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Innohep® Is and What It Is Used for • If You Have Kidney Problems

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Innohep® Is and What It Is Used for • If You Have Kidney Problems Scale Get-up Material No Sent by e-maiL l 5. RBE 100% GB 066478-XX Subject Date Date 14/09/20 066478 INS 205 x 315 mm with 2 foils 27/05/20 066478-XX Colour Sign. Sign. SOP_000647, SOP_000962, SOP_000647, SOP_000962 Black OMA SOP_003993 and and SOP_008676 SOP_008676 Preparation Place of production Strength ® Packsize innohep syringe 20,000 IU/ml France Comments: Page 1 of 2 Font size: 9 pt Headings 10 pt Mock-up for reg. purpose IFR012-01 - 205 x 315 mm Page 4 of 4 Page 1 of 4 066478-XX Package leaflet: Information for the user syringe 20,000 IU/ml tinzaparin 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. 066478 • 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. • In this leaflet innohep 20,000 IU/ml syringe will be called innohep. What is in this leaflet • If you have an artificial heart valve. 1. What innohep® is and what it is used for • If you have kidney problems. 2. What you need to know before you use innohep® • If you have asthma, as this medicine contains sodium 3. How to use innohep® metabisulfite (see “Important information about some of the 4. Possible side effects ingredients of innohep” below). 5. How to store innohep® 6. Contents of the pack and other information innohep should not be interchanged with other low molecular weight heparin products. This is because they are not exactly 1. What innohep® is and what it is used for the same and you could experience problems with your blood innohep is a type of heparin – a low molecular weight heparin clotting. – and belongs to a group of medicines called anticoagulants; these medicines affect how your blood clots. Elderly people innohep prevents clotting, allowing normal blood flow Because kidney problems are more likely if you are elderly, through the arteries and veins. you may have a blood test to check how well your kidneys are working and to monitor the activity of innohep. innohep is used in adults to treat: • Harmful blood clots that have formed in a deep vein Children and adolescents (deep vein thrombosis, DVT). This usually occurs in a leg. innohep is not intended for use in children and adolescents • Clots that may travel in your bloodstream and cause a under the age of 18 years. blockage (a thromboembolism). • A clot that has travelled to your lung and caused a blockage Other medicines and innohep (pulmonary embolism, PE). This can cause breathing Tell your doctor, pharmacist or nurse if you are taking, have difficulties and chest pain. recently taken or might take any other medicines. • Blood clots that have developed because of cancer and to This includes any medicines bought without a prescription. prevent further clots from forming. You must tell your doctor, pharmacist or nurse if you are 2. What you need to know before you use innohep® taking any of the following medicines as you may be likely to Do not use innohep bleed more easily: • If you are allergic to tinzaparin or any of the other ingredients of this medicine (listed in section 6). • Non-steroidal anti-inflammatory drugs (such as ibuprofen or • If you have ever had a reaction to heparin that caused a diclofenac): for arthritis or aches or pains. severe drop in the number of your clotting cells (platelets) - • Aspirin: either for reducing pain and inflammation, or the this reaction is called heparin-induced thrombocytopenia (HIT). lower dose for thinning of the blood. • If you have ever had a major bleed (for instance: in the brain, • Platelet aggregation inhibitors (such as clopidogrel): for spine, eye or stomach, into a muscle or the womb, or any stopping harmful blood clots forming. conditions which make you bleed severely, such as • Thrombolytic agents (such as streptokinase): for dissolving haemophilia). blood clots. • If you have a condition called septic endocarditis (an • Vitamin K antagonists (such as warfarin): for stopping inflammation of the lining of the heart and heart valves). harmful blood clots. • If you are using innohep to treat blood clots and are going to • Activated protein C: for getting rid of blood clots. receive spinal/epidural anaesthesia or lumbar puncture. • Anticoagulation, taken by mouth (such as rivaroxaban, dabigatran or apixaban) for stopping harmful blood clots. Important: You must not have an epidural/spinal anaesthetic within 24 hours after your last injection of innohep. You must Pregnancy and breast-feeding wait at least 4 to 6 hours after having a spinal anaesthetic, or If you are pregnant or breast-feeding, think you may be after the catheter has been removed, before you start using pregnant or are planning to have a baby, ask your doctor, innohep again. pharmacist or midwife for advice before using this medicine. You may have a blood test before you start using this You must not have an epidural anaesthetic to help with your medicine and at intervals while you are using it; this is to labour or surgery within 24 hours of your last injection of check the level of the clotting cells (platelets) and potassium in innohep. your blood. Warnings and precautions You must wait at least 4 to 6 hours after having a spinal Do not inject innohep into a muscle. See section 3, “How to anaesthetic, or after the catheter has been removed, before you start using innohep again. use innohep®”. This medicine may make you bleed more easily, so when you Driving and using machines are being given other injections or having any procedures This medicine should not have any effect on your ability to carried out, tell the doctor, nurse or dentist that you are using drive or use machines. However, you should check with your innohep. doctor if you feel any side effect that may stop you from driving or using machines. If you have a brain tumour, you will be monitored closely because medicines such as innohep that prevent blood from Important information about some of the ingredients of forming clots, may cause bleeding into the skull. innohep innohep 20,000 IU/ml syringe contains sodium metabisulfite: Talk to your doctor, pharmacist or nurse before using • Sodium metabisulfite can cause an allergic reaction which innohep may result in breathing difficulties. See section 4. • If you are pregnant or think you may be pregnant. See the • This medicine contains 40 mg sodium (main component of section “Pregnancy and breast-feeding”. cooking/table salt) in each mL. This is equivalent to 2% of • If you have a condition which makes you more likely to bleed. the recommended maximum daily dietary intake of sodium • If you are being treated with other injections into your muscles. for an adult. • If you have a medical condition such as diabetes mellitus or metabolic acidosis which may cause high levels of Please ask your doctor or pharmacist if you are worried about potassium in your blood (hyperkalaemia). any of the ingredients in this medicine. Scale Get-up Material No Sent by e-maiL l 100% GB 066478-XX Subject Date Date INS 205 x 315 mm with 2 foils 27/05/20 Colour Sign. Sign. Black OMA Preparation Place of production Strength ® Packsize innohep syringe 20,000 IU/ml France Comments: Page 2 of 2 IFR012-01 - 205 x 315 mm IFR012-01 - 205 x 315 mm Page 4 of 4 Page 1 of 4 Page 2 of 4 Page 3 of 4 3. How to use innohep® • An itchy red rash with heat and swelling on your skin Always use this medicine exactly as your doctor, pharmacist (dermatitis). or nurse has told you. Check with one of them if you are not • Rash. sure that you understand how to give the injection or if you • Itchy skin. are unsure about anything else to do with the medicine. Rare side effects (may affect up to 1 in 1000 people) Your doctor may decide that you or a carer may inject this • Your blood may form more harmful clots. A drop in the medicine. You will be shown how to give the injection and number of clotting cells (platelets) in your blood may give should only do the injection when you have been instructed you these symptoms. Your doctor can explain this more. how to do so. 11. The used syringe, even when the orange safety device is in • Changes in your blood test results. The amount of potassium place, should be handled with care and should be disposed may be increased. This is more likely to happen if you have How much innohep to use Bend the orange safety device down away from the cap of in a “sharps” container (i.e. a special bin for needles) severe kidney problems or diabetes. Your doctor can explain on the needle. Remove the protective needle cap without immediately. If a “sharps” container is not readily available this more. Adults, including the elderly: bending the needle. To keep the needle clean, make sure it then please put the used syringe back into the plastic • Hives. The dose depends on your weight and this will be worked out does not touch anything. The syringe is now ready for use.
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