Enoxaparin Rovi

Package leaflet: Information for the patient

ENOXAPARINA ROVI 2,000 IU (20 mg) in 0.2 mL solution for injection in pre-filled syringe, 4,000 IU (40 mg) in 0.4 mL solution for injection in pre-filled syringe, 6,000 IU (60 mg) in 0.6 mL solution for injection in pre-filled syringe, 8,000 IU (80 mg) in 0.8 mL solution for injection in pre-filled syringe, 10,000 IU (100 mg) in 1 mL solution for injection in pre-filled syringe

enoxaparin sodium
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 the active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).
ENOXAPARINA ROVI works in two ways.

1. It prevents the growth of existing blood clots. This helps the body to break them down and prevents them from causing harm.
2. It prevents the formation of new blood clots.
   ENOXAPARINA ROVI can be used for:

• Treating existing blood clots.
• Preventing the formation of blood clots in the following situations:
  • before and after surgery
  • in case of acute illness requiring reduced mobility
  • if you have had a blood clot due to cancer, to prevent further clots
  • in unstable angina (a condition in which insufficient blood reaches the heart)
  • after a heart attack
• Preventing the formation of blood clots in the tubing of dialysis machines (used by 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 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 the 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 platelets (cells responsible for blood clotting) (this reaction is called heparin-induced thrombocytopenia) within the last 100 days, or if you have antibodies against enoxaparin in your blood.
• If you are actively bleeding or have a disease with a high risk of bleeding (such as a stomach ulcer, recent brain or eye surgery), including recent hemorrhagic stroke.
• If you are using ENOXAPARINA ROVI to treat blood clots and you will undergo spinal or epidural anesthesia or a lumbar puncture within 24 hours.

Warnings and precautions
ENOXAPARINA ROVI must not be used interchangeably with other medicines belonging to the group of low molecular weight heparins. These medicines are not identical and do not have the same activity or usage instructions.
Consult your doctor before using ENOXAPARINA ROVI if:

• you have previously had a reaction to heparin that caused a significant decrease in platelet count
• you are scheduled to undergo spinal or epidural anesthesia or lumbar puncture (see Surgery and anesthesia): observe the recommended time interval between ENOXAPARINA ROVI use and this procedure
• you have had a heart valve implanted
• you suffer from endocarditis (an infection of the inner lining of the heart)
• you suffer from a stomach ulcer
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or diabetic eye disease (diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if over 75 years
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (levels can be checked with a blood test)
• you are currently taking medicines that may affect bleeding (see next section – Other medicines)

You may need to have blood tests before starting this medicine and regularly during treatment to monitor your platelet count (blood cells involved in clotting) and blood potassium levels.
Children and adolescents
The safety and efficacy of enoxaparin have not been established in children or adolescents.
Other medicines and ENOXAPARINA ROVI
Inform your doctor or pharmacist if you are taking or might take any other medicines.

• Warfarin – used to thin the blood.
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see also section 3, Switching anticoagulant medicines).
• Dextran injection – used as a blood volume expander.
• Ibuprofen, diclofenac, ketorolac, or other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) – used to treat pain and inflammation in arthritis and other conditions.
• Prednisolone, dexamethasone, or other medicines used to treat asthma, rheumatoid arthritis, and other conditions.
• Medicines that increase potassium levels in the blood, such as potassium salts, diuretics, and certain heart medications. Surgery and anesthesia If you are scheduled for a spinal puncture or surgery requiring epidural or spinal anesthesia, inform your doctor that you are using ENOXAPARINA ROVI. Refer to the section "Do not use ENOXAPARINA ROVI". Also inform your doctor of any spinal problems or previous spinal surgery.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
If you are pregnant and have a mechanical heart valve, you may be at 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 taking this medicine.
Driving and using machines
ENOXAPARINA ROVI does not affect your ability to drive or operate machinery.
It is recommended that the healthcare provider record the brand name and batch number of the product you are using.
ENOXAPARINA ROVI contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to use ENOXAPARINA ROVI

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Administration of the medicine

• ENOXAPARINA ROVI is normally administered by a doctor or nurse, as it must be given by injection.
• When discharged from the hospital, you may need to continue using ENOXAPARINA ROVI and therefore may need to self-administer it (see instructions below on how to do so).
• ENOXAPARINA ROVI is usually administered by subcutaneous (under the skin) injection.
• ENOXAPARINA ROVI may be administered by intravenous (into a vein) injection after certain types of heart attack or surgical procedures.
• ENOXAPARINA ROVI may be added to the arterial line at the beginning of each dialysis session. Do not inject ENOXAPARINA ROVI into a muscle.

How much medicine will be administered to you

• Your doctor will decide the dose of ENOXAPARINA ROVI you should receive. The dose depends on the reason for treatment.
• If you have kidney problems, you may receive a lower dose of ENOXAPARINA ROVI.

1. Treatment of existing blood clots in the bloodstream

   • 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 should continue receiving ENOXAPARINA ROVI.

2. Prevention of blood clots in the following situations:

   • Surgery or periods of reduced mobility due to illness

     • The dose depends on your risk of developing a clot. You will receive either 2,000 IU (20 mg) or 4,000 IU (40 mg) of ENOXAPARINA ROVI daily.
     • If surgery is planned, the first injection is usually given 2 hours or 12 hours before the operation.
     • In case of reduced mobility due to illness, 4,000 IU (40 mg) of ENOXAPARINA ROVI is usually administered daily.
     • Your doctor will decide how long you should continue receiving ENOXAPARINA ROVI.

   • After a heart attack
     ENOXAPARINA ROVI can be used for two different types of heart attack: STEMI (ST-segment elevation myocardial infarction) or Non-STEMI (NSTEMI). The dose of ENOXAPARINA ROVI depends on your age and the type of heart attack.

     NSTEMI heart attack:

     • The recommended dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
     • Your doctor will usually also prescribe aspirin (acetylsalicylic acid).
     • Your doctor will decide how long you should continue taking ENOXAPARINA ROVI.

     STEMI heart attack if you are under 75 years of age:

     • An initial dose of 3,000 IU (30 mg) of ENOXAPARINA ROVI will be administered as an intravenous injection.
     • At the same time, you will also receive ENOXAPARINA ROVI by subcutaneous (under the skin) injection. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
     • Your doctor will usually also prescribe aspirin (acetylsalicylic acid).
     • Your doctor will decide how long you should continue taking ENOXAPARINA ROVI.

     STEMI heart attack if you are 75 years of age or older:

     • The recommended dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
     • The maximum dose of ENOXAPARINA ROVI for the first two injections is 7,500 IU (75 mg).
     • Your doctor will decide how long you should continue receiving ENOXAPARINA ROVI.

   • For patients undergoing a procedure called percutaneous coronary intervention (PCI):
     Depending on when ENOXAPARINA ROVI was last administered, your doctor may decide to give an additional dose of ENOXAPARINA ROVI before the PCI. The medicine will be injected into a vein.

3. Prevention of blood clots in dialysis machine tubing

   • The recommended dose is 100 IU (1 mg) per kilogram of body weight.
   • ENOXAPARINA ROVI is added to the 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 dose of 50–100 IU (0.5–1 mg) per kilogram of body weight if needed.

Instructions for using the syringe
How to self-administer the ENOXAPARINA ROVI injection
If you are able to self-administer ENOXAPARINA ROVI, your doctor or nurse will show you how to do it. Do not attempt to inject the medicine yourself unless you have been properly trained. If you have any doubts, consult your doctor or nurse immediately. Administering the injection correctly under the skin (called "subcutaneous injection") will help reduce pain and bruising at the injection site.

Before injecting ENOXAPARINA ROVI

• Gather the items you will need: syringe, alcohol swab or soap and water, and a sharps container.
• Check the expiry date on the medicine. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the medicine inside is a clear solution. If not, use another syringe.
• Make sure you know how much medicine you are to inject.
• Examine your abdomen to see if the previous injection caused redness, skin discoloration, swelling, oozing, or pain. If so, contact your doctor or nurse.

Instructions for self-injection of ENOXAPARINA ROVI
(Instructions for syringes without safety device)

Preparing the injection site

1. Choose an area on the right or left side of your abdomen. It should be at least 5 centimeters away from the navel and toward the outer side (flank).

• Do not administer the injection within 5 cm of the navel or near scars or bruises.
• Alternate the injection site between the right and left sides of the abdomen, depending on the location of the last injection.

2. Wash your hands. Clean (without rubbing) the injection site with an alcohol swab or soap and water.
3. Sit or lie down in a comfortable position so you are relaxed. Make sure you can clearly see the injection site. A padded chair, armchair, or bed supported with pillows is ideal.

Selecting the dose

1. Carefully remove the needle cap from the syringe. Discard the cap.

• Do not press the plunger before the injection to remove air bubbles. This may cause loss of medicine.
• After removing the cap, avoid letting the needle touch any other objects to ensure it remains clean (sterile).

2. If the amount of medicine in the syringe matches the prescribed dose, no dose adjustment is needed. The syringe is ready for injection.
3. If the dose is based on body weight, you may need to adjust the dose in the syringe to match the prescribed amount. In this case, you can remove 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 by gently tapping the syringe with the needle pointing downward. The syringe is now ready for injection.

Injection

1. Hold the syringe in your dominant hand (like a pencil). With your other hand, gently pinch the cleaned area of your abdomen between your index finger and thumb to create a skin fold.

• Make sure to keep the skin fold throughout the entire injection.

2. Hold the syringe so that the needle is pointing straight down (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with your thumb to deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all the medicine in the syringe.
4. Remove the needle from the injection site by pulling it straight out. Point the needle away from yourself and anyone nearby. Release the skin fold.

After completing the injection

1. To avoid bruising, do not rub the injection site after the injection.
2. Dispose of the used syringe in a sharps container. Close the container tightly and keep it out of reach of children. When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions.

Any unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.

If you think the dose is too strong (e.g., if you experience unexpected bleeding) or too weak (e.g., the dose does not seem effective), speak with 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. It should be at least 5 centimeters from the navel and toward the outer side (flank).

• Do not administer the injection within 5 cm of the navel or near scars or bruises.
• Alternate the injection site between the right and left sides of the abdomen, depending on the location of the last injection.

2. Wash your hands. Clean (without rubbing) the injection site with an alcohol swab or soap and water.
3. Sit or lie down in a comfortable position so you are relaxed. Make sure you can clearly see the injection site. A padded chair, armchair, or bed supported with pillows is ideal.

Selecting the dose

1. Carefully remove the needle cap from the syringe. Discard the cap.

• Do not press the plunger before the injection to remove air bubbles. This may cause loss of medicine.
• After removing the cap, avoid letting the needle touch any other objects to ensure it remains clean (sterile).

2. If the amount of medicine in the syringe matches the prescribed dose, no dose adjustment is needed. The syringe is ready for injection.
3. If the dose is based on body weight, you may need to adjust the dose in the syringe to match the prescribed amount. In this case, you can remove 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 by gently tapping the syringe with the needle pointing downward. The syringe is now ready for injection.

Injection

1. Hold the syringe in your dominant hand (like a pencil). With your other hand, gently pinch the cleaned area of your abdomen between your index finger and thumb to create a skin fold.

• Make sure to keep the skin fold throughout the entire injection.

2. Hold the syringe so that the needle is pointing straight down (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with your thumb to deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all the medicine in the syringe.
4. Remove the needle from the injection site by pulling it straight out. Point the needle away from yourself and anyone nearby. The safety mechanism is activated by firmly pressing the plunger rod. The protective shield will automatically cover the needle and produce an audible "click," confirming activation of the device. Release the skin fold.

After completing the injection

1. To avoid bruising, do not rub the injection site after the injection.
2. Dispose of the used syringe in a sharps container. Close the container tightly and keep it out of reach of children. When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions.

Changing Anticoagulant Treatment

• Switching from ENOXAPARINA ROVI to anticoagulants known as vitamin K antagonists (e.g., Warfarin)
  Your doctor will prescribe blood tests called INR and will instruct you when to stop taking ENOXAPARINA ROVI.
• Switching from anticoagulants known as vitamin K antagonists (e.g., Warfarin) to ENOXAPARINA ROVI
  Stop taking vitamin K antagonists. Your doctor will prescribe blood tests called INR and will instruct you when to start taking ENOXAPARINA ROVI.
• Switching from ENOXAPARINA ROVI to direct oral anticoagulant therapy
  Stop taking ENOXAPARINA ROVI. Start taking the direct oral anticoagulant 0–2 hours before the time when the next injection would have been due, then continue as usual.
• Switching from direct oral anticoagulant therapy to ENOXAPARINA ROVI
  Stop taking the direct oral anticoagulant. Do not start treatment with ENOXAPARINA ROVI until 12 hours after taking the final dose of the direct oral anticoagulant.

If you use 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 notice any signs of problems. If a child accidentally injects or ingests ENOXAPARINA ROVI, take them immediately to the emergency room.

If you forget to use ENOXAPARINA ROVI
If you forget to take a dose, take it as soon as you remember. Do not take a double dose on the same day to make up for the missed dose. Keeping a diary will help you avoid missing doses.

If you stop using ENOXAPARINA ROVI
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
It is important that you continue receiving ENOXAPARINA ROVI injections for as long as your doctor decides. If you stop them, a blood clot may form, which could be very dangerous.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other similar medicines (medicines to reduce blood clotting), ENOXAPARINA ROVI can cause bleeding, which may potentially be life-threatening. In some cases, bleeding may not be obvious.
If you experience any type of bleeding that does not stop on its own, or if you experience signs of excessive bleeding (extreme weakness, fatigue, paleness, dizziness, headache or unexplained swelling), contact your doctor immediately.
Your doctor may decide to monitor you closely or switch your medication.
Stop using enoxaparin and contact a doctor immediately if you notice 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 (generalized acute exanthematous pustulosis). You must inform your doctor immediately
• If you have signs of a blood vessel blockage caused by a blood clot, such as:
• Cramping pain, redness, warmth or swelling in one of the legs – symptoms of deep vein thrombosis
• Shortness of breath, chest pain, fainting or coughing up blood – symptoms of pulmonary embolism
• If you develop a painful rash with dark red spots under the skin that do not fade when pressed. Your doctor may ask you to have 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)

• Bruising more easily than usual. This may be due to a blood disorder with low platelet count
• Pink spots on the skin. These are more likely to appear in the area where ENOXAPARINA ROVI was injected
• Skin rash (bumps, hives)
• Itchy, red skin
• Bruising or pain at the injection site
• Decrease in red blood cells
• High number of platelets in the blood
• Headache

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache, which may be a sign of bleeding in the brain
• Abdominal pain and swelling. You may have bleeding in the stomach
• Large, irregular red skin lesions with or without blisters
• Skin irritation (local irritation)
• Yellowing of the skin or eyes and darker urine. This may indicate a liver problem

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

• Severe allergic reaction. Signs of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• Increased potassium levels in the blood. This is more likely in people with kidney problems or diabetes. Your doctor may check this with a blood test
• Increased number of eosinophils in the blood. Your doctor may check this with a blood test
• Hair loss
• Osteoporosis (a condition that makes bones more fragile) after prolonged use
• Tingling, numbness, and muscle weakness (particularly in the lower part of the body) if undergoing spinal puncture or spinal anaesthesia
• Loss of bladder or bowel control (inability to control when to go to the toilet)
• Hard mass or nodule at the injection site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ENOXAPARINA ROVI

Store below 25 °C. Do not freeze.
The pre-filled syringes are for single use only. Dispose of all unused medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the syringe is damaged or if the solution is not clear.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ENOXAPARINA ROVI contains

• The active substance is sodium enoxaparin.

Each pre-filled syringe contains sodium enoxaparin with 2,000 IU anti-Xa activity (equivalent to 20 mg)
in 0.2 mL of water for injectable preparations.
Each pre-filled syringe contains sodium enoxaparin with 4,000 IU anti-Xa activity (equivalent to 40 mg)
in 0.4 mL of water for injectable preparations.
Each pre-filled syringe contains sodium enoxaparin with 6,000 IU anti-Xa activity (equivalent to 60 mg)
in 0.6 mL of water for injectable preparations.
Each pre-filled syringe contains sodium enoxaparin with 8,000 IU anti-Xa activity (equivalent to 80 mg)
in 0.8 mL of water for injectable preparations.
Each pre-filled syringe contains sodium enoxaparin with 10,000 IU anti-Xa activity (equivalent to 100 mg)
in 1 mL of water for injectable preparations.

• The other component is water for injectable preparations.

Description of the appearance of ENOXAPARINA ROVI and contents of the pack
ENOXAPARINA ROVI is a clear, colourless to pale yellow solution for injection in a pre-filled glass syringe of type I, equipped with a needle for injection, with or without an automatic safety device. It is supplied as follows:
ENOXAPARINA ROVI 2,000 IU (20 mg) in 0.2 mL solution for injection in a 0.5 mL non-graduated pre-filled syringe.
Packs of 2, 6, 10, 20 and 50 syringes.
ENOXAPARINA ROVI 4,000 IU (40 mg) in 0.4 mL solution for injection in a 0.5 mL non-graduated pre-filled syringe.
Packs of 2, 6, 10, 20, 30 and 50 syringes.
ENOXAPARINA ROVI 6,000 IU (60 mg) in 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.
ENOXAPARINA ROVI 8,000 IU (80 mg) in 0.8 mL solution for injection in a 1 mL graduated pre-filled syringe.
Packs of 2, 6, 10, 12, 20, 24, 30 and 50 syringes.
ENOXAPARINA ROVI 10,000 IU (100 mg) in 1 mL solution for injection in a 1 mL graduated pre-filled syringe.
Packs of 2, 6, 10, 12, 20, 24, 30 and 50 syringes.
Not all pack sizes may be marketed.
In some packs, the pre-filled syringes 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)
Marketing Authorization Holder for sale
Rovi Biotech, S.R.L.
Viale Achille Papa, 30
20149 - Milano (Italy)

This medicinal product is authorized 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
Belgium, France, Luxembourg, Netherlands: Enoxaparine Becat
Spain, Portugal, Italy: Enoxaparina Rovi
Greece: Enoxaparin Rovi
Slovenia: Enoksaparin Rovi
Bulgaria, Czech Republic, Estonia, Croatia, Hungary, Latvia, Poland, Romania and Slovakia: Losmina
Ireland, United Kingdom (Northern Ireland): Arovi