Milrinone 1mg/ml Solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Milrinone is and what it is used for
2. What you need to know before you are given Milrinone
3. How you will be given Milrinone
4. Possible side effects
5. How to store Milrinone
6. Contents of the pack and other information

• Short-term treatment of severe congestive heart failure (where the heart cannot pump enough blood to the rest of the body) when other medicines have not worked
• Treatment after a heart operation for when your heart is having difficulty pumping blood around your body.

• short term treatment (up to 35 hours) of severe congestive heart failure (where the heart cannot pump enough blood to the rest of the body) when other medicines have not worked
• short term treatment (up to 35 hours) of acute heart failure after a heart operation i.e. when your heart is having difficulty pumping blood around your body.

• you are allergic (hypersensitive) to milrinone or any of the other ingredients of this medicine (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• you have lost body fluids and are severely dehydrated.

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before having Milrinone.

Talk to your doctor, nurse or pharmacist before you are given milrinone if you:

• are having or have just had a heart attack
• have severe heart valve problems such as narrowing, thickening or blockage of your heart valves
• have uneven or uncontrolled fast heartbeats. You may also be experiencing pounding in your chest, light-headedness, fainting and shortness in breath
• have low blood pressure which may make you feel dizzy, light-headed or faint
• have previously taken water tablets (diuretics) which caused you to have heart problems
• have low levels of potassium in your blood. Your doctor may do blood tests to check this
• have kidney problems.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Milrinone.

The following should be considered in addition to warnings and precautions described for adults.

Before giving Milrinone, your doctor will check a lot of parameters such as heart rhythm and blood pressure. He/she will order blood tests as well.

The infusion will not start if your child’s heart rhythm and blood pressure is not stable.

Please tell your doctor if your child:

• has kidney problems
• is a preterm infant or has a low birth weight
• has a certain heart problem named Patent Ductus Arteriosus: a connection between two major blood vessels (aorta and pulmonary artery) which persists though it should be closed.

In these cases, your doctor will decide if your child will be treated with Milrinone.

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Milrinone can affect the way some other medicines work. Also some medicines can affect the way Milrinone works.

In particular, tell your doctor, nurse or pharmacist if you are taking:

• digoxin (used for heart problems)
• water tablets (diuretics)
• medicines used to treat high blood pressure or angina (chest pain) such as amlodipine, nifedipine or felodipine.

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

This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially 'sodium-free'.

• This medicine is usually given in a ‘drip’ after being diluted using either 0.45% sodium chloride infusion, 0.9% sodium chloride infusion or 5% glucose infusion
• If you feel the effect of your medicine is too weak or too strong, tell your doctor or nurse.

• Your doctor will decide how much medicine you should have based on your body weight
• If you have problems with your kidneys, you may be given a lower dose.

• Your doctor should give you a first dose of 50 micrograms for every kilogram of your weight over a period of 10 minutes
• This is then followed by a smaller dose between 0.375 and 0.75 micrograms for every kilogram of body weight per minute, as needed
• The medicine is usually given for 2 to 3 days, but it may be given for up to 5 days
• If you are having this medicine after a heart operation, it will usually only be given for up to 12 hours.

• Your doctor should give your child a first dose ranging between 50 and 75 micrograms for every kilogram of his weight, over a period of 30 to 60 minutes
• This is then followed by a dose ranging from 0.25 to 0.75 micrograms for every kilogram of his/her weight per minute according to your child’s response to the treatment and occurrence of side effects. Milrinone can be given for up to 35 hours.

During infusion, your child will be closely monitored: your doctor will check a lot of parameters such as heart rhythm and blood pressure and blood will be taken to evaluate the response to therapy and occurrence of side effects.

It is unlikely that your doctor or nurse will give you too much of this medicine. Your doctor and nurse will check your progress and the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine. The following effects may happen if you have too much Milrinone: feeling dizzy, light-headedness and fainting (due to low blood pressure) and an uneven heartbeat.

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse.

Keep having Milrinone until your doctor tells you to stop. Do not stop having Milrinone just because you feel better. If you stop, your illness may get worse.

Your doctor or nurse will use an electrocardiogram (ECG) to check how well your heart works. They will also carry out blood tests and check your blood pressure and pulse rate.

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, fainting or losing consciousness. The chances of this happening are very rare.

Common (affects less than 1 in 10 people)

• Uneven, increased or fast heartbeats. You may also experience pounding in your chest, feel light-headed, faint or short of breath.

Uncommon (affects less than 1 in 100 people)

• Ventricular fibrillation – a serious heart rhythm problem.
  Signs of this include very fast, uneven or forceful heartbeat (palpitations), dizziness and loss of consciousness. You may also feel sick, have cold sweats, shortness of breath and chest pain
• Thrombocytopenia – a blood problem. Signs of this are that you may bruise more easily than usual
• Chest pain.

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

• Torsades de Pointes – a serious heart rhythm problem. Signs of this include very fast, uneven or forceful heartbeat (palpitations), dizziness and loss of consciousness. You may also feel sick, have cold sweats, shortness of breath, unusual pale complexion and chest pain
• Difficulty breathing, wheezing or tightness in the chest.

Common (affects less than 1 in 10 people)

• Low blood pressure. Signs of this include feeling dizzy, lightheaded or fainting. If you also notice signs like a fast or uneven heartbeat or chest pain this could be a more serious side effect (see above)
• Headache.

Uncommon (affects less than 1 in 100 people)

• Feeling shaky
• Low levels of potassium in your blood. Signs of this are tiredness, confusion, muscle weakness and muscle cramps. This may be due to low levels of potassium in your body.

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

• Skin rashes including at the site of the injection.

Uncommon (affects less than 1 in 100 people)

• A blood test may show changes in the way the liver is working.

Talk to your doctor, nurse or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

In addition to side effects observed in adults, the following were reported in children and adolescents:

Frequency not known:

• Bleeding into the fluid-filled areas (ventricles) surrounded by the brain (intraventricular haemorrhage)
• A heart problem known as Patent Ductus Arteriosus: a connection between two major blood vessels (aorta and pulmonary artery) which persists though it should be closed. This can cause excess fluid in the lungs, bleedings, destruction of the bowel or part of the bowel and possibly be fatal
• Changes in the way the kidneys are working if you already have low blood pressure.

Moreover, compared to adults, decrease in the number of platelets in the blood seems to occur more often in children and the risk of this side effect is increased with the duration of the Milrinone infusion. Heart rhythm troubles seem to occur less often in children than in adults.

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.

The active substance is: milrinone. Each ml of solution contains 1mg milrinone. Each 10ml ampoule contains 10mg milrinone.

The other ingredients are: (S)-lactic acid, anhydrous glucose, water for injections and the pH adjusters sodium hydroxide and lactic acid (see end of section 2).

Milrinone is a clear, colourless to pale yellow, sterile solution, practically free from particles. It is supplied in 10ml clear, neutral glass (Type I, PhEur) ampoules. It is available in packs of ten ampoules.

Other sources of information

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

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Product name Reference number

Milrinone 1mg/ml Solution for Injection/Infusion 29831/0619

This is a service provided by the Royal National Institute of Blind People.

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

United Kingdom, Ireland and Malta: Milrinone 1mg/ml Solution for Injection/Infusion