02 - Electronic Medicines Compendium

1 Package leaflet: Information for the patient Lansoprazole 15mg, 30mg Gastro-Resistant Capsules Read all of this leaflet carefully If you get a rash on your skin, especially in before you start taking this medicine areas exposed to the sun, tell your doctor because it contains important as soon as you can, as you may need to information for you. stop your treatment with Lansoprazole Capsules. Remember to also mention any Keep this leaflet. You may need to other ill-effects like pain in your joints. read it again. If you have any further questions, ask Other Medicines and Lansoprazole your doctor or pharmacist. Capsules This medicine has been prescribed Tell your doctor or pharmacist if you are for you only. Do not pass it on to taking, have recently taken or might take others. It may harm them, even if their any other Medicines . signs of illness are the same as yours. In particular tell your doctor or If you get any side effects, talk to your pharmacist if you are taking Medicines doctor or pharmacist.

2 This includes containing any of the following active any possible side effects not listed in substances as Lansoprazole Capsules this leaflet. See section 4. may affect the way these Medicines work: HIV protease inhibitors such as What is in this leaflet: atazanavir and nelfinavir (used to treat 1 What Lansoprazole Capsules HIV). are and what they are used for methotrexate (used to treat autoimmune disease and cancer). 2 What you need to know ketoconazole, itraconazole, rifampicin before you take Lansoprazole (used to treat infections). Capsules digoxin (used to treat heart problems). 3 How to take Lansoprazole warfarin (used to treat blood clots). Capsules theophylline (used to treat asthma). tacrolimus (used to prevent transplant 4 Possible side effects rejection). 5 How to store Lansoprazole fluvoxamine (used to treat depression Capsules and other psychiatric diseases). 6 Contents of the pack and other antacids (used to treat heartburn or information acid regurgitation).

3 Sucralfate (used for healing ulcers). 1 What Lansoprazole Capsules St John s wort (Hypericum perforatum). are and what they are used for (used to treat mild depression). The active ingredient in Lansoprazole Lansoprazole Capsules with food Capsules is lansoprazole, which is a proton pump inhibitor. Proton pump and drink For the best results from your medicine inhibitors reduce the amount of acid that you should take Lansoprazole Capsules at your stomach makes. least 30 minutes before food. Your doctor may prescribe Lansoprazole for the following indications: Pregnancy and breast-feeding treatment of duodenal and stomach If you are pregnant or breast-feeding, ulcer think you may be pregnant or are treatment of inflammation in your planning to have a baby, ask your doctor oesophagus (reflux oesophagitis) or pharmacist for advice before taking prevention of reflux oesophagitis this medicine. treatment of heartburn and acid Driving and using machines regurgitation Side effects such as dizziness, vertigo, treatment of infections caused by the tiredness and visual disturbances bacteria Helicobacter pylori when given sometimes occur in patients taking in combination with antibiotic therapy Lansoprazole Capsules.

4 If you experience treatment or prevention of duodenal side effects like these you should take or stomach ulcer in patients requiring caution as your ability to react may be continued NSAID treatment (NSAID decreased. treatment is used against pain or inflammation) You alone are responsible to decide treatment of Zollinger-Ellison if you are in a fit condition to drive a syndrome. motor vehicle or perform other tasks that demand increased concentration. Your doctor may have prescribed Because of their effects or undesirable Lansoprazole for another indication or effects, one of the factors that can reduce with a dose different from that which is your ability to do these things safely is written in this information leaflet. Please your use of Medicines . follow your doctor's instructions for Descriptions of these effects can be taking your medicine. found in other sections. You must talk to a doctor if you do not Read all the information in this leaflet for feel better or if you feel worse after 14 guidance.

5 Days. Discuss with your doctor or pharmacist if you are unsure about anything. 2 What you need to know before you take Lansoprazole Capsules Lansoprazole Capsules contain Do not take Lansoprazole Capsules: sucrose if you are allergic to lansoprazole or If you have been told by your doctor that any of the other ingredients of this you have an intolerance to some sugars, medicine (listed in section 6). contact your doctor before taking this medicinal product. Warnings and precautions Talk to your doctor or pharmacist before This medicine contains less than 1. taking Lansoprazole Capsules. mmol sodium (23 mg) per capsule, that is to say essentially sodium-free'. Talk to your doctor or pharmacist if you have serious liver disease. The doctor may 3 How to take Lansoprazole have to adjust your dosage. Capsules Your doctor may perform or have Always take this medicine exactly as your performed an additional investigation doctor has told you.

6 Check with your called an endoscopy in order to diagnose doctor or pharmacist if you are not sure. your condition and/or exclude malignant Swallow the capsule whole with a glass disease. of water. If you find the capsules difficult If diarrhoea occurs during the treatment to swallow, your doctor may advise on with Lansoprazole, contact your doctor alternative ways to take your medicine. immediately, as Lansoprazole has been Do not crush or chew these capsules associated with a small increase in or the content of an emptied capsule infectious diarrhoea. because this will stop them from working properly. If your doctor has given you Lansoprazole Capsules in addition to other Medicines If you are taking Lansoprazole Capsules intended for the treatment of once a day, try to take them at the same Helicobacter pylori infection (antibiotics) time each day. You may get best results or together with anti-inflammatory if you take lansoprazole first thing in the Medicines to treat your pain or rheumatic morning.

7 Disease: please also read the package If you are taking Lansoprazole Capsules leaflets of these Medicines carefully. twice a day, you should have the first Taking a proton pump inhibitor like dose in the morning and the second dose Lansoprazole, especially over a period in the evening. of more than one year, may slightly increase your risk of fracture in the hip, The dose of Lansoprazole Capsules wrist or spine. Tell your doctor if you depends on your condition. The have osteoporosis or if you are taking recommended doses of Lansoprazole corticosteroids (which can increase the Capsules for adults are given below. Your risk of osteoporosis). doctor will sometimes prescribe you a different dose and will tell you how long If you take Lansoprazole Capsules on a your treatment will last. long-term basis (longer than 1 year) your doctor will probably keep you under treatment of heartburn and acid regular surveillance.

8 You should report regurgitation: one 15mg or 30mg any new and exceptional symptoms and capsule every day for 4 weeks. If circumstances whenever you see your symptoms persist you should report to doctor. your doctor. If your symptoms are not Talk to your doctor before taking relieved within 4 weeks, please contact Lansoprazole Capsules: your doctor. if you have low vitamin B12 levels or treatment of duodenal ulcer : one have risk factors for low vitamin B12 30mg capsule every day for 2 weeks. levels and receive long-term treatment with Lansoprazole Capsules. As with treatment of stomach ulcer : one 30mg all acid reducing agents, Lansoprazole capsule every day for 4 weeks. Capsules may lead to a reduced treatment of inflammation in your absorption of vitamin B12. oesophagus (reflux oesophagitis): one if you are due to have a specific blood 30mg capsule every day for 4 weeks. test (Chromogranin A). i f you have ever had a skin reaction Long-term prevention of reflux after treatment with a medicine similar oesophagitis: one 15mg capsule every to Lansoprazole Capsules that reduces day, your doctor may adjust your dose to stomach acid.

9 One 30mg capsule every day. Continued top of next column Continued over page BBBB2400. Lansoprazole All strengths Gastro-resistant Capsules PIL - UK. approved for print/date Item number: BBBB2400 Colours Non Printing Colours 1. Black 1. Originator: Dimensions: 140x540. Origination Date: 31/08/2021 Min Body Text Size: 9pt 2. 2. Revision Date: 08/09/2021 Supplier: Liconsa 3. 3. Revised By: 4. 5. Proof Round 02 Technical Approval Date sent: 31/08/2021. Date received: 02/09/2021. 6. Cartons and label leaflets only . (labels only when specified) German GTIN 14 (incorporating PZN): N/A. * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. treatment of infection of Helicobacter Very rare (may affect up to 1 in 10,000. pylori: The recommended dose is one people): 30mg capsule in combination with two inflammation of your mouth different antibiotics in the morning and (stomatitis).

10 One 30mg capsule in combination with colitis (bowel inflammation). two different antibiotics in the evening. changes in test values such as sodium, treatment will usually be every day for 7 cholesterol and triglyceride levels days. a reduction in the number of white blood cells which may decrease The recommended combinations of your resistance to infection. If you antibiotics are: experience an infection with symptoms 30mg Lansoprazole together with 250- such as fever and serious deterioration 500 mg clarithromycin and 1000mg of your general condition, or fever amoxicillin with local infection symptoms such as 30mg Lansoprazole together with sore throat/pharynx/mouth or urinary 250mg clarithromycin and 400-500mg problems you should see your doctor metronidazole. immediately. A blood test will be taken to check possible reduction of white If you are being treated for infection blood cells (agranulocytosis).