Patient leaflet - Eptifibatide Accord 2 mg / ml solution for injection

1. What Eptifibatide Accord is and what it is used for

Eptifibatide Accord is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming.

It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes. It is usually given with aspirin and unfractionated heparin.

2. What you need to know before you are given Eptifibatide Accord

Do not use Eptifibatide Accord:

if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6).
if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding) in the past 30 days.
if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke).
if you have had a brain tumour or a condition that affects the blood vessels around the brain.
if you had a major operation or severe injury during the past 6 weeks.
if you have or have had bleeding problems.
if you have or have had difficulty with your blood clotting or a low blood platelet count.
if you have or have had severe hypertension (high blood pressure).
if you have or have had severe kidney or liver problems.
if you have been treated with another medicine of the same type as Eptifibatide Accord.

Please tell your doctor if you have had any of these conditions. If you have any questions, ask your doctor or hospital pharmacist or nurse.

Warnings and precautions

Eptifibatide Accord is recommended for use only in adult, hospitalised patients in coronary care units.
Eptifibatide Accord is not intended for use in children or adolescents less than 18 years of age.

Before and during your treatment with Eptifibatide Accord, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding.

During use of Eptifibatide Accord, you will be checked carefully for any signs of unusual or unexpected bleeding.

Talk to your doctor or hospital pharmacist or nurse before using Eptifibatide Accord.

Other medicines and Eptifibatide Accord

To avoid the possibility of interactions with other medicines please tell your doctor or hospital pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Particularly: blood thinners (oral anticoagulants) or medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Eptifibatide Accord treatment).

Pregnancy, breast-feeding and fertility

Eptifibatide Accord is not usually recommended for use during pregnancy. Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby. Your doctor will weigh up the benefit to you against the risk to your baby of using Eptifibatide Accord while you are pregnant.

If you are breast-feeding a baby, breast-feeding should be interrupted during the treatment period.

Eptifibatide Accord contains sodium

This medicine contains 34.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Eptifibatide Accord

Eptifibatide Accord is given into the vein by direct injection followed by an infusion (drip solution). The dose given is based on your weight. The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 microgram/kg/minute for up to 72 hours. If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/minute.

If percutaneous coronary intervention (PCI) is performed during Eptifibatide Accord therapy, the intravenous solution may be continued for up to 96 hours.

You must also be given doses of aspirin and heparin (if not contraindicated in your case).

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

4. Possible side effects

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

Very common side effects

These may affect more than 1 in 10 people

minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with
surgical procedures).
- anaemia (decreased number of red blood cells).

Common side effects

These may affect up to 1 in 10 people

inflammation of a vein.

Uncommon side effects

These may affect up to 1 in 100 people

reduction in the number of platelets (blood cells necessary for blood clotting).
reduced blood flow to the brain.

Very rare side effects

These may affect up to 1 in 10,000 people

serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs).
fatal bleeding.
severe reduction in the number of platelets (blood cells necessary for blood clotting).
skin rash (such as hives).
sudden, severe allergic reaction.

If you notice any signs of bleeding, notify your doctor or hospital pharmacist or nurse immediately. Very rarely, bleeding has become severe and even fatal. Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.

If you develop severe allergic reaction or hives, notify your doctor or hospital pharmacist or nurse immediately.

Other events that may occur in patients, who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heartbeat, low blood pressure, shock or cardiac arrest.

Reporting of side effects

If you get any side effects, talk to your doctor or hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Eptifibatide Accord

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 carton and the vial after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C).

Keep the vial in the outer package in order to protect from light. However, protection of Eptifibatide Accord solution from light is not necessary during administration.

Before using, the vial contents should be inspected.

Eptifibatide Accord should not be used if it is noticed that particulate matter or discoloration is present.

Any unused medicine after opening should be thrown away.

Do not throw away any medicines via wastewater or household waste. Ask your hospital pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 70 mm

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