Fibrosta is used to help assist the blood flow to your heart and to help prevent chest pain and heart attacks. It works by preventing platelets, cells found in the blood, from forming blood clots. 

This medicine may also be used in patients whose heart vessels are dilated with a balloon (percutaneous coronary intervention or PCI). This is a procedure, possibly with implantation of a small tube (stent), to improve the blood flow to the heart. 

Fibrosta is intended for use with aspirin and unfractionated heparin.

Do not use Fibrosta

• If you are allergic (hypersensitive) to tirofiban or any of the other ingredients of Fibrosta (listed in Section 6 “What Fibrosta contains”).
• If you are bleeding internally or have a history of bleeding internally within the last 30 days.
• If you have a history of bleeding in the brain, brain tumor or abnormal blood vessels in the brain.
• If you have severe uncontrolled high blood pressure (malignant hypertension).
• If you have a low blood platelet count (thrombocytopenia) or problems with blood clotting.
• If you developed thrombocytopenia if you had received treatment with Fibrosta or another medicine in the same group of drugs previously.
• If you have a history of stroke within the last 30 days or any history of stroke with bleeding.
• If you have been seriously injured or had a major operation within the last 6 weeks.
• If you have severe liver disease.

Your doctor will review your medical history to see if you are at an increased risk of any side effects associated with being given this medicine.

Warnings and precautions
Talk to your doctor before using Fibrosta, if you have or have had:

• Any medical problems
• Any allergies
• 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 intestine (duodenum) within the last 3 months
• A recent bleeding disorder (within 1 year) such as bleeding in the stomach or intestine, or blood in your urine or stool
• Recent spinal procedure
• A history or symptoms of splitting of the aorta (aortic dissection)
• Uncontrolled high blood pressure (hypertension)
• An inflammation of the lining around your heart (pericarditis)
• An inflammation of the blood vessels (vasculitis)
• Problems with the blood vessels in the back of your eye (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

Other medicines and Fibrosta
In general, tirofiban can be used with other medicines. Please tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines 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 medicines that help prevent your blood from clotting such as warfarin.

Fibrosta with food and drink
Food and drink have no effect on this medicine.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines
Due to your disease state, you will not be able to drive or operate machinery while Fibrosta is being used.

Fibrosta contains sodium
Fibrosta contains sodium. This medicine contains 189 mg sodium (main component of cooking/table salt) in each 50 ml. This is equivalent to 9.45% of the recommended maximum daily dietary intake of sodium for an adult.

Fibrosta should be prescribed by a qualified doctor who is experienced in the management of heart attacks.

You have been given, or are about to be given, Fibrosta into a vein. Your doctor will decide on the appropriate dose, depending on your condition and your weight.

Use in Children
The use in children is not recommended.

If you use more Fibrosta  than you should
Your dose of Fibrosta is carefully monitored and checked by your doctor and pharmacist.

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 use Fibrosta
Your doctor will decide when to administer the dose.

If you stop using Fibrosta
Your doctor will decide when treatment should be stopped. However, if you wish to stop your treatment earlier, you should discuss other options with your doctor.

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

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

The most common side effect of treatment with tirofiban is bleeding which could occur anywhere in the body. This can become serious and may, rarely, be fatal.

If side effects occur, they may need medical attention. While using tirofiban, if you develop any of the following symptoms, you should contact your doctor immediately:

• Signs of bleeding in the skull such as pain in the head, sensory impairments (visual or hearing), difficulties in speech, numbness or problems with movement or balance
• Signs of internal bleeding such as coughing up blood or blood in your urine or stool
• Signs of serious allergic reactions such as difficulties in breathing and dizziness

Below is a list of side effects that have occurred in some people following treatment with tirofiban. The side effects are listed in decreasing order of frequency.

Very common (may affect more than 1 in 10 people):

• Bleeding after surgery
• Bleeding under the skin at the site of an injection, or into a muscle, causing swelling
• Small red bruises on the skin
• Invisible blood in urine or stool
• Feeling sick
• Headache

Common (may affect up to 1 in 10 people):

• Blood in urine
• Coughing up of blood
• Nose bleeds
• Bleeding in the gums and mouth
• Bleeding from vessel puncture site
• Reduction in red blood cells (reduced haematocrit and haemoglobin)
• Decreases in platelet count below 90,000/mm³
• Fever

Uncommon (may affect up to 1 in 100 people):

• Bleeding in the stomach or intestines
• Vomiting of blood
• Decreases in platelet count below 50,000/mm³

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

• Bleeding in the skull
• Haematoma in the spinal region
• Bleeding in the abdomen of the internal organs
• Accumulation of blood around the heart
• Bleeding in the lung
• Acute and/or severe decreases in platelet counts below < 20,000/mm³
• Severe allergic reactions with tightness of chest, hives or nettle rash, including reactions that cause difficulty in breathing and dizziness

Keep this medicine out of the sight and reach of children.

Store below 30°C. Do not freeze.

Store in the original package in order to protect from light.

After dilution the product should be used immediately. If not used immediately, in use storage conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.

Do not use this medicine after the expiry date which is stated on the package after “EXP”.  The expiry date refers to the last day of that month.

Do not use this medicine if you notice visible particles or discolouration of the solution before use.

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