Clexane

Leaflet accompanying the packaging: patient information

Clexane, 30,000 IU (300 mg) / 3 ml, solution for injection
Enoxaparin sodium

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Clexane and what is it used for
• 2. Important information before using Clexane
• 3. How to use Clexane
• 4. Possible side effects
• 5. How to store Clexane
• 6. Contents of the packaging and other information

1. What is Clexane and what is it used for

Clexane contains the active substance enoxaparin sodium. It belongs to a group of medicines called low molecular weight heparins or LMWH.

How Clexane works

Clexane works in two ways:

• 1) It prevents the growth of existing blood clots. This helps the body to dissolve existing blood clots, making them no longer harmful.
• 2) It prevents the formation of new blood clots in the patient's blood.

What Clexane is used for

Clexane can be used for:

• Treating blood clots that are already present in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following cases: before and after surgery, during a short-term illness when the patient will be unable to move for a period, in patients who have developed blood clots in the circulating blood due to cancer, to further prevent the formation of new blood clots.
• Preventing the formation of blood clots in unstable angina (when insufficient blood is supplied to the heart muscle) or after a heart attack.
• Preventing the formation of clots in dialysis tubes (used in people with severe kidney function disorders).

2. Important information before using Clexane

The medicine contains 15 mg of benzyl alcohol per 1 ml. Benzyl alcohol may cause allergic reactions.

Do not use Clexane if:

• the patient is allergic to: enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6), heparin or other low molecular weight heparins, such as nadroparin, tinzaparin, or dalteparin. Symptoms of an allergic reaction may include: rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes.
• the patient has had a reaction to heparin that caused a significant decrease in the number of blood cells responsible for blood clotting (platelets) in the last 100 days.
• the patient has antibodies against enoxaparin in their blood.
• the patient has severe bleeding or a medical condition associated with an increased risk of bleeding, such as: stomach ulcers, recent brain or eye surgery, including recent hemorrhagic stroke.
• the patient is using Clexane to treat blood clots and is scheduled to have a lumbar puncture or spinal or epidural anesthesia within 24 hours.
• the patient is a premature infant or newborn in the first month of life - due to the risk of severe toxic effects, including respiratory disorders (respiratory distress syndrome). Clexane should not be used in these patients. If in doubt, consult a doctor or pharmacist before using Clexane.

Warnings and precautions

Clexane should not be exchanged with other low molecular weight heparins such as nadroparin, tinzaparin, or dalteparin. This is because they are not exactly the same, differ in activity, and have different instructions for use.

Before using Clexane, consult a doctor or pharmacist if:

• the patient has ever had a reaction to heparin that caused a significant decrease in the number of blood cells responsible for blood clotting (platelets).
• the patient has a heart valve replacement.
• the patient has endocarditis (infection of the membrane lining the heart).
• the patient has stomach ulcers.
• the patient has recently had a stroke.
• the patient has high blood pressure.
• the patient has diabetes or has problems with blood vessels in the eyes caused by diabetes (diabetic retinopathy).
• the patient has recently had eye or brain surgery.
• the patient is elderly (over 65 years), especially if they are over 75 years old.
• the patient has kidney disease.
• the patient has liver disease.
• the patient is underweight or overweight.
• the patient has an increased level of potassium in the blood (which can be checked with a blood test).
• the patient is currently taking medicines that may cause bleeding (see section 2 "Clexane and other medicines").
• the patient has spinal problems or has had spinal surgery. If any of the above situations apply to the patient or if the patient has doubts, consult a doctor or pharmacist before using Clexane.

Patient with liver or kidney disease should contact their doctor. A large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Tests and monitoring

Before starting to use this medicine and periodically during its use, the patient may undergo a blood test to check the number of platelets in the blood and the level of potassium.

Use in children and adolescents

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

Clexane and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Warfarin - a medicine used to thin the blood.
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see section 3 "Changing anticoagulant medicine").
• Dextrans - used as a blood substitute.
• Ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory medicines 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 that increase the level of potassium in the blood, such as potassium salts, diuretics, and certain heart medicines.

Surgical procedures and anesthetics

If the patient is scheduled to have a lumbar puncture or surgery under spinal or epidural anesthesia, they should inform their doctor that they are using Clexane.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Women with pregnancy and mechanical heart valve may have an increased risk of blood clots. The doctor should discuss this with the patient.

Women who are breastfeeding or plan to breastfeed should consult their doctor before using this medicine.

Pregnant or breastfeeding women should contact their doctor, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Driving and using machines

Clexane does not affect the ability to drive or use machines.

Clexane in multi-dose vials contains benzyl alcohol

• Clexane in multi-dose vials contains benzyl alcohol (15 mg / ml). It is a preservative. It can cause poisoning and allergic reactions in infants and children under 3 years of age. The medicine should not be used in premature infants and newborns in the first month of life due to the risk of severe toxic effects, including respiratory disorders.
• It is recommended that pregnant women use a Clexane product that does not contain benzyl alcohol.

The doctor should document the trade name and batch number of the product used.

3. How to use Clexane

This medicine should always be used exactly as prescribed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Using the medicine

• Clexane will usually be given to the patient by a doctor or nurse. This is because it requires injection.
• Clexane is usually given by subcutaneous injection.
• Clexane may be given by intravenous injection after certain types of heart attack or after surgery.
• Clexane may be introduced into the dialysis tube that carries blood out of the body (into the arterial line) at the start of the dialysis session.
• Clexane must not be given by intramuscular injection.

Dose of the medicine

• The doctor will decide what dose of Clexane the patient should take. This depends on the reason for using the medicine.
• In patients with kidney disease, the patient may receive a lower dose of Clexane.
• 1) Treatment of blood clots in the patient's blood
• 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.
• The doctor will decide how long the patient should receive Clexane.
• 2) Prevention of blood clot formation in the patient's blood during surgery or during periods of reduced mobility due to illness
• The dose depends on the patient's risk of blood clot formation. The patient will receive Clexane in a dose of 2000 IU (20 mg) or 4000 IU (40 mg) daily.
• In the case of planned surgery, the first injection is usually given 2 hours or 12 hours before surgery.
• If the patient has reduced mobility due to illness, they will usually receive Clexane in a dose of 4000 IU (40 mg) daily.
• The doctor will decide how long the patient should receive Clexane.
• 3) Prevention of blood clot formation in patients with unstable angina or after a heart attack
• Clexane can be used in two different types of heart attack.
• The dose of Clexane will depend on the patient's age and the type of heart attack they had.

Non-ST segment elevation myocardial infarction (heart attack without ST segment elevation):

• The usual dose of Clexane is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also takes aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Clexane.

ST segment elevation myocardial infarction (heart attack with ST segment elevation) in patients under 75 years of age:

• The initial dose of Clexane is 3000 IU (30 mg) given intravenously.
• Clexane will also be given subcutaneously. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also takes aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Clexane.

Patient undergoing percutaneous coronary intervention (PCI):

• Depending on when the last dose of Clexane was given, the doctor may decide to give an additional dose of Clexane before the PCI procedure. The medicine will be given intravenously.
• 4) Prevention of blood clot formation in dialysis tubes
• The usual dose of Clexane is 100 IU (1 mg) per kilogram of body weight.
• Clexane is injected into the dialysis tube that carries blood out of the body (into the arterial line) at the start of the dialysis session.
• This dose is usually sufficient for a 4-hour dialysis session. However, if necessary, the doctor may give the patient an additional dose of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight.

Self-administration of Clexane

If the patient is able to self-administer Clexane, the doctor or nurse will demonstrate how to do it. Do not attempt to self-administer if the patient has not been trained. If in doubt, consult a doctor or nurse immediately.

Before self-administering Clexane

• Prepare all necessary items: multi-dose vial, syringe, alcohol swab or soap and water, and a container for medical waste.
• Check the expiration date on the packaging. Do not use the medicine after the expiration date.
• Check if the vial is damaged or if the liquid is clear. If not, use another vial.
• Make sure what dose is to be injected.
• Examine the abdomen to check if the last injection caused redness, skin discoloration, swelling, discharge, or if it is still painful. If so, consult a doctor or nurse.
• Clexane should be injected just under the skin of the abdomen, but not too close to the navel or any scar (at least 5 cm away from them). Decide where the injection will be given. The medicine should be administered alternately in the left or right side of the abdomen.

Instructions for self-administering Clexane:

Preparing the injection site

• 1) Choose the injection site in the right or left side of the abdomen. The injection site should be at least 5 cm away from the navel towards the sides.
• Do not inject within 5 cm of the navel or around existing scars or bruises.
• Change the injection site between the left and right side of the abdomen, depending on the site of the previous injection.
• 2) Wash hands. Clean the injection site with an alcohol swab or soap and water.
• 3) Sit or lie down in a comfortable position, relaxed. Make sure the injection site is in sight. A chair, couch, or bed with pillows for support will be suitable.

Injection

• 1) Draw the correct dose from the vial using the correct syringe. A drop may appear at the end of the needle. If so, remove the drop by tapping the syringe with the needle facing down before injecting.
• 2) Hold the syringe in the hand used for writing (like a pencil). With the other hand, gently grasp the cleaned skin of the abdomen between the thumb and index finger, creating a skin fold.
• Make sure to maintain the skin fold during the injection.
• 3) Hold the syringe with the needle facing down (at a 90° angle). Insert the entire length of the needle into the skin fold.
• 4) Press the plunger with the thumb. This will inject the medicine into the abdominal fat tissue. Inject the entire contents of the syringe.
• 5) Remove the needle from the injection site, pulling it out straight. Keep the needle away from yourself and others. Now you can release the skin fold.

After the injection

• 1) To avoid bruising, do not rub the injection site after the injection.
• 2) Dispose of the used syringe in a container for medical waste. Close the container and store it out of sight and reach of children. If the container is full, dispose of it according to the doctor's or pharmacist's instructions.

Any unused medicines or waste should be disposed of in accordance with local regulations.

Changing anticoagulant medicine

• Changing Clexane to medicines that thin the blood, such as vitamin K antagonists (e.g., warfarin)The doctor will recommend blood tests to determine the INR and inform the patient when to stop taking Clexane.
• Changing vitamin K antagonists (e.g., warfarin) to ClexaneStop taking the vitamin K antagonist. The doctor will recommend blood tests to determine the INR and inform the patient when to start taking Clexane.
• Changing Clexane to direct oral anticoagulantsStop taking Clexane. Then start taking the direct oral anticoagulant 0 to 2 hours before the scheduled time of the next injection, and then continue taking the medicine as usual.
• Changing direct oral anticoagulants to ClexaneStop taking the direct oral anticoagulant. Clexane treatment can be started 12 hours after the last dose of the direct oral anticoagulant.

Using a higher dose of Clexane than recommended

If the patient thinks they have used too much or too little Clexane, they should immediately inform their doctor, pharmacist, or nurse, even if they do not notice any problems. In case of accidental injection or ingestion of Clexane by a child, immediately go to the hospital emergency department.

Missing a dose of Clexane

If a dose is missed, take it as soon as possible. Do not take a double dose to make up for the missed dose. Keeping a diary helps to ensure that no dose is missed.

Stopping Clexane

It is important to continue injecting Clexane until the doctor recommends stopping it. If treatment is stopped, a blood clot may form, which can be very dangerous.

If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

Stop using Clexane and consult a doctor or nurse immediately if:

the patient experiences symptoms of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes).

If any of the following symptoms occur, stop using Clexane and seek medical attention immediately:

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

Like other similar medicines used to reduce blood clotting, Clexane can cause bleeding. This can be life-threatening. In some cases, bleeding may not be immediately visible.

Consult a doctor immediately if:

• the patient experiences any bleeding that does not stop on its own.
• the patient shows signs of excessive bleeding, such as weakness, fatigue, paleness, dizziness with headaches, or swelling of unknown origin. The doctor may decide to monitor the patient more closely or change the medicine.

Consult a doctor immediately if:

• the patient experiences any signs of a blood clot, such as: crampy pain, redness, increased warmth, or swelling in one leg - these are symptoms of deep vein thrombosis.

shortness of breath, chest pain, fainting, or coughing up blood - these are symptoms of pulmonary embolism.

• if the patient experiences a painful rash or dark red spots under the skin that do not disappear when pressed. The doctor may order blood tests to check the platelet count.

Other side effects:

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

• bleeding.
• increased liver enzyme activity.

Common(may affect up to 1 in 10 people):

• increased tendency to bruise - this may be due to a decrease in platelet count.
• red spots on the skin - these changes are more likely to occur at the injection site.
• skin rash (hives).
• itching, redness of the skin.
• bruising or pain at the injection site.
• decreased red blood cell count.
• increased platelet count.
• headaches.

Uncommon(may affect up to 1 in 100 people):

• sudden severe headache - this may be a sign of bleeding into the brain.
• feeling of tenderness and swelling in the stomach - this may be a sign of bleeding into the stomach.
• large, red, irregularly shaped skin lesions with blisters or without blisters.
• skin irritation (local irritation).
• the patient may notice yellowing of the skin or eyes and darker urine. This may indicate liver disease.

Rare(may affect up to 1 in 1000 people):

• severe allergic reaction - symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• increased level of potassium in the blood - this is more likely in people with kidney disease or diabetes. The doctor may check this with a blood test.
• increased number of eosinophils in the blood - the doctor may check this with a blood test.
• hair loss.
• osteoporosis (a condition in which bones are more prone to fractures) after long-term use of the medicine.
• tingling, numbness, and weakness of the muscles (especially in the lower part of the body) after lumbar puncture or spinal or epidural anesthesia.
• loss of control over the bladder or bowels (a condition in which the patient is unable to control when they need to go to the toilet).
• hardening or a lump at the injection site.

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa.

Tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder or its representative in Poland.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Clexane

Do not store above 25°C.

After opening the vial, use the medicine within 28 days.

Store the medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the month stated.

Do not use this medicine if the vial is cracked, there are particles in the solution, or the solution has an unusual color (see "What Clexane looks like and what the pack contains").

Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Clexane contains

• The active substance is enoxaparin sodium. Each ml contains 100 mg of enoxaparin sodium, which corresponds to 10,000 IU of anti-Xa activity. Each 3 ml vial contains 30,000 IU (300 mg) of enoxaparin sodium.
• The other ingredients are benzyl alcohol and water for injections.

What Clexane looks like and what the pack contains

Clexane is a clear, colorless or yellowish solution for injection in a glass vial.

Pack sizes: 1, 5, and 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi Winthrop Industrie

82, Avenue Raspail

94250 Gentilly

France

Manufacturer

Sanofi-Aventis Deutschland GmbH

Brüningstraße 50 / Industriepark Höchst

65926 Frankfurt am Main

Germany

For more information about this medicine and its authorized names in the European Economic Area, contact the representative of the marketing authorization holder in Poland:

Sanofi Sp. z o.o.

ul. Marcina Kasprzaka 6

01-211 Warszawa

tel: +48 22 280 00 00

Date of last revision of the leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (www.urpl.gov.pl)