Enoxaparin Rovi 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enoxaparina Rovi 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringe

enoxaparin 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, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Enoxaparina Rovi is and what it is used for
2. What you need to know before using Enoxaparina Rovi
3. How to use Enoxaparina Rovi
4. Possible side effects
5. How to store Enoxaparina Rovi
6. Contents of the pack and other information

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

Enoxaparina Rovi contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).

Enoxaparina Rovi works in two ways:

1. Preventing existing blood clots from getting larger. This helps your body to break them down and prevents further damage.
2. Inhibiting the formation of new blood clots.

Enoxaparina Rovi can be used to:

• Treat blood clots that are already present.

• Prevent the formation of blood clots in the following situations:

• Before and after surgical procedures.

• When you have an acute illness and are facing a period of reduced mobility.

• If you have had a blood clot due to cancer, to prevent further clots from forming.

• When you have unstable angina (a condition in which insufficient blood reaches the heart).

• After a heart attack.

• Prevent the formation of blood clots in the tubing of dialysis equipment (used in people with severe kidney problems).

2. What you need to know before using Enoxaparina Rovi

Do not use Enoxaparina Rovi

• If you are allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.
• If you are allergic to heparin or other low molecular weight heparins, such as nadroparin, tinzaparin or dalteparin.
• If you have previously had a reaction to heparin causing a severe decrease in the number of blood cells involved in clotting (platelets) —this reaction is known as heparin-induced thrombocytopenia— within the last 100 days, or if you have antibodies against enoxaparin in your blood.
• If you are experiencing severe bleeding or have conditions with a high risk of bleeding (such as stomach ulcer, recent eye or brain surgery), including recent hemorrhagic stroke.
• If you are using Enoxaparina Rovi to treat blood clots and are scheduled to receive spinal anaesthesia, epidural anaesthesia or lumbar puncture within 24 hours.

Warnings and precautions

Enoxaparina Rovi must not be interchanged with other medicines in the group of low molecular weight heparins. This is because they are not exactly the same and do not have identical activity or usage instructions.

Consult your doctor or pharmacist before using Enoxaparina Rovi if:

• You have ever had a reaction to heparin causing a severe drop in platelet count
• You are scheduled to receive spinal/lumbar anaesthesia or lumbar puncture (see "Surgery and anaesthesia"): a time delay between Enoxaparina Rovi administration and the procedure must be observed
• You have had a heart valve implanted
• You have endocarditis (an infection of the inner lining of the heart)
• You have a history of gastric ulcer
• You have recently had a stroke (cerebrovascular accident)
• You have high blood pressure
• You have diabetes or diabetes-related blood vessel problems in the eyes (known as diabetic retinopathy)
• You have recently undergone eye or brain surgery
• You are elderly (over 65 years old), and especially if over 75 years old
• You have kidney problems
• You have liver problems
• You have very low body weight or are overweight
• You have high levels of potassium in your blood (which may be detected by a blood test)
• You are currently taking medicines that affect bleeding (see below - Use of Enoxaparina Rovi with other medicines)

You may need to have a blood test before starting this medicine and while using it, to monitor levels of blood cells involved in clotting (platelets) and potassium levels in your blood.

Children and adolescents

The safety and efficacy of enoxaparin in children or adolescents have not been established.

Use of Enoxaparina Rovi with other medicines

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

• Warfarin – used to reduce blood clotting
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see also section 3, “Switching anticoagulant treatment”)
• Dextran injection – used as a blood volume substitute
• Ibuprofen, diclofenac, ketorolac and other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation in arthritis and other conditions
• Prednisolone, dexamethasone and other medicines used to treat asthma, rheumatoid arthritis and other conditions
• Medicines that increase potassium levels in blood, such as potassium salts, diuretics (water tablets), and some medicines used to treat heart conditions.

Surgery and anaesthesia

If you are scheduled for a lumbar puncture or a surgical procedure requiring spinal or epidural anaesthesia, inform your doctor that you are using Enoxaparina Rovi. See “Use of Enoxaparina Rovi with other medicines”. Also inform your doctor if you have any spinal problems or have previously undergone 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 medicine.

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

If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.

Driving and using machines

Enoxaparina Rovi does not affect the ability to drive or operate machinery.

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

Enoxaparina Rovi contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose, which is considered essentially "sodium-free".

3. How to use Enoxaparin Rovi

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use of the medicine

• Your doctor or nurse will normally administer Enoxaparin Rovi to you. This is because it must be given by injection.
• When you return home, you may need to continue using Enoxaparin Rovi and may have to administer it yourself (see instructions on how to do so).
• Enoxaparin Rovi is usually administered by injection under the skin (subcutaneous route).
• Enoxaparin Rovi may be administered by injection into your veins (intravenous route) after certain types of heart attacks and surgical procedures.
• Enoxaparin Rovi may be added to the tube draining from the body (arterial line) at the beginning of a dialysis session.

Do not administer Enoxaparin Rovi into muscle (intramuscular route).

What dose you will be given

• Your doctor will decide the dose of Enoxaparin Rovi you will receive. The dose depends on the reason for which it is being used.
• If you have kidney problems, you may be given a lower dose of Enoxaparin Rovi.

1. Treatment of blood clot formation:

• The usual dose is 150 IU (1.5 mg) per kilogram of body weight once daily or 100 IU (1 mg) per kilogram of body weight twice daily.
• Your doctor will decide how long you will receive Enoxaparin Rovi.

2. Prevention of blood clot formation in the following situations:

?Surgery or periods of limited mobility due to illness

• The dose depends on your risk of developing a clot. You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Enoxaparin Rovi per day.
• If you are undergoing surgery, the first injection is usually given 2 or 12 hours before the operation.
• If you have reduced mobility due to illness, you will usually be given 4,000 IU (40 mg) of Enoxaparin Rovi per day.
• Your doctor will decide how long you will receive Enoxaparin Rovi.

?After having had a heart attack

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

NSTEMI heart attack:

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

STEMI heart attack if under 75 years of age:

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

STEMI heart attack if 75 years of age or older:

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

For patients undergoing percutaneous coronary intervention (PCI):

Depending on when you received your last Enoxaparin Rovi injection, your doctor may decide to administer an additional dose of Enoxaparin Rovi before a PCI procedure. This would be given as an intravenous injection.

3. Prevention of blood clot formation in dialysis equipment tubing:

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Enoxaparin Rovi is added to the tube draining from the body (arterial line) at the beginning of the dialysis session. This amount is usually sufficient for a 4-hour session. However, your doctor may administer an additional injection of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight if necessary.

Instructions for using the syringe

If you are going to self-inject Enoxaparin Rovi

If you are able to self-inject Enoxaparin Rovi, your doctor or nurse will show you how to do it. Do not attempt to inject yourself unless you have been properly trained. If you are unsure what to do, consult your doctor or nurse immediately. Correct subcutaneous injection technique helps reduce pain and bruising at the injection site.

Before self-injecting Enoxaparin Rovi

? Prepare what you will need: syringe, alcohol swab or soap and water, and a sharps container.

? Check the medicine's expiration date. Do not use if expired.

? Check that the syringe is undamaged and that the medicine solution is clear and transparent. If not, use another syringe.

? Make sure you know the dose you are to inject.

? Examine the area of your abdomen where the last injection was given for redness, skin discoloration, swelling, discharge, or persistent pain. If any of these occur, consult your doctor or nurse.

Instructions for self-injecting Enoxaparin Rovi:

(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 away from the navel and toward either side.

? Do not inject within 5 cm around your navel or near scars or bruises.

? Alternate between the left and right sides of your abdomen, depending on where the last injection was given.

2. Wash your hands. Clean (do not rub) the injection site with an alcohol swab or soap and water.
3. Sit or lie down in a comfortable position so you are relaxed. Ensure you can clearly see the injection site. A couch, reclining chair, or bed with pillows is ideal.

Selecting the dose

1. Carefully remove the needle cap from the syringe by pulling it off. Discard the cap.

? Before injecting, do not press the plunger to remove air bubbles. This may result in loss of medicine.

? After removing the cap, do not touch anything with the needle to ensure it remains clean (sterile).

2. If the amount of medicine in the syringe matches your prescribed dose, no dose adjustment is needed. 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 your prescribed dose. In this case, expel the excess medicine by holding the syringe pointing downward (to keep the air bubble in the syringe) and expelling the excess into a container.
4. A drop may appear at the tip of the needle. If so, remove the drop before injection by gently tapping the syringe with the needle pointing downward. You are now ready to administer the injection.

Administering the injection

1. Hold the syringe with your writing hand (as if holding a pencil). With your other hand, gently pinch the cleaned area of your abdomen between your index finger and thumb to form a skin fold.

? Make sure to hold this skin fold throughout the injection.

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

3. Press the plunger with your thumb to deliver the medicine into the fatty tissue of your abdomen. Complete the injection by using all the medicine in the syringe.
4. Remove the needle straight out from the injection site. Point the needle away from yourself and others. You may now release the skin fold.

After finishing

1. To avoid bruising, do not rub the injection site after injecting.
2. Place the used syringe in a sharps container. Close the container tightly and keep it out of children's reach. When the container is full, dispose of it as instructed by your doctor or pharmacist.

Disposal of unused medicine and all materials that have come into contact with it must comply with local regulations.

If you feel the dose is too high (e.g., if you experience unexpected bleeding) or too low (e.g., if the dose does not seem effective), 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 away from the navel and toward either side.

? Do not inject within 5 cm around your navel or near scars or bruises.

? Alternate between the left and right sides of your abdomen, depending on where the last injection was given.

2. Wash your hands. Clean (do not rub) the injection site with an alcohol swab or soap and water.
3. Sit or lie down in a comfortable position so you are relaxed. Ensure you can clearly see the injection site. A couch, reclining chair, or bed with pillows is ideal.

Selecting the dose

1. Carefully remove the needle cap from the syringe by pulling it off. Discard the cap.

? Before injecting, do not press the plunger to remove air bubbles. This may result in loss of medicine.

? After removing the cap, do not touch anything with the needle to ensure it remains clean (sterile).

2. If the amount of medicine in the syringe matches your prescribed dose, no dose adjustment is needed. 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 your prescribed dose. In this case, expel the excess medicine by holding the syringe pointing downward (to keep the air bubble in the syringe) and expelling the excess into a container.

4. A drop may appear at the tip of the needle. If so, remove the drop before injection by gently tapping the syringe with the needle pointing downward. You are now ready to administer the injection.

Administering the injection

1. Hold the syringe with your writing hand (as if holding a pencil). With your other hand, gently pinch the cleaned area of your abdomen between your index finger and thumb to form a skin fold.

? Make sure to hold this skin fold throughout the injection.

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

3. Press the plunger with your thumb to deliver the medicine into the fatty tissue of your abdomen. Complete the injection by using all the medicine in the syringe.

4. Remove the needle straight out from the injection site while keeping your finger on the plunger. The needle should be pointed away from the user and any other person present. The safety mechanism activates when the plunger is firmly pressed. The protective sleeve will automatically cover the needle and emit an audible click, confirming activation of the device. You may now release the skin fold.

After finishing

1. To avoid bruising, do not rub the injection site after injecting.
2. Place the used syringe in a sharps container. Close the container tightly and keep it out of children's reach. When the container is full, dispose of it as instructed by your doctor or pharmacist.

Disposal of unused medicine and all materials that have come into contact with it must comply with local regulations.

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

Switching anticoagulant therapy

• Switching from Enoxaparin Rovi to vitamin K antagonist anticoagulants (e.g., warfarin)

Your doctor will order a blood test for a parameter called INR and will tell you when to stop Enoxaparin Rovi treatment.

• Switching from vitamin K antagonist anticoagulants (e.g., warfarin) to Enoxaparin Rovi

Stop using the vitamin K antagonist. Your doctor will order a blood test for a parameter called INR and will tell you when to start Enoxaparin Rovi.

• Switching from Enoxaparin Rovi to direct oral anticoagulants

Stop using Enoxaparin Rovi. Start taking the direct oral anticoagulant 0–2 hours before your next scheduled injection, then continue as usual.

• Switching from direct oral anticoagulant to Enoxaparin Rovi

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

If you use more Enoxaparin Rovi than you should

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

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

If you forget to use Enoxaparin Rovi

If you forget to take a dose, take it as soon as you remember. Do not use a double dose on the same day to make up for missed doses. To help ensure you do not miss any doses, it may be helpful to use a diary.

If you stop using Enoxaparin Rovi

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

It is important that you continue receiving Enoxaparin Rovi until your doctor decides to stop treatment. If you stop using it, a blood clot may form, which could be very dangerous.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Like other similar medicines (medicines to reduce blood clots), Enoxaparin Rovi could cause bleeding, which could potentially be life-threatening. In some cases, bleeding may not be obvious.

If you notice any episode of bleeding that does not stop on its own, or if you experience 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 strict observation or change your medication.

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

• Any sign of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
• A widespread, 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 have any signs of a blood vessel blockage caused by a blood clot, such as:

• Cramping pain, redness, warmth, or swelling in one of your legs – symptoms of deep vein thrombosis.

• Difficulty breathing, chest pain, fainting, or coughing up blood – symptoms of pulmonary embolism.

• If you develop a painful skin rash with dark red spots under the skin that do not fade when pressed.

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

General list of possible adverse effects:

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

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Bruising more easily than usual. This could be due to a blood problem caused by a low platelet count.
• Pinkish skin patches. These occur more frequently at the site where Enoxaparin Rovi was injected.
• Skin rash (wheals, hives).
• Redness and itching of the skin.
• Bruising or pain at the injection site.
• Decrease in the number of red blood cells in the blood.
• Increase in the number of platelets in the blood.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache. This could be a sign of bleeding in the brain.
• Tenderness and swelling of the stomach. This could indicate gastrointestinal bleeding.
• Large, irregular red lesions on the skin, with or without blisters.
• Skin irritation (local irritation).
• You may notice yellowing of the skin or eyes, and darkening of the urine. This could be due to a liver problem.

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 levels in the blood. This is more likely to occur in people with kidney problems or diabetes. Your doctor can check this with a blood test.
• Increased number of eosinophils in the blood. Your doctor can check this with a blood test.
• Hair loss.
• Osteoporosis (a condition in which bones are more likely to fracture).
• Tingling, numbness, and muscle weakness (especially in the lower part of the body) after having had a lumbar puncture or spinal anaesthesia.
• Loss of bladder or bowel control (inability to control urination or defecation).
• Hardening or nodule at the injection site.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enoxaparin Rovi

Store below 25 °C. Do not freeze.

The pre-filled syringes of Enoxaparin Rovi contain a single dose; discard any unused portion of the product.

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

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.

Do not use this medicine if the syringe is damaged or if the solution is not clear.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enoxaparina Rovi

• The active substance is enoxaparin sodium.

Each pre-filled syringe contains enoxaparin sodium with anti-Xa activity of 4,000 IU (equivalent to 40 mg) in 0.4 ml of water for injection.

• The other component is water for injection.

Presentation of the product and contents of the pack

Enoxaparina Rovi is a clear, colourless to pale yellow injectable solution in a type I glass pre-filled syringe equipped with an injection needle, with or without an automatic safety device. It is available as follows:

Enoxaparina Rovi 4,000 IU (40 mg)/0.4 ml solution for injection in 0.5 ml pre-filled syringe without graduated scale.

Pack sizes of 2, 6, 10, 20, 30 and 50 syringes.

Only certain pack sizes may be marketed.

In some pack sizes, the pre-filled syringe may be supplied 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 medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under 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

Date of the most recent review of this leaflet: January 2025

Other sources of information

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