Hibor 3.500 IU anti Xa/0.2 ml solution for injection in pre-filled syringes

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HIBOR 3,500 IU anti Xa/0.2 ml

solution for injection in pre-filled syringes

Bemiparin sodium

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Contents of the leaflet:

1. What HIBOR 3,500 IU is and what it is used for
2. What you need to know before using HIBOR 3,500 IU
3. How to use HIBOR 3,500 IU
4. Possible adverse effects
5. How to store HIBOR 3,500 IU
6. Contents of the pack and other information

1. What HIBOR 3,500 IU is and what it is used for

The active substance in HIBOR is bemiparine sodium, which belongs to a group of medicines called anticoagulants. These medicines help prevent blood from clotting in the veins.

HIBOR 3,500 IU is used to: prevent blood clots (for example, in the leg veins and/or lungs) that may occur in patients undergoing orthopedic surgery, in patients not undergoing surgery but who are at high risk of developing clots, and in patients who have previously experienced clots and who have transient risk factors.

It is also used to prevent clot formation in the extracorporeal circulation circuit during hemodialysis.

2. What you need to know before using HIBOR 3,500 IU

Do not use HIBOR 3,500 IU

• If you are allergic to bemiparin sodium, heparin, or a similar product (such as enoxaparin, dalteparin, or nadroparin), or to any of the other ingredients of this medicine (listed in section 6).

• If you have had an allergic reaction after treatment with a medicine containing heparin.

• If you are allergic to any substance derived from pork.

• If you have Heparin-Induced Thrombocytopenia (HIT), a condition that causes a significant decrease in your platelet count (or, if as a result of HIT, you have another condition called Disseminated Intravascular Coagulation (DIC), in which your platelets would clump together if you used HIBOR).

• If you have a disease called endocarditis (inflammation of the heart walls and heart valves).

• If you have any disorder that causes a tendency to bleed excessively.

• If you have a severe liver or pancreatic disorder.

• If you have any internal organ injury or damage that could involve a high risk of internal bleeding (for example, active peptic ulcer, cerebral aneurysm [inflammation of the walls of brain arteries], or brain tumor).

• If you have had cerebral hemorrhage.

• If you have had or currently have an injury, or are scheduled for surgery involving the brain, spinal cord, eyes and/or ears within the past 2 months.

• If you are using HIBOR, you must not be given epidural or spinal anesthesia (an anesthetic injected into the spinal canal) as this could be dangerous. Therefore, make sure your doctor knows you are using HIBOR before any surgery.

Warnings and precautions
Talk to your doctor before using HIBOR 3,500 IU

• If you have liver disease.
• If you have kidney disease. Your doctor may consider special monitoring. If your condition is severe, your doctor may consider adjusting your dose.
• If you have high blood pressure and/or it is difficult to control.
• If you have ever had a peptic ulcer that is no longer active.
• If you have thrombocytopenia, a condition in which there are fewer than normal platelets in the blood, leading to bruising and easy bleeding.
• If you have kidney or bladder stones.
• If you have any condition that causes you to bleed easily.
• If you have eye problems due to blood vessel disorders.
• If you have diabetes.
• If blood tests have shown that you have high levels of potassium in your blood.
• Double-check that your doctor knows you are using HIBOR if you are to undergo a lumbar puncture (a spinal tap in the lower part of the spine for diagnostic testing).

Use of HIBOR 3,500 UI with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

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

Special tests that you may need

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

Pregnancy, breastfeeding and fertility

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

Driving and operating machinery

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

3. How to use HIBOR 3,500 IU

Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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

This medicine must never be injected into a muscle or mixed with any other injection. It is usually administered once daily.

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

If your doctor has instructed you to self-inject this medicine, carefully follow your doctor's instructions (See section “How to self-inject HIBOR?”).

The recommended dose is:

Adults (18–64 years)

Undergoing orthopedic surgery:

• You will receive one dose of the product (the contents of one syringe = 3,500 IU) before or after your operation.
• On the following days, you will receive a daily dose of the product (the contents of one syringe = 3,500 IU).

At high risk of developing blood clots:

• You will receive a daily dose of the product (the contents of one syringe = 3,500 IU), for the period determined by your doctor.

Who have previously experienced blood clots:

• You will receive a daily dose of the product (the contents of one syringe = 3,500 IU), for a maximum period of 3 months.

IU: The potency of this medicine is expressed in international units of anti-Xa activity.

Elderly (65 years and older)

Generally receive the same dose as other adult patients. If you have liver or kidney problems, please inform your doctor, as they may decide to monitor you very closely. If your kidney disease is mild or moderate, dose adjustment is not considered necessary.

Patients with renal impairment

If your kidney disease is severe, your doctor may consider dose adjustment necessary.

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

Patients with hepatic impairment

There are insufficient data for your doctor to recommend dose adjustment.

Use in children and adolescents

HIBOR is not recommended for use in children.

How to self-inject HIBOR

HIBOR must never be injected into a muscle, as this could cause bleeding into the muscle. Before giving your first injection, you must receive instructions on the correct way to use this medicine and on the proper technique for self-injection. These instructions must be provided by a doctor or other qualified healthcare professional.

Follow these steps:

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

• To keep the needle sterile, ensure it does not touch anything.
• The pre-filled syringe is ready for use.
• Before injection, do not push the plunger to remove air bubbles, as this may result in loss of medication.

• Hold the syringe in one hand and, with the other hand, use your index finger and thumb to pinch a fold of skin in the cleaned area.
• Insert the entire needle into the skin fold, holding the syringe as upright as possible on the body surface, at a 90º angle.
• Push the plunger, making sure to keep the skin fold pinched until the plunger is fully depressed.

• Remove the syringe from the injection site while keeping your finger on the plunger rod, and keep the syringe upright. Release the skin fold.

• For syringes with a safety device: Point the needle away from yourself and anyone nearby. Activate the safety system by firmly pressing the plunger rod. The protective cover will automatically cover the needle, and you will hear an audible click confirming activation of the safety shield.

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

Warnings:

• The safety system can only be activated once the syringe has been emptied.

• The safety system should only be activated after removing the needle from the patient's skin.

• Do not reuse the needle shield after injection.

• Activation of the safety system may cause a small amount of liquid to splash. For your safety, activate the safety system with the device pointed downward and away from yourself and anyone nearby.

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

If you think the effect of HIBOR 3,500 IU is too strong (for example, if you experience unexpected bleeding) or too weak (for example, if the dose does not seem to be working), inform your doctor or pharmacist.

If you use more HIBOR 3,500 IU than you should

This may cause bleeding. In such a case, contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you.

In case of overdose or accidental administration, call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use HIBOR 3,500 IU

Do not use a double dose to make up for missed doses. If this happens, consult your doctor as soon as possible to determine what you should do.

If you stop using HIBOR

Always consult your doctor before stopping this medicine.

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

4. Possible adverse effects

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

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

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

• Unusual or unexpected bleeding, for example, blood in urine or stools, which may lead to hemorrhagic anemia.

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

• Severe decrease in platelet count (Type II thrombocytopenia), which may lead to bruising, bleeding from gums, nose and mouth, and skin rashes.
• Skin damage (necrosis) at injection sites.
• If you have undergone a lumbar puncture or have received epidural or spinal anaesthesia, HIBOR may cause bleeding in the spinal cord and formation of hematomas. This could result in loss of strength or sensation in the legs and lower part of your body and/or fecal and urinary incontinence. These hematomas may cause varying degrees of disability, including prolonged or permanent paralysis. If this occurs, stop using HIBOR 3,500 IU and inform your doctor or nurse immediately.
• Severe allergic reactions (fever, tremor, difficulty breathing, swelling of the vocal cords, dizziness, sweating, urticaria, rash, itching, low blood pressure, hot flushes, redness, fainting, bronchial constriction, laryngeal swelling).

Other adverse effects:

Very common (affects more than 1 in 10 patients):

• Bruising, skin spots, itching and mild pain at the sites where the medicine was injected.

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

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

Uncommon (may affect at least 10 out of 1,000 patients):

• Mild allergic skin reactions (rash, skin eruption, urticaria, pruritus, wheals).
• Mild and transient decrease in platelet count (Type I thrombocytopenia), which may appear in blood tests.

Frequency not known (cannot be estimated from available data):

• Hyperkalaemia (increased blood potassium levels).
• Bone fragility (osteoporosis), which has been associated with long-term heparin treatment.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of HIBOR 3,500 IU

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

Do not store above 30°C. Do not freeze.

Do not use this medicine if you observe:

• The protective packaging is open.
• The protective packaging is damaged.
• The medicine contained in the syringe is cloudy.
• Small particles in the medicine.

Once the blister containing the syringe has been opened, the medicine must be used immediately.

Expiry date

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Disposal

This medicine is supplied in syringes for single use only.

Place used syringes in a hazardous waste container.

Do not store them after use.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

Composition of HIBOR 3,500 IU

The active substance is: Bemiparin sodium 3,500 IU.

The other component is: Water for injections.

Appearance of the product and contents of the container

The medicinal product contained in the syringes is a clear, colourless or slightly yellowish solution, free from visible particles.

HIBOR 3,500 IU is available in packs of 2, 10, 30 and 50 pre-filled syringes. Each syringe contains 0.2 ml of solution. Each 0.2 ml syringe provides a dose of 3,500 IU of bemiparin sodium.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS FARMACÉUTICOS ROVI, S.A.
C/ Julián Camarillo, 35
28037 MADRID

Manufacturer

ROVI Pharma Industrial Services, S.A.
C/ Julián Camarillo, 35
28037 MADRID

LABORATORIOS FARMACÉUTICOS ROVI, S.A.
C/ Julián Camarillo, 35
28037 MADRID

Date of the most recent review of this leaflet: 05/2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/