Amiodaron hameln

Leaflet attached to the packaging: INFORMATION FOR THE USER

Amiodarone hameln, 50 mg/ml, concentrate for solution for injection/infusion

Amiodarone hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Amiodarone hameln and what is it used for

Amiodarone hameln is used to treat irregular heart rhythm, known as arrhythmia.
The action of amiodarone is to control the heart rhythm if it is not normal.
Amiodarone hameln is administered when rapid action of the medicine is needed or when taking tablets is not possible.
The doctor will administer the injection, and the patient's condition will be monitored in the hospital or under the supervision of a specialist.

2. Important information before using Amiodarone hameln

When not to use Amiodarone hameln

• if the patient is allergic to amiodarone, iodine, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a slow heart rate (so-called sinus bradycardia) or irregular heart rhythm (e.g., atrioventricular block, sick sinus syndrome),
• if the patient has other heart disorders without a pacemaker, for example, if there is an atrioventricular block (a type of conduction disorder in the heart),
• if the patient has thyroid disorders - the doctor will perform a thyroid test before administering the medicine,
• if the patient is taking other medicines that may affect the heart rhythm (see also subsection "Amiodarone hameln and other medicines").
• if the person receiving the medicine is a premature or full-term newborn.

If the patient is on the waiting list for a heart transplant, the doctor may change the treatment method.
This is because taking amiodarone before a heart transplant has shown an increased risk of life-threatening complications (primary graft dysfunction, PGD), where the transplanted heart stops working properly within the first 24 hours after surgery.

Amiodarone hameln must not be administered:

• if the patient is pregnant or breastfeeding (the medicine can only be used in life-threatening situations).

Warnings and precautions

The doctor will carefully and regularly monitor the ECG, blood pressure, and liver and thyroid function:

• if the patient's heart function worsens or heart failure occurs,
• if the patient has low blood pressure,
• if the patient has liver disorders,
• if the patient has any lung disorders, including asthma,
• if the patient has any thyroid disorders.

Special caution is required when using Amiodarone hydrochloride 50 mg/ml. Consult a doctor, pharmacist, or nurse if:

• there are any vision problems (which may be symptoms of optic neuropathy or optic neuritis);
• the person receiving the medicine is an infant or child under 3 years of age;
• blisters or skin bleeding occur, covering the areas around the lips, eyes, mouth, nose, and genitals; flu-like symptoms and fever (this may be a symptom of Stevens-Johnson syndrome);
• there is a severe blistering rash, where skin layers may peel off, leaving large areas of exposed skin on the body; general poor condition, fever, chills, and muscle pain (toxic epidermal necrolysis);
• the patient is currently taking a medicine containing sofosbuvir for the treatment of hepatitis C, as this may cause life-threatening slow heart rhythm (the doctor may consider alternative treatment methods; if amiodarone and sofosbuvir treatment is necessary, additional heart rhythm monitoring may be required).

The patient should immediately inform their doctor if they are taking a medicine containing sofosbuvir for the treatment of viral hepatitis C and experience any of the following during treatment:
slow or irregular heartbeat or arrhythmia,
shortness of breath or worsening of existing shortness of breath,
chest pain,
dizziness,
palpitations,
fainting or loss of consciousness.
If the above warnings apply to the patient or have applied in the past, they should
consult a doctor.

Amiodarone hameln and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important in the case of the following medicines, which may interact with amiodarone:

• medicines used for irregular heart rhythm (e.g., quinidine, procainamide, disopyramide, and sotalol),
• medicines that improve blood flow to the brain (e.g., vinpocetine),
• medicines used for mental disorders (e.g., sultopride, sulpiride, pimozide) and some types of medicines called phenothiazines (e.g., thioridazine),
• medicines used for digestive disorders (e.g., cisapride),
• medicines used for infections (e.g., moxifloxacin, erythromycin),
• pentamidine injection (used for certain types of pneumonia),
• certain antidepressants (e.g., amitriptyline, clomipramine, dosulepin, doxepin, imipramine, lofepramine, nortriptyline, trimipramine, maprotiline),
• medicines used for the treatment of hay fever, rash, or other allergies, called antihistamines (e.g., terfenadine),
• medicines used for the treatment of malaria (e.g., halofantrine),
• sofosbuvir, used for the treatment of hepatitis C.

Not recommended for concurrent use
It is not recommended to use the following medicines concurrently with amiodarone:

• medicines used for heart disease and high blood pressure, called beta-adrenergic blockers (e.g., propranolol),
• medicines used for the treatment of chest pain (angina pectoris) or high blood pressure, called calcium antagonists (e.g., diltiazem or verapamil).

Concurrent use requiring caution
Special caution is required when using the following medicines concurrently with amiodarone. These medicines may decrease potassium levels in the blood, which can increase the risk of life-threatening arrhythmias:

• laxatives - used for constipation (e.g., bisacodyl, senna),
• corticosteroids - used for inflammatory conditions (e.g., prednisolone),
• tetracosactide - used for the diagnosis of certain hormonal disorders,
• diuretics (e.g., furosemide),
• amphotericin B administered intravenously - used for fungal infections.

Amiodarone may enhance the effect of the following medicines:

• medicines used to thin the blood (e.g., warfarin) - the doctor will adjust the dose and closely monitor the treatment,
• phenytoin - used for the treatment of seizures,
• digoxin - used for heart disease - the doctor will closely monitor the patient's condition and adjust the digoxin dose,
• flecainide - used for arrhythmia - the doctor will closely monitor the patient's condition and adjust the flecainide dose,
• medicines used for high cholesterol, called statins (e.g., simvastatin or atorvastatin),
• cyclosporin, tacrolimus, and sirolimus - used to prevent organ rejection,
• fentanyl - used for pain relief,
• lidocaine - a local anesthetic,
• sildenafil - used for erectile dysfunction,
• midazolam and triazolam - used for relaxation, e.g., before a medical procedure,
• ergotamine - used for migraine.

Surgical procedures

If a surgical procedure is planned, the patient should inform their doctor about taking amiodarone.

Amiodarone hameln with food and drink

While taking this medicine, the patient should not drink grapefruit juice. This is because drinking grapefruit juice while taking amiodarone may increase the risk of side effects.

Pregnancy and breastfeeding

The doctor will only recommend Amiodarone hameln during pregnancy if they believe the benefits of treatment outweigh the risks. During pregnancy, Amiodarone hameln can only be used in life-threatening situations.
Using Amiodarone hameln is contraindicated during breastfeeding. If amiodarone needs to be administered to a breastfeeding patient, breastfeeding should be stopped.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and operating machinery

Amiodarone may affect the ability to drive and operate machinery. If side effects occur, the patient should not drive or operate machinery.
In such cases, the patient should consult their doctor.

Amiodarone hameln contains benzyl alcohol

This medicine contains 22.2 mg of benzyl alcohol in each milliliter. It may cause allergic reactions. Administering benzyl alcohol to small children is associated with the risk of serious side effects, including breathing difficulties (so-called "gasping syndrome"). Do not administer to newborns (up to 4 weeks of age). Do not administer to small children (under 3 years of age) for more than a week without consulting a doctor or pharmacist.
Patients with liver or kidney disease, pregnant or breastfeeding women (see section 2 - Pregnancy and breastfeeding) should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called "metabolic acidosis").

3. How to use Amiodarone hameln

Amiodarone is administered intravenously by a doctor or nurse (by injection or infusion).

Dosage

The daily dose of Amiodarone hameln depends on the severity of the disease. The doctor will determine the dose and duration of treatment individually for each patient.
Unless the doctor recommends otherwise, the usual dose is 5 mg per kilogram of body weight. The medicine should be injected over at least 3 minutes.
Intravenous injection:

• the administered dose should not be greater than 5 mg per kilogram of body weight,
• the dose should be administered slowly, over at least 3 minutes (unless the medicine is administered to a patient during resuscitation),
• the doctor will wait at least 15 minutes before the next injection,
• repeated or continuous administration may cause vein inflammation and skin damage at the injection site (the surrounding skin may be warm, tender, and red) - in such cases, it is recommended to insert a "central line" by a doctor.

Intravenous infusion:

• the administered dose is 5 mg/kg of body weight, diluted in 250 ml of 5% glucose solution,
• the dose should be administered over 20 minutes to 2 hours,
• administration can be repeated 2-3 times a day.

Most side effects occur during treatment when a higher dose of Amiodarone hameln is administered. Therefore, the doctor will administer the smallest possible dose of Amiodarone hameln to the patient. This will minimize side effects.
See also subsection "Using a higher dose of Amiodarone hameln than recommended".
Adults
Usually, the dose is 5 mg per kilogram of body weight, administered over 20 minutes to 2 hours.
Depending on the patient's condition, the doctor may recommend a dose of 10 mg - 20 mg per kilogram of body weight over 24 hours.
In life-threatening situations, the doctor may administer 150 mg - 300 mg in a slow injection lasting at least 3 minutes.
The doctor will monitor the patient's response to Amiodarone hameln and adjust the dose accordingly.
Children and adolescents
Data on the efficacy and safety of amiodarone in children are limited. The doctor will determine the appropriate dose.
Elderly patients
As with all patients, the doctor will recommend the smallest effective dose. The doctor will determine the dose suitable for the patient and closely monitor their heart rhythm and thyroid function.
The doctor will change the form of the medicine to tablets as soon as possible.

Using a higher dose of Amiodarone hameln than recommended

Since the medicine will be administered in a hospital or under the supervision of a doctor, it is unlikely that the patient will receive a higher dose than recommended.
However, if a higher dose than recommended is administered, the doctor will closely monitor the patient's health and provide supportive treatment if necessary.
The following symptoms may occur: nausea, vomiting, constipation, or excessive sweating, as well as abnormally slow or fast heart rhythm.
If there are any further doubts about using this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Amiodarone hameln can cause side effects, although not everybody gets them.
Amiodarone hydrochloride 50 mg/ml may remain in the blood for up to a month after treatment is stopped. During this time, side effects can still occur.

Stop taking amiodarone hydrochloride 50 mg/ml and inform your doctor, nurse, or pharmacist or go to the hospital immediately if you experience any of the following:

Very rare(occurring in less than 1 in 10,000 people):

• allergic reactions (symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue);
• slow heart rate, dizziness, unusual tiredness, and shortness of breath (this may occur especially in people over 65 years of age or in people with arrhythmia);
• arrhythmia (this may lead to a heart attack, so it is essential to go to the hospital immediately);
• yellowing of the skin or eyes (jaundice), feeling tired or nauseous, loss of appetite, abdominal pain, or high fever (these may be symptoms of liver dysfunction or damage, which can be very dangerous);
• difficulty breathing or chest tightness, persistent cough, wheezing, weight loss, and fever (this may be caused by pneumonia, which can be very dangerous).

Frequency not known(cannot be estimated from the available data):

• life-threatening arrhythmia of the type torsades de pointes;
• swelling of the skin and mucous membranes (angioedema);
• blisters or peeling of the skin around the lips, eyes, mouth, nose, and genitals, flu-like symptoms, and fever (Stevens-Johnson syndrome);
• severe blistering rash, where skin layers may peel off, leaving large areas of exposed skin on the body, general poor condition, fever, chills, and muscle pain (toxic epidermal necrolysis);
• skin inflammation characterized by blisters filled with fluid (bullous dermatitis);
• flu-like symptoms and rash on the face, followed by prolonged rash with high fever, increased liver enzyme activity in blood tests, and increased white blood cell count (eosinophilia) and lymph node enlargement (DRESS).

In case of any of the following severe side effects, stop using Amiodarone hydrochloride 50 mg/ml and consult a doctor immediately - emergency treatment may be necessary:

Very rare(occurring in less than 1 in 10,000 people):

• central nervous system disorders: headaches (which usually worsen in the morning or after coughing or exertion), nausea, seizures, fainting, vision problems, or confusion.

Inform your doctor, nurse, or pharmacist as soon as possible if you experience any of the following side effects:

Common(occurring in less than 1 in 10 people):

• peeling and itchy rashes (exfoliative dermatitis);
• dizziness, fainting, or loss of consciousness (may be temporary and is caused by a decrease in blood pressure).

Frequency not known(cannot be estimated from the available data):

• pancreatitis, which causes severe abdominal and back pain;
• seeing, hearing, or feeling things that are not there (hallucinations);
• There may be an increased number of infections. This may be due to a decrease in the number of white blood cells (neutropenia);
• significant decrease in the number of white blood cells, which increases the likelihood of infections (agranulocytosis);
• Loss of vision in one eye or blurred vision and (or) worsening of color vision. The patient may feel pain or tenderness in the eyes and pain when moving the eyeballs. (optic neuropathy or optic neuritis);
• feeling extremely anxious or agitated, weight loss, increased sweating, and inability to tolerate heat (hyperthyroidism);
• overgrowth of tissue found in larger bones of the body (bone marrow granuloma).

Inform your doctor, nurse, or pharmacist if any of the following side effects worsen or persist for more than a few days:

Very common(occurring in more than 1 in 10 people):

• blurred vision or seeing a colored aura in dazzling light.

Common(occurring in less than 1 in 10 people)

• slow heart rate;
• at the injection or infusion site, the following may occur:
• pain,
• redness of the skin or change in skin color,
• local tissue damage,
• leakage of fluid,
• swelling caused by fluid in the skin,
• inflammation or inflammation of blood vessels,
• hardening of tissue,
• infection;
• trembling when moving hands or feet.
• Decreased sexual desire

Uncommon(occurring in less than 1 in 100 people):

• feeling of numbness or weakness, tingling, or burning in any part of the body.

Rare(occurring in less than 1 in 1,000 people):

• allergic reaction to benzyl alcohol (an excipient).

Very rare(occurring in less than 1 in 10,000 people):

• changes in liver enzyme activity at the beginning of treatment, which can be detected in blood tests;
• nausea;
• headache;
• sweating;
• hot flashes;
• general poor condition, confusion, or weakness, nausea (nausea), loss of appetite, irritability (this may be a symptom of the syndrome of inappropriate antidiuretic hormone secretion, SIADH);
• conduction disorders.

Frequency not known(frequency cannot be estimated from the available data):

• life-threatening complication after heart transplantation (primary graft dysfunction), where the transplanted heart stops working properly (see section 2, Warnings and precautions);
• hives (itchy, lumpy rash);
• back pain;
• decreased sexual desire;
• hypothyroidism (extreme fatigue, weakness, or exhaustion, weight gain, constipation, and muscle pain, sensitivity to low temperatures);
• confusion (delirium).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al.
Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Amiodarone hameln

• The doctor or pharmacist is responsible for storing Amiodarone hameln. They are also responsible for the proper disposal of any unused remains of the medicine.
• Do not store above 25°C. Do not store in the refrigerator or freeze.
• Store the ampoules in the outer packaging to protect them from light.
• The diluted solution should be used immediately.
• Store the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month stated.
• Do not use the medicine if the solution is not clear or contains any particles, or if the packaging is damaged.
• For single use only. Unused solution should be discarded.

6. Contents of the packaging and other information

What Amiodarone hameln contains

The active substance of the medicine is amiodarone hydrochloride.
Each milliliter of the concentrate for solution for injection/infusion contains 50 milligrams (mg) of amiodarone hydrochloride, which corresponds to 46.9 mg of amiodarone.
One ampoule of 3 ml of the concentrate contains 150 mg of amiodarone hydrochloride.
One ampoule of Amiodarone hameln diluted according to the recommendations in 250 ml of 5% glucose solution allows for a concentration of 0.6 mg/ml of amiodarone hydrochloride.
The other ingredients are: polysorbate 80 (E433), benzyl alcohol, water for injections.

What Amiodarone hameln looks like and contents of the pack

Clear, light yellow, sterile solution.
Pack sizes:
Amiodarone hameln is available in glass ampoules of 5 ml with 3 ml of concentrate for solution for injection/infusion, in packs of 5 or 10 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder:
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Manufacturer:
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovak Republic
hameln rds s.r.o.
Horná 36
90001 Modra
Slovak Republic

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: 05/2022

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Information intended for healthcare professionals only:

GUIDELINES FOR PREPARATION:

Amiodarone hameln, 50 mg/ml, concentrate for solution for injection/infusion

• Clear, light yellow, sterile solution.
• pH 3.5 - 4.5.
• For intravenous administration.

There have been reports of crystallization of Amiodarone hameln, 50 mg/ml, concentrate for solution for injection/infusion. Check each ampoule before administration and only use if it does not contain crystalline content. Consider using in-line intravenous filters with the possibility of connection to the infusion set as an additional precaution.
Amiodarone is incompatible with physiological saline solution and can only be administered after dilution in 5% glucose solution.

Pharmaceutical incompatibilities

Amiodarone may cause the release of the plasticizer DEHP (di-2-ethylhexyl phthalate) into the solution when medical equipment containing DEHP is used. To minimize exposure to DEHP, amiodarone should be administered in an infusion solution using DEHP-free sets, e.g., made of polyolefin (PE, PP) or glass. Do not add any other substances to the amiodarone infusion solution.
The medicine must not be mixed with other medicines, except for those listed below.
Do not mix other products in the same syringe. Do not administer other medicines in the same infusion line.
If treatment with amiodarone hydrochloride 50 mg/ml concentrate for solution for injection/infusion needs to be continued, it should be done in an intravenous infusion line.

Dilution

The medicine should be diluted in 5% glucose solution.

To dilute each ampoule, use a maximum of 250 ml of 5% glucose solution.
Dilutions with a lower concentration are unstable. Amiodarone, diluted in 5% glucose solution to a concentration of less than 0.6 mg/ml, is unstable. Solutions containing less than 2 ampoules of Amiodarone hameln in 500 ml of 5% glucose solution are unstable and should not be used.
Dilution should be performed under aseptic conditions. Check the solution visually for particulate matter and discoloration before administration. The solution should only be used if it is clear and free of particles.

Stability of the solution

The diluted product is physically and chemically stable for 24 hours at 25°C. However, for microbiological reasons, the medicine should be used immediately after dilution. If the product is not used immediately, the user is responsible for the storage time and conditions before use, and this should not be longer than 24 hours at a temperature of 2 to 8°C, unless the dilution took place under controlled and validated aseptic conditions.

Storage

Do not store above 25°C. Do not store in the refrigerator or freeze.
Store the ampoules in the outer packaging to protect them from light.
Intended for single use only. Any unused remains of the medicine or its waste should be disposed of in accordance with local regulations.