SZ00000LT000

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

Read all of this leaflet carefully before you start taking 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

•    This medicine has been prescribed for you only Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    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.

ASANDOZ

What Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is and what it is used for

What you need to know before Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is given

How Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is used

Maintenance dose:

10 - 20 mg per kg bodyweight in physiological glucose solution can be given every 24 hours (on average 600 to 800 mg/ 24 hours up to a maximum of 1200 mg/ 24 hours accordingly 4-5 ampoules, maximum 8 ampoules) for a few days.

In some conditions the medicine may be given as a slow injection of 150-300 mg in 10-20 ml 5% glucose over a minimum of 3 minutes. If Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and

Infusion is given in this way you will be closely monitored.

As soon as an adequate response has been obtained using intravenous treatment, you may be switched to oral treatment.

Elderly patients should be closely monitored during treatment, particularly for thyroid function.

Use in children and adolescents

There are only limited data on the efficacy and safety in children. Your doctor will decide on an appropriate dose.

Patients with liver and kidney problems

Although no dosage adjustment for patients with kidney or liver abnormalities has been defined during chronic treatment with oral amiodarone, close clinical monitoring is prudent for elderly patients.

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

If you are given more Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion than you should

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. However, tell your doctor or pharmacist if you have any concerns.

than normal, pale skin, breathlessness and frequent infections. These can all occur if you have a very low number of the blood cells.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme

(www.mhra.gov.uk/yellowcard). By reporting side affects you can help provide more information on the safety of this medicine.

How to store Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion

4 Possible side effects

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 outer carton and vials after EXP. The expiry date refers to the last day of that month.

Concentrate

Do not store above 25°C. Keep the vials in the outer carton in order to protect from light.

Diluted medicinal product

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. 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.

For single use only.

Discard any unused solution.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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

If any of the following happen, tell your doctor immediately. These are very serious side effects and you may need urgent medical attention.

•    breathing difficulties

•    chest pain

•    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), you may feel you are going to faint and there may be inflammation of some of your blood vessels.

If you experience any of the following tell your doctor as soon as possible.

Very common (may affect more than 1 in 10 people)

•    blurred eyesight or seeing a coloured halo in dazzling light

•    burning more easily in the sun (see ‘Protect your skin from sunlight’ in Section 2)

Common (may affect up to 1 in 10 people)

•    generally moderate slow heart rate

•    decrease in blood pressure

•    local injection site reactions including swelling, pain, redness, infection, and pigmentation changes (blue or grey marks on parts of your skin exposed to sunlight, especially the face)

•    feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat.These could be signs of an illness called ‘hyper-thyroidism’

•    feeling extremely tired, weak or ‘run-down’, weight gain, being unable to stand the cold, constipation and aching muscles. These could be signs of an illness called ‘hypo-thyroidism’

•    trembling when you move your arms or legs

•    muscle weakness

•    nightmares

•    problems sleeping

Uncommon (may affect up to 1 in 100 people)

•    feeling numb or weak, tingling or burning feelings in any part of your body

•    dizziness

Rare (may affect up to 1 in 1,000 people)

•    the excipients benzyl alcohol may cause hypersensitivity reactions

Very rare (may affect up to 1 in 10,000 people)

•    chest pain or palpitations, or abnormal heart rhythm

•    nausea

•    liver disorders

•    generalised allergic reactions such as swelling of the face, lips and/or tongue, shortness of breath, headaches, breathing difficulties (with or without fever)

•    inability to breathe

•    hot flushes

•    sweating

•    red, scaly patches of skin, loss of hair or loosening of nails (called ‘exfoliative dermatitis’)

•    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’

•    skin rash

•    skin redness during radio-therapy

•    moving unsteadily or staggering, slurred or slow speech

•    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

•    headache

Not known (frequency cannot be estimated from the available data)

•    hives (itchy, lumpy rash)

•    back pain

•    weakness, bleeding or bruising more easily

2x------------------------------------------------------------

Contents of the pack and other information

What Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion contains

•    The active substance is amiodarone hydrochloride. Each 3 millilitre vial contains 150 mg of amiodarone hydrochloride.

One millilitre sterile concentrate contains 50 mg of amiodarone hydrochloride.

•    The other ingredients are benzyl alcohol (20.2 mg/ml), polysorbate 80, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

What Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion looks like and contents of the pack

Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion is a clear yellowish, sterile solution free from particles, contained in an amber glass vial closed with a rubber stopper and aluminium seal with a grey flip-off button.

The vials are packed in cartons containing 1, 5, 6, 10 or 25 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

or

Salutas Pharma GmbH Dieselstrasse 5 70839 Gerlingen Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57 1526 Ljubljana Slovenia

This leaflet was last revised in 05/2014.

D00000000

SZ00000LT000

Intravenous infusion:

The calculated dose is diluted with 250 ml 5% glucose. See section 4.2 of the Summary of product characteristics.

Intravenous injection:

150-300 mg (corresponding to 3-6 ml Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection and Infusion) is

diluted with 10-20 ml 5% glucose. See section 4.2 of the Summary of product characteristics.

Any unused product or waste material should be disposed of in accordance with local requirements.

The use of administration equipment or devices containing plasticizers such as DEHP (di-2-ethylhexylphthalate) in the presence of amiodarone may result in leaching out of DEHP. In order to minimise patient exposure to DEHP, in any case when the administration will take more than 2 hours, the final amiodarone dilution for infusion should preferably be administered through non DEHP-containing sets, like glass or polyolefin sets (PE, PP).

Diluted medicinal product

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. 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.    _SZ0“°