Ticlopidine hydrochloride, DE/H/0203/001, 11.04.16 Package Leaflet: Information for the patient /…/ Ticlopidine hydrochloride Read all of this leaflet carefully before you start taking 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What /…/ is and what it is used for 2. What you need to know before you take /…/ 3. How to take /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. What /…/ is and what it is used for /…/ belongs to a group of medicines called antiplatelet agents, which help to prevent blood clots. /…/ is used to help prevent strokes in patients who have previously had a stroke or in those who are considered to be at risk of having a stroke. It is also used to help prevent blood clots in patients undergoing haemodialysis. 2. What you need to know before you take /…/ Do not take /…/ if you are allergic to ticlopidine hydrochloride or any of the other ingredients of this medicine (listed in section 6) if you have very recently had a stroke if you have organic lesions which are liable to bleed such as a stomach or intestinal ulcer or bleeding in the brain if you have a serious bleeding disorder if you have or have ever had abnormal results from blood tests, such as a low white cell or platelet count. Warnings and precautions Talk to your doctor or pharmacist before taking /…/. Take special care with /…/ if you have liver problems if you have kidney problems if you have a bleeding or blood clotting disorder if you have any surgery (including at the dentist) 1 Ticlopidine hydrochloride, DE/H/0203/001, 11.04.16 if you take medicines such as aspirin, heparin, non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen, or anticoagulants e.g. warfarin due to the increased risk of bleedings during the concomitant use with /…/. For planned surgery be sure to tell your doctor well in advance as he or she may recommend you stop taking your tablets temporarily. If you have emergency surgery make sure you tell the doctor or dentist you are taking /…/. Your doctor will carry out routine blood tests to check your blood chemistry. These will usually be every two weeks during the first three months of treatment, and two weeks after stopping treatment if this is within the first three months. You should stop taking /…/ and contact your doctor immediately if you develop persistent unexplained fever, sore throat or mouth ulcers, prolonged or unusual bleeding, bruising, a purple rash, tarry stools or neurological symptoms such as hallucinations, bizarre behavior, altered mental status, stroke-like symptoms, headaches or kidney problems. Your doctor will order a blood test and decide whether or not you may start taking /…/ again. Please tell your doctor if you have kidney problems. He may want to monitor you more closely. Contact your doctor if you develop signs of liver inflammation (hepatitis) such as jaundice (yellowing of the skin and whites of the eyes), light-coloured stools, dark urine. Children and adolescents The use of /…/ in children and adolescents is not recommended. Other medicines and /…/ Talk to your doctor or pharmacist if you are taking any of the following: A selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression Pentoxifylline, a medicine used for poor circulation to the arms and legs Medicines which increase the risk of bleeding, such as aspirin, heparin, non-steroidal anti- inflammatory drugs (NSAIDs) e.g. ibuprofen, or anticoagulants e.g. warfarin Cimetidine (an anti-ulcer drug), as this increases the amount of ticlopidine hydrochloride in the blood Theophylline (for breathing problems), sedatives, sleeping pills or phenazone (an NSAID) as these drugs may remain in the body for longer than usual and your doctor may need to adjust your dose Antacids (for indigestion), as the effectiveness of ticlopidine hydrochloride may be reduced Ciclosporin (used following organ transplant), as the effectiveness of the ciclosporin may be reduced and your dose of ciclosporin may need to be adjusted Digoxin (for heart problems), as there may be a slight decrease in the amount of digoxin in the blood Phenytoin (for epilepsy), as the amount of phenytoin in the blood may vary from usual Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. /…/ with food and drink Take your tablets during a meal so that you are less likely to feel sick or have diarrhoea. Pregnancy and breast-feeding Do not take /…/ if you are pregnant or breast-feeding. 2 Ticlopidine hydrochloride, DE/H/0203/001, 11.04.16 Driving and using machines The side effects of /…/, such as dizziness, may affect your ability to drive and use machines, especially if taken with alcohol. 3. How to take /…/ Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed with a drink of water (after half the meal has been taken). The recommended dose is: Adults Take one tablet, twice a day. Do not take more than two tablets in one day. Use in children and adolescents The use in children and adolescents is not recommended. If you take more /…/ than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. Overdose may cause prolonged bleeding and severe stomach problems. If you forget to take /…/ If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. If you stop taking /…/ Do not stop taking /…/ without consulting your doctor. It is important to continue taking this medicine even if you feel well. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. Blood and blood vessel problems Common (may affect up to 1 in 10 users) Blood disorders (which may be characterised by fever or chills, sore throat, ulcers in the mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising). If blood disorders do occur this is most likely during the first three months of treatment. Uncommon (may affect up to 1 in 100 users) Reduction in blood platelets (thrombocytopenia), which increases the risk of bruising and bleeding An abnormal breakdown of red blood cells (haemolytic anaemia) 3 Ticlopidine hydrochloride, DE/H/0203/001, 11.04.16 An infection in the blood (sepsis), which can cause fever or chills, rapid heartbeat or rapid breathing; and septic shock (a life-threatening form of sepsis which can lead to multiple organ failure) due to a reduction of a certain type of white blood cells (agranulocytosis) Bleeding or bruising under the skin, nosebleeds Bleeding in the eye, blood in the urine An increased risk of bleeding during or after operations Severe bleedings. Rare (may affect up to 1 in 1,000 users) A drop in the number of red and white blood cells and platelets (pancytopenia), a failure of the bone marrow to produce new blood cells A potentially life-threatening disorder called thrombotic-thrombocytopenic purpura. The symptoms of this are unusual bleeding or unexplained bruising, anaemia or jaundice, fever, stroke-like symptoms, kidney problems Leukaemia Higher than normal platelet count (thrombocytosis) Bleeding in the brain. Not known (frequency cannot be estimated from the available data) Bleeding into the stomach or intestine. Other side effects Common (may affect up to 1 in 10 users) Dizziness, headache Digestive disturbances such as feeling sick, vomiting and diarrhoea. These mostly occur during the first three months of treatment but usually wear off within a few days Increase in liver enzymes Allergic skin reactions such as itching or rash (including hives). If skin reactions do occur this is most likely within the first three months of treatment Long term treatment may cause an increase in blood fat levels (e.g. cholesterol and triglycerides), although this does not appear to affect the risk of heart or blood vessel problems. Uncommon (may affect up to 1 in 100 users) Loss of appetite Tingling, numbness or one-sided weakness (sensory disturbances) Ulcers in the stomach or upper part of the intestine Increase in bilirubin Inflammation and peeling of the skin (exfoliative dermatitis) Feeling weak and tired (asthenia), general aches and pains. Rare (may affect up to 1 in 1,000 users) Depression, nervousness, difficulty sleeping Ringing in the ears Changes in the sense of taste Irregular heartbeat (palpitations) Inflammation of the liver (hepatitis) and yellowing of the skin and whites of the eyes (jaundice) in the first months of treatment Generally feeling unwell Sweating.