Lansoprazole 30 Mg Gastro-Resistant Capsules
LANSOPRAZOLE 15 mg GASTRO-RESISTANT CAPSULES, HARD LANSOPRAZOLE 30 mg GASTRO-RESISTANT CAPSULES, HARD Lansoprazole
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
IN THIS LEAFLET:
1. What Lansoprazole is and what it is used for
2. Before you take Lansoprazole
3. How to take Lansoprazole
4. Possible side effects
5. How to store Lansoprazole
6. Contents of the pack and other information
OWHAT LANSOPRAZOLE IS AND WHAT IT IS 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 doctor's instructions for taking your medicine.
BEFORE YOU TAKE LANSOPRAZOLE
Do not take Lansoprazole:
• if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansoprazole
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).
Warnings and precautions
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.
If you take Lansoprazole 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.
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).
Other medicines and Lansoprazole
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 John's wort (Hypericum perforatum) (used to treat mild depression).
Taking Lansoprazole with food and drink and alcohol
For the best results from your medicines you should take Lansoprazole at least 30 minutes before food.
Pregnancy and breast-feeding and fertility
If you are pregnant, breast-feeding or if there is a chance you might be pregnant ask your doctor for advice before taking this 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
Lansoprazole contains sucrose
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.
HOW TO TAKE LANSOPRAZOLE
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
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 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.
Zollinger-Ellison syndrome: The usual dose is two 30 mg capsules every day to start with, then depending on how you respond to Lansoprazole the dose that your doctor decides is best for you.
Lansoprazole should not be given to children.
Take your medicine exactly as your doctor has told you. You should check with your doctor if you are not sure how to take your medicine.
If you take more Lansoprazole than prescribed
If you take more Lansoprazole than you have been told to, seek medical advice quickly.
If you forget to take Lansoprazole
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 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
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.
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
• feeling or being sick, diarrhoea, stomach pains, constipation, wind, dry or sore mouth or throat
• changes in liver function test values
• skin rash, itching
• tiredness.
The following side effects are uncommon (occur in less than 1 in 100 patients):
• changes in blood cell counts
• depression
• joint or muscle pain, fracture of the hip, wrist or spine
• fluid retention or swelling.
The following side effects are rare (occur in less than 1 in 1000 patients):
• anaemia (paleness)
• insomnia, hallucinations, confusion
• restlessness, vertigo, feelings of ants creeping over the skin (paresthesiae), drowsiness, trembling
• visual disturbances
• inflammation of your tongue (glossitis), candidiasis (fungal infection, may affect skin or the mucosa), pancreatitis, a change in the way things taste
• inflammation of the liver (may be seen as yellow skin or eyes)
• skin reactions such as burning or pricking feeling under the skin, bruising, reddening, hair loss, sensitivity to light
• kidney problems
• breast swelling in males
• fever, excessive sweating, angiodema, loss of appetite, impotence; 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):
• 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)
• colitis (bowel inflammation), inflammation of your mouth (stomatitis)
• very severe skin reactions with reddening, blistering, severe inflammation and skin loss
• severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
• changes in test values such as sodium, cholesterol and triglyceride levels.
The occurrence of the following side effects is not known (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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
HOW TO STORE LANSOPRAZOLE
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 label carton bottle packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package. Keep the container (bottle) tightly closed, in order to protect from moisture.
Use the contents within 3 months of opening the container.
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.
©CONTENTS OF THE PACK AND OTHER INFORMATION
What Lansoprazole contains
• The active substance is lansoprazole.
Each capsule contains 15 milligram or 30 milligram of lansoprazole.
• The capsules also contain sugar granules (sucrose, maize starch), povidone, disodium hydrogen phosphate dihydrate, sodium laurylsulphate, methacrylic acid -ethyl acrylate copolymer (1:1) dispersion 30 per cent, talc, macrogol, titanium dioxide (E 171), polysorbate 80.
Capsule shell: gelatin, titanium dioxide (E171). The 15 mg capsule also contains red iron oxide (E172).
What Lansoprazole looks like and contents of the pack
Capsules 15 mg: white/red-brownish gelatine capsule containing white or light brown or lightly pink enteric-coated pellets.
Capsules 30 mg: white gelatine capsule containing white, light brown or lightly pink enteric-coated pellets.
Pack sizes:
A plastic container of 14, 28, 56 and 98 capsules. Containers for 14, 28 or 56 capsules contain a desiccant. The container for 98 capsules contains two desiccants.
Boxes of 7, 14, 28, 49, 56 and 98 capsules in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d, Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
This leaflet was last approved in 07/2011
85779-V
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TEVA UK LIMITED FP1872E