Hibor 12.500 U.I. anti Xa/0.5 ml solution for injection in pre-filled syringes

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HIBOR 12,500 IU anti Xa/0.5 ml

solution for injection in pre-filled syringes

Bemiparin sodium

Read all of this leaflet carefully before you start 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, 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 yours, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What HIBOR 12,500 IU is and what it is used for
2. What you need to know before using HIBOR 12,500 IU
3. How to use HIBOR 12,500 IU
4. Possible side effects
5. How to store HIBOR 12,500 IU

Contents of the pack and other information

1. What HIBOR 12,500 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 12,500 IU is used to treat dangerous blood clots that form, for example, in the leg veins and/or in the lungs (deep vein thrombosis with or without pulmonary embolism).

2. What you need to know before using HIBOR 12,500 IU

Do not use HIBOR 12,500 IU:

• If you are allergic to bemiparin sodium, heparin, or a similar product (such as enoxaparin, dalteparin, 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 any medicine containing heparine.
• If you are allergic to any substance derived from pork.
• If you have Heparin-Induced Thrombocytopenia (HIT), a condition causing a significant decrease in your platelet count (or, if as a result of HIT, you suffer from 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 severe liver or pancreatic disease.
• If you have any internal organ injury or damage that could pose a high risk of internal bleeding (for example, active peptic ulcer, cerebral aneurysms [inflammation of the walls of brain arteries], or brain tumors).
• 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
Consult your doctor before starting to use HIBOR 12,500 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 dose adjustment necessary.
• 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 your blood tests have shown elevated potassium levels in your blood.
• If you suddenly develop skin spots, bruising, and/or painful red spots on your skin.
• Double-check that your doctor knows you are using HIBOR if you are to undergo a lumbar puncture (a needle insertion into the lower part of the spine for testing).

Use of HIBOR 12,500 IU with other medicines

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

Consult your doctor if you think you may be taking:

• Any medicine that is injected into the muscle, as such 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 (NSAIDs), such as ibuprofen, for example, used for arthritis.
• Corticosteroids such as prednisolone, used to treat inflammatory diseases like 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 to increase blood volume, such as dextran.
• An injectable medicine for heart problems called nitroglycerin.

Special tests 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, then every 3 to 4 days thereafter until treatment ends).
• If you have certain conditions (diabetes, kidney disease) or are taking medicines to prevent potassium loss, your doctor may monitor your blood potassium levels.

Pregnancy and breastfeeding

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 or operate machinery.

3. How to use HIBOR 12,500 IU

Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult 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 do I self-inject HIBOR?”).

The recommended dose is:

Adults (18-64 years)

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

• Less than 50 kg, the dose will be 0.2 milliliters (= 5,000 IU).
• Between 50 and 70 kg, the dose will be 0.3 milliliters (= 7,500 IU).
• Between 71 and 100 kg, the dose will be 0.4 milliliters (= 10,000 IU).
• Between 101 and 120 kg, the dose will be 0.5 milliliters (= 12,500 IU).
• More than 120 kg, the dose will be adjusted according to your exact weight to the equivalent of 115 IU daily per kilogram of body weight.

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

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 closely. If you have mild or moderate kidney disease, dose adjustment is not considered necessary.

Patients with renal impairment

If you have severe kidney disease, your doctor may consider adjusting the dose to 75% (approximately 85 anti-Xa IU/kg once daily).

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

Patients with hepatic impairment

There is insufficient data for your doctor to recommend a dose adjustment.

Use in children and adolescents

HIBOR is not recommended for use in children.

How do I self-inject HIBOR?

HIBOR must never be injected into a muscle, as this could cause bleeding within the muscle.

Before administering 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 another appropriately qualified healthcare professional.

Follow these steps:

• Wash your hands thoroughly and sit or lie down in a comfortable position.
• Choose an area on the waist at least 5 centimeters away from the navel and from any scars or bruises, and clean the skin thoroughly.
• Use different injection sites each day, for example, first on the left side and next time on the right side.
• 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 to 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 the cleaned skin 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 holding 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 on 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 in the nearest sharps container (needle pointing inward), close the container tightly with the lid, and place it out of the reach of children.

Warnings:

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

• The safety system must 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 maximum safety, activate the safety system with it 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 12,500 IU is too strong (for example, if you experience unexpected bleeding) or too weak (for example, if the dose does not seem effective), inform your doctor or pharmacist.

If you use more HIBOR 12,500 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. Telephone: 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use HIBOR 12,500 IU

Do not use a double dose to make up for a missed dose. 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 medicine, ask your doctor, pharmacist, or nurse.

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 or 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 12,500 UI and inform your doctor or nurse immediately.
• Severe allergic reactions (increased body temperature, tremor, difficulty breathing, swelling of the vocal cords, dizziness, sweating, urticaria, rash, itching, drop in 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, hives).
• 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of HIBOR 12,500 IU

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

Do not store above 25°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 single-use syringes.

Dispose of used syringes in a hazardous waste container.

Do not keep them after use.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of HIBOR 12,500 IU

The active substance is: Bemiparin sodium 12,500 IU.

The other component is: Water for injections.

Appearance of the medicine and contents of the pack

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

HIBOR 12,500 IU is available in packs of 2, 10, 30 and 50 pre-filled syringes. Each syringe contains 0.5 ml of solution. Each 0.5 ml syringe provides a dose of 12,500 IU of bemiparin sodium.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 revision of this leaflet: 05/2023

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