HIBOR 10,000 IU Anti-Xa / 0.4 ml PRE-FILLED SYRINGE SOLUTION FOR INJECTION

Introduction

Package Leaflet: Information for the User

HIBOR 10,000 IU anti-Xa/0.4 ml

Injectable solution 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What HIBOR 10,000 IU is and what it is used for
2. What you need to know before you use HIBOR 10,000 IU
3. How to use HIBOR 10,000 IU
4. Possible side effects
5. Storage of HIBOR 10,000 IU
6. Contents of the pack and further information

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

The active substance of 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 or without pulmonary embolism).

2. What you need to know before you use 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, dalteparina, nadroparina) 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 that contains heparin.
• If you are allergic to any substance derived from pigs.
• If you have Heparin-Induced Thrombocytopenia (HIT), a disease that causes a significant decrease in your platelet count (or, as a result of HIT, you suffer from another disease called Disseminated Intravascular Coagulation (DIC), in which your platelets clump together if you use HIBOR).

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

• If you have any type of disorder that causes you to bleed excessively.
• If you have a severe liver or pancreas disorder.

• If you have any type of damage or injury to your internal organs that could imply a high risk of internal bleeding (e.g., active stomach ulcers, 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 will have surgery on the brain, spinal cord, eyes, and/or ears in the last 2 months.

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

Warnings and precautionsConsult your doctor before starting to use HIBOR 10,000 IU.

• If you are sick with liver disease.
• If you are sick with kidney disease. Your doctor may consider special monitoring. In case your disease is severe, your doctor may consider it necessary to adjust the dose.
• If your blood pressure is high and/or difficult to control.
• If you have ever had a stomach ulcer that is no longer active.
• If you have thrombocytopenia, a disease in which there are fewer platelets than normal in the blood, which causes bruising and easy bleeding.
• If you have kidney or bladder stones.
• If you have any type of disease that causes you to bleed easily.
• If you have eye problems due to blood vessel problems.
• If you have diabetes.
• If your test results have shown that you have high potassium levels in your blood.
• Make sure your doctor knows you are using HIBOR if you are going to have a lumbar puncture (a puncture in the lower back for analysis).

Using HIBOR 10,000 IU with other medicines

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

Consult your doctor if you think you may be using:

• Any medicine 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.
• Medicines that may increase potassium levels in the blood, such as some diuretics and antihypertensives (used to reduce 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 count controlled. Your doctor will decide if it is necessary and when (e.g., before starting treatment, on the first day of treatment, then every 3 or 4 days until the end of treatment).
• If you have certain diseases (diabetes, kidney disease) or if you are taking medicines to prevent potassium loss, your doctor may monitor your potassium levels in your blood.

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 your ability to drive or use machines.

3. How to use HIBOR 10,000 IU

Follow exactly the administration instructions of this medicine indicated by your doctor, pharmacist, or nurse. If in doubt, ask 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 give you the injection in the hospital. You may need to continue receiving HIBOR when you go home.

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

Your doctor will tell you how long you should be given this medicine.

If your doctor has told you that you can inject this medicine yourself, follow your doctor's instructions carefully (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 than 50 kilograms, the dose will be 0.2 milliliters (= 5,000 IU).
• Between 50 and 70 kilograms, the dose will be 0.3 milliliters (= 7,500 IU).
• Between 71 and 100 kilograms, the dose will be 0.4 milliliters (= 10,000 IU).
• Between 101 and 120 kilograms, the dose will be 0.5 milliliters (= 12,500 IU).
• More than 120 kilograms, the dose will be adjusted based on your exact weight to the equivalent of 115 IU per day per kilogram of body weight.

IU: the potency of this medicine is described in international units of anti-Xa activity.

Elderly (65 years and over)

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 monitor you closely. If your kidney disease is mild or moderate, no dose adjustment is considered necessary.

Patients with renal insufficiency

In case your kidney disease is severe, your doctor may consider it necessary to adjust the dose to 75% (approximately 85 IU anti-Xa/kg once a day).

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

Patients with hepatic insufficiency

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

Use in children and adolescents

HIBOR is not recommended in children.

How do I inject HIBOR?

HIBOR should never be injected into a muscle because it could cause bleeding within the muscle. Before you give yourself your first injection, you should receive instructions on the correct use of this medicine and the correct injection technique. These instructions should be given by a doctor or other qualified healthcare professional.

You should follow these steps:

• Wash your hands well and sit or lie down in a comfortable position.
• Choose a waist area that is at least 5 centimeters from the navel and any scar or bruise, and clean the skin in that area well.
• Use a different site for the injection each day, 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-filled syringe is ready to use.
• Before the injection, do not push the plunger to eliminate air bubbles, as you may lose medicine.

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

• Remove 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: Direct the needle away from you and anyone present, activate the safety system by pressing firmly on the plunger. The protective sleeve will automatically cover the needle, and you will hear a audible click that confirms the activation of the protector.

• Dispose of the syringe immediately by throwing it into the nearest sharps container (needle first), close the container well with the lid, and keep it out of the reach of children.

Warnings:

• The safety system can only be activated once the syringe is empty.
• Activation of the safety system should only be performed after removing the needle from the patient's skin.
• Do not reuse the needle protection after injection.
• Activation of the safety system may splash a minimal amount of liquid. For your maximum safety, activate the safety system by directing 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 think the effect of HIBOR 10,000 IU is too strong (e.g., because you experience unexpected bleeding) or too weak (e.g., because the dose does not seem to work), tell your doctor or pharmacist.

If you use more HIBOR 10,000 IU than you should

This can cause bleeding. In this case, consult your doctor or go to the emergency department of the nearest hospital with this leaflet.

In case of overdose or accidental administration, call the Toxicology Information Service. Phone 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 forgotten doses. If this happens, you should consult your doctor as soon as possible to find out what to do.

If you stop using HIBOR

Always consult your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

Rare (may affect up to 1 in 1,000 people):

• Severe decrease in platelet count (Type II Thrombocytopenia), which can lead to bruising, bleeding gums, nose, and mouth, and rashes.
• Skin damage (necrosis) at the injection sites.
• If you have had a lumbar puncture or have been given epidural or spinal anesthesia, HIBOR may cause bleeding in the spinal cord and the formation of hematomas. This could cause loss of strength or sensation in the legs and lower part of your body and/or incontinence of feces and urine. These hematomas can cause different degrees of disability, including prolonged or permanent paralysis. If this happens, stop using HIBOR 10,000 IU and tell your doctor or nurse immediately.
• Severe allergic reactions (fever, shivering, difficulty breathing, swelling of the vocal cords, dizziness, sweating, hives, rash, itching, low blood pressure, flushing, fainting, bronchial constriction, laryngeal edema).

Other side effects:

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

• Bruises, skin spots, itching, and some pain in the areas where you injected the medicine.

Common (may affect up to 1 in 100 people):

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

Uncommon (may affect up to 1 in 1,000 people):

• Mild allergic reactions on the skin (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 the available data):

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side 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 notice:

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

Once the blister pack containing the syringe is opened, the medicine should be used immediately.

Expiry date

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

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

Disposal

This medicine is presented in single-use syringes.

Deposit used syringes in a sharps container.

Do not store them after use.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

HIBOR 10,000 UI Composition

The active ingredient is: Sodium Bemiparin 10,000 UI

The other components are: Water for injectables.

Product Appearance and Package Contents

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

HIBOR 10,000 UI is available in boxes 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 sodium bemiparin of 10,000 UI.

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 Last Revision of this Leaflet: 05/2023

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