AGGRASTAT®

Single dose vial

tirofiban hydrochloride

What is in this leaflet

This leaflet answers some common questions about AGGRASTAT. It does not
contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you using AGGRASTAT against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or
pharmacist.

Keep this leaflet. You may need to read it again.

What AGGRASTAT is used for

AGGRASTAT, in combination with heparin (another medicine used to prevent
blood clots), is used to prevent complications that may occur in people who have
unstable angina (a type of chest pain) or are having a heart attack.

AGGRASTAT belongs to a group of medicines called platelet aggregation
inhibitors.

It works by preventing cells in the blood, called platelets, from sticking
together to form blood clots. If blood clots are not treated or prevented, they
can block blood vessels. This can lead to complications such as angina or heart
attacks.

Before you are given AGGRASTAT

When you must not be given it

Do not use AGGRASTAT if you have an allergy to AGGRASTAT or any of the
ingredients listed at the end of this leaflet.

Do not use AGGRASTAT if you have any of the following medical conditions:

• bleeding inside your body
• a history of bleeding in the brain
• a history of brain tumour
• a history of abnormal or deformed arteries or veins
• a history of swelling and weakening of a part of a blood vessel, also
  called aneurysm
• major surgery or physical trauma, including falls or blows to the body or
  head, especially within the last month
• a history, symptoms or signs or aortic disection, a disease of a large
  blood vessel
• severe, uncontrolled high blood pressure
• pericarditis, a condition which involves swelling of the lining that
  surrounds the heart.

Do not use AGGRASTAT if you have received AGGRASTAT before and developed a low
platelet count.

If you are not sure whether you have received AGGRASTAT before and developed a
low platelet count, ask your doctor.

Do not use AGGRASTAT if have conditions that require treatment with medicines
to dissolve blood clots.

Do not use AGGRASTAT if you are breast-feeding or intend to breast-feed.

AGGRASTAT is not recommended for use while breast-feeding. It is not known
whether it passes into breast milk.

Do not use AGGRASTAT in children.

The safety and effectiveness in children have not been established.

If you are not sure whether you should start receiving AGGRASTAT, talk to
your doctor.

Before you are given it

Tell your doctor if:

1. you are pregnant
   
   Like most medicines, AGGRASTAT is generally not recommended during pregnancy.
   However, if there is a need to consider using AGGRASTAT during pregnancy, your
   doctor will discuss the possible risks and benefits to you and your unborn
   baby.
2. you have or have had any medical conditions, especially the following:
   • any bleeding problems, including stomach bleeding, or blood in your
     urine or stools, within the last year
   • blood clotting problems or platelet diseases, including low platelet
     count
   • disease of the blood vessels of the brain, including stroke, within the
     last year
   • problems with the blood vessels in the back of your eye/s
   • kidney disease
   • a recent spinal/epidural procedure.
3. if you have any allergies to any other medicines or any other substances,
   such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you
are given AGGRASTAT.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines
that you buy without a prescription from your pharmacy, supermarket or health
food shop. Some medicines and AGGRASTAT may interfere with each other. This
includes medicines used to dissolve or prevent blood clots, including warfarin.

These medicines may be affected by AGGRASTAT, or may affect how well it
works. You may need different amounts of your medicine, or you may need to take
different medicines.

Your doctor or pharmacist has more information on medicines to be careful
with or to avoid while being given AGGRASTAT.

How AGGRASTAT is given

AGGRASTAT is given as a slow injection into a vein.

AGGRASTAT must only be given by a doctor or nurse.

Your doctor will decide what dose and how long you will receive AGGRASTAT.
This depends on your condition, the procedure you're having and other factors,
such as your weight and kidney function.

Adverse Effects

Tell your doctor, nurse, or pharmacist as soon as possible if you do not feel
well while you are being given AGGRASTAT.

AGGRASTAT helps most people, but it may have unwanted adverse effects in a
few people. All medicines can have adverse effects. Sometimes they are serious,
most of the time they are not. You may need medical treatment if you get some of
the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or nurse immediately if you notice any unusual bleeding or
bruising.

This includes bleeding gums, nose bleeds, blood in your urine, bloody or black,
tarry stools, coughing up blood, vomiting blood or material that looks like
coffee grounds.

These may be serious adverse effects of AGGRASTAT. You may need urgent
medical attention.

Tell your doctor or nurse if you notice any of the following and they worry
you:

• fever
• nausea
• headache
• rash or allergic reaction.

These are usually mild adverse effects of AGGRASTAT.

Other adverse effects not listed above may also occur in some patients. Tell
your doctor if you notice any other effects.

Do not be alarmed by this list of possible adverse effects. You may not
experience any of them.

Storage

AGGRASTAT will be stored in the pharmacy or on the ward.

The solution is kept in a cool, dry place where the temperature stays below 30°C
and where it is protected from light.

Product Description

What it looks like

AGGRASTAT Concentrate for Infusion comes in a glass vial, containing 50 mL of
solution.

Ingredients

Active ingredients:

• AGGRASTAT Concentrate for Infusion - 0.25 mg of tirofiban per mL.

Inactive ingredients:

• citric acid anhydrous
• sodium citrate dihydrate
• sodium chloride
• water for injections