50 mg/ml concentrate for solution for injection or infusion 
amiodarone hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Amiodarone Hameln is and what it is used for 
2. What you need to know before you are given Amiodarone Hameln 
3. How Amiodarone Hameln is given 
4. Possible side effects 
5. How to store Amiodarone Hameln 
6. Contents of the packaging and other information 

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

Amiodarone is a so-called antiarrhythmic and is used to treat an irregular heartbeat. Amiodarone works by controlling the heart if it is not beating normally.

As a solution for injection, amiodarone is usually given only when a quick response is required or if you are unable to take tablets.

Your doctor will give you an injection and you will be monitored in a hospital or under the supervision of a specialist.

Amiodarone contained in Amiodarone Hameln may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 receive Amiodarone Hameln

Do not use Amiodarone Hameln

  • if you are allergic to amiodarone, iodine, or any of the other ingredients of this medicine (listed in section 6).
  • if your heart beats slower than usual (so-called sinus bradycardia ) or if you have a disease that causes irregular heartbeats (eg sinoatrial heart block or diseased sinus syndrome).
  • if you have any other heart problems and do not have a pacemaker, for example, if you have AV block (a type of conduction disorder in the heart).
  • if your thyroid gland is not working properly. Your doctor should examine your thyroid function before taking this medicine.
  • if you are taking certain other medicines that may affect your heartbeat (see also “Other medicines and Amiodarone Hameln”).
  • if the person being given the medicine is a premature baby or a newborn baby or children under 3 years of age.

You must not be given Amiodarone Hameln:

  • if you are pregnant or breastfeeding (use is only permitted in life-threatening situations).

Warnings and cautions

Special care should be taken by the physician and close and regular monitoring (eg ECG and blood pressure, liver and thyroid function) is required:

– if you have a weak heart or heart failure.

– if you have low blood pressure.

– if you have liver problems.

– if you have any lung problems including asthma.

– if you have problems with your thyroid gland.

Ask your doctor if any of the above apply to you or have previously affected you.

Other medicines and Amiodarone Hameln

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important with the following medicines as they may interact with amiodarone:

• Medicines for irregular heartbeat (eg quinidine, procainamide, disopyramide, and sotalol).

• Medicines to improve the blood supply to the brain (eg wine stoves).

• Medicines for mental illness (eg sultopride, pimozide) and certain other types of medicines called phenothiazines (eg thioridazine).

• Medicines used for indigestion (eg cisapride).

• Medicines for infection (eg moxifloxacin, erythromycin).

• Injections of pentamidine (used in certain types of pneumonia ).

• Some antidepressants (eg amitriptyline, clomipramine, dosulepin, doxepine, imipramine, lofepramine, nortriptyline, trimiprimine, maoprotiline).

• Antihistamines for hay fever, rash, or other allergies (eg terfenadine).

• Medicines for malaria (eg halofantrine).

Not recommended

The use of the following medicines with amiodarone is not recommended:

• Beta-blockers, drugs for heart disease and high blood pressure (e.g. propranolol).

• Calcium antagonists, drugs for chest pain (angina), or high blood pressure (such as diltiazem or verapamil).

Caution

The following medicines should be used with amiodarone with caution. These drugs can cause low potassium levels in the blood, which can increase the risk of life-threatening heart rhythm disorders.

  • Laxatives – used for constipation (eg bisacodyl, senna).
  • Corticosteroids – used for inflammation (eg prednisolone ).
  • Tetracosactide – used in the investigation of certain hormonal problems.
  • Diuretics ( diuretics ) e.g. furosemide .
  • Amphotericin when given directly into a vein – used against fungal infections.

Amiodarone may increase the effects of the following medicines:

  • Blood thinners (eg warfarin ). Your doctor should adjust the dose one and monitor the treatment closely.
  • Phenytoin – used to treat seizures.
  • Digoxin – used for heart problems. Your doctor should monitor your treatment closely and may adjust the digoxin dose.
  • Flecainide – used for irregular heartbeats. Your doctor should monitor your treatment closely and may adjust the dose of flecainide.
  • Statins, medicines for high cholesterol (eg simvastatin or atorvastatin).
  • Ciclosporin or tacrolimus – used to prevent rejection after transplantation.
  • Fentanyl – used to relieve pain.
  • Lidocaine – a local anesthetic.
  • Sildenafil – used to treat erection problems.
  • Midazolam and triazolam – are used to help you relax before a medical procedure.
  • Ergotamine – used for migraines.

Surgery

If you are going to have surgery, you must tell the doctors who are treating you that you have received amiodarone.

Amiodarone Hameln with food, drink, and alcohol

Do not drink grapefruit juice while using amiodarone as grapefruit juice may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

Your doctor will only prescribe Amiodarone Hameln if he or she believes the benefits outweigh the risks during pregnancy. Amiodarone Hameln should only be used during pregnancy in life-threatening situations.

You should not be treated with Amiodarone Hameln if you are breast-feeding. If you receive amiodarone during pregnancy or breast-feeding, breast-feeding should be stopped.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amiodarone may affect the ability to drive or use machines. Do not drive or use machines if you are affected. In that case, consult a doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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.

Amiodarone Hameln contains benzyl alcohol

This medicine contains 22.2 mg/ml benzyl alcohol which may cause allergic reactions. Benzyl alcohol is associated with the risk of serious side effects such as difficulty breathing (so-called “gasping syndrome”) in young children.

Do not give this medicine to newborns (up to 4 weeks of age). When a doctor considers the drug to be clearly necessary, it can be given to young children (younger than 3 years) for a period of (normally) no more than a week.

If you have impaired liver or kidney function, are pregnant, or breast-feeding (see section 2-Pregnancy and breast-feeding), consult your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

3. How Amiodarone Hameln is given

Amiodarone is given into a vein ( intravenously as an injection or infusion ) and is administered by a doctor or nurse.

Dosage

The daily dose of amiodarone depends on the severity of the disease. Dose one and the duration of treatment is determined by the doctor who adjusts the dose individually.

Unless your doctor prescribes otherwise, the usual dose is 5 mg/kg body weight. The drug is injected for at least 3 minutes.

When Amiodarone is given as an injection:

  • shall dose s above 5 mg/kg body weight is not used.
  • dose one should be given as a slow injection for at least 3 minutes (unless you are receiving the medicine for resuscitation).
  • the doctor must wait at least 15 minutes before receiving another injection.
  • Repeated or continuous use may cause inflammation of the vein and damage the skin at the injection site (the surrounding skin may feel hot and tender and redness may occur). In such a situation, it is recommended that your doctor use a central venous catheter.

When Amiodarone is given as an infusion:

a dose of 5 mg/kg body weight diluted in 250 ml glucose 50 mg/ml should be used.

dose one should be given for a period of between 20 minutes and 2 hours.

– The administration one can be repeated 2-3 times a day.

Side effects that occur during treatment usually occur when too large amounts of amiodarone have been used. Therefore, the lowest possible dose of amiodarone should be given. This reduces side effects to a minimum. See also “If you have been given too much Amiodarone Hameln”.

Adults

The usual dose is 5 mg for each kilogram of your bodyweight for 20 minutes to 2 hours.

You may then receive an additional dose of 10 to 20 mg for each kilogram of body weight every 24 hours depending on your illness.

In an emergency, your doctor may decide to give you a dose of 150 mg to 300 mg as a slow injection of 3 minutes.

Your doctor will monitor how you respond to Amiodarone and dose one will be adjusted accordingly.

Children and young people

There are only limited data on the efficacy and safety of children. Your doctor will determine the correct dose.

Older

As with all patients, it is important that the lowest effective dose is used. Your doctor will carefully calculate how much Amiodarone you should be given and closely monitor your heart rate and thyroid function.

Your doctor will switch to amiodarone in tablet form as soon as it is considered appropriate.

If you use more Amiodarone Hameln than you should 

Because you are receiving this medicine in a hospital or under the supervision of a doctor, it is unlikely that you will receive too much.

If you have nevertheless received a higher dose than recommended, you will be closely monitored by your doctor and receive supportive care if necessary.

You may experience the following side effects: nausea, vomiting, constipation, and sweating. You may have an abnormally slow or fast heart rate.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects are grouped according to the following frequencies:
Very common occurs in more than 1 user in 10
Usual occurs in 1 to 10 users out of 100
Less common occurs in 1 to 10 users out of 1,000
Rare occurs in 1 to 10 users out of 10,000
Very rare occurs in more than 1 user in 10,000
No known frequency can not be calculated from available data

The following side effects have been reported:

Very common:

  • Blurred vision or seeing colored rings at the dazzling light

Usual:

  • Slow heart rate
  • Drop-in blood pressure and fast heart rate. These side effects occur immediately after injection. The effects are usually moderate and short-lived. They can be serious if you have been given too much Amiodarone Hameln too quickly.
  • At the place where you are given injection one or infusion one, you can experience:
    • pain
    • skin redness or change in skin color
    • local tissue death
    • leakage of fluid (from blood vessels to surrounding tissue )
    • swelling caused by fluid accumulation in the skin
    • inflammation or inflamed blood vessels
    • induration
    • infection
  • Tremors when moving arms or legs
  • Itchy, red rash ( eczema )

Uncommon:

  • A feeling of weakness or numbness, stinging or burning sensation in any part of the body

Rare:

  • Allergic reactions. Symptoms of such reactions include:
    • low platelet count accompanied by a bruising and bleeding tendency
    • blood vessel diseases
    • kidney diseases
  • The excipient benzyl alcohol may cause hypersensitivity reactions.

Very rare:

  • Feeling sick, feeling confused or weak, nausea, decreased appetite, irritation. This can be a disease called inadequate ADH – secretion (SIADH, “Syndrome of Inappropriate anti-diuretic hormone secretion”).
  • Headache
  • Increased pressure in the skull accompanied by headache, nausea, and vomiting
  • Severe heart rate
  • The occurrence of new cardiac arrhythmias or exacerbation of existing cardiac arrhythmia
  • Conduction disorders
  • Hot flashes
  • Breathing difficulties
  • Lung injury
  • Nausea
  • Abnormal liver function values
  • Acute dysfunction of the liver
  • Sweating
  • Loss of vision in one eye or blurred vision / affected color vision. Your eyes may feel sore or irritated and hurt to touch. This may be a sign of a disease called optic neuropathy or neuritis ( inflammation of the optic nerve ).
  • Anaphylactic shock. Symptoms of anaphylactic shock include:
    • severe drop in blood pressure
    • pallor
    • restlessness
    • weak and fast heartbeats
    • cold and sticky skin
    • impaired consciousness

No known frequency

  • Hyperthyroidism (overactive thyroid gland ) – you may feel extreme restlessness or anxiety, weight loss, and increased sweating. You may have difficulty coping with high temperatures. Talk to your doctor as soon as possible if you experience any of these symptoms.
  • Hypothyroidism (underactive thyroid gland ) – you may feel extreme fatigue, weakness and fatigue, weight gain, constipation, and muscle aches. You may have difficulty coping with low temperatures.
  • Sudden inflammation of the pancreas ( acute pancreatitis ); confusion ( delirium ); life-threatening skin reactions characterized by rash, blisters, skin detachment, and pain ( toxic epidermal necrolysis, Stevens-Johnson syndrome, bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS)).

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Amiodarone Hameln

  • Your doctor or pharmacist is responsible for storing Amiodarone Hameln. They are also responsible for ensuring that unused medicines are discarded according to current instructions.
  • Do not store above 25 ° C. Store in a cold place. Do not freeze. Keep the vial are in the outer carton. Sensitive to light.
  • A diluted solution should be used immediately.
  • 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 carton after EXP. The expiration date is the last day of the specified month.
  • Do not use this medicine if the solution is cloudy or contains particles or if the container is damaged.
  • For single use only. Unused solution should be discarded.

6. Contents of the packaging and other information

Content declaration

The active substance is amiodarone hydrochloride.

Each milliliter of concentrate for solution for injection/infusion contains 50 milligrams (mg) of amiodarone hydrochloride equivalent to 46.9 mg of amiodarone.

1 ampoule of 3 ml Amiodarone Hameln contains 150 mg of amiodarone hydrochloride.

One ampoule of Amiodarone Hameln diluted as recommended in 250 ml glucose 50 mg/ml contains amiodarone hydrochloride at a concentration of 0.6 mg/ml.

Other ingredients are:

Polysorbate 80 (E433)

Benzyl alcohol

Water for injections.

What the medicine looks like and the contents of the pack

Amiodarone Hameln is a clear, pale yellow, sterile particle-free solution.

Pack sizes:

Amiodarone Hameln is available as a 5 ml ampoule of glass with 3 ml concentrate for solution for injection or infusion, in packs of 5 or 10 ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

hameln pharma gmbh

Inselstraße 1

31787 Hameln

Germany

Manufacturer:

HBM Pharma sro

Sklabinská 30

03680 Martin

Slovakia

hameln rds as

Horná 36

90001 Modra

Slovakia

This medicinal product is authorized under the European Economic Area under the names:

Bulgaria: Amiodarone Hameln 50 mg/ml

Denmark: Amiodarone Hameln

Finland : Amiodarone Hameln 50 mg / ml Injection / Infusion Concentrate, most commonly

Croatia: Amiodarone Hameln 50 mg / ml octopine concentrate for injection / infusion

Netherlands: Amiodarone HCl Hamelin 50 mg/ml

Norway: Amiodarone Hameln

Poland: Amiodarone Hameln

Slovakia: Amiodarone Hameln 50 mg / ml

Slovenia: Amjodaron Hameln 50 mg / ml concentrate for injection / infusion

United Kingdom: Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection / Infusion

Czech Republic: Amiodarone Hameln

Germany: Amiodarone -Hameln 50 mg/ml concentrate for the preparation of an injection/infusion solution

Hungary: Amiodarone Hameln 50 mg/ml

Austria: Amiodarone Hameln 50 mg / ml concentrate for the preparation of an injection / infusion solution

Muhammad Nadeem

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