Hibor 10.000 IU anti-Xa/0.4 ml solution for injection in pre-filled syringes

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HIBOR 10,000 IU anti Xa/0.4 ml

solution for injection in pre-filled syringes

Bemiparin sodium

Read the entire 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, 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, since 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 10,000 IU is and what it is used for
2. What you need to know before using HIBOR 10,000 IU
3. How to use HIBOR 10,000 IU
4. Possible adverse effects
5. How to store HIBOR 10,000 IU
6. Contents of the pack and other information

1. What HIBOR 10,000 IU is and what it is used for

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

HIBOR 10,000 IU is used to treat dangerous blood clots that form, for example, in the veins of the legs and/or lungs (deep vein thrombosis with/without pulmonary embolism).

2. What you need to know before using HIBOR 10,000 IU

Do not use HIBOR 10,000 IU

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

• If you have had an allergic reaction after being treated 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 develop 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 you to bleed excessively easily.

• 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 stomach 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 to undergo surgery on 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 anaesthesia (an anaesthetic 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 starting to use HIBOR 10,000 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 stomach 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 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 needle inserted into the lower part of the spine for testing).

Use of HIBOR 10,000 IU with other medicines

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

Talk to your doctor if you think you may be taking:

• Any medicine that is injected into 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 (NSAIDs), 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 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 if this is necessary and when (for example, before starting treatment, on the first day of treatment, then every 3 to 4 days during treatment until it ends).
• If you have certain conditions (diabetes, kidney disease) or are taking medicines that 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use HIBOR 10,000 IU

Follow exactly the administration instructions for 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?”).

Recommended dose:

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, who may decide to monitor you very 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 it necessary to adjust the dose to 75% (approximately 85 anti-Xa IU/kg once daily).

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

Patients with hepatic impairment

There are insufficient data for your doctor to recommend a 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 administering your first injection, you must receive instructions on the correct way to use this medicine and on the proper self-injection technique. These instructions must be provided by a doctor or other 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 cm away from the navel and from any scars or bruises, and clean the skin in that area well.
• Use different injection sites each day; for example, first on the left side, then 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 press the plunger to remove air bubbles, as you may lose some of the medicine.

• Hold the syringe in one hand and, with the other hand, use your index finger and thumb to pinch the cleaned area of skin to form a skin fold.
• Insert the entire needle into the skin fold, keeping 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 by 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 the plunger rod. The protective shield will automatically cover the needle, and you will hear an audible click confirming activation of the safety device.

• Immediately dispose of the syringe by placing it into the nearest sharps container (needle pointing inward), close the container tightly with the lid, and keep it out of children's reach.

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.

• Activating the safety system may cause a small amount of liquid to splash. For your maximum safety, activate the safety system with the syringe 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 feel that the effect of HIBOR 10,000 IU is too strong (for example, if you experience unexpected bleeding) or too weak (for example, if the dose does not seem to work), inform your doctor or pharmacist.

If you use more HIBOR 10,000 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 10,000 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 find out what you should do.

If you stop treatment with 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:

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

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

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

• Severe decrease in the number of platelets (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 your legs and lower 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 10,000 IU and report it immediately to your doctor or nurse.
• Severe allergic reactions (increased body temperature, tremor, difficulty breathing, swelling of the vocal cords, dizziness, sweating, urticaria, rash, itching, low blood pressure, hot flushes, redness, fainting, bronchial constriction, swelling of the larynx).

Other adverse effects:

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

• Bruising, skin spots, itching, and mild pain at the injection sites.

Common (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 the number of platelets (Type I thrombocytopenia), which may appear in blood tests.

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

• Hyperkalemia (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 through 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 10,000 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 solution 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 must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE 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 10,000 IU

The active substance is: Bemiparin sodium 10,000 IU

The other component is: Water for injections.

Appearance of the medicinal product and contents of the container

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

HIBOR 10,000 IU is available in packs of 2, 10, 30 and 50 pre-filled syringes. Each syringe contains 0.4 ml of solution. Each 0.4 ml syringe provides a dose of 10,000 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/