INHIXA 50 000 IU (500 MG)/5 ML SOLUTION FOR INJECTION - Patient leaflet, side effects, dosage

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Package leaflet: Information for the user

Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose container

Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose container

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 further questions, ask your doctor, pharmacist or nurse.

! This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

! If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Inhixa is and what it is used for

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

• 3. How to use Inhixa

• 4. Possible side effects

• 5. How to store Inhixa

• 6. Contents ofthe pack and other information

1. what inhixa is and what it is used for

Inhixa contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).

Inhixa works in two ways:

• 1) Stopping existing blood clots from getting bigger. This helps your body to break them down and stop them causing you harm.

• 2) Stopping blood clots forming in your blood.

Inhixa can be used to:

C Treat blood clots that are in your blood

C Stop blood clots from forming in your blood in the following situations:

o Before and after an operation

o When you have an acute illness and face period of limited mobility

o If you have experienced a blood clot due to cancer to prevent further clots from forming.

o When you have unstable angina (a condition when not enough blood gets to your heart)

o After a heart attack

C Stop blood clots forming in the tubes of your dialysis machine (used for people with severe kidney problems).

2. what you need to know before you use inhixa

Do not use Inhixa

C If you are allergic to enoxaparin sodium or any of the other ingredients ofthis medicine (listed in section 6). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

C If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.

C If you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) – this reaction is called heparin-induced thrombocytopenia – within the last 100 days or if you have antibodies against enoxaparin in your blood.

C If you are bleeding heavily or have a condition with a high risk of bleeding (such as stomach ulcer, recent surgery ofthe brain or eyes), including recent bleeding stroke.

C If you are using Inhixa to treat blood clots in your body and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours.

C If the patient is a premature or newborn baby up to 1 month because of the risk of severe toxicity including abnormal respiration (“gasping syndrome”).

Warnings and precautions

Inhixa should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins. This is because they are not exactly the same and do not have the same activity and instructions for use.

Talk to your doctor or pharmacist before using Inhixa if:

C you have ever had a reaction to heparin that caused a severe drop in the number of your platelets

C you are going to receive spinal or epidural anesthesia or lumbar puncture (see Operations and Anaesthetics): a delay should be respected between Inhixa use and this procedure

C you have had a heart valve fitted

C you have endocarditis (an infection of the inner lining of the heart)

C you have history of gastric ulcer

C you have had a recent stroke

C you have high blood pressure

C you have diabetes or problems with blood vessels in the eye caused by diabetes (called diabetic retinopathy)

C you have had an operation recently on your eyes or brain

C you are elderly (over 65 years old) and especially if you are over 75 years old

C you have kidney problems

C you have liver problems

C you are underweight or overweight

C you have high level of potassium in your blood (this may be checked with a blood test)

C you are currently using medicines which affect bleeding (see section below – Other medicines and Inhixa).

You may have a blood test before you start using this medicine and at intervals while you are using it; this is to check the level of the clotting cells (platelets) and potassium in your blood.

Children and adolescents

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

Other medicines and Inhixa

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

• Warfarin – another anticoagulant medicine used for thinning the blood
• Acetylsalicylic acid (also known as aspirin or ASA), clopidogrel or other medicines used to stop blood clots from forming (see also in section 3, “Changing anticoagulant medicine”)
• Dextran injection – used as a blood replacer
• Ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory agents which are used to treat pain and swelling in arthritis and other conditions
• Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
• Medicines which increase potassium level in your blood such as potassium salts, water pills, some medicines for heart problems.

Operations and anaesthetics

If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are using Inhixa. See “Do not use Inhixa”. Also, tell your doctor if you have any problem with your spine or if you ever had spinal surgery.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

If you are breast-feeding or plan to breast-feed, you should ask your doctor for advice before taking this medicine.

Driving and using machines

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

Traceability

It is important to keep a record of the batch number of your Inhixa. So, every time you get a new package of Inhixa, note down the date and the batch number (which is on the packaging after Lot) and keep this information in a safe place.

Inhixa contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose within the recommended dose range, that is to say essentially ‚sodium-free‘.

Inhixa contains benzyl alcohol

Inhixa contains benzyl alcohol (45 mg/3 mL; 75 mg/5 mL). Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.

Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease, or ifyou are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

3. how to use inhixa

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Ifyou use more Inhixa than you should

If you think that you have used too much or too little Inhixa, tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem. If a child accidentally injects or swallows Inhixa, take the child to a hospital casualty department straight away.

If you forget to use Inhixa

If you forget to give yourself a dose, have it as soon as you remember. Do not give yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary will help to make sure you do not miss a dose.

Ifyou stop using Inhixa

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

It is important for you to keep having Inhixa injections until your doctor decides to stop them. If you stop, you could get a blood clot which can be very dangerous.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other anticoagulant medicines (medicines to reduce blood clotting), Inhixa may cause bleeding which may potentially be lifethreatening. In some cases the bleeding may not be obvious.

If you experience any bleeding that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling), consult your doctor immediately.

Your doctor may decide to keep you under closer observation or change your medicine.

Stop using Inhixa and talk to a doctor or nurse at once ifyou get any signs of a severe allergic reaction (such as difficulty breathing, swelling ofthe lips, mouth, throat or eyes).

You should tell your doctor straight away

• If you have any sign of blockage of a blood vessel by a blood clot such as:

• & cramping pain, redness, warmth, or swelling in one of your legs – these are symptoms of deep vein thrombosis

• & breathlessness, chest pain, fainting or coughing up blood – these are symptoms of a pulmonary embolism

• If you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.

Your doctor may ask you to have performed a blood test to check your platelet count.

Overall list of possible side effects:

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

• Bleeding.
• Increases in liver enzymes.

Common (may affect up to 1 in 10 people)

• You bruise more easily than usual. This could be because of a blood problem with low platelet counts.
• Pink patches on your skin. These are more likely to appear in the area you have been injected with Inhixa.
• Skin rash (hives, urticaria).
• Itchy red skin.
• Bruising or pain at the injection site.
• Decreased red blood cell count.
• High platelet counts 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.
• A feeling of tenderness and swelling in your stomach. You may have bleeding in your stomach.
• Large red irregularly shaped skin marks with or without blisters.
• Skin irritation (local irritation).
• Yellowing of your skin or eyes and your urine becoming darker. These may be signs of a liver problem.

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

• Severe allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• Increased potassium in your blood. This is more likely to happen in people with kidney problems or diabetes. Your doctor will be able to check this by carrying out a blood test.
• An increase in the number of white blood cells called eosinophils in your blood. Your doctor will be able to check this by carrying out a blood test.
• Hair loss.
• Osteoporosis (a condition where your bones are more likely to break) after long-term use.
• Tingling, numbness and muscular weakness (particularly in the lower part ofyour body) when you have had a spinal puncture or a spinal anaesthetic.
• Loss of control over your bladder or bowel (so you cannot control when you go to the toilet).
• Hard mass or lump at the injection site.

5. how to store inhixa

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

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Store below 25 °C. Do not freeze.

After first opening

Chemical and physical in-use stability has been demonstrated for 28 days at 25 °C.

From a microbiological point ofview, once opened, the medicine may be stored for a maximum of 28 days below 25°C. Other in-use storage times and conditions are the responsibility ofthe user.

After dilution with sodium chloride 9 mg/ml (0.9%) solution for infusion or 5% glucose solution for injection

Chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C.

From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the medicine should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of user.

Do not use this medicine if you notice any visible change in the appearance of the solution.

Discard any unused medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Inhixa contains

! The active substance is enoxaparin sodium.

Each mL contains 10,000 IU (100 mg)enoxaparin sodium.

One vial (3.0 mL) contains 30,000 IU (300 mg) enoxaparin sodium.

One vial (5.0 mL) contains 50,000 IU (500 mg) enoxaparin sodium.

! The other ingredients are benzyl alcohol (see section 2) and water for injections.

What Inhixa looks like and contents ofthe pack

C 3 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box.

Supplied in packs of 1 vial.

C 5 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and grey aluminium-plastic cap in a cardboard box.

Supplied in packs of 5 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11

1077XX Amsterdam

Netherlands

Manufacturer

Health-Med spotka z ograniczonq odpowiedzialnosciq spotka jawna

Chetmska 30/34

00–725 Warsaw

Poland

For any information about this medicine, please contact the local representative ofthe Marketing Authorisation Holder: Techdow Pharma England Ltd

+441483928995

This leaflet was last revised in December 2021

Other sources of information

Detailed information on this medicine is available on the

Medicines and Healthcare products Regulatory Agency web site:.