EPTIFIBATIDE ACCORD 2 mg/ml INJECTABLE SOLUTION

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

You should not be given 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 a gastric, intestinal, bladder, or other organ bleeding, for example, if you have seen abnormal blood in your stools or urine (except for menstrual bleeding) in the last 30 days.
• if you have had a stroke within the last 30 days or any hemorrhagic stroke (also, make sure your doctor knows if you have ever had a stroke).
• if you have had a brain tumor or a process that affects the blood vessels of the brain.
• if you have had major surgery or a serious injury in the last 6 weeks.
• if you have or have had bleeding problems.
• if you have or have had blood coagulation problems or a low platelet count.
• if you have or have had severe high blood pressure.
• if you have or have had severe liver or kidney problems.
• if you have been treated with another medicine of the same type as Eptifibatide Accord.

If you have had any of the above situations, tell your doctor. If you have any questions, ask your doctor, pharmacist, or nurse.

Warnings and precautions:

• Eptifibatide Accord is only recommended for use in adult patients hospitalized in coronary care units.
• Eptifibatide Accord should not be used in children or adolescents under 18 years of age.
• Before and during treatment with Eptifibatide Accord, blood samples will be analyzed as a safety measure to limit the possibility of unexpected bleeding.
• During the use of Eptifibatide Accord, you will be carefully monitored for signs of unusual or unexpected bleeding.

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

Using Eptifibatide Accord with other medicines

To avoid the possibility of interactions with other medicines, tell your doctor, pharmacist, or hospital nurse if you are using, have recently used, or might use other medicines, including those bought without a prescription.

Especially:

• blood thinners (oral anticoagulants) or
• medicines that prevent the formation of blood clots, such as warfarin, dipyridamole, ticlopidine, aspirin (except for those that you may receive as part of the treatment with Eptifibatide Accord).

Pregnancy and breastfeeding

The use of Eptifibatide Accord is not normally recommended during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will assess whether the benefits of treatment with Eptifibatide Accord for you outweigh the possible risks for your baby.

If you are breastfeeding, breastfeeding should be interrupted during the treatment period.

3. How to use Eptifibatide Accord

Eptifibatide Accord is given into a vein by direct injection followed by an infusion (drip). The dose given is based on your weight. The recommended dose is 180 micrograms/kg given as a bolus (rapid intravenous injection), followed by an infusion of 2.0 micrograms/kg/minute for a maximum of 72 hours. If you have kidney disease, the infusion dose may be reduced to 1.0 microgram/kg/minute.

If a percutaneous coronary intervention is performed during treatment with Eptifibatide Accord, the intravenous solution may be continued for a maximum of 96 hours.

You will also need to receive some doses of acetylsalicylic acid (aspirin) and heparin (if not contraindicated in your case).

If you have any other questions about the use of this product, ask your doctor, 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 the urine, stools, vomiting blood, or bleeding from surgery).
• anemia (decrease in the number of red blood cells or hemoglobin in the blood).

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

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

Rare side effects

These may affect up to 1 in 10,000 people

• severe bleeding (for example, bleeding in the abdomen, brain, or lungs)
• bleeding with a fatal outcome.
• severe decrease in the number of platelets (blood cells necessary for blood clotting).
• skin rash (such as hives or itching).
• severe and sudden allergic reaction.

If you notice any signs of bleeding, tell your doctor, pharmacist, or nurse immediately. Very rarely, bleeding has been severe and even fatal. Safety measures to prevent this from happening include blood tests and close monitoring by healthcare professionals who care for you.

If you show symptoms of a severe allergic reaction or skin rash, tell your doctor, pharmacist, or nurse immediately.

Other effects that may occur in patients who need this type of treatment include those related to the condition for which they are being treated, such as rapid or irregular heartbeats, low blood pressure, shock, or cardiac arrest.

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 outer packaging and on the vial after (EXP). The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

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

Before use, the contents of the vial should be inspected.

Do not use Eptifibatide Accord if you notice particles or a change in color.

Once opened, the unused medicine should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eptifibatide Accord

• The active substance is eptifibatide.
• Eptifibatide Accord 2 mg/ml: Each ml of solution for injection contains 2 mg of eptifibatide.

A 10 ml vial of solution for injection contains 20 mg of eptifibatide.

• The other ingredients are citric acid monohydrate, sodium hydroxide, and water for injections.

Appearance and packaging

Eptifibatide Accord 2 mg/ml solution for injection: 10 ml vial, pack containing one vial.

Eptifibatide Accord 2 mg/ml:The clear, colorless solution is contained in a 10 ml glass vial, closed with a butyl rubber stopper and aluminum cap with easy opening.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona, Spain

Manufacturer:

Accord Healthcare Limited

Sage House

319, Pinner Road, Harrow

Middlesex HA1 4HF

United Kingdom

Wessling Hungary Kft

Fòti ùt 56, Budapest 1047,

Hungary

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/