Label: information for the user

Inhixa 12,000 UI (120 mg)/0.8 ml injectable solution

Inhixa 15,000 UI (150 mg)/1 ml injectable solution

Enoxaparin sodium

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

-Keep this label, 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 you should not give it 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, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What Inhixa is and for what it is used

2.What you need to know before starting to use Inhixa

3.How to use Inhixa

4.Possible adverse effects

5.Storage of Inhixa

6.Contents of the package and additional information

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

Inhixa acts 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.

Inhixa may be used for:

• Treating blood clots.
• Preventing blood clots from forming in the following situations:
• • Before and after surgery.
  • When you have an acute illness and are expected to have reduced mobility.
  • When you have developed blood clots due to cancer, to prevent new 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 in the tubes of the dialysis equipment (used in people with severe kidney problems).

No use Inhixa

• If you are allergic to enoxaparin 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 nadroparin, tinzaparin, or dalteparin.
• If you have had a reaction to heparin that caused a severe decrease in the number of cells involved in blood clotting (platelets) – this reaction is called heparin-induced thrombocytopenia – in the last 100 days or if you have heparin antibodies 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 Inhixa to treat blood clots and are going to receive spinal or epidural anesthesia or lumbar puncture within 24 hours.

Warnings and precautions

Inhixa should not be exchanged with other medications that belong to the group of low molecular weight heparins. 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 Inhixa 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 should be respected between Inhixa and the use of this procedure
• 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) and especially if you are over 75 years old
• You have kidney problems
• You have liver problems
• You have a very low or high body weight
• 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 Inhixa 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 cells involved in blood clotting (platelets) and potassium levels in your blood.

Children and adolescents

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

Using Inhixa with other medications

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

• Warfarin – another anticoagulant medication used to reduce blood clotting
• Acetylsalicylic acid (also known as aspirin 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 Inhixa. See "Using Inhixa 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 machinery

Inhixa does not affect your ability to drive and operate machinery.

Tracking

Keeping a record of your Inhixa batch number is important. Therefore, each time you receive a new package of Inhixa, note the date and batch number (which is on the package after Lot) and store this information in a safe place.

Inhixa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) 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 normally administer Inhixa. This is because it has to be administered by injection.
• When you return home, you may need to continue using Inhixa and administer it yourself (see instructions on how to do it).
• Inhixa is generally administered by subcutaneous injection under the skin.
• Inhixa can be administered by intravenous injection after certain types of heart attacks and surgical operations.
• Inhixa can be added to the tube that comes out of the body (arterial line) at the beginning of dialysis sessions.

Do not administer Inhixa by intramuscular injection.

How much will be administered

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

1) Treatment of blood clot formation:

2) Interruption of blood clot formation in the following situations:

Inhixa can be used in two different types of heart attacks, called STEMI (ST-elevation myocardial infarction) or non-STEMI (NSTEMI). The amount of Inhixa you 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 generally be told to also take aspirin.
• Your doctor will decide how long you will receive Inhixa.

STEMI heart attack if under 75 years:

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

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 Inhixa administered in the first two injections is 7,500 UI (75 mg).
• Your doctor will decide how long you will receive Inhixa.

For patients undergoing percutaneous coronary intervention (PCI):

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

3) Interruption of blood clot formation in dialysis tubes:

• The usual dose is 100 UI (1 mg) per kilogram of body weight.
• Inhixa 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/kg (0.5 to 1 mg/kg) per kilogram of body weight, if necessary.

Self-administration of an Inhixa injection with a preloaded syringe without a needle shield

If you can administer this medication yourself, your doctor or nurse will show you how to do it. Do not attempt to inject yourself if you have not been taught how to do it. If you do not know what to do, consult your doctor or nurse immediately.

Before injecting Inhixa

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

-Check if the syringe is not damaged and the liquid inside is transparent. If not, use another syringe.

-Do not use this medication if you observe any change in its appearance.

-Check the amount to be injected.

-Review your abdomen to see if the last injection caused redness, skin color change, swelling, pus, or pain. If so, talk to your doctor or nurse.

-Decide the area where the medication will be injected. Alternate, each time you inject, the right side of the abdomen (belly) with the left. This medication should be injected just below the skin of the abdomen, but not too close to the navel or any scars (at least 5 cm away from them).

-The preloaded syringe is for single use.

Instructions for self-injecting Inhixa

1)Wash your hands and the injection area with water and soap. Dry them.

2)Sit or lie down in a comfortable and relaxed position. Make sure you can see the area where you will inject. It is best to do this in a recliner, a sofa, or a bed with pillows to support you.

3)Choose an area on the right or left side of the belly. It should be more than 5 cm away from the navel and towards the sides.

Remember.Do not inject in the 5 cm around the navel or in scars or hematomas that may be present. Inject in the opposite area to the one used the previous time (alternating the right side of the belly with the left).

4)Take the blister pack containing the preloaded syringe out of the box. Open the blister pack and remove the preloaded syringe.

5)Carefully remove the needle cap from the syringe, pulling it. The syringe is preloaded and ready for use.

Do notpress the plunger before injecting. Once you have removed the cap, do not touch anything with the needle. This way, you will ensure that the needle remains clean (sterile).

6)Hold the syringe with the hand you write with (as if it were a pencil) and, with the other hand, gently pinch the area of the abdomen between your index and middle finger to form a skin fold.

Make sure tosustain the skin fold during the entire injection.

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

8)Press the plunger with your thumb. This way, you will inject the medication into the fatty tissue of the abdomen. Make sure to sustain the skin fold during the entire injection.

9)Remove the needle, pulling it straight out.

To avoid a hematoma, do not rub the injection area after it has been injected.

10)Deposit the used syringe in the sharp objects container. Close the container lid tightly and place it out of reach of children.

When the container is full, dispose of it as your doctor or pharmacist has instructed. Do not throw it in the trash.

Self-administration of an Inhixa injection with a preloaded syringe with a needle shield

Your syringe is preloaded and includes a needle shield to protect you from a needlestick injury.

If you can administer this medication yourself, your doctor or nurse will show you how to do it. Do not attempt to inject yourself if you have not been taught how to do it. If you do not know what to do, consult your doctor or nurse immediately.

Before injecting Inhixa

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

-Check if the syringe is not damaged and the liquid inside is transparent. If not, use another syringe.

-Do not use this medication if you observe any change in its appearance.

-Check the amount to be injected.

-Review your abdomen to see if the last injection caused redness, skin color change, swelling, pus, or pain. If so, talk to your doctor or nurse.

-Decide the area where the medication will be injected. Alternate, each time you inject, the right side of the abdomen (belly) with the left. This medication should be injected just below the skin of the abdomen, but not too close to the navel or any scars (at least 5 cm away from them).

-The preloaded syringe is for single use.

Instructions for self-injecting Inhixa

1)Wash your hands and the injection area with water and soap. Dry them.

2)Sit or lie down in a comfortable and relaxed position. Make sure you can see the area where you will inject. It is best to do this in a recliner, a sofa, or a bed with pillows to support you.

3)Choose an area on the right or left side of the belly. It should be more than 5 cm away from the navel and towards the sides.

Remember.Do not inject in the 5 cm around the navel or in scars or hematomas that may be present. Inject in the opposite area to the one used the previous time (alternating the right side of the belly with the left).

4)Take the blister pack containing the preloaded syringe out of the box. Open the blister pack and remove the preloaded syringe.

5)Carefully remove the needle cap from the syringe, pulling it. The syringe is preloaded and ready for use.

Do notpress the plunger before injecting. Once you have removed the cap, do not touch anything with the needle. This way, you will ensure that the needle remains clean (sterile).

6)Hold the syringe with the hand you write with (as if it were a pencil) and, with the other hand, gently pinch the area of the abdomen between your index and middle finger to form a skin fold.

Make sure tosustain the skin fold during the entire injection.

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

8)Press the plunger with your thumb. This way, you will inject the medication into the fatty tissue of the abdomen. Make sure to sustain the skin fold during the entire injection.

9)Remove the needle, pulling it straight out. Do not stop pressing the plunger!

To avoid a hematoma, do not rub the injection area after it has been injected.

10)Release the plunger and allow the syringe to move upwards until the entire needle is stored and blocked in its place.

11)Deposit the used syringe in the sharp objects container. Close the container lid tightly and place it out of reach of children.

When the container is full, dispose of it as your doctor or pharmacist has instructed. Do not throw it in the trash.

Change of anticoagulant treatment

• Change from Inhixa to medications that reduce blood clotting called vitamin K antagonists (e.g. warfarin)

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

• Change from vitamin K antagonists (e.g. warfarin) to Inhixa

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

• Change from Inhixa to direct oral anticoagulants (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)

Stop using Inhixa. Start taking the direct oral anticoagulant 0-2 hours before the time when you would have had the next Inhixa injection, and then continue as you normally do.

• Change from direct oral anticoagulants to Inhixa

Stop taking the direct oral anticoagulant. Do not start Inhixa treatment until 12 hours have passed since the last dose of the direct oral anticoagulant.

If you use more Inhixa than you should

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

If you forget to use Inhixa

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.

If you interrupt Inhixa treatment

If you have any other questions about the use of this medication, ask your doctor or pharmacist or nurse. It is essential that you continue to receive Inhixa 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 gets them.

Like other anticoagulant medicines (medicines to reduce blood clots), Inhixa may cause bleeding, which could potentially put your life in danger. In some cases, the bleeding may not be noticeable.

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 Inhixa and inform your doctor or nurse immediately if you experience any signs of severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).

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

• A generalised, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

You must inform your doctor

• If you experience any signs 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 bruises more frequently than usual. This could be due to a blood problem caused by a low platelet count.
• Pink patches on the skin. They appear more frequently in the area where Inhixa has been injected.
• Rash on the skin (hives, urticaria).
• Redness and itching on the skin.
• Bruise 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 haemorrhage.
• Sensation of tenderness to the touch and swelling of the stomach. It could be indicative of gastric haemorrhage.
• Large, irregular red marks on the skin, with or without blisters.
• Irritation on the skin (local irritation).
• Yellowing of the skin or eyes, and darkening of the urine colour. These could be signs of liver problems.

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store below 25 °C. Do not freeze.

The solution must be used within 8 hours after its dilution.

Do not use this medication if you observe any visible change in the appearance of the solution.

Pre-filled Inhixa syringes are for single use only. Dispose of unused medication contents.

Medications should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Inhixa

-The active principle is enoxaparin sodium.

Each milliliter contains 15,000 UI (150mg) of enoxaparin sodium.

Each pre-filled syringe of 0.8ml contains 12,000UI (120mg) of enoxaparin sodium.

Each pre-filled syringe of 1ml contains 15,000UI (150mg) of enoxaparin sodium.

-The other components are water for injectable preparations.

Appearance of the product and contents of the package

Inhixa 12,000 UI (120 mg)/0.8 ml is 0.8ml of solution contained in:

• a transparent, colorless, neutral glass syringe of typeI, with a fixed needle and a closed needle protector with a chlorobutyl rubber stopper and a purple polypropylene plunger. The syringe may be equipped in addition with a needle protector.

This medicine is presented in packages of:

• 2, 10, and 30pre-filled syringes
• 10 and 30 pre-filled syringes with needle protector

Inhixa 15,000 UI (150 mg)/1 ml is 1ml of solution contained in:

• a transparent, colorless, neutral glass syringe of typeI, with a fixed needle and a closed needle protector with a chlorobutyl rubber stopper and a dark blue polypropylene plunger. The syringe may be equipped in addition with a needle protector.

This medicine is presented in packages of:

• 2, 10, and 30pre-filled syringes
• 10 and 30 pre-filled syringes with needle protector

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11

1077XX Amsterdam

Netherlands

Manufacturer

SciencePharma spólka z ograniczona odpowiedzialnoscia

Chelmska 30/34

00-725 Warsaw

Poland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.