).

• Withdrawal symptoms (see “When the medication is stopped” in section 3 above)

• Drug abuse

Elderly

• Elderly people taking benzodiazepines, such as midazolam, is at higher risk of falling and fractures

• Life-threatening side effects are also more likely to occur in people over 60 years of age.

How to store Midazolam Hameln

• Your doctor or pharmacist will be responsible for storing Midazolam Hameln. They are also responsible for disposing of the remaining Midazolam Hameln by current instructions.

• Keep this medicine out of the reach and sight of children.

• Do not use this medicine after the expiry date which is stated on the carton after “EXP:”. The expiration date is the last day of the specified month.

• Do not use medicines if the ampoule/vial or package is damaged.

• Store the ampoules/vials in the outer carton. Sensitive to light.

Do not store above 25 ° C. Do not freeze.

Contents of the pack and other information

Content declaration

The active substance is midazolam (as midazolam hydrochloride).

Midazolam Hameln 1 mg / ml solution: 1 ml contains 1 mg midazolam (as midazolam hydrochloride).

Midazolam Hameln 5 mg / ml solution: 1 ml contains 5 mg midazolam (as midazolam hydrochloride).

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

What the medicine looks like and contents of the pack

Midazolam Hameln is a clear, colorless solution (solution for injection/infusion). The medicine is supplied in colorless glass ampoules and glass vials.

Midazolam Hameln 1 mg/ml solution for injection or infusion is available in the following pack sizes:

• 2 ml, 5 ml, 10 ml glass ampoules: pack of 5, 10, 25, 50 or 100 ampoules

• 50 ml glass vials, closed with a bromobutyl rubber stopper: pack of 1, 5, 10 vials

Midazolam Hameln 5 mg/ml solution for injection/infusion is available in the following pack sizes:

• 1 ml, 2 ml, 3 ml, 5 ml, 10 ml, 18 ml glass ampoules: pack of 5, 10, 25 , 50 or 100 ampoules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

hameln pharma gmbh

Inselstraße 1

31787 Hameln

Germany

Manufacturer

Siegfried Hameln GmbH

Langes Feld 13

31789 Hameln

Germany

HBM Pharma sro

Sklabinská 30

03680 Martin

Slovakia

hameln rds as

Horná 36

900 01 Modra