The name of your medicine is Peptazol 30mg enteric coated pellets filled in capsules. The active ingredient in Peptazol capsules is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes. Your doctor may prescribe Peptazol for the following indications: • Treatment of duodenal (gut) and stomach ulcers • Treatment or prevention of reflux oesophagitis (acid from the stomach escapes into the food pipe causing damage and inflammation) • Treatment of heartburn and acid regurgitation (too much acid in your stomach) • Treat an infection caused by Helicobacter pylori. This is a bacterial infection which can cause inflammation of the stomach and can also cause ulcers. Treating Helicobacter pylori infection helps to heal these conditions and prevent them from returning. • Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used to relieve pain or inflammation) • Treatment of Zollinger-Ellison syndrome (where the stomach makes large amounts of acid. This can lead to diarrhea and pain in the stomach). Your doctor may have prescribed Peptazol for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctor`s instructions for taking your medicine

Do not take lansoprazole and tell your doctor if: • You are allergic (hypersensitive) to lansoprazole or any of the other ingredients of these capsules (listed in section 6: Further Information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You are taking a medicine containing atazanavir (used to treat HIV). Do not take lansoprazole if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist. Special warnings and precautions: Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping this medication. SCLE after previous treatment with proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Take special care and check with your doctor before taking lansoprazole if: • You have liver problems your doctor may want to adjust your dose. • Your doctor may arrange for you to have an endoscopic examination (where a very small camera is inserted down your oesophagus (food pipe) to look into your stomach). This will help find out what is causing your symptoms. It can help to exclude more serious causes of your symptoms such as stomach cancer. • If you take lansoprazole on a long-term basis (longer than 1 year) your doctor will probably ask to see you regularly so he can check how well you are doing. Tell your doctor if you notice any new symptoms or if any of your symptoms are getting worse. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking lansoprazole. Do this even if they applied only in the past. Taking a proton pump inhibitor like lansoprazole, 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). Taking Peptazol with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because lansoprazole can affect the way some other medicines work. Also, some medicines can affect on the way lansoprazole works. In particular, check with your doctor or pharmacist if you are taking any of the following medicines: • 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 problems). • Antacids (used to treat heartburn or acid regurgitation). • Sucralfate (used for healing ulcers). • St John’s wort sometimes called Hypericum perforatum (used to treat mild depression). If you are not sure, talk to your doctor or pharmacist before taking lansoprazole. Taking Peptazol with food and drink You should take lansoprazole at least 30 minutes before food. Pregnancy and breast-feeding Talk to your doctor before taking lansoprazole if: • You are pregnant, think you may be pregnant or are planning to get pregnant. • You are breast-feeding. Driving and using machines You may feel dizzy, tired, sick, have a headache or problems with your eyesight while taking lansoprazole. If this happens, do not drive or use any tools or machines

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 Peptazol capsules twice a day, you should have the first dose in the morning and the second dose in the evening. The dose of Peptazol depends on your condition. The recommended doses of Peptazol capsules 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 15mg or 30mg 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 30mg capsule every day for 2 weeks Treatment of stomach ulcer: one 30mg capsule every day for 4 weeks Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30mg capsule every day for 4 weeks. Long term prevention of reflux oesophagitis: one 15mg capsule every day, your doctor may adjust your dose to one 30mg capsule every day. Treatment of infection of Helicobacter Pylori: the recommended dose is one 30mg capsule in combination with two different antibiotics in the morning and one 30mg 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: • 30mg Peptazol together with 250-500 mg clarithromycin and 1000 mg amoxicillin • 30mg Peptazol 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 30mg capsule every day for 4 weeks. Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day. Zollinger-Ellison syndrome: the recommended dose is two 30mg capsules every day to start with, then depending on how you respond to Peptazol capsules the dose that your doctor decides is best for you. Use in children Peptazol capsules should not be given to children. Always take this medicine exactly as your doctor or pharmacist has told you, check with your doctor or pharmacist if you are not sure. If you take more Peptazol capsules than prescribed If you take more Peptazol capsules than you have been told to, seek medical advice quickly. Contact your nearest casualty department or tell your doctor or pharmacist at once. If you forget to take Peptazol Capsules If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. If this happens skip the missed doss and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule. If you stop taking Peptazol 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 medicine, ask your doctor, pharmacist or nurse.

Like all medicines, Peptazol enteric coated pellets filled in capsules can cause side effects, although not everybody gets them. Stop taking lansoprazole and see a doctor or go to a hospital straightaway if: • You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Peptazol enteric coated pellets filled in capsules. • You have blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and a high temperature. These could be signs of something called Stevens-Johnson syndrome. • You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. These could be signs of toxic epidermal necrolysis. • You get symptoms such as: yellowing of your skin or whites of your eyes, tiredness and fever. This may be due to inflammation of the liver or changes in the way your liver is working While these are serious side effects that require urgent medical attention, they are all rare or very rare (affect less than 1 in 1000 people). Tell your doctor as soon as possible if: • You get long lasting diarrhoea and keep being sick. This can happen because lansoprazole lowers the natural acid in your stomach which would normally help to kill the bacteria there. This, in turn, can lead to stomach infections. • You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis. • You have difficulty in passing water (urine) or you notice blood in your urine. This may be due to kidney problems or changes in the way your kidneys are working. • You bruise more easily than usual or you get more infections than usual. This could be due to a blood problem. Your doctor may want to carry out a blood test. The above side effects are all rare or very rare (affect less than 1 in 1000 people). If any of the following side effects gets serious or lasts longer than a few days, tell your doctor or pharmacist: Common (affects less than 1 in 10 people) • Headaches, feeling dizzy or tired, or a general feeling of being unwell. • Diarrhea, constipation, stomach pains, feeling sick (nausea) or being sick (vomiting), wind. • Dry or sore mouth or throat. • Skin rash, itching. • Changes in the way your liver is working (shown by a blood test). Uncommon (affects less than 1 in 100 people) • Low mood (depression). • Joint or muscle pain. • Water retention which may cause swollen arms or legs. • Fracture of the hip, wrist or spine (if lansoprazole is used in high doses and over a long period of time). Rare (affects less than 1 in 1000 people) • Fever. • Feeling restless, drowsy or confused. • Seeing or hearing things which are not there (hallucinations). • Numbness, tingling, pricking, burning or creeping on the skin (paraesthesia). • Difficulty sleeping (insomnia). • Problems with your vision. • Feeling dizzy, possibly with a “spinning” feeling (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, red or purple spots which may be itchy or blister. • Excessive sweating. • Being more sensitive to the sun than usual. • Hair loss (alopecia). • Trembling. • Feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia. • Swelling of the breasts in men, being unable to get or keep an erection (impotence). • Candidiasis fungal infection, such as thrush, which may affect your oesophagus (food pipe). Very rare (affects less than 1 in 10,000 people) • Inflammation of your mouth (stomatitis). • Colitis (bowel inflammation). • Changes in test values such as sodium, cholesterol and triglyceride levels. Not known (frequency cannot be estimated from the available data) • If you are on lansoprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium. • Possible increased risk of clostridium difficile –associated diarrhea (CDAD) with proton pump inhibitor use especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. CDAD has been reported with use of nearly all antibacterial agents. If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children. Do not use Peptazol after the expiry date, which is stated on the carton after “EXP”. Do not store above 30°C.