Prasugrel 10Mg Film-Coated Tablets

Package leaflet: Information for the user Prasugrel 5mg film-coated tablets Prasugrel 10mg film-coated tablets

Read all of this leaflet carefully before When a blood vessel is damaged, for example if you start taking this medicine because it it is cut, platelets clump together to help form contains important information for you. a blood clot (thrombus). Therefore, platelets are essential to help stop bleeding. If clots form • Keep this leaflet. You may need to read it within a hardened blood vessel such as an again. artery they can be very dangerous as they can • If you have any further questions, ask cut off the blood supply, causing a heart attack your doctor or pharmacist. (myocardial infarction), stroke or death. Clots • This medicine has been prescribed for in arteries supplying blood to the heart may you only. Do not pass it on to others. It also reduce the blood supply, causing unstable angina (a severe chest pain). may harm them, even if their signs of illness are the same as yours. Prasugrel Tablets inhibit the clumping of • If you get any side effects, talk to your platelets and so reduces the chance of a blood doctor or pharmacist. This includes any clot forming. possible side effects not listed in this leaflet. See section 4. You have been prescribed Prasugrel Tablets because you have already had a heart attack • The full name of this medicine is or unstable angina and you have been treated Prasugrel 5mg, 10mg film-coated tablets with a procedure to open blocked arteries in the but within this leaflet it will be referred to heart. You may also have had one or more stents as Prasugrel Tablets. placed to keep open a blocked or narrowed artery supplying blood to the heart. Prasugrel What is in this leaflet Tablets reduce the chances of you having a further heart attack or stroke or of dying from 1 What Prasugrel Tablets are and what one of these atherothrombotic events. Your they are used for doctor will also give you acetylsalicylic acid (e.g. 2 What you need to know before you aspirin), another anti-platelet agent. take Prasugrel Tablets 3 How to take Prasugrel Tablets 2 4 Possible side effects What you need to know before you 5 How to store Prasugrel Tablets take Prasugrel Tablets 6 Contents of the pack and other Do not take Prasugrel Tablets information • If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may 1 What Prasugrel Tablets are and what be recognised as a rash, itching, a swollen face, they are used for swollen lips or shortness of breath. If this has happened to you, tell your doctor immediately. Prasugrel Tablets contain the active substance • If you have a medical condition that is currently prasugrel and belong to a group of medicines causing bleeding, such as bleeding from your called anti-platelet agents. Platelets are very stomach or intestines. small cell particles that circulate in the blood. • If you have ever had a stroke or a transient ischaemic attack (TIA). • If you have severe liver disease.

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Prasugrel 5mg & 10mg Tablets PIL - UK

approved for print/date Item number: BBBA3695 Colours Non Printing Colours 1. Black 1. Originator: R.Wrey Dimensions: 176 x 270 2. 2. Origination Date: 03/01/19 Min Body Text Size: 11pt Revision Date: 07.01.19 Supplier: Invent Pharma 3. 3. Revised By: S.Anson 4. 5. Proof Round Technical Date sent: 03/01/19 6. 4 Approval Date received: [email protected]

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 Warnings and precautions Other medicines and Prasugrel Tablets Before you take Prasugrel Tablets Tell your doctor if you are taking, have recently Talk to your doctor before taking Prasugrel taken or might take any other medicines, Tablets. including medicines obtained without a prescription, dietary supplements and herbal You should tell your doctor before taking remedies. It is particularly important to tell your Prasugrel Tablets if any of the situations doctor if you are being treated with clopidogrel mentioned below apply to you: (an anti-platelet agent), warfarin (an anti- • If you have an increased risk of bleeding such coagulant), or “non steroidal anti inflammatory as: drugs” for pain and fever (such as ibuprofen, - age of 75 years or older. Your doctor should naproxen, etoricoxib). If given together with prescribe a daily dose of 5mg as there is a Prasugrel Tablets these medicines may increase greater risk of bleeding in patients older than the risk of bleeding. 75 years - a recent serious injury Tell your doctor if you are taking morphine or - recent surgery (including some dental other opioids (used to treat severe pain). procedures) - recent or recurrent bleeding from the Only take other medicines while you are on stomach or intestines (e.g. a stomach ulcer or Prasugrel Tablets if your doctor tells you that colon polyps) you can. - body weight of less than 60kg. Your doctor should prescribe a daily dose of 5mg of Pregnancy and breast-feeding Prasugrel Tablets if you weigh less than 60kg Tell your doctor if you become pregnant or are - renal (kidney) disease or moderate liver trying to become pregnant while you are taking problems Prasugrel Tablets. - taking certain types of medicines (see ‘Taking You should use Prasugrel Tablets only after other medicines’ below) discussing with your doctor the potential - planned surgery (including some dental benefits and any potential risks to your unborn procedures) in the next seven days. Your child. doctor may wish you to stop taking Prasugrel Tablets temporarily due to the increased risk If you are pregnant or breast-feeding, think you of bleeding may be pregnant or are planning to have a baby, • If you have had allergic reactions ask your doctor or pharmacist for advice before (hypersensitivity) to clopidogrel or any other taking this medicine. anti-platelet agent please tell your doctor before starting treatment with Prasugrel Driving and using machines Tablets. If you then take Prasugrel Tablets Prasugrel Tablets are unlikely to affect your and experience allergic reactions that may be ability to drive or use machines. recognised as a rash, itching, a swollen face, swollen lips or shortness of breath you need to Prasugrel Tablets contain lactose, sucrose tell your doctor immediately. and sodium. If you have been told by a doctor that you have While you are taking Prasugrel Tablets: an intolerance to some sugars, contact your You should tell your doctor immediately if you doctor before taking this medicine. develop a medical condition called Thrombotic This medicine contains less than 1 mmol sodium Thrombocytopaenic Purpura (or TTP) that (23mg) per tablet, that is to say essentially includes fever and bruising under the skin ‘sodium-free’. that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes 3 How to take Prasugrel Tablets (jaundice) (see section 4 ‘Possible side effects’). Always take this medicine exactly as your Children and adolescents doctor has told you. Check with your doctor or Prasugrel Tablets should not be used in children pharmacist if you are not sure. and adolescents below 18 years of age.

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Prasugrel 5mg & 10mg Tablets PIL - UK

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 The usual dose of Prasugrel Tablets is 10mg per • Sudden dizziness or sudden severe headache day. You will start the treatment with a single with no known cause dose of 60mg. If you weigh less than 60kg or All of the above may be signs of a stroke. Stroke is are more than 75 years of age, the dose is 5mg an uncommon side effect of Prasugrel Tablets in Prasugrel Tablets per day. patients who have never had a stroke or transient ischaemic attack (TIA). Your doctor will also tell you to take acetylsalicylic acid- they will tell you the exact Also contact your doctor immediately if you dose to take (usually between 75mg and 325mg notice any of the following: daily). • Fever and bruising under the skin that may appear as red pinpoint dots, with or without You may take Prasugrel Tablets with or without unexplained extreme tiredness, confusion, food. Take your dose at around the same time yellowing of the skin or eyes (jaundice). (see every day. Do not break or crush the tablet. section 2 ‘What you need to know before you take Prasugrel Tablets’) It is important that you tell your doctor, dentist • A rash, itching, or a swollen face, swollen lips/ and pharmacist, that you are taking Prasugrel tongue, or shortness of breath. These may be Tablets. signs of a severe allergic reaction (see section 2 ‘What you need to know before you take If you take more Prasugrel Tablets than Prasugrel Tablets’) you should Contact your doctor or hospital straight away, Tell your doctor promptly if you notice any of the as you may be at risk of excessive bleeding. You following: should show the doctor your pack of Prasugrel • Blood in your urine Tablets. • Bleeding from your rectum, blood in your stools or black stools If you forget to take Prasugrel Tablets • Uncontrollable bleeding, for example from a cut If you miss your scheduled daily dose, take Prasugrel Tablets when you remember. If you All of the above may be signs of bleeding, the forget your dose for an entire day, just resume most common side effect with Prasugrel Tablets. taking Prasugrel Tablets at its usual dose the Although uncommon, severe bleeding can be next day. Do not take a double dose to make up life-threatening. for a forgotten dose. Common side effects (may affect up to 1 in 10 If you stop taking Prasugrel Tablets people) Do not stop taking Prasugrel Tablets without • Bleeding in the stomach or bowels consulting your doctor; if you stop taking • Bleeding from a needle puncture site Prasugrel Tablets too soon, your risk of a heart • Nose bleeds attack may be higher. • Skin rash • Small red bruises on the skin (ecchymoses) If you have any further questions on the use of • Blood in urine this medicine, ask your doctor or pharmacist. • Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling) 4 Possible side effects • Low haemoglobin or red blood cell count (anaemia) Like all medicines, this medicine can cause side • Bruising effects, although not everybody gets them. Contact your doctor immediately if you notice Uncommon side effects (may affect up to 1 in any of the following: 100 people) • Sudden numbness or weakness of the arm, • Allergic reaction (rash, itching, swollen lips/ leg or face, especially if only on one side of the tongue, or shortness of breath) body • Spontaneous bleeding from the eye, rectum, • Sudden confusion, difficulty speaking or gums or in the abdomen around the internal understanding others organs • Sudden difficulty in walking or loss of balance • Bleeding after surgery or co-ordination • Coughing up blood Continued top of next column • Blood in stools Continued over page

Prasugrel 5mg & 10mg Tablets PIL - UK

5 How to store Prasugrel Tablets Not all pack sizes may be marketed.

Keep this medicine out of the sight and reach of Marketing Authorisation Holder children. Accord Healthcare Limited Sage House Do not use this medicine after the expiry date, 319 Pinner Road which is stated on the blister and carton after North Harrow EXP. The expiry date refers to the last day of that Middlesex month. HA1 4HF United Kingdom This medicinal product does not require any special temperature storage conditions. Store in Manufacturer the original package. Laboratorios Lesvi, S.L. Avda. Barcelona, 69 Do not throw away any medicines via Sant Joan Despí - Barcelona wastewater or household waste. Ask your 08970 pharmacist how to throw away medicines you Spain no longer use. These measures will help protect the environment. This leaflet was last revised in: January 2019 If you would like a 6 Contents of the pack and other information leaflet with larger text, please contact What Prasugrel Tablets contain 01271 385257. The active substance is prasugrel. Prasugrel 5mg film-coated tablets: Each tablet contains 5mg of prasugrel. Prasugrel 10mg film-coated tablets: Each tablet contains 10mg of prasugrel.

The other ingredients are crospovidone, lactose monohydrate, croscarmellose sodium, cellulose microcrystalline, sucrose fatty acid ester, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc, iron oxide yellow (E172) and Iron oxide red (E172) (10mg tablets only)

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Prasugrel 5mg & 10mg Tablets PIL - UK