AGGRASTAT Concentrate for solution for infusion

Read all of this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What AGGRASTAT is and what it is used for
• 2. Before you take AGGRASTAT
• 3. How to take AGGRASTAT
• 4. Possible side effects
• 5. How to store AGGRASTAT
• 6. Further information

Do not take AGGRASTAT

You should not receive AGGRASTAT if you:

• are allergic to any of its ingredients. (See What AGGRASTAT Contains)
• are bleeding internally or have a history of bleeding internally within the last 30 days.
• have a history of bleeding in the brain, brain tumor or abnormal blood vessels in the brain.
• have severe uncontrolled high blood pressure (malignant hypertension).
• have a low blood platelet count (thrombocytopenia) or problems with blood clotting.
• developed thrombocytopenia if you had received treatment with AGGRASTAT or another medicine in the same group of drugs previously.
• have a history of stroke within the last 30 days or any history of stroke with bleeding.
• have been seriously injured or had a major operation within the last 6 weeks.
• have severe liver failure.

Take special care with AGGRASTAT

Tell your doctor about any medical problems you have or have had, and about any allergies.

Tell your doctor if you have or have had:

• cardiopulmonary resuscitation (CPR), a biopsy, or a procedure to break up kidney stones within the last 2 weeks
• been seriously injured or had a major operation within the last 3 months
• an ulcer in the stomach or duodenum within the last 3 months
• a recent bleeding disorder (within 1 year) such as gastrointestinal bleeding, or blood in your urine or stool
• recent spinal/epidural procedure
• a history or symptoms of aortic dissection (splitting of the aorta)
• uncontrolled high blood pressure (hypertension)
• an inflammation of the lining around your heart (pericarditis)
• an inflammation of the blood vessels
• problems with the blood vessels in your retina
• treatment with medications that help to prevent or dissolve blood clots
• kidney problems
• a special intravenous line inserted under your collar bone within the last 24 hours
• heart failure
• very low blood pressure due to a failing heart (cardiogenic shock)
• a liver disorder
• low blood count or anemia

Taking other medicines

In general, AGGRASTAT can be used with other drugs. However, it is important to tell your doctor about other drugs that you are taking, including those obtained without a prescription, as some drugs may affect each other's action. It is especially important to tell your doctor if you are taking other drugs that help prevent your blood from clotting such as warfarin.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant. Your doctor will decide if you should receive AGGRASTAT. If you are breast-feeding or intend to breast-feed, consult your doctor.

Use in Children

Safety and effectiveness in children have not been established.

Driving and using machines

No data are available on whether AGGRASTAT impairs the ability to drive or operate machinery.

Important information about some of the ingredients of AGGRASTAT

This medicinal product contains approximately 8.2 mEq (approximately 189 mg) of sodium per 50 mL vial which should be taken into consideration by patients on a controlled sodium diet.

If you take more AGGRASTAT than you should

The most frequently reported symptom of overdose is bleeding. If you notice bleeding, you should notify your health care professional immediately.

If you forget to take AGGRASTAT

Your doctor will decide when to administer the dose.

Some patients may experience the following side effects with AGGRASTAT:

[Common: occurring in at least 1 of 100 and less than 1 of 10 patients treated]

Nervous system disorders:

Common: headache

Disorders of the stomach and intestines:

Common: nausea

General disorders and administration site conditions:

Common: fever

Investigations

The most common changes of laboratory parameters associated with AGGRASTAT related to bleeding: reduction of hemoglobin and hematocrit levels and an increased occurrence of occult blood in urine and feces.

Occasionally during AGGRASTAT therapy an acute or fall in the platelet count or thrombocytopenia occurred with a decrease of platelet count to below 90,000/mm3. Rarely a decrease of platelet count to less than 50,000/mm3 occurred. These decreases were reversible upon discontinuation of AGGRASTAT. Acute and severe platelet decreases have been observed in patients with no prior history of thrombocytopenia upon readministration of GP IIb/IIIa receptor antagonists.

The following additional adverse reactions have been reported infrequently in post-marketing experience; they are derived from spontaneous reports for which precise incidences cannot be determined:

Blood and lymphatic system disorders:

Intracranial bleeding, retroperitoneal bleeding, hemopericardium, pulmonary haemorrhage, and epidural haematoma in the spinal region. Fatal bleedings have been reported rarely.

Acute and/or severe (<20,000/mm3) decreases in platelet counts which may have been associated with chills, low-grade fever or bleeding complications (see Investigations above).

Immune system disorders:

Severe allergic reactions (e.g. bronchospasm, urticaria) including anaphylactic reactions. The reported cases have occurred during initial treatment (also on the first day) and during readministration of tirofiban. Some cases have been associated with severe thrombocytopenia (platelet counts < 10,000/mm3).

What AGGRASTAT Contains

The active ingredient is tirofiban hydrochloride monohydrate.

1 ml of concentrate for solution for infusion contains 281 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 250 micrograms tirofiban.

The other ingredients are:

sodium chloride

sodium citrate dihydrate

citric acid anhydrous

water for injections

hydrochloric acid and/or sodium hydroxide (for pH adjustment).

What AGGRASTAT looks like and contents of pack

AGGRASTAT is a clear, colorless concentrated solution available in a 50 ml Type I glass vial

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Product Manufacturer