Package Insert: Information for the User

HIBOR 12.500 UI anti Xa/0.5 ml

Injectable solution in preloaded syringes

Bemiparin sodium

Read this package insert carefully before starting to use this medication, as it contains important information for you

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4

Contents of the package and additional information

The active ingredient of HIBOR is bemiparin sodium, which belongs to a group of medications calledanticoagulants. These medications help prevent blood from clotting in the veins.

HIBOR 12.500 UI is used to treat life-threatening blood clots that form, for example, in the veins of the legs and/or lungs (deep vein thrombosis with/without pulmonary embolism).

No use HIBOR 12.500 UI:

• If you are allergic to sodium bemiparin, heparin, or a similar product (such as enoxaparin, dalteparin, nadroparina) or to any of the other components of this medication (listed in section 6).
• If you have had an allergic reaction after being treated with a medication that contains heparin.
• If you are allergic to any porcine-derived substance.
• If you have Heparin-Induced Thrombocytopenia (HIT), a disease that causes a significant decrease in your platelet count (or, if as a result of HIT, you suffer from another disease called Disseminated Intravascular Coagulation (DIC), in which your platelets would clump if you used HIBOR).
• If you have endocarditis (inflammation of the heart walls and heart valves).
• If you have a condition that causes excessive bleeding.
• If you have a severe liver or pancreas disorder.
• If you have suffered internal organ damage or injury that may pose a high risk of internal bleeding (e.g., active stomach ulcer, cerebral aneurysms [inflammation of the walls of the brain arteries] or brain tumors).
• If you have had a cerebral hemorrhage.
• If you have had or have a lesion or are to undergo surgery in the brain, spinal cord, eyes, and/or ears in the past 2 months.
• If you are using HIBOR, you will not be able to receive epidural or spinal anesthesia (an injected anesthetic in the spinal cord) because it could be hazardous. Therefore, ensure that your doctor knows that you are using HIBOR before any surgery.

Warnings and PrecautionsConsult your doctor before starting to use HIBOR 12.500 UI.

• If you have liver disease.
• If you have kidney disease. Your doctor may consider special monitoring. If your disease is severe, your doctor may consider a dose adjustment.
• If you have high blood pressure and/or difficult-to-control blood pressure.
• If you have had a stomach ulcer that is no longer active.
• If you have thrombocytopenia, a disease in which there are fewer than normal platelets in the blood, which causes bruising and easy bleeding.
• If you have kidney stones or bladder stones.
• If you have a condition that causes you to bleed easily.
• If you have eye problems due to blood vessel problems.
• If you have diabetes.
• If your blood potassium levels have been shown to be elevated by your test results.
• If, suddenly, you develop skin spots, bruises, and/or painful red spots.
• Ensure that your doctor knows that you are using HIBOR if you are to undergo a lumbar puncture (a needle prick in the lowest part of the spine for analysis).

Use of HIBOR 12.500 UI with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Consultyour doctor if you think you may be using:

• Any medication that is injected into the muscle, because these injections should be avoided while you are being treated with HIBOR.
• Other anticoagulants such as warfarin and/or acenocoumarol (vitamin K antagonists) to treat and/or prevent blood clots.
• Non-steroidal anti-inflammatory drugs, such as ibuprofen, for example, for arthritis.
• Corticosteroids such as prednisolone, to treat inflammatory diseases, such as arthritis.
• Platelet inhibitors, such as aspirin, ticlopidine, or clopidogrel, to prevent blood clots.
• Medications that may increase blood potassium levels, such as some diuretics and antihypertensives (used to reduce blood pressure).
• Medications to increase blood volume, such as dextran.
• An injectable medication for heart problems called nitroglycerin.

Special analyses you may need

• Some patients may need to have their platelet count in the blood monitored. Your doctor will decide if it is necessary and when (e.g., before starting treatment, the first day of treatment, subsequently every 3 or 4 days until treatment is completed).
• If you have certain diseases (diabetes, kidney disease) or if you are taking medications to prevent potassium loss, your doctor may monitor your potassium levels in the blood.

Pregnancy and breastfeeding

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

Driving and operating machines

HIBOR does not affect the ability to drive and operate machines.

Follow exactly the administration instructions of this medication as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.

HIBOR is injected under the skin, usually in a skin fold on one side of the waist (abdomen) or in the upper part of the hip. Normally, your doctor or nurse will administer the injection in the hospital. You may need to continue receiving HIBOR when you return home.

This medicationmust neverbe injected into a muscleor mixed with any other injection.

It is normally administered once a day.

Your doctor will tell you how long you should receive this medication.

If your doctor has told you that you can inject this medication yourself, follow carefully the instructions from your doctor (See section “How do I inject HIBOR?”).

The recommended dose is:

Adults(18-64 years)

The daily dose will depend on your body weight. If you weigh:

• Less than50 kilograms, the dose will be 0.2 milliliters (= 5,000 UI).
• Between50 and 70kilograms, the dose will be 0.3 milliliters ( = 7,500 UI).
• Between71 and 100 kilograms, the dose will be 0.4 milliliters ( = 10,000 UI).
• Between101 and 120 kilograms, the dose will be 0.5 milliliters ( = 12,500 UI).
• More than120 kilograms,the dose will be adjusted, according to your exact weight, to the equivalent of 115 UI per day per kilogram.

UI: The potency of this medication is described in international units of anti-Xa activity.

Seniors(65 years and older)

They usually receive the same dose as other adult patients. If you have liver or kidney problems, please inform your doctor, as they may decide to closely monitor you. If your kidney disease is mild or moderate, no dose adjustment is considered necessary.

Patients with renal insufficiency

If your kidney disease is severe, your doctor may consider a dose adjustment to 75% (approximately 85 UI anti-Xa/kg once a day).

If your kidney disease is mild or moderate, no dose adjustment is necessary.

Patients with hepatic insufficiency

There are not enough data for your doctor to recommend a dose adjustment.

Use in children and adolescents

HIBOR is not recommended for children.

How do I inject HIBOR?

HIBOR must never be injected into a muscle because it could cause bleeding inside the muscle.

Before your first injection, you should receive instructions on the correct way to use this medication and on the correct technique for self-injection. These instructions should be given by a doctor or other qualified healthcare professional.

You should follow these steps:

• Wash your hands thoroughly and sit or lie down in a comfortable position.
• Choose a zone on the waist that is at least 5 centimeters away from the navel and any scars or bruises, and clean the skin in that area.
• Use a different site each day for the injection, for example, first on the left side and the next time on the right.
• Remove the cap that covers the needle of the HIBOR syringe.

• To keep the needle sterile, make sure it does not touch anything.
• The pre-loaded syringe is already ready for use.
• Before the injection, do not push the plunger to remove air bubbles, as you may lose medication.

• Hold the syringe with one hand and with the other, using your index and middle fingers, take a pinch of the skin area you cleaned to form a fold.
• Insert the entire needle into the skin fold, keeping the syringe as upright as possible on the surface of the body, at a 90-degree angle.
• Push the plungermaking sure to keep the skin fold in the same position until the plunger is fully down.

• Withdraw the syringe from the injection site, keeping your finger on the plunger and the syringe upright. Release the skin fold.

• For syringes with a safety device:Point the needle away from you and anyone present, activate the safety system by pressing firmly on the plunger. The protective cover will automatically cover the needle, and you will hear an audible click that confirms the activation of the protector.

• Immediately dispose of the syringe by throwing it into the nearest sharps container (with the needle pointing in), close the container tightly and place it out of reach of children.

Warnings:

• The safety system can only be activated once the syringe is empty.
• The activation of the safety system should only be done after removing the needle from the patient's skin.
• Do not reuse the needle protector after the injection.
• Activation of the safety system may splash a small amount of liquid. For your maximum safety, activate the safety system pointing it downwards and away from you and anyone present.

• Do not rub the skin where the injection was given. This will help prevent bruising.

If you estimate that the effect of HIBOR 12,500 UI is too strong (for example, because you experience unexpected bleeding) or too weak (for example, because the dose does not seem to work), inform your doctor or pharmacist.

If you use more HIBOR 12,500 UI than you should

This may cause bleeding. In this case, consult your doctor immediately or go to the nearest hospital emergency room with this leaflet.

In case of overdose or accidental administration, call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medication and the amount administered.

If you forgetto use HIBOR 12,500 UI

Do not use a double dose to compensate for the missed doses. If this happens, you should consult your doctor as soon as possible for instructions on what to do.

If you interrupt treatment with HIBOR

Always consult your doctor before stopping this medication.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop using HIBOR and consult your doctor or nurse (or go immediately to the nearest hospital emergency service) immediately if you experience any of the following side effects:

Frequent(may affect between 1 and 10 of every 100 patients):

• Unusual or unexpected bleeding, for example, blood in the urine or stool, which may cause hemorrhagic anemia.

Rare(may affect between 1 and 10 of every 1,000 patients):

• Severe decrease in platelet count (Type II thrombocytopenia), which may lead to bruising, bleeding gums, nose, and mouth, and rashes.
• Damage to the skin (necrosis) at injection sites.
• If you have had a lumbar puncture or have received epidural or spinal anesthesia, HIBOR may cause bleeding in the spinal cord and the formation of hematomas. This could cause weakness or numbness in the legs and lower body and/or incontinence of stool and urine. These hematomas may cause varying degrees of disability, including prolonged or permanent paralysis. If this occurs, stop using HIBOR 12,500 UI and immediately inform your doctor or nurse.
• Severe allergic reactions (body temperature increase, tremor, difficulty breathing, vocal cord swelling, dizziness, sweating, urticaria, rash, itching, low blood pressure, hot flashes, redness, syncope, bronchial constriction, laryngeal swelling).

Other side effects:

Very frequent (affect more than 1 in 10 patients):

• Bruising, skin spots, itching, and some pain in the areas where the medication was injected.

Frequent (may affect between 1 and 10 of every 100 patients):

• A mild and transient increase in certain liver enzymes (transaminases) that may appear in blood tests.

Infrequent (may affect at least 10 of every 1,000 patients):

• Mild allergic reactions on the skin (hives, skin rash, urticaria, pruritus, papules).
• Mild and transient decrease in platelet count (Type I thrombocytopenia) that may appear in blood tests.

Unknown frequency (cannot be estimated from available data):

• Hyperkalemia (elevated potassium levels in the blood).
• Bone fragility (osteoporosis) associated with prolonged use of heparin treatment.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C. Do not freeze.

Do not usethis medicationif you observe:

• That theprotective packagingisopen.
• That the protective packaging isdamaged.
• That the medication contained in the syringe isturbid.
• Small particles in the medication.

Once the blister containing the syringe is opened, the medication must be used immediately.

Expiry Date

Do not use this medication after the expiry date that appears on the packaging after CAD.

The expiry date is the last day of the month indicated.

Disposal

This medication is presented insyringes for single use.

Dispose of used syringes in a hazardous waste container.

Do not store them after use.

Medications should not be thrown away through the drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. In this way, you will help protect the environment.

Composition of HIBOR 12.500 UI

The active ingredient is: Bemiparin sodium 12.500 UI

The other components are: Water for injections.

Appearance of the product and content of the packaging

The medication contained in the syringes is a transparent, colorless or slightly yellowish solution, without visible particles.

HIBOR 12.500 UI is available in boxes of 2, 10, 30, and 50 preloaded syringes. Each syringe contains 0.5 ml of solution. Each 0.5 ml syringe provides a dose of bemiparin sodium of 12.500 UI.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LABORATORIOS FARMACÉUTICOS ROVI, S.A.

C/ Julián Camarillo, 35

28037 MADRID

Responsible for manufacturing

ROVI Pharma Industrial Services, S.A.

C/ Julián Camarillo, 35

28037 MADRID

LABORATORIOS FARMACÉUTICOS ROVI, S.A.

C/ Julián Camarillo, 35

28037 MADRID

Last review date of this leaflet: 05/2023

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/