Midazolam Panpharma - Midazolam uses, dose and side effects

Midazolam Panpharma belongs to a group of medicines called benzodiazepines. It is a short-acting drug used to induce sedation (a state of calm, drowsiness, or sleep) and reduces anxiety, muscle tension. It has antispasmodic effects and causes memory loss (anterograde amnesia ).

This medicine is used:

for “awake sedation” (a state of calm or drowsiness where you stay awake) of adults and children.
for sedation of adults and children in the intensive care unit.
in anesthesia in adults (as sedatives and hypnotic drugs before initiating anesthesia, as an anesthetic or in combination with other drugs used in anesthesia)
as sedative and sleep-inducing before initiating anesthesia in children.

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

What you need to know before you use Midazolam Panpharma

Do not use Midazolam Panpharma

if you are allergic to benzodiazepines or any of the other ingredients of this medicine (listed in section 6).
if you have severe breathing difficulties and need to undergo “awake sedation”.

Warnings and cautions

Take special care with Midazolam Panpharma

This medicine should only be administered by an experienced doctor in a ward fully equipped to monitor and support respiratory and cardiac function and by people who are specially trained to recognize and treat expected side effects.

Administration of midazolam may reduce the contractions of the heart and cause respiratory arrest. Serious side effects on the heart and airways have been reported in rare cases. These side effects have included decreased breathing, respiratory and/or cardiac arrest. To avoid such events, the injection should be given slowly and the dose should be as low as possible.

Particular caution should be exercised when using Midazolam Panpharma in infants or children. Tell your doctor if your child has a heart defect. Your child will be closely monitored and dose one will be adjusted specifically.

Patients under 6 months of age who receive sedation in the intensive care unit are more likely to develop respiratory problems, so they will be dosed gradually and their respiration and oxygen levels will be observed.

When midazolam is given as a sedative and hypnotic before initiating anesthesia, you will be closely monitored for how you react and to ensure that you receive the correct dose, as sensitivity varies depending on the patient.

The use of midazolam is not recommended for newborns and children up to 6 months of age.

Unexpected reactions and memory loss regarding new events (anterograde amnesia ) have been reported with midazolam (see section 4, “Possible side effects”).

Tell your doctor if you:

is over 60 years old
have a chronic illness or are debilitated (for example, if you have chronic breathing problems or suffer from a kidney, liver or heart disease)
has myasthenia gravis (a neuromuscular disease characterized by muscle weakness)
have abused alcohol or drugs
use other medicines, including over-the-counter medicines (for more information see section “Other medicines and Midazolam Panpharma”)
is or thinks you are pregnant.

Withdrawal symptoms

Benzodiazepines, such as midazolam, may make you addicted if used for a long time (for example in intensive care). This means that if you suddenly stop treatment or reduce the dose too quickly, you may get withdrawal symptoms.
These symptoms may include:
– headache
– muscle pain
– strong anxiety (anxiety), tension, restlessness, confusion, or bad mood (irritation)
– sleep problems
– mood swings
– hallucinations (see or possibly hear things that do not exist)
– seizures.

Long-term
treatment If you are treated with midazolam for a long time, you may become tolerant (midazolam becomes less effective) or you may become addicted to the drug.

After a long period of treatment (such as in an intensive care unit), the following withdrawal symptoms may occur headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, insomnia, mood swings, hallucinations, and seizures. Your doctor will gradually reduce your dose to prevent these effects from affecting you.

Other medicines and Midazolam Panpharma

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

This is extremely important, as concomitant use of more than one medicine may enhance or weaken the effects of the medicines. For example, the effects of midazolam may be enhanced by medicines such as sedatives, hypnotics, antidepressants, narcotic painkillers (very strong painkillers), anesthetics, and certain anti-allergy medicines ( antihistamines ).

Concomitant use of Midazolam Panpharma with opioids (strong painkillers, opioid treatment drugs, 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 Panpharma at the same time as an opioid medicine, dose one and the duration of treatment should be limited by your doctor.

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

The effects of midazolam given in a vein ( intravenously ) may also be increased with medicines such as antifungal medicines ( ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole), medicines for bacterial infections (erythromycin, clarithromycin), medicines used to treat high blood pressure ( diltiazem ), to treat HIV (saquinavir and other HIV protease inhibitors ) and to lower cholesterol (atorvastatin).

The effects of midazolam given in a vein ( intravenously ) can be reduced by medicines used to treat infections caused by mycobacteria such as tuberculosis (rifampicin, carbamazepine, phenytoin ), as well as by St. John’s wort, a (traditional) herbal medicine.

Midazolam Panpharma with food, drink and alcohol

Alcohol may increase the sedative effects of midazolam and should therefore be avoided.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Midazolam may pass into breast milk and if you are breastfeeding, do not do so for 24 hours after receiving this medicine.

Driving and using machines

This medicine may make you drowsy, forgetful or affect your concentration and coordination. This can affect your ability to perform more difficult tasks, e.g. to drive a car or use machines. After receiving midazolam, do not drive or use machines until you have fully recovered. Your doctor will tell you when you can do it again. After the treatment, you should always be accompanied home by a responsible adult.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Important information about some of the ingredients of Midazolam Panpharma

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

How to use Midazolam Panpharma

Midazolam Panpharma should only be given by experienced doctors in a fully equipped ward to monitor and support respiratory and cardiac function and by people who are specially trained to recognize and treat expected side effects.

Dosage and how the medicine is given
Your doctor will decide which dose is right for you. The doses vary widely and depend on the planned treatment and the sedation required. Your weight, age, general health, how you react to the medicine, and if other medicines are required at the same time also affect the dose you receive.

If you are going to get strong painkillers, you will get these first and then get Midazolam Panpharma in the dose that is tailored specifically for you.

Midazolam Panpharma is given slowly, as an injection into a vein ( intravenously ), as a drip ( infusion ), as an injection into a muscle ( intramuscularly ), or via the rectum.

If you use more Midazolam Panpharma than you should

It is unlikely that you will get an overdose. Your medicine will be given by a doctor.
If you accidentally overdose, this can lead to drowsiness, ataxia (inability to coordinate muscle movements), dysarthria (speech disorder) and nystagmus (involuntary eye movements), loss of reflexes, apnea (respiratory arrest), hypotension (low blood pressure ), decreased heart rate and breathing still coming. Overdose may require intensive monitoring of vital bodily functions, symptomatic treatment of cardiac and respiratory effects, and the use of a benzodiazepine antagonist (a drug that counteracts the effect of benzodiazepines).

Possible side effects

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

Seek medical attention immediately if you get any of the following symptoms. They can be life-threatening and you may need urgent medical attention:

Anaphylactic shock (a life-threatening allergic reaction ). Signs may include sudden rash, itching or raised rash ( hives ) and swelling of the face, lips, tongue or other parts of the body. Shortness of breath, wheezing or difficulty breathing may also occur
Myocardial infarction (cardiac arrest). Signs may include chest pain that may spread to your neck and shoulders and down your left arm.
Respiratory problems or respiratory complications (sometimes leading to respiratory arrest).
Choking and sudden blockage of the airways ( laryngospasm )

Life-threatening side effects are more likely to occur in adults over 60 years of age and in those who already have difficulty breathing or heart problems, especially if the injection is given too quickly or in high doses.

For a list of side effects associated with midazolam discontinuation, see section 2 of this leaflet.

Other possible side effects:

Immune system:

general allergic reactions (skin reactions, cardiovascular reactions, wheezing).

Impact on behavior:

excitement
restlessness
hostility, outbursts of rage or aggression
indignation

Muscle problem:

muscle spasms and muscle tremors (tremors in the muscles that you can not control)

Mental problems and problems in the nervous system:

confusion
euphoria (to feel very happy or elated)
hallucinations (see or possibly hear things that do not exist)
drowsiness and prolonged sedation
decreased alertness
headache
dizziness
difficulty coordinating the muscles
seizures in premature babies and newborns
temporary memory loss. How long this lasts depends on how much midazolam you have been given. You may experience this after your treatment. In some cases, the memory loss has been prolonged (has persisted for a long period).

Problems with heart and blood circulation:

low blood pressure
slow heart rate
redness of the face and neck (swelling), fainting or headache.

Breathing difficulties:

shortness of breath
hiccup.

Stomach, intestinal and oral problems:

nausea or vomiting
constipation
dry mouth .

Skin problems:

rash
hives (increased skin rash)
itching .

Injection site problems:

redness
skin swelling
blood clots or pain at the injection site.

Generally:

fatigue (exhaustion).

Elderly patients:

Elderly patients taking benzodiazepines have an increased risk of falling and having a fracture (bone fracture).
Life-threatening side effects are more likely to occur in adult patients over 60 years of age and those who already have difficulty breathing or heart problems, especially when injected too quickly or in high doses .

How to store Midazolam Panpharma

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

Do not use this medicine after the expiry date which is stated on the ampoule/vial label after EXP.

The expiration date is the last day of the specified month.

Keep the ampoule or vial in the outer carton. Sensitive to light.

After dilution, the solution must be used immediately. If the solution is not used immediately, the time before and conditions of storage before and after dilution is the user’s responsibility.

Do not use Midazolam Panpharma if you notice particles in the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is midazolam.

Midazolam Panpharma 1 mg / ml solution for injection :

Each ml contains 1 mg of midazolam.

One 5 ml ampoule contains 5 mg midazolam.

Midazolam Panpharma 5 mg / ml solution for injection :

Each ml contains 5 mg of midazolam.

One 1 ml ampoule contains 5 mg midazolam.

One 3 ml ampoule contains 15 mg of midazolam.

One 10 ml vial contains 50 mg of midazolam.

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

What the medicine looks like and contents of the pack

Midazolam Panpharma 1 mg / ml solution for injection :

The medicine is available as a solution for injection in a 5 ml ampoule

Pack sizes: 5, 6, 10, or 25.

Midazolam Panpharma 5 mg / ml solution for injection :

The medicine is available as a solution for injection in:

1 ml ampoule , pack sizes: 1, 5, 6, 10 or 25

3 ml ampoule , pack sizes: 1, 5, 6, 10 or 25

10 ml vial , pack sizes: 1, 5, 6, 10 or 25

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

PANPHARMA

ZI du Claire

35133 Luitré

France

Manufacturer:

PANPHARMA GmbH

Bunsenstrasse 4

22946 Trittau

Germany