Package leaflet: Information for the patient Lansoprazole 15mg, 30mg Gastro-Resistant Capsules Read all of this leaflet carefully If you get a 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 • Keep this leaflet. You may need to Capsules. Remember to also mention any other ill-effects like pain in your joints. read it again. • If you have any further questions, ask If you are on Lansoprazole Capsules for your doctor or pharmacist. more than three months it is possible • This medicine has been prescribed that the levels of magnesium in your for you only. Do not pass it on to blood may fall. Low levels of magnesium others. It may harm them, even if their can be seen as fatigue, involuntary muscle contractions, disorientation, signs of illness are the same as yours. convulsions, dizziness, increased heart • If you get any side effects, talk to your rate. If you get any of these symptoms, doctor or pharmacist. This includes please tell your doctor promptly. Low any possible side effects not listed in levels of magnesium can also lead to a this leaflet. See section 4. reduction in potassium or calcium levels in the blood. Your doctor may decide to What is in this leaflet: perform regular blood tests to monitor 1 What Lansoprazole Capsules your levels of magnesium. are and what they are used for Other medicines and Lansoprazole 2 What you need to know Capsules before you take Lansoprazole Tell your doctor or pharmacist if you are Capsules taking, have recently taken or might take 3 How to take Lansoprazole any other medicines. Capsules In particular tell your doctor or 4 Possible side effects pharmacist if you are taking medicines 5 How to store Lansoprazole containing any of the following active Capsules substances as Lansoprazole Capsules may affect the way these medicines work: 6 Contents of the pack and other • HIV protease inhibitors such as information atazanavir and nelfinavir (used to treat 1 What Lansoprazole Capsules HIV) • methotrexate (used to treat are and what they are used for autoimmune disease and cancer) The active ingredient in Lansoprazole • , , rifampicin Capsules is lansoprazole, which is a (used to treat infections) proton pump inhibitor. Proton pump •  (used to treat heart problems) inhibitors reduce the amount of acid that • warfarin (used to treat blood clots) your stomach makes. •  (used to treat asthma) Your doctor may prescribe Lansoprazole • tacrolimus (used to prevent transplant for the following indications: rejection) • Treatment of duodenal and stomach •  (used to treat depression ulcer and other psychiatric diseases) • Treatment of inflammation in your • antacids (used to treat heartburn or oesophagus (reflux oesophagitis) acid regurgitation) • Prevention of reflux oesophagitis •  (used for healing ulcers) • Treatment of heartburn and acid • St John´s wort (Hypericum perforatum) regurgitation (used to treat mild depression). • Treatment of infections caused by the bacteria when given Lansoprazole Capsules with food in combination with therapy and drink • Treatment or prevention of duodenal For the best results from your medicine or stomach ulcer in patients requiring you should take Lansoprazole Capsules at continued NSAID treatment (NSAID least 30 minutes before food. treatment is used against pain or and breast-feeding inflammation) If you are pregnant or breast-feeding, • Treatment of Zollinger-Ellison think you may be pregnant or are syndrome. planning to have a baby, ask your doctor Your doctor may have prescribed or pharmacist for advice before taking Lansoprazole for another indication or this medicine. with a dose different from that which is written in this information leaflet. Please Driving and using machines Side effects such as dizziness, vertigo, follow your doctor’s instructions for tiredness and visual disturbances taking your medicine. sometimes occur in patients taking You must talk to a doctor if you do not Lansoprazole Capsules. If you experience feel better or if you feel worse after 14 side effects like these you should take days. caution as your ability to react may be decreased. 2 What you need to know before You alone are responsible to decide you take Lansoprazole Capsules if you are in a fit condition to drive a Do not take Lansoprazole Capsules: motor vehicle or perform other tasks • if you are allergic to lansoprazole or that demand increased concentration. any of the other ingredients of this Because of their effects or undesirable medicine (listed in section 6). effects, one of the factors that can reduce Warnings and precautions your ability to do these things safely is your use of medicines. Talk to your doctor or pharmacist before Descriptions of these effects can be taking Lansoprazole Capsules. found in other sections. Talk to your doctor or pharmacist if you Read all the information in this leaflet for have serious disease. The doctor may guidance. have to adjust your dosage. Discuss with your doctor or pharmacist if Your doctor may perform or have you are unsure about anything. performed an additional investigation called an endoscopy in order to diagnose Lansoprazole Capsules contain your condition and/or exclude malignant sucrose disease. If you have been told by your doctor that you have an intolerance to some sugars, If diarrhoea occurs during the treatment contact your doctor before taking this with Lansoprazole, contact your doctor medicinal product. immediately, as Lansoprazole has been associated with a small increase in This medicine contains less than 1 infectious diarrhoea. mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’. If your doctor has given you Lansoprazole Capsules in addition to other medicines 3 How to take Lansoprazole intended for the treatment of Helicobacter pylori infection () Capsules or together with anti-inflammatory Always take this medicine exactly as your medicines to treat your pain or rheumatic doctor has told you. Check with your disease: please also read the package doctor or pharmacist if you are not sure. leaflets of these medicines carefully. Swallow the capsule whole with a glass Taking a proton pump inhibitor like of water. If you find the capsules difficult Lansoprazole, especially over a period to swallow your doctor may advise on of more than one year, may slightly alternative ways to take your medicine. increase your risk of fracture in the hip, Do not crush or chew these capsules wrist or spine. Tell your doctor if you or the content of an emptied capsule have or if you are taking because this will stop them from working corticosteroids (which can increase the properly. risk of osteoporosis). If you are taking Lansoprazole Capsules If you take Lansoprazole Capsules on a once a day, try to take them at the same long-term basis (longer than 1 year) your time each day. You may get best results doctor will probably keep you under if you take lansoprazole first thing in the regular surveillance. You should report morning. any new and exceptional symptoms and If you are taking Lansoprazole Capsules circumstances whenever you see your twice a day, you should have the first doctor. dose in the morning and the second dose Talk to your doctor before taking in the evening. Lansoprazole Capsules: • if you have low levels or The dose of Lansoprazole Capsules have risk factors for low vitamin B12 depends on your condition. The levels and receive long-term treatment recommended doses of Lansoprazole with Lansoprazole Capsules. As with Capsules for adults are given below. Your all acid reducing agents, Lansoprazole doctor will sometimes prescribe you a Capsules may lead to a reduced different dose and will tell you how long absorption of vitamin B12. your treatment will last. • if you are due to have a specific blood test (Chromogranin A). • if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Capsules that reduces stomach acid.

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Lansoprazole 15mg & 30mg Gastro-resistant Capsules PIL - UK

approved for print/date Item number: BBBB1588 Colours Non Printing Colours 1. Black 1. Originator: RH Dimensions: 140x540 Origination Date: 14-06-21 Min Body Text Size: 9pt 2. 2. Revision Date: Supplier: Liconsa 3. 3. Revised By: 4. 5. Proof Round 14-06-21 Technical Date sent: 6. 01 Approval Date received: 14-06-21 [email protected]

Cartons and label leaflets only  (labels only when specified) German GTIN 14 (incorporating PZN): * 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. 12.02.2020 Treatment of heartburn and acid Rare (may affect up to 1 in 1,000 people): regurgitation: one 15mg or 30mg •  capsule every day for 4 weeks. If • restlessness, drowsiness, confusion, symptoms persist you should report to hallucinations, , visual your doctor. If your symptoms are not disturbances, vertigo relieved within 4 weeks, please contact • a change in the way things , loss of your doctor. appetite, inflammation of your tongue (glossitis) Treatment of duodenal ulcer: one • skin reactions such as burning or 30mg capsule every day for 2 weeks. pricking feeling under the skin, bruising, reddening and excessive Treatment of stomach ulcer: one 30mg sweating capsule every day for 4 weeks. • sensitivity to light Treatment of inflammation in your • hair loss • feelings of ants creeping over the skin oesophagus (reflux oesophagitis): one (paraesthesia), trembling 30mg capsule every day for 4 weeks. • anaemia (paleness) Long-term prevention of reflux • kidney problems oesophagitis: one 15mg capsule every • pancreatitis day, your doctor may adjust your dose to • breast swelling in males, impotence one 30mg capsule every day. • candidiasis (fungal infection, may affect skin or the mucosa). Treatment of infection of Helicobacter pylori: The recommended dose is one Very rare (may affect up to 1 in 10,000 people): 30mg capsule in combination with two • inflammation of your mouth different antibiotics in the morning and (stomatitis) 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 The recommended combinations of blood cells which may decrease 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 and 1000mg of your general condition, or fever 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). because you have an ulcer, it is unlikely that your ulcer will return if the infection Not known (frequency cannot be is successfully treated. To give your estimated from the available data): medicine the best chance of working, • rash, possibly with pain in the joints take it at the right time and do not miss • low levels of magnesium in your blood a dose. (hypomagnesaemia), low levels of calcium in your blood (hypocalcaemia), Treatment of duodenal or stomach low levels of potassium in your blood ulcer in patients requiring continued (hypokalaemia) (see section 2) NSAID treatment: one 30mg capsule • visual hallucinations. every day for 4 weeks. Reporting of side effects Prevention of duodenal or stomach If you get any side effects, talk to your ulcer in patients requiring continued doctor, pharmacist or nurse. This includes NSAID treatment: one 15mg capsule any possible side effects not listed in this every day, your doctor may adjust your leaflet. You can also report side effects dose to one 30mg capsule every day. directly via the Yellow Card Scheme at: Zollinger-Ellison syndrome: The www.mhra.gov.uk/yellowcard or search recommended dose is two 30mg for MHRA Yellow Card in the Google Play capsules every day to start with, then or Apple App Store. depending on how you respond to By reporting side effects you can help Lansoprazole Capsules, the dose that provide more information on the safety your doctor decides is best for you. of this medicine. Use in children Lansoprazole Capsules should not be 5 How to store Lansoprazole given to children. Capsules If you take more Lansoprazole Keep this medicine out of the sight and reach of children. Capsules than you should If you take more Lansoprazole Capsules Do not take this medicine after the expiry than you have been told to, seek medical date which is stated on the blister and advice quickly. Contact your nearest carton. The expiry date refers to the last casualty department or tell your doctor day of that month. or pharmacist at once. Do not store above 25°C. If you forget to take Lansoprazole Store in the original package in order to Capsules protect from moisture. If you forget to take a dose, take it as soon Do not throw away any medicines as you remember unless it is nearly time via wastewater or household waste. for your next dose. If this happens, skip Ask your pharmacist how to throw the missed dose and take the remaining away medicines you no longer use. capsules as normal. Do not take a double These measures will help protect the dose to make up for a forgotten capsule. environment. If you stop taking Lansoprazole Capsules 6 Contents of the pack and other Do not stop treatment early because information your symptoms have got better. Your What Lansoprazole Capsules condition may not have been fully healed contain and may reoccur if you do not finish your • The active substance is lansoprazole. course of treatment. Each capsule contains 15mg or 30mg lansoprazole. If you have any further questions on the • The other ingredients are: use of this medicine, ask your doctor or pharmacist. Capsule content: Sugar spheres (sucrose and maize starch), Sodium 4 Possible side effects laurilsulfate, Meglumine, Mannitol Like all medicines, this medicine (E421), Hypromellose, Macrogol, Talc, can cause side effects, although not Polysorbate 80, Titanium dioxide everybody gets them. (E171), Methacrylic Acid-Ethyl Acrylate Copolymer (1:1), Dispersion 30% If you get any of the following side effects, stop taking Lansoprazole Capsule shell: Gelatin, Titanium dioxide Capsules and tell your doctor (E171) immediately, or contact the casualty Capsule shell of 15mg also contains: department at your nearest hospital: Quinoline yellow (E104) •  (symptoms may include swollen face, tongue or pharynx, What Lansoprazole Capsules look difficulty to swallow, hives and like and contents of the pack difficulties to breathe) 15 mg gastro-resistant capsules, hard: • severe hypersensitivity reactions opaque yellow cap and body capsules. including anaphylactic shock Each capsule contains white or almost (symptoms may include fever, rash, white spherical microgranules. swelling and sometimes a fall in blood pressure) 30 mg gastro-resistant capsules, hard: • very severe skin reactions with opaque white cap and body capsules. reddening, blistering, severe Each capsule contains white or almost inflammation and skin loss (Stevens- white spherical microgranules. Johnson Syndrome, toxic epidermal Lansoprazole Capsules are available in necrolysis, erythema multiforme) blister packs containing 7, 14, 28, 56 or 98 • inflammation of the liver (may be capsules. seen as yellow skin or eyes). Not all pack sizes may be marketed. Other side effects Common (may affect up to 1 in 10 Marketing Authorisation Holder people): Accord, Barnstaple, EX32 8NS, UK • headache, dizziness Manufacturer • diarrhoea, , stomach pains, LABORATORIOS LICONSA, S.A. feeling or being sick, wind, dry or sore Avda. Miralcampo, Nº 7, Polígono mouth or throat Industrial Miralcampo, • skin rash, itching 19200 Azuqueca de Henares • changes in liver function test values (Guadalajara), • tiredness Spain • benign polyps in the stomach. Uncommon (may affect up to 1 in 100 This leaflet was last revised in people): June 2021 • depression • joint or muscle pain If you would like a • fluid retention or swelling • changes in blood cell counts leaflet with larger • fracture of the hip, wrist or spine (see text, please contact section 2 ‘Warnings and precautions’). 01271 385257.

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Lansoprazole 15mg & 30mg Gastro-resistant Capsules PIL - UK

approved for print/date Item number: BBBB1588 Colours Non Printing Colours 1. Black 1. Originator: RH Dimensions: 140x540 Origination Date: 14-06-21 Min Body Text Size: 9pt 2. 2. Revision Date: Supplier: Liconsa 3. 3. Revised By: 4. 5. Proof Round 14-06-21 Technical Date sent: 6. 01 Approval Date received: 14-06-21 [email protected]

Cartons and label leaflets only  (labels only when specified) German GTIN 14 (incorporating PZN): * 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. 12.02.2020