50 mg/ml is and what it is 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 Hydrochloride 50 mg/ml is given when a quick response is needed or if you are unable to take tablets.

Your doctor will give you this medicine and you will be monitored under hospital or specialist supervision.

2. what you need to know before you are given amiodarone hydrochloride 50 mg/ml

Do not use Amiodarone Hydrochloride 50 mg/ml:

• if you are allergic to amiodarone, iodine or any of the other ingredients of this medicine (listed in see 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 Hydrochloride 50 mg/ml”).
• if the person that would be given this medicine is a premature baby or full-term newborn baby.

If you are on a heart transplant waiting list, your doctor may change your treatment. This is because taking amiodarone before heart transplantation has shown an increased risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working properly within the first 24 hours after surgery.

Amiodarone Hydrochloride 50 mg/ml 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.

Take special care with Amiodarone Hydrochloride 50 mg/ml. Check with your doctor, pharmacist or nurse if:

• you have any problems with your eyesight. This includes an illness called ‘optic neuropathy’ or ‘neuritis’.
• the person having the medicine is an infant or child under 3 years old
• you have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’.
• you have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic epidermal necrolysis).
• you currently take a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring.

Tell your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:

• Slow or irregular heartbeat or heart rhythm problems;
• Shortness of breath or worsening of existing shortness of breath;
• Chest pain;
• Light-headedness;
• Palpitations;
• Near-fainting or fainting.

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 Hydrochloride 50 mg/ml

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).
• Sofosbuvir, used for the treatment of hepatitis C.

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 Hydrochloride 50 mg/ml with food and drink

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking amiodarone can increase your chance of getting side effects.

Pregnancy and breast-feeding

Your doctor will prescribe Amiodarone Hydrochloride 50 mg/ml only if he considers the benefit of treatment outweighs the risks during your pregnancy. Amiodarone Hydrochloride 50 mg/ml can be used during pregnancy in life-threatening circumstances only.

You should not be given Amiodarone Hydrochloride 50 mg/ml if you are breast-feeding. If you are given amiodarone during pregnancy or breast-feeding, breastfeeding 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 this 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 Hydrochloride 50 mg/ml contains benzyl alcohol

This medicine contains 22.2 mg benzyl alcohol in each ml. It may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.

This medicine will not be given to newborn babies (up to 4 weeks old). When administration is considered to be clearly necessary by a doctor, this medicine can be given to young children (less than 3 years old) for a period of (normally) no more than one week.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease are pregnant or breast feeding (also see section 2 – Pregnancy and breast-feeding). This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

• 3. HOW AMIODARONE HYDROCHLORIDE
  
  50 MG/ML 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 Hydrochloride 50 mg/ml 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 Hydrochloride 50 mg/ml is given as an intravenous 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 Amiodarone Hydrochloride 50 mg/ml is given as an intravenous infusion

• you should be given a dose of 5 mg/kg bodyweight diluted in 250 ml of a glucose 5% 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 Hydrochloride 50 mg/ml. You should therefore be given the lowest possible dose of Amiodarone Hydrochloride 50 mg/ml. This will keep side effects to a minimum. See also “If you have received more Amiodarone Hydrochloride 50 mg/ml than you should”.

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.

-----K------------------------------------------------------------------------

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

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

• – Clear pale yellow sterile solution practically free from particles

• – pH 3.5–4.5

• – For intravenous use

Incompatibilities

Amiodarone is incompatible with saline solution and may only be administered in a glucose 5% 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.

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 medicine must not be mixed with other medicines except those mentioned below.

Do not mix other preparations in the same syringe. Do not inject other preparations in the same line. If treatment with Amiodarone Hydrochloride 50 mg/ml should be continued, this should be via intravenous infusion.

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 Hydrochloride 50 mg/ml and the dose will be adjusted accordingly.

Children and adolescents

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 Hydrochloride 50 mg/ml 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 Hydrochloride 50 mg/ml 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.

Amiodarone Hydrochloride 50 mg/ml may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.

Stop having Amiodarone Hydrochloride 50 mg/ml and tell a doctor, nurse or pharmacist or go to a hospital straight away if:

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

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• Your heartbeat becomes very slow or stops beating.

You may also feel dizzy, unusually tired and short of breath. This may occur especially in people over 65 years old or to people with other heartbeat problems

• Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away
• You get yellowing of the skin or eyes (jaundice), feel tired or sick, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage which can be very dangerous
• Difficulty breathing or tightness in the chest, coughing which will not go away, wheezing, weight loss and fever. This could be due to inflammation of your lungs which can be very dangerous

Frequency not known (Cannot be estimated from the available data)

• You have life-threatening irregular heartbeat (Torsade de pointes)
• You have swelling of the skin and mucous membranes (angioneurotic oedema)
• Symptoms include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flulike symptoms and fever. This could be a condition called Stevens-Johnson syndrome
• You have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic Epidermal Necrolysis)
• Inflammation of the skin characterized by fluid filled blisters (bullous dermatitis)
• You have flu like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (DRESS)

Stop having Amiodarone Hydrochloride 50 mg/ml and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

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

• Headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea), fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with your brain

Tell your doctor as soon as possible if you have any of the following side effects:

Common (affects less than 1 in 10 people)

• Scaly and itching rashes (eczema)
• Dizziness, lightheadedness, fainting. This may occur temporarily and is due to lowering of blood pressure.

Frequency not known (Cannot be estimated from the available data)

• Inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)
• You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)
• Severe reduction in the number of white blood cells which makes infections more likely (agranulocytosis).
• You get loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy’ or ‘neuritis’
• Feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat. These could be signs of an illness called ‘hyperthyroidism’.
• Overgrowth of tissue found inside the body’s larger bones (bone marrow granulomas).

Tell your doctor, nurse or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

• Blurred eyesight or seeing a coloured halo in dazzling light

Common (affects less than 1 in 10 people)

• Slightly slower heartbeat
• 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

• Trembling when you move your arms or legs Uncommon (affects less than 1 in 100 people)
• Feeling numb or weak, tingling or burning feelings in any part of your body

Rare (affects less than 1 in 1,000 people)

• The excipient benzyl alcohol may cause hypersensitivity reactions

-----X---------------------------------------------------

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.

Dilution

The medicine should be diluted with glucose 5%.

For each ampoule, a maximum of 250 ml glucose 5% should be used. Greater dilutions are unstable. Amiodarone, diluted in a glucose 5% solution to a concentration of < 0.6 mg/ml, is not stable. Solutions containing less than 2 Amiodarone Hydrochloride 50 mg/ ml ampoules in 500 ml of glucose 5% are unstable and must not be used.

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

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

• Changes in the amount of liver enzymes at the beginning of treatment. This can be seen in blood tests
• Feeling sick (nausea)
• Headache
• Sweating
• Hot flushes
• 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)
• Heart conduction disorders

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

• Life-threatening complication after heart transplantation (primary graft dysfunction) in which the transplanted heart stops working properly (see section 2, Warnings and precautions)
• Hives (itchy, lumpy rash)
• Back pain
• Decrease in sex drive
• 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
• Confusion (delirium)

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, Website: www. mhra.gov.uk/y­ellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMIODARONE HYDROCHLORIDE 50 MG/ML

• Your doctor or pharmacist is responsible for storing Amiodarone Hydrochloride 50 mg/ml. They are also responsible for disposing of any unused Amiodarone Hydrochloride 50 mg/ml correctly.
• Do not store above 25°C. Do not refrigerate or freeze. Keep the ampoule in the outer carton in order to protect from light.
• 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 pack after EXP. 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.
• For single use only. Discard any unused solution.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Amiodarone Hydrochloride 50 mg/ml contains The active substance is amiodarone hydrochloride.

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

1 ampoule with 3 ml Amiodarone Hydrochloride 50 mg/ ml contains 150 mg amiodarone hydrochloride.

One ampoule of Amiodarone Hydrochloride 50 mg/ ml diluted as recommended in 250 ml of glucose 5% 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 Hydrochloride 50 mg/ml looks like and contents of the pack

Clear, pale yellow sterile solution practically free from particles.

Pack sizes:

Amiodarone Hydrochloride 50 mg/ml is available as 5 ml glass ampoule with 3 ml concentrate for solution for injection/infusion in packs of 5 or 10.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: hameln pharma gmbh InselstraBe 1

31787 Hameln

Germany

Distributor:

hameln pharma ltd

Nexus, Gloucester Business Park

Gloucester, GL3 4AG, United Kingdom

Manufacturer:

HBM Pharma s.r.o.

Sklabinska 30

03680 Martin

Slovak Republic

hameln rds a.s.

Horna 36

90001 Modra

Slovak Republic

This medicinal product is authorised in the Member States of the EEA under the following names:

AT	Amiodaron-hameln 50 mg/ml Konzentrat zur Herstellung einer Injektions- /Infusionslosung
BG	Amiodaron Hameln 50 mg/ml
CZ	Amiodaron Hameln
DE	Amiodaron-hameln 50 mg/ml Konzentrat zur Herstellung einer Injektions-/Infusionslosung
DK	Amiodaron Hameln
FI	Amiodaron Hameln 50 mg/ml injektio/ infuusiokonsen­traatti, liuosta varten
HR	Amiodaronklorid Hameln 50 mg/ml koncentrat za otopinu za injekciju/infuziju
HU	Amiodaron Hameln 50 mg/ml
NL	Amiodaron HCl Hameln 50 mg/ml
NO	Amiodaron Hameln
PL	Amiodaron Hameln
RO	Amiodarona Hameln 50 mg/ml concentrat pentru solutie injectabila / perfuzabila
SE	Amiodaron Hameln
SI	Amjodaron Hameln 50 mg/ml koncentrat za raztopino za injiciranje/in­fundiranje
SK	Amiodaron Hameln 50 mg/ml
UK	Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion

This leaflet was last revised in 12/2020.

502095_02/52/20

particles.

Stability in solution

The diluted product is physically and chemically stable for 24 hours at 25°C. However, from a microbiological viewpoint, the medicine should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

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.

For single dose use only. Any unused medicine or waste material should be disposed of in accordance with local requirements.

PACKAGE LEAFLET: INFORMATION FOR THE USER hameln

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion 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. See section 4.

What is in this leaflet:

• 1. What Amiodarone Hydrochloride 50 mg/ml is and what it is used for

• 2. What you need to know before you are given Amiodarone Hydrochloride 50 mg/ml

• 3. How Amiodarone Hydrochloride 50 mg/ml is given

• 4. Possible side effects

• 5. How to store Amiodarone Hydrochloride

50 mg/ml

6. contents of the pack and other information

• 1. WHAT AMIODARONE

HYDROCHLORIDE 50 MG/ML IS

AND WHAT IT IS 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 Hydrochloride 50 mg/ml is given when a quick response is needed or if you are unable to take tablets.

Your doctor will give you this medicine and you will be monitored under hospital or specialist supervision.

2. what you need to know before you are given amiodarone hydrochloride 50 mg/ml

Do not use Amiodarone Hydrochloride 50 mg/ml:

• if you are allergic to amiodarone, iodine or any of the other ingredients of this medicine (listed in see 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 Hydrochloride 50 mg/ml”).
• if the person that would be given this medicine is a premature baby or full-term newborn baby.

If you are on a heart transplant waiting list, your doctor may change your treatment. This is because taking amiodarone before heart transplantation has shown an increased risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working properly within the first 24 hours after surgery.

Amiodarone Hydrochloride 50 mg/ml 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.

Take special care with Amiodarone Hydrochloride 50 mg/ml. Check with your doctor, pharmacist or nurse if:

• you have any problems with your eyesight. This includes an illness called ‘optic neuropathy’ or ‘neuritis’.
• the person having the medicine is an infant or child under 3 years old
• you have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’.
• you have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic epidermal necrolysis).
• you currently take a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring.

Tell your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:

• Slow or irregular heartbeat or heart rhythm problems;
• Shortness of breath or worsening of existing shortness of breath;
• Chest pain;
• Light-headedness;
• Palpitations;
• Near-fainting or fainting.

Consult your doctor if any of the abovementioned warnings apply to you, or have applied to you in the past .

Other medicines and Amiodarone Hydrochloride 50 mg/ml

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).
• Sofosbuvir, used for the treatment of hepatitis C.

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 lifethreatening 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 Hydrochloride 50 mg/ml with food and drink

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking amiodarone can increase your chance of getting side effects.

Pregnancy and breast-feeding

Your doctor will prescribe Amiodarone Hydrochloride 50 mg/ml only if he considers the benefit of treatment outweighs the risks during your pregnancy. Amiodarone Hydrochloride 50 mg/ml can be used during pregnancy in lifethreatening circumstances only.

You should not be given Amiodarone Hydrochloride 50 mg/ml 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 this 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 Hydrochloride 50 mg/ml contains benzyl alcohol

This medicine contains 22.2 mg benzyl alcohol in each ml. It may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.

This medicine will not be given to newborn babies (up to 4 weeks old). When administration is considered to be clearly necessary by a doctor, this medicine can be given to young children (less than 3 years old) for a period of (normally) no more than one week.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease are pregnant or breast feeding (also see section 2 – Pregnancy and breast-feeding). This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

• 3. HOW AMIODARONE

HYDROCHLORIDE 50 MG/ML 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 Hydrochloride 50 mg/ml 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 Hydrochloride 50 mg/ml is given as an intravenous 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 Amiodarone Hydrochloride 50 mg/ml is given as an intravenous infusion

• you should be given a dose of 5 mg/kg bodyweight diluted in 250 ml of a glucose 5% 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 Hydrochloride 50 mg/ml. You should therefore be given the lowest possible dose of Amiodarone Hydrochloride 50 mg/ml. This will keep side effects to a minimum. See also “If you have received more Amiodarone Hydrochloride 50 mg/ml than you should”.

-----^^-----------------------------------------------------------------------

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

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

• – Clear pale yellow sterile solution practically free from particles

• – pH 3.5–4.5

• – For intravenous use

Incompatibilities

Amiodarone is incompatible with saline solution and may only be administered in a glucose 5% 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.

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 medicine must not be mixed with other medicines except those mentioned below.

Do not mix other preparations in the same syringe. Do not inject other preparations in the same line. If treatment with Amiodarone Hydrochloride 50 mg/ml should be continued, this should be via intravenous infusion.

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.

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 Hydrochloride 50 mg/ml and the dose will be adjusted accordingly.

Children and adolescents

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 Hydrochloride 50 mg/ml 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 Hydrochloride 50 mg/ml 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 5 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.

Amiodarone Hydrochloride 50 mg/ml may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.

Stop having Amiodarone Hydrochloride 50 mg/ml and tell a doctor, nurse or pharmacist or go to a hospital straight away if:

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

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• Your heartbeat becomes very slow or stops beating.

You may also feel dizzy, unusually tired and short of breath. This may occur especially in people over 65 years old or to people with other heartbeat problems

• Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away
• You get yellowing of the skin or eyes (jaundice), feel tired or sick, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage which can be very dangerous
• Difficulty breathing or tightness in the chest, coughing which will not go away, wheezing, weight loss and fever. This could be due to inflammation of your lungs which can be very dangerous

Frequency not known (Cannot be estimated from the available data)

• You have life-threatening irregular heartbeat (Torsade de pointes)
• You have swelling of the skin and mucous membranes (angioneurotic oedema)
• Symptoms include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome
• You have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic Epidermal Necrolysis)
• Inflammation of the skin characterized by fluid filled blisters (bullous dermatitis)
• You have flu like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (DRESS)

Stop having Amiodarone Hydrochloride 50 mg/ml and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

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

• Headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea), fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with your brain

Tell your doctor as soon as possible if you have any of the following side effects:

Common (affects less than 1 in 10 people)

• Scaly and itching rashes (eczema)
• Dizziness, lightheadedness, fainting. This may occur temporarily and is due to lowering of blood pressure.

Frequency not known (Cannot be estimated from the available data)

• Inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)
• You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)
• Severe reduction in the number of white blood cells which makes infections more likely (agranulocytosis).
• You get loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy’ or ‘neuritis’
• Feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat. These could be signs of an illness called ‘hyperthyroidism’.
• Overgrowth of tissue found inside the body’s larger bones (bone marrow granulomas).

Tell your doctor, nurse or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

• Blurred eyesight or seeing a coloured halo in dazzling light

Common (affects less than 1 in 10 people)

• Slightly slower heartbeat
• 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

= -----X------------------------------------------

Dilution

The medicine should be diluted with glucose 5%.

For each ampoule, a maximum of 250 ml glucose 5% should be used. Greater dilutions are unstable. Amiodarone, diluted in a glucose 5% solution to a concentration of < 0.6 mg/ml, is not stable. Solutions containing less than 2 Amiodarone Hydrochloride 50 mg/ml ampoules in 500 ml of glucose 5% are unstable and must not be used.

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.

llllllllll

• Trembling when you move your arms or legs Uncommon (affects less than 1 in 100 people)
• Feeling numb or weak, tingling or burning feelings in any part of your body

Rare (affects less than 1 in 1,000 people)

• The excipient benzyl alcohol may cause hypersensitivity reactions

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

• Changes in the amount of liver enzymes at the beginning of treatment. This can be seen in blood tests
• Feeling sick (nausea)
• Headache
• Sweating
• Hot flushes
• 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)
• Heart conduction disorders

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

• Life-threatening complication after heart transplantation (primary graft dysfunction) in which the transplanted heart stops working properly (see section 2, Warnings and precautions)
• Hives (itchy, lumpy rash)
• Back pain
• Decrease in sex drive
• 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
• Confusion (delirium)

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, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store amiodarone hydrochloride 50 mg/ml

• Your doctor or pharmacist is responsible for storing Amiodarone Hydrochloride 50 mg/ml. They are also responsible for disposing of any unused Amiodarone Hydrochloride 50 mg/ml correctly.
• Do not store above 25°C. Do not refrigerate or freeze. Keep the ampoule in the outer carton in order to protect from light.
• 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 pack after EXP. 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.
• For single use only. Discard any unused solution.

6. contents of the pack and other information

What Amiodarone Hydrochloride 50 mg/ml contains

The active substance is amiodarone

hydrochloride.

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

1 ampoule with 3 ml Amiodarone Hydrochloride 50 mg/ml contains 150 mg amiodarone hydrochloride.

One ampoule of Amiodarone Hydrochloride 50 mg/ml diluted as recommended in 250 ml of glucose 5% 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 Hydrochloride 50 mg/ml looks like and contents of the pack

Clear, pale yellow sterile solution practically free from particles.

Pack sizes:

Amiodarone Hydrochloride 50 mg/ml is available as 5 ml glass ampoule with 3 ml concentrate for solution for injection/infusion in packs of 5 or 10.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: hameln pharma gmbh InselstraBe 1

31787 Hameln

Germany

Distributor:

hameln pharma ltd

Nexus, Gloucester Business Park

Gloucester, GL3 4AG, United Kingdom

Manufacturer:

HBM Pharma s.r.o.

Sklabinska 30

03680 Martin

Slovak Republic

hameln rds a.s.

Horna 36

90001 Modra

Slovak Republic

This medicinal product is authorised in the Member States of the EEA under the following names:

AT	Amiodaron-hameln 50 mg/ml Konzentrat zur Herstellung einer Injektions- /Infusionslosung
BG	Amiodaron Hameln 50 mg/ml
CZ	Amiodaron Hameln
DE	Amiodaron-hameln 50 mg/ml Konzentrat zur Herstellung einer Injektions-/Infusionslosung
DK	Amiodaron Hameln
FI	Amiodaron Hameln 50 mg/ml injektio/ infuusiokonsen­traatti, liuosta varten
HR	Amiodaronklorid Hameln 50 mg/ml koncentrat za otopinu za injekciju/infuziju
HU	Amiodaron Hameln 50 mg/ml
NL	Amiodaron HCl Hameln 50 mg/ml
NO	Amiodaron Hameln
PL	Amiodaron Hameln
RO	Amiodarona Hameln 50 mg/ml concentrat pentru solutie injectabila / perfuzabila
SE	Amiodaron Hameln
SI	Amjodaron Hameln 50 mg/ml koncentrat za raztopino za injiciranje/in­fundiranje
SK	Amiodaron Hameln 50 mg/ml
UK	Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion

This leaflet was last revised in 12/2020.

502095_02/52/20

particles.

Stability in solution

The diluted product is physically and chemically stable for 24 hours at 25°C. However, from a microbiological viewpoint, the medicine should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

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.

For single dose use only. Any unused medicine or waste material should be disposed of in accordance with local requirements.

PACKAGE LEAFLET: INFORMATION FOR THE USER hameln

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion 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. See section 4.

What is in this leaflet:

• 1. What Amiodarone Hydrochloride 50 mg/ml is and what it is used for

• 2. What you need to know before you are given Amiodarone Hydrochloride 50 mg/ml

• 3. How Amiodarone Hydrochloride 50 mg/ml is given

• 4. Possible side effects

• 5. How to store Amiodarone Hydrochloride

50 mg/ml

6. contents of the pack and other information

• 1. WHAT AMIODARONE

HYDROCHLORIDE 50 MG/ML IS

AND WHAT IT IS 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 Hydrochloride 50 mg/ml is given when a quick response is needed or if you are unable to take tablets.

Your doctor will give you this medicine and you will be monitored under hospital or specialist supervision.

2. what you need to know before you are given amiodarone hydrochloride 50 mg/ml

Do not use Amiodarone Hydrochloride 50 mg/ml:

• if you are allergic to amiodarone, iodine or any of the other ingredients of this medicine (listed in see 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 Hydrochloride 50 mg/ml”).
• if the person that would be given this medicine is a premature baby or full-term newborn baby.

If you are on a heart transplant waiting list, your doctor may change your treatment. This is because taking amiodarone before heart transplantation has shown an increased risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working properly within the first 24 hours after surgery.

Amiodarone Hydrochloride 50 mg/ml 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.

Take special care with Amiodarone Hydrochloride 50 mg/ml. Check with your doctor, pharmacist or nurse if:

• you have any problems with your eyesight. This includes an illness called ‘optic neuropathy’ or ‘neuritis’.
• the person having the medicine is an infant or child under 3 years old
• you have blistering or bleeding of the skin, including around your lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’.
• you have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic epidermal necrolysis).
• you currently take a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring.

Tell your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:

• Slow or irregular heartbeat or heart rhythm problems;
• Shortness of breath or worsening of existing shortness of breath;
• Chest pain;
• Light-headedness;
• Palpitations;
• Near-fainting or fainting.

Consult your doctor if any of the abovementioned warnings apply to you, or have applied to you in the past .

Other medicines and Amiodarone Hydrochloride 50 mg/ml

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).
• Sofosbuvir, used for the treatment of hepatitis C.

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 lifethreatening 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 Hydrochloride 50 mg/ml with food and drink

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking amiodarone can increase your chance of getting side effects.

Pregnancy and breast-feeding

Your doctor will prescribe Amiodarone Hydrochloride 50 mg/ml only if he considers the benefit of treatment outweighs the risks during your pregnancy. Amiodarone Hydrochloride 50 mg/ml can be used during pregnancy in lifethreatening circumstances only.

You should not be given Amiodarone Hydrochloride 50 mg/ml 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 this 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 Hydrochloride 50 mg/ml contains benzyl alcohol

This medicine contains 22.2 mg benzyl alcohol in each ml. It may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.

This medicine will not be given to newborn babies (up to 4 weeks old). When administration is considered to be clearly necessary by a doctor, this medicine can be given to young children (less than 3 years old) for a period of (normally) no more than one week.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease are pregnant or breast feeding (also see section 2 – Pregnancy and breast-feeding). This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

• 3. HOW AMIODARONE

HYDROCHLORIDE 50 MG/ML 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 Hydrochloride 50 mg/ml 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 Hydrochloride 50 mg/ml is given as an intravenous 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 Amiodarone Hydrochloride 50 mg/ml is given as an intravenous infusion

• you should be given a dose of 5 mg/kg bodyweight diluted in 250 ml of a glucose 5% 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 Hydrochloride 50 mg/ml. You should therefore be given the lowest possible dose of Amiodarone Hydrochloride 50 mg/ml. This will keep side effects to a minimum. See also “If you have received more Amiodarone Hydrochloride 50 mg/ml than you should”.

-----^^-----------------------------------------------------------------------

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

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

• – Clear pale yellow sterile solution practically free from particles

• – pH 3.5–4.5

• – For intravenous use

Incompatibilities

Amiodarone is incompatible with saline solution and may only be administered in a glucose 5% 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.

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 medicine must not be mixed with other medicines except those mentioned below.

Do not mix other preparations in the same syringe. Do not inject other preparations in the same line. If treatment with Amiodarone Hydrochloride 50 mg/ml should be continued, this should be via intravenous infusion.

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.

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 Hydrochloride 50 mg/ml and the dose will be adjusted accordingly.

Children and adolescents

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 Hydrochloride 50 mg/ml 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 Hydrochloride 50 mg/ml 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 5 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.

Amiodarone Hydrochloride 50 mg/ml may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.

Stop having Amiodarone Hydrochloride 50 mg/ml and tell a doctor, nurse or pharmacist or go to a hospital straight away if:

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

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• Your heartbeat becomes very slow or stops beating.

You may also feel dizzy, unusually tired and short of breath. This may occur especially in people over 65 years old or to people with other heartbeat problems

• Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away
• You get yellowing of the skin or eyes (jaundice), feel tired or sick, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage which can be very dangerous
• Difficulty breathing or tightness in the chest, coughing which will not go away, wheezing, weight loss and fever. This could be due to inflammation of your lungs which can be very dangerous

Frequency not known (Cannot be estimated from the available data)

• You have life-threatening irregular heartbeat (Torsade de pointes)
• You have swelling of the skin and mucous membranes (angioneurotic oedema)
• Symptoms include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome
• You have a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may also feel generally unwell, have a fever, chills and aching muscles (Toxic Epidermal Necrolysis)
• Inflammation of the skin characterized by fluid filled blisters (bullous dermatitis)
• You have flu like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (DRESS)

Stop having Amiodarone Hydrochloride 50 mg/ml and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

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

• Headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea), fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with your brain

Tell your doctor as soon as possible if you have any of the following side effects:

Common (affects less than 1 in 10 people)

• Scaly and itching rashes (eczema)
• Dizziness, lightheadedness, fainting. This may occur temporarily and is due to lowering of blood pressure.

Frequency not known (Cannot be estimated from the available data)

• Inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)
• You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)
• Severe reduction in the number of white blood cells which makes infections more likely (agranulocytosis).
• You get loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy’ or ‘neuritis’
• Feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat. These could be signs of an illness called ‘hyperthyroidism’.
• Overgrowth of tissue found inside the body’s larger bones (bone marrow granulomas).

Tell your doctor, nurse or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

• Blurred eyesight or seeing a coloured halo in dazzling light

Common (affects less than 1 in 10 people)

• Slightly slower heartbeat
• 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

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Dilution

The medicine should be diluted with glucose 5%.

For each ampoule, a maximum of 250 ml glucose 5% should be used. Greater dilutions are unstable. Amiodarone, diluted in a glucose 5% solution to a concentration of < 0.6 mg/ml, is not stable. Solutions containing less than 2 Amiodarone Hydrochloride 50 mg/ml ampoules in 500 ml of glucose 5% are unstable and must not be used.

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.

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• Trembling when you move your arms or legs Uncommon (affects less than 1 in 100 people)
• Feeling numb or weak, tingling or burning feelings in any part of your body

Rare (affects less than 1 in 1,000 people)

• The excipient benzyl alcohol may cause hypersensitivity reactions

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

• Changes in the amount of liver enzymes at the beginning of treatment. This can be seen in blood tests
• Feeling sick (nausea)
• Headache
• Sweating
• Hot flushes
• 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)
• Heart conduction disorders

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

• Life-threatening complication after heart transplantation (primary graft dysfunction) in which the transplanted heart stops working properly (see section 2, Warnings and precautions)
• Hives (itchy, lumpy rash)
• Back pain
• Decrease in sex drive
• 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
• Confusion (delirium)

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, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store amiodarone hydrochloride 50 mg/ml

• Your doctor or pharmacist is responsible for storing Amiodarone Hydrochloride 50 mg/ml. They are also responsible for disposing of any unused Amiodarone Hydrochloride 50 mg/ml correctly.
• Do not store above 25°C. Do not refrigerate or freeze. Keep the ampoule in the outer carton in order to protect from light.
• 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 pack after EXP. 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.
• For single use only. Discard any unused solution.