Lansoprazole 15mg Gastro-Resistant Capsules
Lansoprazole 15mg and 30mg Gastro-resistant Capsules
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, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Index:
1. What Lansoprazole Capsules are and what they are used for
2. What you need to know before you take Lansoprazole Capsules
3. How to take Lansoprazole Capsules
4. Possible side effects
5. How to store Lansoprazole Capsules
6. Contents of the pack and other information
1. What Lansoprazole Capsules are and what they are used for
The active ingredient in Lansoprazole 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 Lansoprazole 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 diarrhoea and pain in the stomach).
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 doctor’s instructions for taking your medicine.
2. What you need to know before you take Lansoprazole capsules Do not take Lansoprazole:
• if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6)
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking 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 Capsules 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.
If you take Lansoprazole Capsules on a long-term basis (longer than 1 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.
Talk to your doctor before taking Lansoprazole Capsules if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Capsules that reduces stomach acid.
If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Lansoprazole Capsules. Remember to also mention any other ill-effects like pain in your joints.
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).
Tell your doctor before taking this medicine if you are due to have a specific blood test (Chromogranin A).
Other medicines and Lansoprazole Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 John's wort (Hypericumperforatum) (used to treat mild depression)
Lansoprazole Capsules with food
For the best results from your medicines you should take Lansoprazole Capsules at least 30 minutes before food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Use of Lansoprazole Capsules is not recommended during pregnancy, as there is no adequate experience on the use of lansoprazole during pregnancy.
There is insufficient experience with use of lansoprazole during breast-feeding. Based on the results of animal studies, it is thought that lansoprazole crosses into the breast milk.
When making a decision as to whether breast-feeding or therapy with lansoprazole should be continued or discontinued, your treating physician will consider the benefits of breast-feeding for your child and the benefits of therapy with Lansoprazole for you.
Driving and using machines
Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking Lansoprazole Capsules. 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.
Lansoprazole Capsules contain sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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 Capsules 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 Capsules twice a day, you should have the first dose in the morning and the second dose in the evening.
The dose of Lansoprazole Capsules depends on your condition. The recommended doses of Lansoprazole 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 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
Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks
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.
Treatment of infection of Helicobacter pylori: The recommended 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.
Zollinger-Ellison syndrome: The recommended dose is two 30 mg capsules every day to start with, then depending on how you respond to Lansoprazole Capsules the dose that your doctor decides is best for you.
Use in children
Lansoprazole 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 Lansoprazole Capsules than prescribed
If you take more Lansoprazole 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 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 medicine, ask your doctor, pharmacist or nurse.
4. Possible Side Effects
Like all medicines, this medicine 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 (paresthesiae), 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.
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).
The following side effect are frequency not known:
• 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, disorentation, 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.
• rash, possibly with pain in the joints.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
5. How to store Lansoprazole Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Lansoprazole Capsules contain
• The active substance is lansoprazole
• The other ingredients are:
Capsule content: Sugar spheres (sucrose and maize starch), Sodium laurilsulphate, Meglumine, Mannitol (E421), Hypromellose, Macrogol, Talc, Polysorbate 80, Titanium dioxide (E171), Methacrylic Acid-Ethyl Acrylate Copolymer (1:1), Dispersion 30%
Capsule shell: Gelatin, Titanium dioxide (E171)
Capsule shell of 15 mg also contains: Quinoline yellow (E104)
What Lansoprazole Capsules look like and contents of the pack
Lansoprazole 15mg Gastro-resistant capsules are hard, white/ red-brownish gelatine capsules. The capsules are filled with white or light brown or lightly pink enteric-coated pellets.
Lansoprazole 30mg Gastro-resistant capsules are hard, white gelatin capsules. The capsules are filled with white or light brown or lightly pink enteric-coated pellets.
Pack sizes are 28 capsules.
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
This leaflet was last revised in November 2016