Eptifibatide Alida

PACKAGE LEAFLET

Package leaflet: information for the patient

Eptifibatide Alida 0.75 mg/mL solution for infusion

Eptifibatide
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, hospital pharmacist, or nurse.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Eptifibatide Alida is and what it is used for
2. What you need to know before being administered Eptifibatide Alida
3. How to use Eptifibatide Alida
4. Possible side effects
5. How to store Eptifibatide Alida
6. Contents of the pack and other information

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

Eptifibatide Alida is a platelet aggregation inhibitor. This means that it helps prevent the formation of blood clots.
It is used in adults whose heart muscle is not receiving an adequate supply of oxygen and nutrients
(presentation of severe coronary insufficiency). Subsequently, spontaneous and recent chest pain occurs, associated with altered electrical activity of the heart or changes in biochemical parameters.
Eptifibatide Alida is usually administered together with aspirin and unfractionated heparin.

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

Do not be given Eptifibatide Alida if:

• you are allergic to eptifibatide or to any of the other ingredients of this medicine (listed in section 6);
• you have recently had bleeding from the stomach, intestine, bladder or other organs; for example, if you have noticed abnormal blood loss in your urine or stools (except menstrual blood) within the last 30 days;
• you have had a stroke within the last 30 days or any episode of hemorrhagic stroke (make sure your doctor is aware of this);
• you have had a brain tumour or diseases that may affect the blood vessels in the brain;
• you have undergone major surgery or suffered severe trauma within the previous 6 weeks;
• you have had or currently have bleeding problems;
• you have had or currently have coagulation disorders or a low platelet count;
• you have had or currently have high blood pressure (hypertension);
• you have had or currently have severe kidney or liver problems;
• you have already been treated with another medicine of the same type as Eptifibatide Alida.

If you have any of these conditions, inform your doctor. If you have any doubts, ask your doctor, hospital pharmacist or nurse.

Warnings and precautions:

• Eptifibatide Alida is recommended only for adult patients hospitalised in coronary care units.

• Before and during treatment with Eptifibatide Alida, blood samples will be tested as a precautionary measure to reduce the risk of unexpected bleeding.

• While you are receiving Eptifibatide Alida, you will be closely monitored for any signs of unusual or unexpected bleeding.

Children and adolescents:
Do not use in children or adolescents under 18 years of age.

Other medicines and Eptifibatide Alida:
To avoid possible interactions with other medicines, inform your doctor, hospital pharmacist or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription. In particular:

• blood thinners (oral anticoagulants) or
• medicines that prevent blood clots such as warfarin, dipyridamole, ticlopidine, aspirin (except those that may be administered as part of treatment with Eptifibatide Alida).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning a pregnancy, consult your doctor.
Eptifibatide Alida is generally not recommended for use during pregnancy.
Your doctor will assess the benefit to you against the risk to the unborn child.
If you are breastfeeding, you must stop breastfeeding during the treatment period.

3. How to use Eptifibatide Alida

This medicinal product is for hospital use only and must be administered by experienced medical personnel.
Eptifibatide Alida is administered intravenously as an initial bolus injection followed by an infusion (drip solution). The administered dose is based on body weight. The recommended dose is 180 micrograms per kilogram of body weight given as a rapid intravenous bolus injection, followed by an infusion of 2 micrograms per kilogram of body weight per minute, up to 72 hours. If you have renal impairment, the infusion dose may be reduced to 1 microgram per kilogram of body weight per minute.
If a percutaneous coronary intervention (PCI) is performed during treatment with Eptifibatide Alida, the intravenous infusion may be continued for up to 96 hours.
You will also be given aspirin and heparin, unless contraindicated in your case.
If you have any doubts about the use of this medicinal product, please consult your doctor, hospital pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Very common
May occur in more than 1 out of 10 people

• Bleeding of minor or major severity (for example, blood in urine, blood in faeces, blood in vomit, or bleeding following surgical procedures);
• Anaemia (reduced number of red blood cells in the blood).

Common
May occur in up to 1 out of 10 people

• Inflammation of a vein.

Uncommon
May occur in up to 1 out of 100 people

• Reduction in platelet count (blood cells necessary for blood clotting);
• Reduced blood flow to the brain.

Very rare
May occur in up to 1 out of 10,000 people

• Severe bleeding (for example, internal bleeding in the abdomen, brain, or lungs);
• Bleeding leading to death;
• Severe reduction in platelet count (blood cells necessary for blood clotting);
• Skin rash (such as urticaria);
• Sudden and severe allergic reactions.

If you notice any signs of bleeding, inform your doctor, hospital pharmacist, or nurse immediately. Very rarely, bleeding has led to serious consequences and even death. Safety measures to prevent these events include blood tests and careful monitoring by the healthcare staff caring for you.

If you experience a severe allergic reaction or urticaria, inform your doctor, hospital pharmacist, or nurse immediately.

Other events that may occur in patients requiring this type of treatment include those related to the conditions being treated, such as rapid or irregular heartbeat, low blood pressure, shock, or cardiac arrest.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist, or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eptifibatide Alida

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on 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 packaging to protect the medicine from light. However,
it is not necessary to protect the Eptifibatide Alida solution from light during administration.
Before use, the contents of the vial should be inspected visually.
Do not use this medicine if you notice particulate matter or changes in the colour of the solution.
Any unused contents after opening must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eptifibatide Alida contains

• The active substance is eptifibatide. Each mL of infusion solution contains 0.75 mg of eptifibatide. A 100 mL vial of infusion solution contains 75 mg of eptifibatide.
• The other components are: citric acid monohydrate, sodium hydroxide and water for injections.

Description of the appearance of Eptifibatide Alida and package contents

Eptifibatide Alida 0.75 mg/mL infusion solution: 100 mL vial, carton pack containing one vial.
The solution is clear, colourless or almost colourless, contained in a 100 mL vial closed with a butyl rubber stopper and sealed with an aluminium cap with a plastic flip-off cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Alida Pharmaceuticals, S.L.
Via Augusta, 15-25 Of. 236,
08174, Sant Cugat del Vallés,
Barcelona
Spain

Manufacturer
Quercus Labo
Wijmenstraat 21p, 9030 Mariakerke
Oost-Vlaanderen
Belgium

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Patient Information Leaflet

Eptifibatide Alida 2 mg/mL solution for injection

Eptifibatide
Generic medicine
Please read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, hospital pharmacist, or nurse.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Eptifibatide Alida is and what it is used for
2. What you need to know before being given Eptifibatide Alida
3. How to use Eptifibatide Alida
4. Possible side effects
5. How to store Eptifibatide Alida
6. Contents of the pack and other information

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

Eptifibatide Alida is a platelet aggregation inhibitor. This means that it helps prevent the formation of blood clots.
It is used in adults in whom the heart muscle does not receive an adequate supply of oxygen and nutrients
(a manifestation of severe coronary insufficiency). This condition leads to recent, spontaneous chest pain
associated with altered electrical activity of the heart or changes in biochemical parameters. Eptifibatide Alida is usually administered in combination with aspirin and unfractionated heparin.

2. What you need to know before Eptifibatide Alida is administered to you

Do not receive Eptifibatide Alida if:

• you are allergic to eptifibatide or to any of the other ingredients of this medicine (listed in section 6);
• you have recently had bleeding from the stomach, intestines, bladder, or other organs; for example, if you have noticed abnormal blood loss in your urine or stools (excluding menstrual blood) within the last 30 days;
• you have had a stroke within the last 30 days or any history of hemorrhagic stroke (make sure your doctor is aware of this event);
• you have had a brain tumor or diseases that may affect the blood vessels in the brain;
• you have undergone major surgery or suffered severe trauma within the previous 6 weeks;
• you have had or currently have bleeding problems;
• you have had or currently have coagulation disorders or a low platelet count;
• you have had or currently have high blood pressure (hypertension);
• you have had or currently have severe kidney or liver problems;
• you have already been treated with another medicine of the same type as Eptifibatide Alida.
  If you have any of these conditions, inform your doctor. If you have any doubts, consult your doctor, hospital pharmacist, or nurse.

Warnings and precautions:

• Eptifibatide Alida is recommended only for adult patients hospitalized in coronary care units.
• Blood samples will be tested before and during treatment with Eptifibatide Alida as a precautionary measure to minimize the risk of unexpected bleeding.
• While receiving Eptifibatide Alida, you will be closely monitored for any signs of unusual or unexpected bleeding.

Children and adolescents
Do not use in children or adolescents under 18 years of age.
Other medicines and Eptifibatide Alida:
To avoid possible interactions with other medicines, inform your doctor, hospital pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. In particular:

• blood thinners (oral anticoagulants) or
• medicines that prevent blood clot formation such as warfarin, dipyridamole, ticlopidine, aspirin (except those that may be administered as part of the treatment with Eptifibatide Alida).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor.
Eptifibatide Alida is generally not recommended for use during pregnancy.
Your doctor will assess the benefit to you against the risk to the unborn child.
If you are breastfeeding, breastfeeding must be discontinued during the treatment period.

3. How to use Eptifibatide Alida

This medicinal product is for hospital use only. It must be administered by experienced medical personnel.
Eptifibatide Alida is administered intravenously as an initial bolus injection followed by a continuous infusion (drip solution). The dose administered is based on body weight. The recommended dose is 180 micrograms per kilogram of body weight given as a rapid intravenous bolus injection, followed by an infusion of 2 micrograms per kilogram of body weight per minute, up to 72 hours. If you have renal impairment, the infusion dose may be reduced to 1 microgram per kilogram of body weight per minute.
If a percutaneous coronary intervention (PCI) is performed during treatment with Eptifibatide Alida, the intravenous infusion may be continued for up to 96 hours.
You will also be given aspirin and heparin, unless contraindicated in your case.
If you have any doubts about the use of this medicinal product, consult your doctor, hospital pharmacist, or nurse.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common
May occur in more than 1 out of 10 people

• Bleeding of minor or major severity (for example, blood in urine, blood in faeces, blood in vomit, or bleeding following surgical procedures);
• Anaemia (reduced number of red blood cells in the blood).

Common
May occur in up to 1 out of 10 people

• Inflammation of a vein.

Uncommon
May occur in more than 1 out of 100 people

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

Very rare
May occur in up to 1 out of 10,000 people

• Severe bleeding (for example, internal bleeding in the abdominal area, brain, or lungs);
• Bleeding leading to death;
• Severe reduction in the number of platelets (blood cells necessary for clotting);
• Skin rash (such as urticaria);
• Sudden and severe allergic reactions.

If you notice any signs of bleeding, inform your doctor, hospital pharmacist, or nurse immediately. Very rarely, bleeding has led to serious consequences and even death. Safety measures to prevent these events include blood tests and careful monitoring by the healthcare staff caring for you.

If you develop a severe allergic reaction or urticaria, inform your doctor, hospital pharmacist, or nurse immediately.

Other events that may occur in patients requiring this type of treatment include those related to the underlying conditions being treated, such as rapid or irregular heartbeat, low blood pressure, shock, or cardiac arrest.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor, hospital pharmacist, or nurse. You can also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Eptifibatide Alida

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 packaging and on 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 packaging to protect the medicine from light. Nevertheless,
it is not necessary to protect the Eptifibatide Alida solution from light during administration.
Before use, the contents of the vial should be inspected visually.
Do not use this medicine if you notice particulate matter or any change in colour of the solution.
Any unused contents after opening must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eptifibatide Alida contains

• The active substance is eptifibatide. Each mL of injectable solution contains 2 mg of eptifibatide. A 10 mL vial of injectable solution contains 20 mg of eptifibatide.
• The other components are: citric acid monohydrate, sodium hydroxide and water for injections.

Description of the appearance of Eptifibatide Alida and contents of the pack

Eptifibatide Alida 2 mg/mL solution for injection: 10 mL vial, carton pack containing one vial.
The clear, colourless or almost colourless solution is contained in a 10 mL vial closed with a butyl rubber stopper and sealed with an aluminium cap and a plastic flip-off cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alida Pharmaceuticals, S.L.
AV Via Augusta, 15-25 Of. 236,
08174 Sant Cugat del Vallés,
Barcelona
Spain

Manufacturer
Quercus Labo
Wijmenstraat 21p, 9030 Mariakerke
Oost-Vlaanderen
Belgium

This medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names: