Enoxaparin Rovi 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enoxaparina Rovi 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringe

enoxaparin 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 you. It may harm them.

  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side 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 Enoxaparin Rovi is and what it is used for

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

Enoxaparin Rovi works in two ways:

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

Enoxaparin Rovi can be used to:

• Treat existing blood clots.

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

• Before and after surgery.

• 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 blood clots in the tubing of the dialysis apparatus (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 sodium enoxaparin or to 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 to other low molecular weight heparins, such as nadroparin, tinzaparin or dalteparin.
• If you have previously had a reaction to heparin that caused 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 (cerebral hemorrhage).
• If you are using Enoxaparina Rovi to treat blood clots and are scheduled to receive spinal anesthesia, epidural anesthesia, 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 starting to use Enoxaparina Rovi if:

• You have ever had a reaction to heparin that caused a severe decrease in platelet count.
• You are scheduled to receive spinal/lumbar anesthesia or lumbar puncture (see "Surgery and anesthesia"): a time delay between Enoxaparina Rovi administration and this 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 of age), and especially if over 75 years.
• 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 you are using it, to monitor levels of blood cells involved in clotting (platelets) and blood potassium levels.

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, “Changing 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 diseases
• Medicines that increase potassium levels in blood, such as potassium salts, diuretics (medicines to eliminate fluid), and some medicines used to treat heart conditions.

Surgery and anesthesia

If you are scheduled for a lumbar puncture or a surgical procedure requiring spinal or epidural anesthesia, 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 are planning 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 blood clots. Your doctor will discuss this with you.

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

Driving and using machines

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

Healthcare professionals are advised to record the trade name and batch number of the product being used.

Enoxaparina Rovi contains sodium

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

3. How to use Enoxaparin Rovi

Follow exactly the instructions for administration of this medicine as 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 intravenous injection 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 any 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 daily.
• If you are undergoing surgery, the first injection is usually given 2 or 12 hours before the operation.
• If you have limited mobility due to illness, you will usually be given 4,000 IU (40 mg) of Enoxaparin Rovi daily.
• Your doctor will decide how long you will receive Enoxaparin Rovi.

?After a heart attack

Enoxaparin Rovi may be used in two different types of heart attacks: 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.

STEMI-type heart attack:

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

STEMI-type heart attack if you are 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 generally advise you to also take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you will receive Enoxaparin Rovi.

STEMI-type heart attack if you are 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 last received an Enoxaparin Rovi injection, your doctor may decide to administer an additional dose of Enoxaparin Rovi before a PCI procedure. This would be given by 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 dose is usually sufficient for a 4-hour session. However, your doctor may administer an additional injection of 50 to 100 IU (0.5 to 1 mg) per kilogram of body weight if necessary.

Instructions for using the syringe

If you are to self-administer Enoxaparin Rovi

If you are able to self-administer 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 (i.e., injection under the skin) will help 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 expiry date of the medicine. Do not use if expired.

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

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

? Check 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 an area on the right or left side of your abdomen, at least 5 cm away from the navel and to 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 for each injection, depending on where the last injection was given.

1. Wash your hands. Clean (do not rub) the injection site with an alcohol swab or soap and water.
2. 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 most suitable.

Selecting the dose

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

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

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

1. If the amount of medication in the syringe matches your prescribed dose, no dose adjustment is needed. You are now ready to administer the injection.
2. If the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed amount. In this case, expel the excess medication by holding the syringe downward (to keep the air bubble in the syringe) and expelling the excess into a container.
3. 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 in your writing hand (like 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.

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

1. Press the plunger with your thumb to deliver the medication into the fatty tissue of your abdomen. Complete the injection by using all the medication in the syringe.
2. 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 completion

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 be in accordance 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 an area on the right or left side of your abdomen, at least 5 cm away from the navel and to 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 for each injection, depending on where the last injection was given.

1. Wash your hands. Clean (do not rub) the injection site with an alcohol swab or soap and water.
2. 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 most suitable.

Selecting the dose

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

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

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

1. If the amount of medication in the syringe matches your prescribed dose, no dose adjustment is needed. You are now ready to administer the injection.

2. If the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed amount. In this case, expel the excess medication by holding the syringe downward (to keep the air bubble in the syringe) and expelling the excess into a container.

3. 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 in your writing hand (like 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.

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

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

3. Remove the needle straight out from the injection site while keeping your finger on the plunger. The needle should be pointed away from you and others. 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. You may now release the skin fold.

After completion

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 be in accordance 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 antagonists (e.g., warfarin)

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

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

Stop using the vitamin K antagonist. Your doctor will request an INR blood test 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, consult 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 administer a dose, do so 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 the use of 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 may cause adverse effects, although not everyone experiences them.

Like other similar medicines (medicines used to reduce blood clots), Enoxaparin Rovi could cause bleeding, which could potentially be life-threatening. In some cases, the bleeding might 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), contact 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).

Contact your doctor immediately

• If you experience any sign 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 disorder caused by a low platelet count.
• Pinkish plaques on the skin. 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, sensitivity to touch, 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 become more likely to fracture).
• Tingling, numbness, and muscle weakness (especially in the lower part of the body) following a lumbar puncture or spinal anesthesia.
• Loss of bladder or bowel control (inability to control urination or defecation).
• Hardening or a nodule at the injection site.

Reporting of adverse effects

If you experience any 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 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 you notice that 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 helps protect the environment.

6. Contents of the pack and other information

Composition of Enoxaparin Rovi

• The active substance is enoxaparin sodium.

Each pre-filled syringe contains enoxaparin sodium with anti-Xa activity of 6,000 IU (equivalent to 60 mg) in 0.6 ml of water for injections.

• The other component is water for injections.

Appearance of the product and contents of the pack

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

Enoxaparin Rovi 6,000 IU (60 mg)/0.6 ml solution for injection in a 1 ml graduated pre-filled syringe.

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

Only some pack sizes may be marketed.

In certain pack sizes, the pre-filled syringe may be supplied in combination with a safety device.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the European Economic Area countries 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 revision 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/)