Lansoprazole 30mg Gastro-Resistant Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. 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. See section 4
What is in this leaflet: j What Lansoprazole Capsules are and what they are used for
What you need to know before you take Lansoprazole Capsules
How to take Lansoprazole Capsules
4 Possible side effects How to store Lansoprazole Capsules
q Contents of the pack and other information
J 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 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 doctor's instructions for taking your medicine.
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 severe or persistent 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.
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).
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.
Children
Lansoprazole Capsules should not be given to children.
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:
• atazanavir (used in treatment of HIV) (see 'Do not take Lansoprazole')
• 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 (Hypericum perforatum) (used to treat mild depression)
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 breastfeeding. 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 breastfeeding 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.
How to take Lansoprazole Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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.
For the best results from your medicine you should take Lansoprazole Capsules at least 30 minutes before food.
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 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.
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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 Lansoprazole together with 250-500mg clarithromycin and 1000mg amoxicillin
• 30mg Lansoprazole together with 250mg clarithromycin and 400500mg 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.
Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15mg capsule every day, your doctor may adjust your dose to one 30mg 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 Lansoprazole Capsules the dose that your doctor decides is best for you.
Use in children
Lansoprazole Capsules should not be given to children.
If you take more Lansoprazole Capsules than you should
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 (may affect up to 1 in 10 people):
• 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 (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1,000 people):
• 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 (may affect up to 1 in 10,000 people):
• 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. (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• 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).
Frequency 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, 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
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 store above 25°C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no 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 15mg also contains: Quinoline yellow (E104)
What Lansoprazole Capsules look like and contents of the pack
15 mg gastro-resistant capsules, hard: opaque yellow cap and body capsules. Each capsule contains white or almost white spherical microgranules.
30 mg gastro-resistant capsules, hard: opaque white cap and body capsules. Each capsule contains white or almost white spherical microgranules.
Lansoprazole Capsules are available in blister packs containing 7, 14, 28, 56 or 98 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Manufacturer
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo,
19200 Azuqueca de Henares (Guadalajara),
Spain
This leaflet was last revised in September 2015
If you would like a leaflet with larger % text, please contact 01271 385257.
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Actavis
Actavis, Barnstaple, EX32 8NS, UK