Product Information for the User

Enoxaparin Rovi 10,000 IU (100 mg)/1 ml Injectable Solution in Preloaded Syringe

Enoxaparin Sodium

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, 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 or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Enoxaparin Rovi and what is it used for

2. What you need to know before starting to use Enoxaparin Rovi

3. How to use Enoxaparin Rovi

4. Possible adverse effects

5. Storage of Enoxaparin Rovi

6. Contents of the package and additional information

Enoxaparina Rovicontains an active ingredient called enoxaparin sodium, which is a low molecular weight heparin (LMWH).

Enoxaparina Roviacts in two ways:

1. Preventing existing blood clots from growing larger. This helps your body break them down and prevent further damage.
2. Interrupting the formation of blood clots in the blood.

Enoxaparina Rovimay be used for:

• Treating blood clots.
• Preventing blood clots from forming in the following situations:

• Before and after a surgical operation.
• When you have an acute illness and must face a period of reduced mobility.
• If you have had a blood clot due to cancer, to prevent further blood clots from forming.
• When you have unstable angina (a condition in which not enough blood reaches the heart).
• After a heart attack.

• Preventing blood clots from forming in the tubes of the dialysis apparatus (used by people with severe kidney problems).

Do not use Enoxaparina Rovi

• If you are allergic to enoxaparina sodium or to any of the other components of this medication (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you are allergic to heparin or to other low molecular weight heparins, such as nadroparina, tinzaparina, or dalteparina.
• If you have had a reaction to heparin that caused a severe decrease in the number of platelets (a reaction known as heparin-induced thrombocytopenia) in the last 100 days or if you have antibodies against enoxaparina in your blood.
• If you are bleeding heavily or have a high risk of bleeding (such as stomach ulcers, recent eye or brain surgery), including recent hemorrhagic stroke.
• If you are using Enoxaparina Rovi to treat blood clots and are going to receive spinal or epidural anesthesia or lumbar puncture within 24 hours.

Warnings and precautions

Do not interchange Enoxaparina Rovi with other medications in the low molecular weight heparin group. This is because they are not exactly the same and do not have the same activity or instructions for use.

Consult your doctor or pharmacist before starting to use Enoxaparina Rovi if:

• You have ever had a reaction to heparin that caused a severe decrease in the number of platelets.
• You are going to receive spinal or lumbar anesthesia or lumbar puncture (see "Surgical procedures and anesthesia"): a delay between Enoxaparina Rovi and the use of this procedure should be respected.
• You have had a heart valve implanted.
• You have endocarditis (a heart infection).
• You have a history of stomach ulcers.
• You have recently had a stroke (cerebral hemorrhage).
• You have high blood pressure.
• You have diabetes or eye blood vessel problems caused by diabetes (diabetic retinopathy).
• You have recently had eye or brain surgery.
• You are an elderly person (over 65 years old), especially if you are over 75 years old.
• You have kidney problems.
• You have liver problems.
• You are underweight or overweight.
• You have high potassium levels in your blood (which could be checked with a blood test).
• You are currently using medications that affect bleeding (see below - Using Enoxaparina Rovi with other medications).

You may need to have a blood test before starting to use this medication, and while you are using it; this is to check the level of platelets and potassium levels in your blood.

Children and adolescents

The safety and efficacy of enoxaparina have not been evaluated in children or adolescents.

Using Enoxaparina Rovi with other medications

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

• Warfarin - used to reduce blood clotting.
• Aspirin (also known as acetylsalicylic acid or AAS), clopidogrel, or other medications used to interrupt blood clot formation (see also section 3, "Changing anticoagulant treatment").
• Dextran injection - used as a blood substitute.
• Ibuprofen, diclofenac, ketorolac, and other medications known as nonsteroidal anti-inflammatory drugs used to treat pain and inflammation in arthritis and other diseases.
• Prednisolone, dexamethasone, and other medications used to treat asthma, rheumatoid arthritis, and other diseases.
• Medications that increase potassium levels in the blood, such as potassium salts, diuretics, and some medications used to treat heart problems.

Surgical procedures and anesthesia

If you are going to have a lumbar puncture or undergo a surgical procedure where spinal or epidural anesthesia will be used, inform your doctor that you are using Enoxaparina Rovi. See "Using Enoxaparina Rovi with other medications". Also inform your doctor if you have any problems with your spine or have had spinal surgery.

Pregnancy and breastfeeding

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

If you are pregnant and have a mechanical heart valve, you may have a higher risk of blood clots. Your doctor will discuss this with you.

If you are breastfeeding or plan to breastfeed, you should consult your doctor before using this medication.

Driving and operating machines

Enoxaparina Rovi does not affect the ability to drive and use machines.

It is recommended that the healthcare professional note the commercial name and batch number of the product you are using.

Enoxaparina Rovi contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; this is, essentially "sodium-free".

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

Medication use

• Your doctor or nurse will usually administer Enoxaparina Rovi. This is because it has to be administered by injection.
• When you return home, you may need to continue using Enoxaparina Rovi and administer it yourself (see the instructions on how to do it).
• Enoxaparina Rovi is usually administered by subcutaneous injection.
• Enoxaparina Rovi can be administered by intravenous injection after certain types of heart attacks and surgical operations.
• Enoxaparina Rovi can be added to the tube that comes out of the body (arterial line) at the beginning of dialysis sessions.

Do not administer Enoxaparina Rovi intramuscularly.

How much will be administered

• Your doctor will decide how much Enoxaparina Rovi will be administered. The amount will depend on the reason it is being used.
• If you have any kidney problems, you may be administered a smaller amount of Enoxaparina Rovi.

• The usual dose is 150 UI (1.5 mg) per kilogram of body weight per day or 100 UI (1 mg) per kilogram of body weight twice a day.
• Your doctor will decide how long you will receive Enoxaparina Rovi.

?Surgical procedures or periods of limited mobility due to illness

• The dose will depend on the likelihood that you will develop a clot. You will be administered 2,000 UI (20 mg) or 4,000 UI (40 mg) of Enoxaparina Rovi per day.
• If you are to undergo surgery, you will usually be administered the first injection 2 or 12 hours before the surgery.
• If you have limited mobility due to illness, you will usually be administered 4,000 UI (40 mg) of Enoxaparina Rovi per day.
• Your doctor will decide how long you will receive Enoxaparina Rovi.

?After a heart attack

Enoxaparina Rovi can be used in two different types of heart attacks, known as STEMI (ST-elevation myocardial infarction) or non-STEMI (NSTEMI). The amount of Enoxaparina Rovi that will be administered will depend on your age and the type of heart attack you have had.

Non-STEMI heart attack:

• The usual dose is 100 UI (1 mg) per kilogram of body weight every 12 hours.
• You will usually be told to also take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you will receive Enoxaparina Rovi.

STEMI heart attack if under 75 years:

• You will be administered an initial intravenous injection of 3,000 UI (30 mg) of Enoxaparina Rovi.
• At the same time, you will be administered a subcutaneous injection of Enoxaparina Rovi. The usual dose is 100 UI (1 mg) per kilogram of body weight every 12 hours.
• You will usually be told to also take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you will receive Enoxaparina Rovi.

STEMI heart attack if 75 years or older:

• The usual dose is 75 UI (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum amount of Enoxaparina Rovi administered in the first two injections is 7,500 UI (75 mg).
• Your doctor will decide how long you will receive Enoxaparina Rovi.

For patients undergoing percutaneous coronary intervention (PCI):

Depending on when you were last administered an injection of Enoxaparina Rovi, your doctor may decide to administer an additional dose of Enoxaparina Rovi before a PCI procedure. This will be administered by intravenous injection.

• The usual dose is 100 UI (1 mg) per kilogram of body weight.
• Enoxaparina Rovi is added to the tube that comes out of the body (arterial line) at the beginning of dialysis sessions. This amount is usually sufficient for a 4-hour session. However, your doctor may perform a new injection of 50 UI to 100 UI (0.5 to 1 mg) per kilogram of body weight if necessary.

Instructions for using the syringe

If you are to administer Enoxaparina Rovi yourself

If you can administer Enoxaparina Rovi yourself, your doctor or nurse will show you how to do it. Do not attempt to administer it yourself if you have not been shown how to do it. If you are unsure, consult your doctor or nurse immediately. If the injection is performed correctly under the skin (which is known as a subcutaneous injection), this will help reduce pain and hematoma at the injection site.

Before administering Enoxaparina Rovi to yourself

?Prepare what you will need: syringe, cotton swab with alcohol or soap and water, and sharp object container.

?Check the expiration date of the medication. If it has expired, do not use it.

?Check that the syringe is not damaged and that the medication solution is transparent. If not, use another syringe.

?Make sure you know the amount to be injected.

?Check in the abdominal area if the last injection caused redness, skin color change, swelling, pus, or pain that still persists. If this occurs, consult your doctor or nurse.

Instructions for administering Enoxaparina Rovi to yourself:

(Instructions for syringes without safety device)

Preparing the injection site

1) Choose a site on the right or left side of your abdomen. At least 5 cm from the navel and towards either side.

?Do not inject within 5 cm of the navel or around it if there are scars or hematomas.

?For self-injection, alternate the left and right sides of your abdomen, depending on where the last injection was administered.

2) Wash your hands. Clean (do not rub) the area where you will administer the injection with a cotton swab with alcohol or soap and water.

3) Sit or lie down in a comfortable position to relax. Make sure you can see the area where you will administer the injection. The most suitable position is in a divan, reclining chair, or bed with pillows.

Selecting the dose

1) Carefully remove the cap from the syringe needle by pulling it. Dispose of the cap.

?Do not press the plunger to remove air bubbles before injecting. This can result in medication loss.

?Once you have removed the cap, do not touch anything with the needle. This will ensure that the needle remains clean (sterile).

2) When the amount of medication in the syringe matches the prescribed dose, there is no need to adjust the dose. You are now ready to administer the injection.

3) If the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can discard the excess medication by keeping the syringe pointing downwards (to keep the air bubble in the syringe) and expelling the excess into a container.

4) A drop may appear at the end of the needle. If this occurs, remove the drop before administering the injection by gently tapping the syringe with the needle pointing downwards. You are now ready to administer the injection.

Administering the injection

1. Hold the syringe with the hand that writes (like a pencil). With the other hand, gently pinch the area you cleaned on your abdomen, between your index finger and thumb, to form a fold in the skin.

?Make sure to hold this skin fold in place while the injection is administered.

1. Hold the syringe so that the needle points straight down (vertically at a 90-degree angle). Insert the entire needle into the skin fold.

3) Press the plunger with your thumb. This will administer the medication into the abdominal fat. Complete the injection using all the medication in the syringe.

4) Remove the needle from the injection site by pulling it straight out and keeping your finger on the plunger. The needle should be oriented away from you and any other people present. Now you can release the skin fold.

When you have finished

1) To avoid hematoma, do not rub the injection site after the injection.

2) Dispose of the used syringe in the sharp object container. Close the container lid tightly and place it out of reach of children. When the container is full, dispose of it as instructed by your doctor or pharmacist.

The disposal of unused medication and all materials that have come into contact with it will be done in accordance with local regulations.

If you think the dose is too high (e.g., if you experience unexpected bleeding) or too low (e.g., if the dose does not seem to be working), consult your doctor or pharmacist.

Instructions for syringes with safety device:

Preparing the injection site

1) Choose a site on the right or left side of your abdomen. At least 5 cm from the navel and towards either side.

?Do not inject within 5 cm of the navel or around it if there are scars or hematomas.

?For self-injection, alternate the left and right sides of your abdomen, depending on where the last injection was administered.

2) Wash your hands. Clean (do not rub) the area where you will administer the injection with a cotton swab with alcohol or soap and water.

3) Sit or lie down in a comfortable position to relax. Make sure you can see the area where you will administer the injection. The most suitable position is in a divan, reclining chair, or bed with pillows.

Selecting the dose

1. Carefully remove the cap from the syringe needle by pulling it. Dispose of the cap.

?Do not press the plunger to remove air bubbles before injecting. This can result in medication loss.

?Once you have removed the cap, do not touch anything with the needle. This will ensure that the needle remains clean (sterile).

1. When the amount of medication in the syringe matches the prescribed dose, there is no need to adjust the dose. You are now ready to administer the injection.

3) If the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can discard the excess medication by keeping the syringe pointing downwards (to keep the air bubble in the syringe) and expelling the excess into a container.

4) A drop may appear at the end of the needle. If this occurs, remove the drop before administering the injection by gently tapping the syringe with the needle pointing downwards. You are now ready to administer the injection.

Administering the injection

1. Hold the syringe with the hand that writes (like a pencil). With the other hand, gently pinch the area you cleaned on your abdomen, between your index finger and thumb, to form a fold in the skin.

?Make sure to hold this skin fold in place while the injection is administered.

1. Hold the syringe so that the needle points straight down (vertically at a 90-degree angle). Insert the entire needle into the skin fold.

1. Press the plunger with your thumb. This will administer the medication into the abdominal fat. Complete the injection using all the medication in the syringe.
2. Remove the needle from the injection site by pulling it straight out and keeping your finger on the plunger. The needle should be oriented away from you and any other people present. The safety device will be activated by firmly pressing the plunger. The protective sleeve will automatically cover the needle and emit an audible click that confirms the activation of the device. Now you can release the skin fold.

When you have finished

1) To avoid hematoma, do not rub the injection site after the injection.

2) Dispose of the used syringe in the sharp object container. Close the container lid tightly and place it out of reach of children. When the container is full, dispose of it as instructed by your doctor or pharmacist.

The disposal of unused medication and all materials that have come into contact with it will be done in accordance with local regulations.

If you think the dose is too high (e.g., if you experience unexpected bleeding) or too low (e.g., if the dose does not seem to be working), consult your doctor or pharmacist.

Changing anticoagulant treatment

• Switching from Enoxaparina Rovi to anticoagulant medications known as vitamin K antagonists (e.g., warfarin)

Your doctor will request a blood test to determine a parameter called INR and will tell you when to stop using Enoxaparina Rovi.

• Switching from anticoagulant medications known as vitamin K antagonists (e.g., warfarin) to Enoxaparina Rovi

Stop using the vitamin K antagonist. Your doctor will request a blood test to determine a parameter called INR and will tell you when to start using Enoxaparina Rovi.

• Switching from Enoxaparina Rovi to direct oral anticoagulants

Stop using Enoxaparina Rovi. Start taking the direct oral anticoagulant 0-2 hours before the next scheduled injection, and then continue as usual.

• Switching from direct oral anticoagulants to Enoxaparina Rovi

Stop taking the direct oral anticoagulant. Do not start Enoxaparina Rovi until 12 hours after the last dose of the direct oral anticoagulant.

Using more Enoxaparina Rovi than you should

If you think you have used too much or too little Enoxaparina Rovi, inform your doctor, nurse, or pharmacist immediately, even if you do not show any signs of a problem. If a child accidentally injects or ingests Enoxaparina Rovi, take them immediately to the emergency department of a hospital.

In case of overdose or accidental administration, consult your doctor immediately or go to the nearest hospital emergency department, bringing this leaflet with you, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

Missing a dose

If you forget to administer a dose, do it as soon as you remember. Do not use a double dose on the same day to compensate for the missed doses. To ensure that you do not forget any doses, it may be helpful to use a calendar.

Stopping treatment with Enoxaparina Rovi

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

It is essential that you continue to receive Enoxaparina Rovi until your doctor decides to stop treatment. If you stop using it, a blood clot may form, which can be very dangerous.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Like other similar medicines (blood-thinning medicines), Enoxaparina Rovi could cause bleeding, which could potentially put your life at risk. In some cases, the bleeding may not be apparent.

If you notice any episode of bleeding that does not stop on its own or if you notice signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately.

Your doctor may decide to keep you under close observation or change your medication.

Stop treatment with enoxaparina and inform your doctor or nurse immediately if you experience any of the following symptoms:

• Any sign of severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
• A generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

You must inform your doctor immediately

• If you experience any sign of a blood clot blocking a blood vessel, such as:

• Cramp-like pain, redness, heat, or swelling in one of your legs - which are symptoms of deep vein thrombosis.
• Difficulty breathing, chest pain, fainting, or coughing up blood - which are symptoms of pulmonary embolism.

• If you have painful skin rash with dark red spots under the skin that do not disappear when pressed.

Your doctor may request a blood test to check your platelet count.

General list of possible side effects:

Very common(may affect more than 1 in 10 people)

• Bleeding.
• Increased liver enzymes.

Common(may affect up to 1 in 10 people)

• If you notice frequent bruising. This could be due to a blood problem caused by a low platelet count.
• Rosy patches on the skin. They appear more frequently in the area where Enoxaparina Rovi has been injected.
• Skin rash (hives, urticaria).
• Redness and itching on the skin.
• Ecchymosis or pain at the injection site.
• Decreased red blood cell count.
• Increased platelet count in the blood.
• Headache.

Uncommon(may affect up to 1 in 100 people)

• Severe sudden headache. This could be a sign of brain hemorrhage.
• Sensation of tenderness to the touch and swelling of the stomach. It could be indicative of gastric hemorrhage.
• Large, irregular skin lesions with or without blisters.
• Skin irritation (local irritation).
• You may notice yellowing of the skin or eyes, and darkening of urine color. This could be due to liver problems.

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

• Severe allergic reaction. Signs of this reaction may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Increased potassium in the blood. This is more likely to occur in people with kidney problems or diabetes. Your doctor will be able to check it by performing a blood test.
• Increased eosinophil count in the blood. Your doctor will be able to check it by performing a blood test.
• Hair loss.
• Osteoporosis (a disease in which the bones may be more likely to fracture).
• Tickling, numbness, and weakness in the muscles (especially in the lower body) when you have had a lumbar puncture or spinal anesthesia.
• Loss of bladder or bowel control (so you cannot control your needs).
• Hardening or nodule at the injection site.

Reporting 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 leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 25 °C. Do not freeze.

Pre-filled syringes of Enoxaparina Rovi contain a single dose; discard any unused portion of the product.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the syringe is damaged or that the product is not transparent.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Enoxaparina Rovi Composition

• The active ingredient is enoxaparin sodium.

Each pre-filled syringe contains enoxaparin sodium with anti-Xa activity of 10,000 UI (equivalent to 100 mg) in 1 ml of injectable water.

• The other components are injectable water.

Product appearance and packaging contents

Enoxaparina Rovi is a transparent, colorless to light yellow injectable solution in a type I glass syringe with a injection needle, with or without an automatic safety device. It is presented as follows:

Enoxaparina Rovi 10,000 UI (100 mg)/1 ml injectable solution in a 1 ml graduated syringe.

Packaging of 2, 6, 10, 12, 20, 24, 30, and 50 syringes.

Only some package sizes may be commercially marketed.

In some package sizes, the pre-filled syringe may be presented with a safety device.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 - Madrid. Spain

Manufacturer

ROVI Pharma Industrial Services, S.A.

Julián Camarillo, 35

28037 - Madrid. Spain

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Austria, Denmark, Finland, Germany, Norway, Sweden:Enoxaparin Becat

Italy, Spain, Portugal:Enoxaparina Rovi

Belgium, France, Luxembourg, Netherlands:Enoxaparine Becat

Greece:Enoxaparin Rovi

Slovenia:Enoksaparin Rovi

Bulgaria, Czech Republic, Estonia, Croatia, Hungary, Latvia, Poland, Romania, Slovakia:Losmina

Ireland, United Kingdom(Northern Ireland):Arovi

Last review date of this leaflet: January 2025

Other sources of information

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