Primacor 1mg/ml Solution for Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you get any possible 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 Primacor is and what it is used for
2. What you need to know before you use Primacor
3. How to use Primacor
4. Possible side effects
5. How to store Primacor
6. Contents of the pack and other information

• You are allergic (hypersensitive) to milrinone or any of the other ingredients of Primacor (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 use this medicine if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Primacor.

Talk to your doctor, nurse or pharmacist before using Primacor if:

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

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

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

Before giving Primacor infusion, 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.
• Your child is a preterm infant or has a low birth weight.
• Your child has a certain heart problem named Patent Ductus Arteriosus – a connection between 2 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 Primacor.

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 Primacor can affect the way some other medicines work.

Also some medicines can affect the way Primacor 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.

Talk to your doctor, nurse or pharmacist before having this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

• This medicine is usually given in a ‘drip’ after being diluted using either a sugar or salt solution.
• 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 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 2-3 days, but it may be given for up to 5 days.
• If you are using 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/her weight, over a period of 30-60 minutes.
• This is then followed by a dose ranging from 0.25-0.75 micrograms for every kilogram of his/her weight per minute according to your child’s response to the treatment and occurrence of side effects. Primacor 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 use too much Primacor: 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 using Primacor until your doctor tells you to stop. Do not stop using Primacor 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.

Uncommon (affects less than 1 in 100 people)

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

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

• Skin rashes including at the site of the injection.

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.

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

• Bleeding into the fluid-filled areas (ventricles) surrounded by the brain (intraventricular haemorrhage).
• A heart problem known as Patent Ductus Arteriosus – a connection between 2 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 Primacor 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 at: 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.

• Each 1 ml of injection contains 1 mg of the active substance, milrinone.
• The other ingredients are lactic acid, glucose anhydrous, water for injection and sodium hydroxide (for pH adjustment).

Primacor is a clear, colourless to pale yellow liquid and is available as 10 ml or 20 ml glass ampoules in boxes of 10.

Not all pack sizes may be marketed.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.