Patient Information Leaflet: Tirofiban Altan 50 micrograms/ml solution for infusion EFG

Read this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Tirofiban Altan and what is it used for

2.What you need to know before you start using Tirofiban Altan

3.How to use Tirofiban Altan

4.Possible side effects

5.Storage of Tirofiban Altan

6.Contents of the pack and additional information

TirofibanAltanis used to help facilitate blood flow to the heartand to prevent chest pain and heart attacks. It works by preventing the aggregation of platelets, cells found in the blood, and that form blood clots.

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

TirofibanAltanis intended to be used with aspirin and unfractionated heparin.

No use TirofibanAltan:

·If you are allergic (hypersensitive) to tirofiban or any of the other components of this medication (listed in section 6)

·If you have internal bleeding or a history of internal bleeding in the last 30 days.

·If you have a history of intracranial hemorrhage, a brain tumor, or abnormal blood vessels in the brain.

·If you have uncontrolled severe hypertension (malignant hypertension).

·If you have a low platelet count (thrombocytopenia) or blood coagulation disorders.

·If you developed thrombocytopenia while being treated with TirofibanAltanor another medication in the same therapeutic group.

·If you have had a history of stroke in the last 30 days or any history of hemorrhagic stroke.

·If you have had a major trauma or major surgery in the last six weeks.

·If you have severe liver failure.

Your doctor will review your medical history to see if you have a higher risk of experiencing side effects associated with the use of this medication.

Warnings and precautions

Consult your doctor before starting to use TirofibanAltan, if you have or have had:

·Any medical problem.

·Any allergy

·CPR, biopsy, or lithotripsy in the last two weeks.

·Severe trauma or major surgery in the last3months.

·Ulcer in the stomach or intestine (duodenum) in the last3months.

·Recent hemorrhagic disorder (in the last year) such as bleeding in the stomach or intestine, or blood in the urine or stool.

·Recent spinal intervention.

·History or symptoms of aortic dissection.

·Uncontrolled hypertension.

·Inflammation of the membrane that covers the heart (Pericarditis).

·Active inflammation of the veins (Vasculitis).

·Retinal hemorrhage.

·Thrombolytic treatment.

·Liver problem.

·Insertion of a special intravenous catheter under the clavicle in the last 24 hours.

·Heart failure.

·Cardiogenic shock (low blood pressure due to heart failure)

·Liver disorder

·Low blood count or anemia

Use of Tirofiban Altan withother medications

TirofibanAltancan generally be used with other medications. Please inform your doctor if you are taking, have taken recently, or may take any other medication, including over-the-counter medications, as it may affect their action. It isvery important to communicate to your doctor if you are taking medications that prevent blood clotting such as warfarin.

Use of Tirofiban Altan with food, drinks, and alcohol

Foods and drinks have no effect on this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machines

Due to your condition, you will not be able to drive or operate machinery while using TirofibanAltan.

Tirofiban Altan contains sodium

This medicine contains 916.28 mg of sodium (main component of table salt or cooking salt) in each 250 ml bag. This is equivalent to 46% of the recommended daily maximum sodium intake for an adult.

TirofibanAltanmust be prescribed by qualified doctors with experience in managing acute coronary syndromes.

TirofibanAltanis administered intravenously. Your doctor will decide on the appropriate dose, depending on your condition and weight.

Use in children

Use in children is not recommended.

If you use more Tirofiban Altan than you should

EYour TirofibanAltandose will be closely monitored and watched by your doctor and pharmacist.

The most reported adverse effect of overdose was bleeding. If you notice bleeding, you must inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use TirofibanAltan

Your doctor will decide when to administer this medication.

If you interrupt treatment with TirofibanAltan

Your doctor will decide when to stop treatment. However, if you want to stop treatment early, you must discuss other options with your doctor.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medicines,this medicinemay cause side effects, although not everyone will experience them.

The most common side effect in treatment with TirofibanAltanis bleeding that can occur anywhere in your body. This side effect can be serious and, rarely, can be fatal.

If you experience side effects, you may need medical attention. While using TirofibanAltan, if you develop any of the following symptoms, you must contact your doctor immediately:

-Signs of intracranial bleeding such as headache, sensory deficits (visual or auditory), speech difficulties, numbness or problems with movement or balance.

-Signs of internal hemorrhage such as coughing up blood or presence of blood in urine or stool.

-Signs of severe allergic reactions such as difficulty breathing or dizziness.

The following side effects have occurred in patients after treatment with TirofibanAltan. These side effects are classified in decreasing order of frequency.

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

Bleeding after surgery

Bleeding under the skin at the injection site, or in the muscle causing inflammation

Small red spots on the skin

Undetectable blood in urine or stool

Dizziness

Headache

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

Blood in urine

Coughing up blood

Nasal bleeding

Bleeding in gums and mouth

Bleeding at the puncture site

Reduction in blood count (reduction in hematocrit and hemoglobin)

Decrease in platelet count below 90,000/mm3

Fever

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

Bleeding in stomach or intestine

Vomiting blood

Decrease in platelet count below 50,000/mm3

Side effects of unknown frequency (cannot be estimated from available data):

Intracranial bleeding

Spinal hematoma

Retroperitoneal bleeding

Accumulation of blood around the heart

Pulmonary hemorrhage

Acute and severe decrease in platelet count below 20,000/mm3

Severe allergic reactions with chest compression, urticaria, including reactions that may cause difficulty breathing and dizziness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.com.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Your doctor or pharmacist will know how to store and dispose of this medication. Keep out of sight and reach of children.

After opening, this medication must be used immediately.

Do not use this medicationafter the expiration date that appears on the package. The expiration date is the last day of the month indicated.

This medication does not require any special storage conditions.

Do not use TirofibanAltanif visible particles or if the solution is discolored before use.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of TirofibanAltan

The active ingredient is tirofiban.

1 ml of infusion solution contains 50 micrograms of tirofiban.

Other ingredients are: sodium acetate trihydrate, acetic acid, sodium chloride, sodium hydroxide (for pH adjustment) and water forinjections.

Appearanceoftheproductandcontentsofthecontainer

TirofibanAltanis a transparent and colorless solution that is presented in 250 ml bags.

Container size: 1 or 3 bags with 250 ml of infusion solution. Some container sizes may only be marketed.

Marketing Authorization Holder:

ALTAN PHARMACEUTICALS S.A.

C/Cólquide 6 Portal 2 1ª Planta – Office F

28230 Las Rozas (Madrid)

Spain

Responsible for Manufacturing:

ALTAN PHARMACEUTICALS S.A.

Industrial Park of Bernedo, s/n

01118 Bernedo (Álava)

Spain

This medicinal product is authorized in the EU member states under the following names:

Tirofiban Ibisqus 50 mikrogramm/ml Infusionslösung

Tirofiban Farmages 50 microgramme/ml solution pour perfusion

Tirofiban Ibigen

Tirofiban G.E.S. 50 microgramos/ml solución para perfusión EFG

Tirofiban 50 micrograms/ml solution for infusion

Last review date of this leaflet:September 2020

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”

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This information is intended solely for healthcare professionals:

This product is intended solely for hospital use, to be used by experienced specialist doctors in the treatment of acute coronary syndromes.

TirofibanAltanmust be administered with unfractionated heparin and oral antiplatelet treatment including acetylsalicylic acid (ASA)

Dosage and administration

In patients treated with an early invasive strategy for acute coronary syndrome without ST elevation (SCA-SEST) and not planning to undergo angiography at least 4 hours and up to 48 hours after diagnosis, TirofibanAltanis administered intravenously at an initial infusion rate of 0.4 micrograms/kg/min for 30 minutes. At the end of the initial infusion, TirofibanAltanmust continue at a maintenance infusion rate of 0.1 micrograms/kg/min. TirofibanAltanmust be administered with unfractionated heparin (usually an intravenous bolus of 50-60 units (U)/kg simultaneously with the start of TirofibanAltantherapy, after approx. 1000 (U) per hour, titrated according to activated partial thromboplastin time (aPTT), which should be approximately twice the normal value) and oral antiplatelet treatment, including but not limited to ASA, unless contraindicated.

In patients with SCA-SEST undergoing planned percutaneous coronary intervention (PCI) within 4 hours of diagnosis or in patients with acute myocardial infarction with primary PCI planned, TirofibanAltanmust be administered using an initial bolus of 25 micrograms/kg administered over a period of 3 minutes, followed by a continuous infusion at a rate of 0.15 micrograms/kg/min for 18-24 hours and up to 48 hours. TirofibanAltanmust be administered with unfractionated heparin and oral antiplatelet treatment, including but not limited to acetylsalicylic acid (ASA), unless contraindicated.

No dose adjustment is required for elderly patients.

Patients with severe renal impairment

In severe renal impairment (creatinine clearance <30)Altanmust be reduced by 50%.

Paediatric population

The safety and efficacy of TirofibanAltanin children have not been established.

No data are available.

Initiation and duration of TirofibanAltan

In patients treated with an early invasive strategy for acute coronary syndrome without ST elevation (SCA-SEST) and not planning to undergo angiography at least 4 hours and up to 48 hours after diagnosis, the dosage regimen of TirofibanAltanthat should be initiated after diagnosis will be 0.4 micrograms/kg/min loading dose. The recommended duration of the maintenance infusion should be at least 48 hours. The infusion of TirofibanAltanand unfractionated heparin should be maintained during coronary angiography, and should be maintained for at least 12 hours and not more than 24 hours after angioplasty/atherectomy. Once the patient is clinically stable and no coronary intervention is planned by the doctor, the infusion should be discontinued. The entire duration of treatment should not exceed 108 hours.

If the patient with a diagnosis of SCA-SEST is treated with an early invasive strategy and undergoes angiography 4 hours after diagnosis, the bolus dosage regimen of TirofibanAltan25 micrograms/kg should be initiated at the start of PCI with a continuous infusion of 12 to 24 hours and up to 48 hours.In patients with acute myocardial infarction with primary PCI planned, the bolus infusion regimen should be initiated as soon as possible after diagnosis.

Concomitant treatment (unfractionated heparin, oral antiplatelet treatment including ASA)

The treatment with unfractionated heparin is initiated with an intravenous bolus of 50-60 U/kg, and continued with a maintenance infusion of 1000 units per hour. The dose of heparin is titrated to maintain an activated partial thromboplastin time (aPTT) of approximately twice the normal value.

Unless contraindicated, all patients should receive oral antiplatelet treatment, including but not limited to ASA, before starting TirofibanAltantherapy. This medication should be continued for at least the duration of the infusion with TirofibanAltan.

The majority of studies investigating the administration of TirofibanAltanas an adjunct to PCI have used ASA in combination with clopidogrel as oral antiplatelet treatment. The efficacy of the combination of TirofibanAltanwith prasugrel or ticagrelor has not been established in randomized and controlled trials.

If angioplasty (PCI) is required, heparin should be discontinued after PCI, and cannulas should be removed once coagulation has returned to normal, for example, when activated clotting time (ACT) is less than 180 seconds (usually 2-6 hours after discontinuing heparin).

Incompatibilities

Cases of incompatibility with diazepam have been reported. Therefore, TirofibanAltanand diazepam should not be administered by the same intravenous route.

No incompatibilities have been found between TirofibanAltanand the following intravenous formulations: atropine sulfate, dobutamine, dopamine, epinephrine hydrochloride, furosemide, heparin, lidocaine, midazolam hydrochloride, morphine sulfate, nitroglycerin, potassium chloride, propranolol hydrochloride, and famotidine injection.

Instructions for use:

Check the expiration date.

Do not extract the solution directly from the container with a syringe.

Indications for the use of containers

Do not use unless the solution is transparent and the closure is intact.

Do not add supplementary medication or extract the solution directly from the bag with a syringe.

WARNING: Do not use plastic containers in series connections, as it may cause air embolism due to the extraction of residual air from the primary container before the completion of the administration of the liquid from the secondary container Preparation for administration

Use according to the dosage table.

A table is provided as a guide for adjusting the dose based on patient weight.

·Whenever the solution and container permit, parenteral drugs should be inspected for the presence of visible particles or coloration before use.

·TirofibanAltanshould only be administered intravenously and may be administered with unfractionated heparin through the same infusion tube.

·It is recommended to administer TirofibanAltanwith a calibrated infusion device using sterile equipment.

·Care should be taken not to prolong the infusion of the initial dose and to avoid errors in calculating the infusion rates for the maintenance dose based on the patient's weight.

Special precautions for storage

Do not use TirofibanAltanafter the expiration date that appears on the labeling and on the outer packaging. The expiration date is the last day of the month indicated.

Appearance of the product and contents of the container

TirofibanAltanis a transparent and colorless solution that is presented in the following form:

bags of 250 ml of colorless, multi-layered polyolefin free of PVC with 2 polyolefin free of PVC tubes and a administration port.

It is packaged in an aluminum pre-printed overbag.

Container size: 1 or 3 bags with 250 ml of infusion solution. Some container sizes may only be marketed.

Special precautions for disposal and other handling

The disposal of unused medicinal product and all materials that have been in contact with it, will be carried out in accordance with local regulations.