INTRODUCTION ABOUT ERSORYN 40 PREFILLED SYRINGE(PFS) ERSORYN 40 PREFILLED SYRINGE(PFS) contains Enoxaparin which belongs to the group of medicines called Anticoagulants. It is used to manage blood clot formation in the body. ERSORYN 40 PREFILLED SYRINGE(PFS) works by stopping the blood clots formation. It also manages the existing blood clots from growing bigger in size. Due to this property, it is highly used as a prophylactic therapy for managing blood clot formation during risky conditions that involves clot formation such as before or after a surgery, during dialysis or after a heart attack or a severe chest pain (angina). It can also be used to reduce the risk of blood clot formation caused due to prolong period of immobility or due to cancer therapy. Before receiving ERSORYN 40 PREFILLED SYRINGE(PFS) inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have diabetes, high blood pressure or a history of stomach ulcer. ERSORYN 40 PREFILLED SYRINGE(PFS) is not recommended for use in patients who are bleeding heavily or have any pre-existing conditions (such as stomach ulcer or stroke) that can increase the risk of internal bleeding. It is also not suitable for use in patients scheduled for spinal anesthesia or lumbar puncture. Inform your doctor before receiving ERSORYN 40 PREFILLED SYRINGE(PFS) if you are pregnant or breastfeeding. The most common side effects of receiving ERSORYN 40 PREFILLED SYRINGE(PFS) are injection site reactions (such as pain or irritation), skin rashes, low platelet count, bleeding or bruising and headache. Consult your doctor if any of these side effect worsens. USES OF ERSORYN 40 PREFILLED SYRINGE(PFS) Manage and manages blood clots in the body HOW ERSORYN 40 PREFILLED SYRINGE(PFS) WORKS ERSORYN 40 PREFILLED SYRINGE(PFS) is an anticoagulant medicine. It inactivates certain proteins (such as coagulation factor II a and X a) in the blood that causes blood clotting. This reduces the chances of blood clot formation within the body which therefore manages blockage of blood vessels. DIRECTIONS FOR USE ERSORYN 40 PREFILLED SYRINGE(PFS) will be given to you only by a doctor or a nurse into the vein (intravenously) or under the skin (subcutaneously). It can also be self-administered by the patients if advised by the physician. Carefully, follow the instructions given by the doctor in case of self-administration. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. SIDE EFFECTS OF ERSORYN 40 PREFILLED SYRINGE(PFS) COMMON Bleeding, bruising Injection site reactions (such as pain or redness) pinky patches on the skin (especially in the injection site) skin rash, itching, redness low RBC count in blood headache UNCOMMON sudden severe headache tender and swollen stomach RARE increased blood potassium levels hair loss osteoporosis (weak and brittle bones) tingling, numbness and muscular weakness (especially in the lower part of the body) especially if you have had a spinal puncture or a spinal anesthetic loss of control over the intestine or bladder Contact your doctor immediately if you experience any of the following side effects after receiving ERSORYN 40 PREFILLED SYRINGE(PFS): severe allergic reactions (such as skin rash, itching, swelling of the face, mouth, throat, tongue leading to difficulty in breathing or swallowing) signs of excessive bleeding (excessive weakness, tiredness, paleness, dizziness, headache or unexplained swelling) severe skin reactions (such as skin rash, itching, skin redness with blisters or peeling of the skin, which may be associated with high fever and joint pains, dark red spots under the skin) cramping pain, redness, warmth, swelling in one of the legs breathlessness, chest pain, coughing up blood HOW TO MANAGE SIDE EFFECTS Headache Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens. Injection Site Reactions Place an ice pack on the affected area. Do not frequently move the injection site. Consult your doctor if the symptom did not improve. WARNING & PRECAUTIONS PREGNANCY Monitoring required ERSORYN 40 PREFILLED SYRINGE(PFS) should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before receiving it. BREASTFEEDING Use with Caution ERSORYN 40 PREFILLED SYRINGE(PFS) should be used with caution in breastfeeding women. Therefore, consult your doctor before receiving it. DRIVING AND USING MACHINES Use with Caution ERSORYN 40 PREFILLED SYRINGE(PFS) does not affect your ability to drive or operate machinery. However, do not drive or handle any heavy tools or machines if your ability is affected by ERSORYN 40 PREFILLED SYRINGE(PFS). ALCOHOL Consult your doctor Avoid consumption of alcohol before receiving ERSORYN 40 PREFILLED SYRINGE(PFS). KIDNEY Use with Caution ERSORYN 40 PREFILLED SYRINGE(PFS) should be used with caution in patients with kidney problems. Therefore, consult your doctor before receiving it. LIVER Use with Caution ERSORYN 40 PREFILLED SYRINGE(PFS) should be used with caution in patients with liver problems. Therefore, consult your doctor before receiving it. ALLERGY Contraindicated Talk to your doctor before receiving ERSORYN 40 PREFILLED SYRINGE(PFS) if you are allergic to Enoxaparin or to any other low molecular weight heparins (such as nadroparin, tinzaparin or dalteparin). HEART DISEASE Use with Caution ERSORYN 40 PREFILLED SYRINGE(PFS) should be used with caution in patients fitted with heart valves and in patients with heart problems (such as heart infections or high blood pressure). Therefore, consult your doctor before receiving it. USE IN PEDIATRICS Consult your doctor The safety and effectiveness of ERSORYN 40 PREFILLED SYRINGE(PFS) have not been established in children and adolescents (aged below 18 years). Your doctor will decide about administering ERSORYN 40 PREFILLED SYRINGE(PFS) to your child after evaluating the risks and benefits of the therapy. USE IN GERIATRICS Use with Caution ERSORYN 40 PREFILLED SYRINGE(PFS) should be used with caution in elderly patients (aged 65 years or older). Therefore, consult your doctor before receiving it. OTHERS ERSORYN 40 PREFILLED SYRINGE(PFS) is not recommended for use if you: have a previous history of heparin-induced thrombocytopenia (low platelet count in blood) have antibodies against enoxaparin in your blood are bleeding heavily have any internal condition that can increase the risk of heavy bleeding (such as stomach ulcer, stroke, surgery) are scheduled for any spinal procedures (such as spinal anesthesia or lumbar puncture) Before receiving ERSORYN 40 PREFILLED SYRINGE(PFS), inform your doctor if you: have a history of stomach ulcers recently had stroke have diabetes have diabetic retinopathy (eye damage caused due to diabetes) recently had surgery on your brain or eyes are underweight or overweight have hyperkalemia (high blood potassium levels) INTERACTIONS A. Drug-Drug interactions: Before receiving ERSORYN 40 PREFILLED SYRINGE(PFS), inform your doctor if you are taking any of the following medicines: warfarin (a medicine used for blood thinning) other medicines used to stop blood clots from forming (Ex. aspirin, clopidogrel, dipyridamole) dextran injection (used to replace blood) medicines used to relieve pain and swelling (Ex. ibuprofen, diclofenac, ketorolac, tromethamine) medicines used to manage asthma, rheumatoid arthritis, and other conditions (Ex. prednisolone, dexamethasone) medicines that increase blood potassium levels (Ex. spironolactone, triamterene, amiloride) sulfinpyrazone (used to manage gout) Overdosage: ERSORYN 40 PREFILLED SYRINGE(PFS) will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms.