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AMIODARONE HYDROCHLORIDE 50 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): AMIODARONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

hameln

Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection/Infusion
Active substance: Amiodarone hydrochloride

Read all of this leaflet carefully before you are given this medicine because it contains important information
for you.
→→ Keep this leaflet. 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 includes any possible side effects not listed in
this leaflet.
What is in this leaflet:
1. What Amiodarone is and what it is used for
2. What you need to know before you are given
Amiodarone
3. How Amiodarone is given
4. Possible side effects
5. How to store Amiodarone
6. Contents of the pack and other information
1. WHAT AMIODARONE IS AND WHAT IT IS USED
FOR
What is Amiodarone used for?
Amiodarone is used to treat irregular beating of your
heart called “arrhythmias”. Amiodarone works by
controlling your heart if it is not beating normally.
Amiodarone as a solution for injection is normally only
given when a quick response is needed or if you are
unable to take tablets.
Your doctor will give you the injection and you will be
monitored under hospital or specialist supervision.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN AMIODARONE
Do not use Amiodarone:
• if you are allergic (hypersensitive) to amiodarone,
iodine or any of the other ingredients of this medicine
(listed in section 6).
• if you have a slower than usual heartbeat (called sinus
bradycardia) or are suffering from an illness which
causes irregular heartbeats (e.g. sino-atrial block, sick
sinus syndrome).
• if you have any other problems with your heart and
do not have a pacemaker, for example if you have AV
block (a type of heart conduction disorder).
• if your thyroid gland is not working properly. Your
doctor should test your thyroid before giving you this
medicine.
• if you are taking certain other medicines which could
affect your heartbeat (see also “Other medicines and
Amiodarone”).
• if the person that would be given this medicine is a
premature baby or a neonate or a child up to 3 years
old.
Amiodarone must not be given:
• if you are pregnant or breast-feeding (its use is only
allowed in life-threatening circumstances).
Warnings and precautions
Your doctor will carefully and regularly monitor your ECG
and blood pressure, liver and thyroid function:
- if you have a weak heart or heart failure.
- if you have low blood pressure.
- if you have liver problems.
- if you have any problems with your lungs including
asthma.
- if you have any problems with your thyroid gland.
Consult your doctor if any of the above mentioned
warnings apply to you, or have applied to you in the
past.
Other medicines and Amiodarone
Please 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 an irregular heartbeat (e.g. quinidine,
procainamide, disopyramide and sotalol).
• Medicines to improve blood supply to the brain (e.g.
vincamine).
• Medicines for mental illnesses (e.g. sultopride,
sulpiride, pimozide) and some types of medicines
called phenothiazines (e.g. thioridazine).
• Medicines used for digestive problems (e.g. cisapride).
• Medicines
for
infections
(e.g.
moxifloxacin,
erythromycin).
• Injections of pentamidine (used in certain types of
pneumonia).
• Certain
antidepressants
(e.g.
amitriptyline,
clomipramine, dosulepin, doxepin, imipramine,
lofepramine, nortriptyline, trimipramine, maprotiline).
• Medicines used for hay fever, rashes or other allergies
called antihistamines (e.g. terfenadine).
• Medicines for malaria (e.g. halofantrine).
Not recommended
It is not recommended to use the following medicines at
the same time as Amiodarone:
• Medicines for heart problems and high blood pressure
called beta-blockers (e.g. propranolol).
• Medicines for chest pain (angina) or high blood
pressure called calcium channel blockers (e.g.
diltiazem or verapamil).
Caution
You should use caution when using the following
medicines at the same time as amiodarone. These
medicines can cause low blood levels of potassium
which can increase the risk of life-threatening irregular
heartbeats.

• Laxatives - used for constipation (e.g. bisacodyl,
senna).
• Corticosteroids - used for inflammation (e.g.
prednisolone).
• Tetracosactide - used to test some hormone problems.
• Diuretics (water tablets) e.g. furosemide.
• Amphotericin, when give directly into a vein - used for
fungal infections.
Amiodarone may increase the effects of the following
medicines:
• Medicines used for thinning the blood (e.g. warfarin).
Your doctor should adjust your dose and monitor your
treatment closely.
• Phenytoin - used to treat fits.
• Digoxin - used for heart problems. Your doctor should
monitor your treatment closely and may adjust your
dose of digoxin.
• Flecainide - used for uneven heart beats. Your doctor
should monitor your treatment closely and may adjust
your dose of flecainide.
• Medicines for high cholesterol called statins (e.g.
simvastatin or atorvastatin).
• Ciclosporin or tacrolimus - used to help prevent
rejection of transplants.
• Fentanyl - used for pain relief.
• Lidocaine - a local anaesthetic.
• Sildenafil - used to treat erection problems.
• Midazolam and triazolam - used to help you relax e.g.
before a medical procedure.
• Ergotamine - used for migraines.
Surgery
If you are to have any surgery, you must tell the doctors
treating you that you are using Amiodarone.
Amiodarone with food and drink
Food and drink do not affect the therapeutic efficacy of
this medicine as it is not administered by the oral route.
Pregnancy and breast-feeding
Your doctor will prescribe Amiodarone only if he considers
the benefit of treatment outweighs the risks during your
pregnancy. Amiodarone can be used during pregnancy in
life-threatening circumstances only.
You should not be given Amiodarone if you are breastfeeding. If you are given 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 your ability to drive or use
machines. Do not drive or use machines if you are
affected. In such a case ask your doctor for advice.
Amiodarone contains benzyl alcohol (22.2 mg/ml).
It may cause toxic reactions and allergic reactions in
infants and children up to 3 years old.
3. HOW AMIODARONE IS GIVEN
Amiodarone is given into a vein (intravenously as an
injection or infusion) and administered by a doctor or
nurse.
Dosage
The daily dose of Amiodarone depends on the severity
of your illness. The dose and the treatment times will
be determined by your doctor, who will adjust these
especially for you.
Unless otherwise prescribed by your doctor, the usual
dose is 5 mg per kg of body weight. Your medicine will be
injected over a period of at least 3 minutes.
When Amiodarone is given as an injection
• you should not be given a dose greater than 5 mg per
kg of body weight.
• the dose should be given to you slowly over a period
of at least 3 minutes (unless you are being given the
medicine for resuscitation).
• the doctor must wait for at least 15 minutes before
giving you another injection.
• repeated or continuous administration may cause
inflammation of the vein and damage to the skin at
the injection site (the surrounding skin may feel warm
and tender and redness may be present) and in such
situations a “central venous catheter” is recommended
for use by your doctor.
When Amiodarione is given as an infusion
- you should be given a dose of 5 mg/kg bodyweight
diluted in 250 ml of 5% glucose solution.
- the dose should be given to you over a period of
20 minutes to 2 hours.
- The administration may be repeated 2-3 times per day.
Most of the side effects which occur during treatment
occur if you are given too much Amiodarone. You
should therefore be given the lowest possible dose of
Amiodarone. This will keep side effects to a minimum.
See also “If you have received more Amiodarone than
you should”.

--------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
PREPARATION GUIDE FOR:

hameln

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion
- Clear pale yellow solution, in a clear and colourless
glass ampoule.
- pH: 3.5-4.5
- For intravenous use
Incompatibilities
Amiodarone is incompatible with saline solution
and may only be administered in a 5% Glucose
Intravenous Infusion solution.
In the presence of amiodarone the use of administration
equipment containing softening agents such as DEHP
(di-2-ethylhexyl phthalate) may cause DEHP to leach
into the solution.

2011_079_03_PB_Amiodarone 50 mg-ml_Agila.indd 1

In order to minimise patient exposure to DEHP, diluted
amiodarone solutions for infusion should be administered
through sets that do not contain DEHP, such as polyolefin
(PE, PP) or glass sets. No other agents may be added to
amiodarone infusions.
This medicinal product must not be mixed with other
medicinal products except those mentioned below.
Before use, the sterile concentrate should be visually
inspected for clarity, particulate matter, discolouration
and the integrity of the container. The solution should
only be used if it is clear and the container is undamaged
and intact.

24.04.2015 13:35:12

Adults
The usual dose is 5 mg for every kilogram of your weight
given over a period of 20 minutes to 2 hours.
You may be given another dose of 10 to 20 mg for every
kilogram of 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 over
3 minutes.
Your doctor will monitor your response to Amiodarone
and the dose will be adjusted accordingly.
Infants and children
There are only limited data on the efficacy and safety in
children. Your doctor will decide on an appropriate dose.
Elderly
As with all patients it is important that the minimum
effective dose is used. Your doctor will carefully calculate
how much Amiodarone you should get and monitor your
heart rate and thyroid function more closely.
Your doctor will change you over to amiodarone tablets
as soon as possible.
If you have received more Amiodarone than you
should
As this medicine will be given to you whilst you are in
hospital or under the care of your doctor it is unlikely that
you will be given too much.
If, however, you have received higher doses than those
recommended you will be carefully monitored by your
doctor and will receive supportive therapy if necessary.
You may experience the following effects: feeling sick,
being sick, constipation or sweating. You may have an
abnormally slow or fast heartbeat.
If you have any further question on the use of
this medicine, ask your doctor or other healthcare
professional.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following side effects have been reported:
Common (affects 1 to 10 users in 100)
• Slow heart rate
• Drop in blood pressure and rapid heart rate. These
side effects occur straight after injection. The effects
are usually moderate and temporary. They can be
serious if you are given too much Amiodarone too
quickly.
• At the site where you are given the injection or infusion
you may experience:
- Pain
- Skin redness or a change in skin colour
- Localised soft-tissue damage
- Fluid leakage
- Swelling caused by fluid within the skin
- Inflammation or inflamed blood vessels
- Abnormally hard tissue
- Infection
Rare (affects 1 to 10 users in 10,000)
• Allergic reactions. Symptoms of such reactions
include:
- A lack of blood platelets accompanied by bruising
and a tendency to bleed
- Blood vessel disorders
- Kidney disorders
• The
excipient
benzyl
alcohol
may
cause
hypersensitivity reactions.
Very rare (affects less than 1 user in 10,000)
• Feeling unwell, confused or weak, feeling sick
(nausea), loss of appetite, feeling irritable. This could
be an illness called ‘syndrome of inappropriate antidiuretic hormone secretion’ (SIADH).
• Headache
• Increase in pressure inside the skull, accompanied by
headache, feeling sick and vomiting
• Severe slow heart beat
• Newly occurring heart rhythm disorder or worsening of
existing heart rhythm disorders.
• Heart conduction disorders
• Hot flushes
• Difficulty in breathing
• Lung damage
• Feeling sick
• Liver function abnormalities
• Acute liver dysfunction
• Sweating
• Anaphylactic shock. Symptoms of anaphylactic shock
include:
- A sharp fall in blood pressure
- Paleness
- Restlessness
- Weak and rapid heartbeat
- Clammy skin
- Reduced consciousness
Frequency not known (cannot be estimated from the
available data)
• Hyperthyroidism (overactive thyroid) – you may feel
extremely restless or agitated and experience weight
loss and increased sweating. You may be unable to
cope with high temperatures. Tell your doctor as soon
as possible if you have any of these symptoms.
• Hypothyroidism (underactive thyroid) – you may feel
extremely tired, weak or ‘run-down’ and experience
weight gain, constipation and aching muscles. You
may be unable to cope with low temperatures.
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 via the Yellow Card Scheme at: www.mhra.gov.
uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE AMIODARONE
• Your doctor or pharmacist is responsible for storing
Amiodarone. They are also responsible for disposing
of any unused Amiodarone correctly.
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date (EXP:)
which is stated on the pack. The expiry date refers to
the last day of that month.
• Do not use this medicine if you notice the solution is
not clear and free of particles or if the container is
damaged.
• Keep the ampoule in the outer carton in order to
protect from light.
• Do not store above 25°C. Do not refrigerate or freeze.
• Reconstituted/diluted solution should be used
immediately.
• For single use only. Discard any unused solution.
6. CONTENTS OF
INFORMATION

THE

PACK

AND

OTHER

What Amiodarone contains
The active substance is amiodarone hydrochloride.
Each millilitre contains 50 milligrams (mg) of amiodarone
hydrochloride equivalent to 46.9 mg amiodarone.
1 ampoule with 3 ml Amiodarone contains 150 mg
amiodarone hydrochloride.
One ampoule of Amiodarone diluted as recommended
in 250 ml of 5% w/v Glucose infusion results in a
concentration of 0.6 mg/ml of amiodarone hydrochloride.
The other ingredients are: Polysorbate 80 (E433), benzyl
alcohol and water for injections.
What Amiodarone looks like and contents of the pack
Amiodarone is a clear, pale yellow sterile solution.
Pack sizes:
Amiodarone is available as 5 ml glass ampoule with
3 ml concentrate for solution for infusion/injection in
packs of 5 or 10.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
hameln pharma plus gmbh
Langes Feld 13
31789 Hameln
Germany
Distributor:
hameln pharmaceuticals ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG, United Kingdom
Manufacturer:
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovak Republic
Agila Specialties Polska
Sp z oo, 10, Daniszewska Str,
03-230 Warsaw
Poland
This medicinal product is authorised in the Member
States of the EEA under the following names:
DE

Amiodaron-hameln 50 mg/ml Konzentrat zur
Herstellung einer Injektions-/Infusionslösung

FI

Amiodaron Hameln 50 mg/ml injektio-/
infuusiokonsentraatti, liuosta varten

SE

Amiodaron Hameln 50 mg/ml koncentrat till
injektions-/infusionsvätska, lösning

UK

Amiodarone Hydrochloride 50 mg/ml
Concentrate for Solution for Injection/Infusion

This leaflet was last revised in 04/2015.

17/15

--------------------------------------------------------------------------------------------------------------------Dilution
The ampoule should be diluted with glucose 5%.
For each ampoule, a maximum of 250 ml glucose 5%
infusion should be used. Greater dilutions are unstable.
Amiodarone, diluted in a 5% glucose solution to a
concentration of <0.6 mg/ml, is not stable. Solutions
containing less than 2 Amiodarone ampoules in 500 ml
of 5% glucose are unstable and must not be used.
Stability in solution
The diluted product is physically and chemically stable
for 24 hours at room temperature. However, from a
microbiological viewpoint, the product should be used
immediately after dilution.

Storage
Do not store above 25°C. Do not refrigerate or freeze.
Keep the ampoules in the outer carton in order to protect
from light.
Amiodarone is intended for single dose use only. Any
unused solution should be discarded immediately after
initial use.
The dilution is to be made under aseptic conditions. The
solution is to be inspected visually for particulate matter
and discoloration prior to administration. The solution
should only be used if the solution is clear and free from
particles.
17/15

2011_079_03_PB_Amiodarone 50 mg-ml_Agila.indd 2

24.04.2015 13:35:12

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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