MercuryPharma

PATIENT INFORMATION LEAFLET

Digoxin 250micrograms/ml Solution for Injection

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

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

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Digoxin 250micrograms/ml Solution for Injection. It will be referred to as Digoxin Injection for ease of use hereafter.

In this leaflet:

1.    What Digoxin Injection is and what it is used for

2.    Before you are given Digoxin Injection

3.    How Digoxin Injection is given

4.    Possible side effects

5.    How to store Digoxin Injection

6.    Further information

1. WHAT DIGOXIN INJECTION IS AND WHAT IT IS USED FOR

Digoxin belongs to a group of medicines called cardiac glycosides. It works by increasing the strength of the heart muscle and slowing the rate of contraction of the heart, i.e. the pulse rate.

Digoxin is used to treat

•    Chronic heart failure. Heart failure is a condition in which the heart fails to pump the blood round the body adequately. This may cause tiredness, breathlessness and ankle swelling

•    Some types of irregular heart beat which may or may not accompany heart failure.

Digoxin injection is given in emergency situations when patients need a high starting dose of this medicine.

2. BEFORE YOU ARE GIVEN DIGOXIN INJECTION

YOU SHOULD NOT BE GIVEN Digoxin Injection if:

•    You know that you are allergic to digoxin or to any other ingredients (see section 6 of this leaflet)

•    You have the following heart problems - specific types of irregular heart beat including those caused by an overdose of digoxin and heart block, and enlargement of the heart muscle. Your doctor will be able to advise you.

Speak to your doctor before you are given this injection if any of these apply to you.

Before you are given Digoxin Injection, your doctor will take special care if any of the following situations apply to you. Make sure your doctor is aware of these situations if it is not already obvious:

•    You have received digoxin (or any other cardiac glycoside) within the last two weeks. In this case your doctor will reconsider your dose

•    You are to receive electric shock treatment to correct an abnormal heart beat

• You suffer from any other problem with your heart, including any abnormal heart beat

• You suffer from a disease of the kidneys or thyroid gland, or from low blood levels of potassium or magnesium or thiamine deficiency or from high blood levels of calcium. Your doctor will be able to advise you

•    You suffer from a severe disease of your lungs or breathing

•    You are elderly

•    You have less oxygen supply to certain parts of your body. The symptoms you may feel are headache, tiredness, breathing difficulty

•    You have had a stroke

•    You have heart disease due to high blood pressure

•    You have abnormal digestion or any problem related to your food digestion or any problem in your gut. You should have periodic tests to assess kidney function and blood electrolyte levels.

Speak to your doctor before you are given this injection if any of these apply to you.

Taking other medicines:

Tell your doctor before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

A large number of drugs can interact with Digoxin Injection which can significantly alter their effects. These drugs include:

•    diuretics (‘water tablets' to help you pass more water)

•    lithium (for depression)

•    corticosteroids (for allergic or inflammatory conditions such as asthma or painful joints or inflammation of joints) and penicillamine (used for inflammation of the joints)

•    medicines used to treat conditions of the gut like heartburn (a burning sensation in the food pipe), ulcers, and inflammation (eg carbenoxolone, antacids, propantheline, indometacin and sulfasalazine)

•    medicines used to treat heart conditions, high blood pressure or circulation disorders (eg. captopril, verapamil, nifedipine, amiodarone, flecainide, quinidine, carvedilol, propafenone, adrenaline, felodipine, diltiazem)

•    some antibiotics (eg. tetracycline, gentamicin, clarithromycin, neomycin, rifampicin, trimethoprim, erythromycin)

•    laxatives (for constipation, eg. kaolin-pectin), and diphenoxylate (for loose stools) and metoclopramide (for feeling sick or vomiting)

•    colestyramine (to reduce blood fat levels)

•    cytostatics (drugs used in the treatment of cancer)

•    phenytoin (for fits or severe nerve pain)

•    medicines for muscle relaxation eg. suxamethonium

•    medicines used to treat anxiety eg. alprazolam

•    medicines used for treatment of the disease related to germs or fungus eg. itraconazole

•    medicine for malaria eg. quinine

•    medicines used to treat high cholesterol eg. atorvastatin

•    medicines used to suppress your immune system eg. ciclosporin

•    medicines used for treatment of kidney failure related disease eg. epoprostenol

•    medicines for asthma eg. salbutamol

•    calcium, particularly if administered rapidly by the intravenous route

•    anti-diabetic drugs eg. acarbose.

The herbal medicine St. John's wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you have already taken St. John's wort, consult your doctor before stopping the St. John's wort preparations.

If you are already taking one of these medicines, speak to your doctor before you receive Digoxin Injection. Pregnancy and breast-feeding

Tell your doctor before you are given this medicine if you are or think you may be pregnant or are planning to become pregnant, or are breast-feeding. As with all drugs, this medicine should only be given in pregnancy and when breast feeding if the doctor thinks it is absolutely necessary.

Driving and using machines

Digoxin may cause some patients to have changes in their sight which could interfere with the ability to drive or to operate machines. If this happens, do not drive or operate machinery and ask your doctor for advice.

Important information about some of the ingredients of Digoxin Injection

This medicinal product contains less than 1 mmol sodium (23mg) per 4ml, i.e. is essentially ‘sodium-free'. This medicinal product also contains small amounts of ethanol (alcohol), less than 100mg per 4ml.

3. HOW DIGOXIN INJECTION IS GIVEN

A dose of digoxin will be dissolved into a solution and slowly injected into a vein over 10 - 20 minutes. This is known as an infusion or drip. The dose should be divided so that one half is given as the first dose and the remainder is given in divided doses every 4 to 8 hours.

Adults: The dose will be calculated by your doctor according to your age and weight.

Infants and children up to age 10 years: The dose will be calculated by the doctor according to weight and age.

If you are elderly, or if you have kidney problems, or if you have received a cardiac glycoside within the past two weeks, your dose will be reduced. Your doctor may want to take blood samples to ensure that your blood levels of digoxin are in the required range.

Use in the elderly:

The tendency to impaired renal function and low lean body mass in the elderly influences the action of digoxin such that high serum digoxin levels and associated toxicity can occur quite readily, unless doses of digoxin lower than those in non-elderly patients are used. Serum digoxin levels should be checked regularly and lowering of the potassium levels should be avoided.

Dose recommendations in renal disorder or with a diuretic therapy:

The dosing recommendations should be reconsidered if patients are elderly or there are other reasons for the renal clearance of digoxin being reduced. A reduction in both initial and maintenance dose should be considered.

In patients receiving diuretics (water tablets) and medicines to reduce high blood pressure (ACE inhibitors) or diuretics alone, the withdrawal of digoxin has been shown to result in some clinical problems.

Monitoring:

Serum concentration of digoxin may be expressed in nanograms/ml (ng/ml).

The serum concentration of digoxin can be determined by radioimmunoassay test. Blood should be taken 6 hours or more after the last dose of digoxin.

Digoxin toxicity is most commonly associated with serum digoxin concentration greater than 2ng/ml. However, toxicity may occur with lower digoxin serum concentrations. In deciding whether a patients symptoms are due to digoxin, the patients clinical state together with the serum potassium level and thyroid function are important factors to be considered.

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

If you think you have been given more Digoxin Injection than you should have

As the injection will be administered under the supervision of a doctor, it is unlikely that you will be given more than is necessary. However, if you have any concerns about the dose of your medicine discuss them with your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines Digoxin Injection can sometimes cause side-effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Tell your doctor or nurse immediately if:

•    you have palpitations,chest pain, shortness of breath or sweating. There can be symptoms of serious heart problem caused by new irregular heart beats. If these happen, tell your doctor immediately.

Other side effects may include:

Common (affects less than 1 in 10 people):

•    slow or irregular heart rate

•    feeling sick,being sick or loose stools

•    skin rash that may be itchy

•    drowsiness or dizziness

•    visual disturbances, with blurred or yellow-green sight.

Uncommon (affects less than 1 in 100 people):

•    depression.

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

•    bruising or bleeding more easily than normal

•    stomach pain caused by lack of blood supply or damage to the gut

•    mental disturbances, you may feel confused, indifferent or unable to judge clearly

•    weakness,tiredness or a general feeling of being unwell

•    breast enlargement in men

•    loss of appetite

•    headache

•    rapid heart rate.

Digoxin injection can very rarely cause serious irregular heart rates. Your doctor may do regular checks to make sure digoxin injection is working safely for you.

If you get any of these side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor at once.

5. HOW TO STORE DIGOXIN INJECTION

Keep this medicine out of the sight and reach of children.

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

Do not use after the expiry date shown on the ampoule and carton. The expiry date refers to the last day of that month.

If only part of an ampoule is used, the remainder should be discarded.

Do not use the ampoule if the contents are discoloured in any way.

6. FURTHER INFORMATION

The active substance is digoxin.

The other ingredients are ethanol, propylene glycol, citric acid monohydrate, sodium phosphate and water for injections.

What Digoxin Injection looks like and contents of pack

Digoxin Injection is a clear, colourless sterile solution presented in clear glass ampoules. Each ampoule contains 2ml of solution and each 2ml of solution contains 500 micrograms (mcg) of digoxin.

The injection is available in packs of 10 ampoules.

Marketing authorisation holder

Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.

Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.

This leaflet was last revised in September 2012

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