LANSOPRAZOLE 30MG GASTRO-RESISTANT CAPSULES
Active substance: LANSOPRAZOLE
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231-30-69714-X LEA LANSOPRAZOLE A/S CAPS TUK
Version:
1
15 August 2012
PL Number(s), PL 00289/1358-9. Teva UK Ltd Licence. (Responsible Regulatory Dept = Post-licence Regulatory Team), MA Holder & Packer: MA Holder: TEVA UK Limited. Packed at TEVA UK Ltd, Eastbourne, Packing line: UHLMANN. Reason for revision: Version 1: Regulatory text updates from Reg. Affairs 15/05/12 12:23. V2: Remove personal details from Header Box.
PAGE 1: FRONT FACE (INSIDE OF REEL) Top of page cut-off to middle of registration mark: 44 mm.
LANSOPRAZOLE 15 mg and 30 mg GASTRO-RESISTANT CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular tell your doctor if you are taking medicines containing any of the following active substances as Lansoprazole may affect the way these drugs work: ketoconazole, itraconazole, rifampicin (used to treat infections) digoxin (used to treat heart problems) theophylline (used to treat asthma) tacrolimus (used to prevent transplant rejection) fluvoxamine (used to treat depression and other psychiatric diseases) antacids (used to treat heartburn or acid regurgitation) sucralfate (used for healing ulcers) St Johns wort (Hypericum perforatum) (used to treat mild depression). Taking Lansoprazole Capsules with food and drink For the best results from your medicines you should take Lansoprazole at least 30 minutes before food.
Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Lansoprazole Capsules are and what they are used for 2. Before you take Lansoprazole Capsules 3. How to take Lansoprazole Capsules 4. Possible side effects 5. How to store Lansoprazole Capsules 6. Further information
1
Pharma code 524
Pregnancy and breast-feeding If you are pregnant, breast-feeding or if there is a chance you might be pregnant ask your doctor for advice before WHAT LANSOPRAZOLE CAPSULES ARE AND WHAT taking this medicine.
THEY ARE USED FOR
The active ingredient in Lansoprazole is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Lansoprazole for the following indications: Treatment of duodenal and stomach ulcer Treatment of inflammation in your oesophagus (reflux oesophagitis) Prevention of reflux oesophagitis Treatment of heartburn and acid regurgitation Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation) Treatment of Zollinger-Ellison syndrome. Your doctor may have prescribed Lansoprazole for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctors instructions for taking your medicine.
Driving and using machines Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Lansoprazole. If you experience side effects like these you should take caution as your ability to react may be decreased. You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines. Descriptions of these effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything. Important information about some of the ingredients of Lansoprazole Capsules Lansoprazole contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
2
BEFORE YOU TAKE LANSOPRAZOLE CAPSULES
Do not take Lansoprazole if you are: allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansoprazole taking a medicine containing the active substance atazanavir (used in the treatment of HIV). Take special care with Lansoprazole Capsules Please tell your doctor if you have serious liver disease. The doctor may have to adjust your dosage. Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as Lansoprazole has been associated with a small increase in infectious diarrhoea. If your doctor has given you Lansoprazole in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully. Taking a proton pump inhibitor like Lansoprazole Capsules, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
3
HOW TO TAKE LANSOPRAZOLE CAPSULES
Swallow the capsule whole with a glass of water. If you find the capsules difficult to swallow your doctor may advise on alternative ways to take your medicine. Do not crush or chew these capsules or the content of an emptied capsule because this will stop them from working properly. If you are taking Lansoprazole once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole first thing in the morning. If you are taking Lansoprazole twice a day, you should have the first dose in the morning and the second dose in the evening. The dose of Lansoprazole depends on your condition. The usual doses of Lansoprazole for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last. Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule for 4 weeks. If symptoms persist you should report to your doctor. If your symptoms are not relieved within 4 weeks, please contact your doctor. Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks. Treatment of stomach ulcer: one 30 mg capsule every day for 4 weeks.
If you take Lansoprazole on a long-term basis (longer than 1 Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks. year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor. Long-term prevention of reflux oesophagitis: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.
Ref:
231-30-69714-X LEA LANSOPRAZOLE A/S CAPS TUK
Version:
1
15 August 2012
PL Number(s), PL 00289/1358-9. Teva UK Ltd Licence. (Responsible Regulatory Dept = Post-licence Regulatory Team), MA Holder & Packer: MA Holder: TEVA UK Limited. Packed at TEVA UK Ltd, Eastbourne, Packing line: UHLMANN. Reason for revision: Version 1: Regulatory text updates from Reg. Affairs 15/05/12 12:23. V2: Remove personal details from Header Box.
PAGE 2: REAR FACE (OUTSIDE OF REEL)
Treatment of infection of Helicobacter pylori: The usual dose is breast swelling in males, impotence candidiasis (fungal infection, may affect skin or the one 30 mg capsule in combination with two different mucosa) antibiotics in the morning and one 30 mg capsule in angioedema; You should see your doctor immediately if combination with two different antibiotics in the evening. you experience symptoms of angioedema, such as swollen Treatment will usually be every day for 7 days. face, tongue or pharynx, difficulty to swallow, hives and The recommended combinations of antibiotics are: difficulties to breath. 30 mg Lansoprazole together with 250-500 mg The following side effects are very rare (occur in less than 1 clarithromycin and 1000 mg amoxicillin in 10000 patients): 30 mg Lansoprazole together with 250 mg clarithromycin severe hypersensitivity reactions including shock. and 400-500 mg metronidazole Symptoms of a hypersensitivity reaction may include If you are being treated for infection because you have an fever, rash, swelling and sometimes a fall in blood ulcer, it is unlikely that your ulcer will return if the infection is pressure successfully treated. To give your medicine the best chance of inflammation of your mouth (stomatitis) working, take it at the right time and do not miss a dose. colitis (bowel inflammation) changes in test values such as sodium, cholesterol and Treatment of duodenal or stomach ulcer in patients requiring triglyceride levels continued NSAID treatment: one 30 mg capsule every day for very severe skin reactions with reddening, blistering, 4 weeks. severe inflammation and skin loss. very rarely Lansoprazole may cause a reduction in the Prevention of duodenal or stomach ulcer in patients requiring number of white blood cells and your resistance to continued NSAID treatment: one 15 mg capsule every day, infection may be decreased. If you experience an infection your doctor may adjust your dose to one 30 mg capsule every with symptoms such as fever and serious deterioration of day. your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary Zollinger-Ellison syndrome: The usual dose is two 30 mg problems you should see your doctor immediately. A capsules every day to start with, then depending on how you blood test will be taken to check possible reduction of respond to Lansoprazole the dose that your doctor decides is white blood cells (agranulocytosis). best for you. Frequency not known If you are on Lansoprazole Capsules for more than three Lansoprazole should not be given to children. months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as Take your medicine exactly as your doctor has told you. You should check with your doctor if you are not sure how to take fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of your medicine. these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or If you take more Lansoprazole Capsules than you should calcium levels in the blood. Your doctor may decide to perform If you take more Lansoprazole than you have been told to, regular blood tests to monitor your levels of magnesium. seek medical advice quickly. If you forget to take Lansoprazole Capsules If you forget to take a dose, take it as soon as your remember unless it is nearly time for your next dose. If this happens skip the missed dose and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule. If you stop taking Lansoprazole Capsules Do not stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment. If you have any further questions on the use of this product, ask your doctor. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5
HOW TO STORE LANSOPRAZOLE CAPSULES
Keep out of the reach and sight of children. Store below 30C. Do not use Lansoprazole Capsules after the expiry date that is stated on the label and carton after EXP:. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
4
POSSIBLE SIDE EFFECTS
Like all medicines, Lansoprazole can cause side effects, although not everybody gets them. The following side effects are common (occur in more than 1 in 100 patients): headache, dizziness diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat skin rash, itching changes in liver function test values tiredness. The following side effects are uncommon (occur in less than 1 in 100 patients): depression joint or muscle pain fluid retention or swelling changes in blood cell counts. fracture of the hip, wrist or spine. The following side effects are rare (occur in less than 1 in 1000 patients): fever restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis) skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating sensitivity to light hair loss feelings of ants creeping over the skin (paraesthesia), trembling anaemia (paleness) kidney problems pancreatitis inflammation of the liver (may be seen as yellow skin or eyes)
6
FURTHER INFORMATION
What Lansoprazole Capsules contain The active substance is lansoprazole. The other ingredients are: sugar spheres (sucrose and maize starch), sodium starch glycolate (type A), sodium laurilsulfate (type A), povidone (K30), potassium oleate, oleic acid, hypromellose, methacrylic acid - ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (E171), talc, carrageenan, Potassium chloride and carnauba wax. The printing ink on the capsules contains the following additional ingredients: shellac (lacca), propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172). What Lansoprazole Capsules look like and contents of the pack Each hard, cellulose capsule has a white cap marked with the letter L and a white body marked with the numbers 15 or 30, depending on the product strength. The capsules contain white to beige gastro-resistant micropellets containing either 15 mg or 30 mg lansoprazole. Lansoprazole Capsules are supplied in Aluminium/Aluminium blisters of 7, 14, 28, 30, 56 and 98 capsules*. *Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom. This leaflet was last updated May 2012 PL 00289/1358-9
69714-X
25 mm.
Posicin de Laetus 6 LANSOPRAZOLE 15 mg and 30 mg GASTRO-RESISTANT CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
DIR. LECTURA
LAETUS
5 mm. DIR. LECTURA
5 mm.
25 mm.
PL Number(s), PL 00289/1358-9. (Responsible Regulatory Officer = Yogesh Toraskar), MA Holder & Packer: Packed at Zaragosa
Reason for revision: Version 1: Regulatory text updates - 15/05/12 12:23. V2: Removal of name from Header box (14/08/12 12:07)
231-30-11112-B LEA LANSOPRAZOLE A/S CAPS TUK
25 mm.
Pregnancy and breast-feeding If you are pregnant, breast-feeding or if The active ingredient in Lansoprazole there is a chance you might be is lansoprazole, which is a proton pregnant ask your doctor for advice pump inhibitor. Proton pump inhibitors before taking this medicine. reduce the amount of acid that your stomach makes. Driving and using machines Side effects such as dizziness, vertigo, Your doctor may prescribe tiredness and visual disturbances Lansoprazole for the following sometimes occur in patients taking indications: Lansoprazole. If you experience side Treatment of duodenal and stomach effects like these you should take ulcer caution as your ability to react may be Treatment of inflammation in your decreased. oesophagus (reflux oesophagitis) Prevention of reflux oesophagitis You alone are responsible to decide if Treatment of heartburn and acid you are in a fit condition to drive a regurgitation motor vehicle or perform other tasks Treatment of infections caused by that demand increased concentration. the bacteria Helicobacter pylori when Because of their effects or undesirable given in combination with antibiotic effects, one of the factors that can therapy reduce your ability to do these things Treatment or prevention of duodenal safely is your use of medicines. or stomach ulcer in patients Descriptions of these effects can be requiring continued NSAID found in other sections. treatment (NSAID treatment is used Read all the information in this leaflet against pain or inflammation) for guidance. Treatment of Zollinger-Ellison syndrome. Discuss with your doctor, nurse or pharmacist if you are unsure about Your doctor may have prescribed Lansoprazole for another indication or anything. with a dose different from that which is Important information about some of written in this information leaflet. the ingredients of Lansoprazole Please follow your doctors Capsules instructions for taking your medicine. Lansoprazole contains sucrose. If you have been told by your doctor that you BEFORE YOU TAKE 2 LANSOPRAZOLE CAPSULES have an intolerance to some sugars, contact your doctor before taking this medicine. Do not take Lansoprazole if you are: allergic (hypersensitive) to lansoprazole or any of the other 3 HOW TO TAKE LANSOPRAZOLE CAPSULES ingredients of Lansoprazole taking a medicine containing the active substance atazanavir (used in Swallow the capsule whole with a glass of water. If you find the capsules the treatment of HIV). difficult to swallow your doctor may advise on alternative ways to take your Take special care with Lansoprazole medicine. Do not crush or chew these Capsules capsules or the content of an emptied Please tell your doctor if you have capsule because this will stop them serious liver disease. The doctor may from working properly. have to adjust your dosage. Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as Lansoprazole has been associated with a small increase in infectious diarrhoea. If you are taking Lansoprazole once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole first thing in the morning. If you are taking Lansoprazole twice a day, you should have the first dose in the morning and the second dose in the evening. The dose of Lansoprazole depends on your condition. The usual doses of Lansoprazole for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.
DIR. LECTURA
In particular tell your doctor if you are taking medicines containing any of the Read all of this leaflet carefully before following active substances as you start taking this medicine. Lansoprazole may affect the way these Keep this leaflet. You may need to drugs work: read it again. ketoconazole, itraconazole, If you have any further questions, rifampicin (used to treat infections) ask your doctor or pharmacist. digoxin (used to treat heart This medicine has been prescribed problems) for you. Do not pass it on to others. It theophylline (used to treat asthma) may harm them, even if their tacrolimus (used to prevent symptoms are the same as yours. transplant rejection) If any of the side effects get serious, fluvoxamine (used to treat or if you notice any side effects not depression and other psychiatric listed in this leaflet, please tell your diseases) doctor or pharmacist. antacids (used to treat heartburn or acid regurgitation) IN THIS LEAFLET: sucralfate (used for healing ulcers) 1. What Lansoprazole Capsules are St Johns wort (Hypericum and what they are used for perforatum) (used to treat mild 2. Before you take Lansoprazole depression). Capsules 3. How to take Lansoprazole Capsules Taking Lansoprazole Capsules with 4. Possible side effects food and drink 5. How to store Lansoprazole Capsules For the best results from your 6. Further information medicines you should take Lansoprazole at least 30 minutes before food. 1 WHAT LANSOPRAZOLE LAETUS
Doble a 74 mm.
LAETUS
Doble a 114 mm.
CAPSULES ARE AND WHAT THEY ARE USED FOR
Doble a 154 mm.
14 August 2012
Version:
2
Ref:
If your doctor has given you Lansoprazole in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please Treatment of heartburn and acid also read the package leaflets of these regurgitation: one 15 mg or 30 mg capsule for 4 weeks. If symptoms medicines carefully. persist you should report to your doctor. If your symptoms are not Taking a proton pump inhibitor like Lansoprazole Capsules, especially over relieved within 4 weeks, please contact your doctor. a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks. if you have osteoporosis or if you are taking corticosteroids (which can Treatment of stomach ulcer: one 30 mg increase the risk of osteoporosis). capsule every day for 4 weeks. If you take Lansoprazole on a Treatment of inflammation in your long-term basis (longer than 1 year) oesophagus (reflux oesophagitis): one your doctor will probably keep you under regular surveillance. You should 30 mg capsule every day for 4 weeks. report any new and exceptional Long-term prevention of reflux symptoms and circumstances oesophagitis: one 15 mg capsule every whenever you see your doctor. day, your doctor may adjust your dose to one 30 mg capsule every day.
25 mm.
Cara A 140 x 470
DIR. LECTURA
LAETUS
DIR. LECTURA Pre-plegado a 235 mm.
LAETUS
DIR. LECTURA
LAETUS
25 mm.
Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. Treatment will usually be every day for 7 days. The recommended combinations of antibiotics are: 30 mg Lansoprazole together with 250-500 mg clarithromycin and 1000 mg amoxicillin 30 mg Lansoprazole together with 250 mg clarithromycin and 400-500 mg metronidazole If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated. To give your medicine the best chance of working, take it at the right time and do not miss a dose. Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 30 mg capsule every day for 4 weeks. Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.
The following side effects are very rare (occur in less than 1 in 10000 patients): severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure inflammation of your mouth (stomatitis) colitis (bowel inflammation) changes in test values such as sodium, cholesterol and triglyceride levels very severe skin reactions with reddening, blistering, severe inflammation and skin loss very rarely Lansoprazole may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).
DIR. LECTURA
LAETUS
Frequency not known If you are on Lansoprazole Capsules for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of Zollinger-Ellison syndrome: The usual magnesium can be seen as fatigue, dose is two 30 mg capsules every day involuntary muscle contractions, disorientation, convulsions, dizziness, to start with, then depending on how you respond to Lansoprazole the dose increased heart rate. If you get any of that your doctor decides is best for you. these symptoms, please tell your doctor promptly. Low levels of magnesium can Lansoprazole should not be given to also lead to a reduction in potassium or children. calcium levels in the blood. Your doctor may decide to perform regular blood Take your medicine exactly as your tests to monitor your levels of doctor has told you. You should check magnesium. with your doctor if you are not sure If any of the side effects become how to take your medicine. serious, or if you notice any side effects not listed in this leaflet, please If you take more Lansoprazole tell your doctor. Capsules than you should If you take more Lansoprazole than you have been told to, seek medical 5 HOW TO STORE CAPSULES LANSOPRAZOLE advice quickly. If you forget to take Lansoprazole Capsules If you forget to take a dose, take it as soon as your remember unless it is nearly time for your next dose. If this happens skip the missed dose and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule. If you stop taking Lansoprazole Capsules Do not stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment. If you have any further questions on the use of this product, ask your doctor. Keep out of the reach and sight of children. Store below 30C. Do not use Lansoprazole Capsules after the expiry date that is stated on the label and carton after EXP:. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Pre-plegado a 235 mm.
Version:
2
PL Number(s), PL 00289/1358-9. (Responsible Regulatory Officer = Yogesh Toraskar), MA Holder & Packer: Packed at Zaragosa
14 August 2012
Reason for revision: Version 1: Regulatory text updates - 15/05/12 12:23. V2: Removal of name from Header box (14/08/12 12:07)
231-30-11112-B LEA LANSOPRAZOLE A/S CAPS TUK
6
FURTHER INFORMATION
4
POSSIBLE SIDE EFFECTS
Like all medicines, Lansoprazole can cause side effects, although not everybody gets them. The following side effects are common (occur in more than 1 in 100 patients): headache, dizziness diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat skin rash, itching changes in liver function test values tiredness. The following side effects are uncommon (occur in less than 1 in 100 patients): depression joint or muscle pain fluid retention or swelling changes in blood cell counts. fracture of the hip, wrist or spine. The following side effects are rare (occur in less than 1 in 1000 patients): fever restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis) skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating sensitivity to light hair loss feelings of ants creeping over the skin (paraesthesia), trembling anaemia (paleness) kidney problems pancreatitis inflammation of the liver (may be seen as yellow skin or eyes) breast swelling in males, impotence candidiasis (fungal infection, may affect skin or the mucosa) angioedema; You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath.
25 mm.
What Lansoprazole Capsules contain The active substance is lansoprazole. The other ingredients are: sugar spheres (sucrose and maize starch), sodium starch glycolate (type A), sodium laurilsulfate (type A), povidone (K30), potassium oleate, oleic acid, hypromellose, methacrylic acid - ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (E171), talc, carrageenan, Potassium chloride and carnauba wax. The printing ink on the capsules contains the following additional ingredients: shellac (lacca), propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172). What Lansoprazole Capsules look like and contents of the pack Each hard, cellulose capsule has a white cap marked with the letter L and a white body marked with the numbers 15 or 30, depending on the product strength. The capsules contain white to beige gastro-resistant micropellets containing either 15 mg or 30 mg lansoprazole. Lansoprazole Capsules are supplied in Aluminium/Aluminium blisters of 7, 14, 28, 30, 56 and 98 capsules*. *Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom. Manufacturer: Teva Pharma S.L.U. Poligono Industrial Malpica, calle C, Numero 4, 50016 Zaragoza, Spain Telephone: 00 34 976 57 17 84 Telefax: 00 34 976 57 26 63 This leaflet was last updated May 2012 PL 00289/1358-9
DIR. LECTURA
Ref:
000000000/P0
11112-B
Cara B 140 x 470
LAETUS
231-30-69714-X LEA LANSOPRAZOLE A/S CAPS TUK
Version:
1
15 August 2012
PL Number(s), PL 00289/1358-9. Teva UK Ltd Licence. (Responsible Regulatory Dept = Post-licence Regulatory Team), MA Holder & Packer: MA Holder: TEVA UK Limited. Packed at TEVA UK Ltd, Eastbourne, Packing line: UHLMANN. Reason for revision: Version 1: Regulatory text updates from Reg. Affairs 15/05/12 12:23. V2: Remove personal details from Header Box.
PAGE 1: FRONT FACE (INSIDE OF REEL) Top of page cut-off to middle of registration mark: 44 mm.
LANSOPRAZOLE 15 mg and 30 mg GASTRO-RESISTANT CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular tell your doctor if you are taking medicines containing any of the following active substances as Lansoprazole may affect the way these drugs work: ketoconazole, itraconazole, rifampicin (used to treat infections) digoxin (used to treat heart problems) theophylline (used to treat asthma) tacrolimus (used to prevent transplant rejection) fluvoxamine (used to treat depression and other psychiatric diseases) antacids (used to treat heartburn or acid regurgitation) sucralfate (used for healing ulcers) St Johns wort (Hypericum perforatum) (used to treat mild depression). Taking Lansoprazole Capsules with food and drink For the best results from your medicines you should take Lansoprazole at least 30 minutes before food.
Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Lansoprazole Capsules are and what they are used for 2. Before you take Lansoprazole Capsules 3. How to take Lansoprazole Capsules 4. Possible side effects 5. How to store Lansoprazole Capsules 6. Further information
1
Pharma code 524
Pregnancy and breast-feeding If you are pregnant, breast-feeding or if there is a chance you might be pregnant ask your doctor for advice before WHAT LANSOPRAZOLE CAPSULES ARE AND WHAT taking this medicine.
THEY ARE USED FOR
The active ingredient in Lansoprazole is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Lansoprazole for the following indications: Treatment of duodenal and stomach ulcer Treatment of inflammation in your oesophagus (reflux oesophagitis) Prevention of reflux oesophagitis Treatment of heartburn and acid regurgitation Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation) Treatment of Zollinger-Ellison syndrome. Your doctor may have prescribed Lansoprazole for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctors instructions for taking your medicine.
Driving and using machines Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Lansoprazole. If you experience side effects like these you should take caution as your ability to react may be decreased. You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines. Descriptions of these effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything. Important information about some of the ingredients of Lansoprazole Capsules Lansoprazole contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
2
BEFORE YOU TAKE LANSOPRAZOLE CAPSULES
Do not take Lansoprazole if you are: allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansoprazole taking a medicine containing the active substance atazanavir (used in the treatment of HIV). Take special care with Lansoprazole Capsules Please tell your doctor if you have serious liver disease. The doctor may have to adjust your dosage. Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as Lansoprazole has been associated with a small increase in infectious diarrhoea. If your doctor has given you Lansoprazole in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully. Taking a proton pump inhibitor like Lansoprazole Capsules, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
3
HOW TO TAKE LANSOPRAZOLE CAPSULES
Swallow the capsule whole with a glass of water. If you find the capsules difficult to swallow your doctor may advise on alternative ways to take your medicine. Do not crush or chew these capsules or the content of an emptied capsule because this will stop them from working properly. If you are taking Lansoprazole once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole first thing in the morning. If you are taking Lansoprazole twice a day, you should have the first dose in the morning and the second dose in the evening. The dose of Lansoprazole depends on your condition. The usual doses of Lansoprazole for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last. Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule for 4 weeks. If symptoms persist you should report to your doctor. If your symptoms are not relieved within 4 weeks, please contact your doctor. Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks. Treatment of stomach ulcer: one 30 mg capsule every day for 4 weeks.
If you take Lansoprazole on a long-term basis (longer than 1 Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks. year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor. Long-term prevention of reflux oesophagitis: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.
Ref:
231-30-69714-X LEA LANSOPRAZOLE A/S CAPS TUK
Version:
1
15 August 2012
PL Number(s), PL 00289/1358-9. Teva UK Ltd Licence. (Responsible Regulatory Dept = Post-licence Regulatory Team), MA Holder & Packer: MA Holder: TEVA UK Limited. Packed at TEVA UK Ltd, Eastbourne, Packing line: UHLMANN. Reason for revision: Version 1: Regulatory text updates from Reg. Affairs 15/05/12 12:23. V2: Remove personal details from Header Box.
PAGE 2: REAR FACE (OUTSIDE OF REEL)
Treatment of infection of Helicobacter pylori: The usual dose is breast swelling in males, impotence candidiasis (fungal infection, may affect skin or the one 30 mg capsule in combination with two different mucosa) antibiotics in the morning and one 30 mg capsule in angioedema; You should see your doctor immediately if combination with two different antibiotics in the evening. you experience symptoms of angioedema, such as swollen Treatment will usually be every day for 7 days. face, tongue or pharynx, difficulty to swallow, hives and The recommended combinations of antibiotics are: difficulties to breath. 30 mg Lansoprazole together with 250-500 mg The following side effects are very rare (occur in less than 1 clarithromycin and 1000 mg amoxicillin in 10000 patients): 30 mg Lansoprazole together with 250 mg clarithromycin severe hypersensitivity reactions including shock. and 400-500 mg metronidazole Symptoms of a hypersensitivity reaction may include If you are being treated for infection because you have an fever, rash, swelling and sometimes a fall in blood ulcer, it is unlikely that your ulcer will return if the infection is pressure successfully treated. To give your medicine the best chance of inflammation of your mouth (stomatitis) working, take it at the right time and do not miss a dose. colitis (bowel inflammation) changes in test values such as sodium, cholesterol and Treatment of duodenal or stomach ulcer in patients requiring triglyceride levels continued NSAID treatment: one 30 mg capsule every day for very severe skin reactions with reddening, blistering, 4 weeks. severe inflammation and skin loss. very rarely Lansoprazole may cause a reduction in the Prevention of duodenal or stomach ulcer in patients requiring number of white blood cells and your resistance to continued NSAID treatment: one 15 mg capsule every day, infection may be decreased. If you experience an infection your doctor may adjust your dose to one 30 mg capsule every with symptoms such as fever and serious deterioration of day. your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary Zollinger-Ellison syndrome: The usual dose is two 30 mg problems you should see your doctor immediately. A capsules every day to start with, then depending on how you blood test will be taken to check possible reduction of respond to Lansoprazole the dose that your doctor decides is white blood cells (agranulocytosis). best for you. Frequency not known If you are on Lansoprazole Capsules for more than three Lansoprazole should not be given to children. months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as Take your medicine exactly as your doctor has told you. You should check with your doctor if you are not sure how to take fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of your medicine. these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or If you take more Lansoprazole Capsules than you should calcium levels in the blood. Your doctor may decide to perform If you take more Lansoprazole than you have been told to, regular blood tests to monitor your levels of magnesium. seek medical advice quickly. If you forget to take Lansoprazole Capsules If you forget to take a dose, take it as soon as your remember unless it is nearly time for your next dose. If this happens skip the missed dose and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule. If you stop taking Lansoprazole Capsules Do not stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment. If you have any further questions on the use of this product, ask your doctor. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5
HOW TO STORE LANSOPRAZOLE CAPSULES
Keep out of the reach and sight of children. Store below 30C. Do not use Lansoprazole Capsules after the expiry date that is stated on the label and carton after EXP:. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
4
POSSIBLE SIDE EFFECTS
Like all medicines, Lansoprazole can cause side effects, although not everybody gets them. The following side effects are common (occur in more than 1 in 100 patients): headache, dizziness diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat skin rash, itching changes in liver function test values tiredness. The following side effects are uncommon (occur in less than 1 in 100 patients): depression joint or muscle pain fluid retention or swelling changes in blood cell counts. fracture of the hip, wrist or spine. The following side effects are rare (occur in less than 1 in 1000 patients): fever restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis) skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating sensitivity to light hair loss feelings of ants creeping over the skin (paraesthesia), trembling anaemia (paleness) kidney problems pancreatitis inflammation of the liver (may be seen as yellow skin or eyes)
6
FURTHER INFORMATION
What Lansoprazole Capsules contain The active substance is lansoprazole. The other ingredients are: sugar spheres (sucrose and maize starch), sodium starch glycolate (type A), sodium laurilsulfate (type A), povidone (K30), potassium oleate, oleic acid, hypromellose, methacrylic acid - ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (E171), talc, carrageenan, Potassium chloride and carnauba wax. The printing ink on the capsules contains the following additional ingredients: shellac (lacca), propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172). What Lansoprazole Capsules look like and contents of the pack Each hard, cellulose capsule has a white cap marked with the letter L and a white body marked with the numbers 15 or 30, depending on the product strength. The capsules contain white to beige gastro-resistant micropellets containing either 15 mg or 30 mg lansoprazole. Lansoprazole Capsules are supplied in Aluminium/Aluminium blisters of 7, 14, 28, 30, 56 and 98 capsules*. *Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom. This leaflet was last updated May 2012 PL 00289/1358-9
69714-X
25 mm.
Posicin de Laetus 6 LANSOPRAZOLE 15 mg and 30 mg GASTRO-RESISTANT CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
DIR. LECTURA
LAETUS
5 mm. DIR. LECTURA
5 mm.
25 mm.
PL Number(s), PL 00289/1358-9. (Responsible Regulatory Officer = Yogesh Toraskar), MA Holder & Packer: Packed at Zaragosa
Reason for revision: Version 1: Regulatory text updates - 15/05/12 12:23. V2: Removal of name from Header box (14/08/12 12:07)
231-30-11112-B LEA LANSOPRAZOLE A/S CAPS TUK
25 mm.
Pregnancy and breast-feeding If you are pregnant, breast-feeding or if The active ingredient in Lansoprazole there is a chance you might be is lansoprazole, which is a proton pregnant ask your doctor for advice pump inhibitor. Proton pump inhibitors before taking this medicine. reduce the amount of acid that your stomach makes. Driving and using machines Side effects such as dizziness, vertigo, Your doctor may prescribe tiredness and visual disturbances Lansoprazole for the following sometimes occur in patients taking indications: Lansoprazole. If you experience side Treatment of duodenal and stomach effects like these you should take ulcer caution as your ability to react may be Treatment of inflammation in your decreased. oesophagus (reflux oesophagitis) Prevention of reflux oesophagitis You alone are responsible to decide if Treatment of heartburn and acid you are in a fit condition to drive a regurgitation motor vehicle or perform other tasks Treatment of infections caused by that demand increased concentration. the bacteria Helicobacter pylori when Because of their effects or undesirable given in combination with antibiotic effects, one of the factors that can therapy reduce your ability to do these things Treatment or prevention of duodenal safely is your use of medicines. or stomach ulcer in patients Descriptions of these effects can be requiring continued NSAID found in other sections. treatment (NSAID treatment is used Read all the information in this leaflet against pain or inflammation) for guidance. Treatment of Zollinger-Ellison syndrome. Discuss with your doctor, nurse or pharmacist if you are unsure about Your doctor may have prescribed Lansoprazole for another indication or anything. with a dose different from that which is Important information about some of written in this information leaflet. the ingredients of Lansoprazole Please follow your doctors Capsules instructions for taking your medicine. Lansoprazole contains sucrose. If you have been told by your doctor that you BEFORE YOU TAKE 2 LANSOPRAZOLE CAPSULES have an intolerance to some sugars, contact your doctor before taking this medicine. Do not take Lansoprazole if you are: allergic (hypersensitive) to lansoprazole or any of the other 3 HOW TO TAKE LANSOPRAZOLE CAPSULES ingredients of Lansoprazole taking a medicine containing the active substance atazanavir (used in Swallow the capsule whole with a glass of water. If you find the capsules the treatment of HIV). difficult to swallow your doctor may advise on alternative ways to take your Take special care with Lansoprazole medicine. Do not crush or chew these Capsules capsules or the content of an emptied Please tell your doctor if you have capsule because this will stop them serious liver disease. The doctor may from working properly. have to adjust your dosage. Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as Lansoprazole has been associated with a small increase in infectious diarrhoea. If you are taking Lansoprazole once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole first thing in the morning. If you are taking Lansoprazole twice a day, you should have the first dose in the morning and the second dose in the evening. The dose of Lansoprazole depends on your condition. The usual doses of Lansoprazole for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.
DIR. LECTURA
In particular tell your doctor if you are taking medicines containing any of the Read all of this leaflet carefully before following active substances as you start taking this medicine. Lansoprazole may affect the way these Keep this leaflet. You may need to drugs work: read it again. ketoconazole, itraconazole, If you have any further questions, rifampicin (used to treat infections) ask your doctor or pharmacist. digoxin (used to treat heart This medicine has been prescribed problems) for you. Do not pass it on to others. It theophylline (used to treat asthma) may harm them, even if their tacrolimus (used to prevent symptoms are the same as yours. transplant rejection) If any of the side effects get serious, fluvoxamine (used to treat or if you notice any side effects not depression and other psychiatric listed in this leaflet, please tell your diseases) doctor or pharmacist. antacids (used to treat heartburn or acid regurgitation) IN THIS LEAFLET: sucralfate (used for healing ulcers) 1. What Lansoprazole Capsules are St Johns wort (Hypericum and what they are used for perforatum) (used to treat mild 2. Before you take Lansoprazole depression). Capsules 3. How to take Lansoprazole Capsules Taking Lansoprazole Capsules with 4. Possible side effects food and drink 5. How to store Lansoprazole Capsules For the best results from your 6. Further information medicines you should take Lansoprazole at least 30 minutes before food. 1 WHAT LANSOPRAZOLE LAETUS
Doble a 74 mm.
LAETUS
Doble a 114 mm.
CAPSULES ARE AND WHAT THEY ARE USED FOR
Doble a 154 mm.
14 August 2012
Version:
2
Ref:
If your doctor has given you Lansoprazole in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please Treatment of heartburn and acid also read the package leaflets of these regurgitation: one 15 mg or 30 mg capsule for 4 weeks. If symptoms medicines carefully. persist you should report to your doctor. If your symptoms are not Taking a proton pump inhibitor like Lansoprazole Capsules, especially over relieved within 4 weeks, please contact your doctor. a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor Treatment of duodenal ulcer: one 30 mg capsule every day for 2 weeks. if you have osteoporosis or if you are taking corticosteroids (which can Treatment of stomach ulcer: one 30 mg increase the risk of osteoporosis). capsule every day for 4 weeks. If you take Lansoprazole on a Treatment of inflammation in your long-term basis (longer than 1 year) oesophagus (reflux oesophagitis): one your doctor will probably keep you under regular surveillance. You should 30 mg capsule every day for 4 weeks. report any new and exceptional Long-term prevention of reflux symptoms and circumstances oesophagitis: one 15 mg capsule every whenever you see your doctor. day, your doctor may adjust your dose to one 30 mg capsule every day.
25 mm.
Cara A 140 x 470
DIR. LECTURA
LAETUS
DIR. LECTURA Pre-plegado a 235 mm.
LAETUS
DIR. LECTURA
LAETUS
25 mm.
Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. Treatment will usually be every day for 7 days. The recommended combinations of antibiotics are: 30 mg Lansoprazole together with 250-500 mg clarithromycin and 1000 mg amoxicillin 30 mg Lansoprazole together with 250 mg clarithromycin and 400-500 mg metronidazole If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated. To give your medicine the best chance of working, take it at the right time and do not miss a dose. Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 30 mg capsule every day for 4 weeks. Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.
The following side effects are very rare (occur in less than 1 in 10000 patients): severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure inflammation of your mouth (stomatitis) colitis (bowel inflammation) changes in test values such as sodium, cholesterol and triglyceride levels very severe skin reactions with reddening, blistering, severe inflammation and skin loss very rarely Lansoprazole may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).
DIR. LECTURA
LAETUS
Frequency not known If you are on Lansoprazole Capsules for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of Zollinger-Ellison syndrome: The usual magnesium can be seen as fatigue, dose is two 30 mg capsules every day involuntary muscle contractions, disorientation, convulsions, dizziness, to start with, then depending on how you respond to Lansoprazole the dose increased heart rate. If you get any of that your doctor decides is best for you. these symptoms, please tell your doctor promptly. Low levels of magnesium can Lansoprazole should not be given to also lead to a reduction in potassium or children. calcium levels in the blood. Your doctor may decide to perform regular blood Take your medicine exactly as your tests to monitor your levels of doctor has told you. You should check magnesium. with your doctor if you are not sure If any of the side effects become how to take your medicine. serious, or if you notice any side effects not listed in this leaflet, please If you take more Lansoprazole tell your doctor. Capsules than you should If you take more Lansoprazole than you have been told to, seek medical 5 HOW TO STORE CAPSULES LANSOPRAZOLE advice quickly. If you forget to take Lansoprazole Capsules If you forget to take a dose, take it as soon as your remember unless it is nearly time for your next dose. If this happens skip the missed dose and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule. If you stop taking Lansoprazole Capsules Do not stop treatment early because your symptoms have got better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment. If you have any further questions on the use of this product, ask your doctor. Keep out of the reach and sight of children. Store below 30C. Do not use Lansoprazole Capsules after the expiry date that is stated on the label and carton after EXP:. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Pre-plegado a 235 mm.
Version:
2
PL Number(s), PL 00289/1358-9. (Responsible Regulatory Officer = Yogesh Toraskar), MA Holder & Packer: Packed at Zaragosa
14 August 2012
Reason for revision: Version 1: Regulatory text updates - 15/05/12 12:23. V2: Removal of name from Header box (14/08/12 12:07)
231-30-11112-B LEA LANSOPRAZOLE A/S CAPS TUK
6
FURTHER INFORMATION
4
POSSIBLE SIDE EFFECTS
Like all medicines, Lansoprazole can cause side effects, although not everybody gets them. The following side effects are common (occur in more than 1 in 100 patients): headache, dizziness diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat skin rash, itching changes in liver function test values tiredness. The following side effects are uncommon (occur in less than 1 in 100 patients): depression joint or muscle pain fluid retention or swelling changes in blood cell counts. fracture of the hip, wrist or spine. The following side effects are rare (occur in less than 1 in 1000 patients): fever restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis) skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating sensitivity to light hair loss feelings of ants creeping over the skin (paraesthesia), trembling anaemia (paleness) kidney problems pancreatitis inflammation of the liver (may be seen as yellow skin or eyes) breast swelling in males, impotence candidiasis (fungal infection, may affect skin or the mucosa) angioedema; You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath.
25 mm.
What Lansoprazole Capsules contain The active substance is lansoprazole. The other ingredients are: sugar spheres (sucrose and maize starch), sodium starch glycolate (type A), sodium laurilsulfate (type A), povidone (K30), potassium oleate, oleic acid, hypromellose, methacrylic acid - ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (E171), talc, carrageenan, Potassium chloride and carnauba wax. The printing ink on the capsules contains the following additional ingredients: shellac (lacca), propylene glycol, ammonium hydroxide, potassium hydroxide, black iron oxide (E172). What Lansoprazole Capsules look like and contents of the pack Each hard, cellulose capsule has a white cap marked with the letter L and a white body marked with the numbers 15 or 30, depending on the product strength. The capsules contain white to beige gastro-resistant micropellets containing either 15 mg or 30 mg lansoprazole. Lansoprazole Capsules are supplied in Aluminium/Aluminium blisters of 7, 14, 28, 30, 56 and 98 capsules*. *Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom. Manufacturer: Teva Pharma S.L.U. Poligono Industrial Malpica, calle C, Numero 4, 50016 Zaragoza, Spain Telephone: 00 34 976 57 17 84 Telefax: 00 34 976 57 26 63 This leaflet was last updated May 2012 PL 00289/1358-9
DIR. LECTURA
Ref:
000000000/P0
11112-B
Cara B 140 x 470
LAETUS
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
