15 mg and 30 mg enteric capsules, hard
lansoprazole
What Lansoprazole Krka is and what it is used for
The active substance in Lansoprazole Krka is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid produced in the stomach.
Your doctor may prescribe Lansoprazole Krka for the following indications in adults:
- treatment of ulcers in the stomach and duodenum
- treatment of inflammation of the esophagus ( reflux esophagitis )
- prevention of reflux esophagitis ( inflammation of the esophagus)
- treatment of heartburn and acid reflux
- treatment of infection is caused by the bacterium Helicobacter pylori when given in combination with antibiotic treatment
- treatment or prevention of ulcers in the stomach or duodenum in patients requiring continued NSAID therapy ( NSAID therapy is used for pain or inflammation )
- treatment of Zollinger-Ellison syndrome.
Lansoprazole contained in Lansoprazole Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
What you need to know before you use Lansoprazole Krka
Do not use Lansoprazole Krka
- if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Lansoprazole Krka.
Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.
Talk to your doctor before taking Lansoprazole Krka if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole Krka that reduces stomach acid.
If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop taking Lansoprazole Krka. Also remember to mention any other side effects, such as joint pain.
Your doctor may or may have done another test called an endoscopy to diagnose your disease and/or rule out malignant disease.
If diarrhea occurs during treatment with Lansoprazole Krka, you should contact your doctor immediately, as Lansoprazole Krka has been associated with a slightly increased incidence of infectious diarrhea.
If your doctor has prescribed you Lansoprazole Krka with other medicines for the treatment of Helicobacter pylori – infection ( antibiotics ) or together with anti-inflammatory drugs for the treatment of pain or rheumatic disease: please also read the package leaflets of these medicines carefully.
If you are taking Lansoprazole Krka for a long time (longer than 1 year), your doctor will probably check you regularly. You should report any new and unusual symptoms and details when you see your doctor.
Use of proton pump inhibitors such as Lansoprazole Krka and especially if you use Lansoprazole Krka for more than a year may increase the risk of having a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.
Talk to your doctor before taking this medicine if you are going to have a specific type of blood test (chromogranin A).
Talk to your doctor before taking lansoprazole if you have low levels of vitamin B12 or risk factors for low vitamin B12 levels and are on long-term treatment with lansoprazole. As with all antacids, lansoprazole may reduce vitamin B12 uptake.
Other medicines and Lansoprazole Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking medicines that contain any of the following active substances, as Lansoprazole Krka may affect the way these medicines work:
- HIV – protease inhibitors such as
- methotrexate (used to treat autoimmune diseases and cancer)
- ketoconazole , itraconazole, rifampicin (used to treat infections )
- digoxin (used to treat heart problems)
- warfarin (used to treat blood clots)
- theophylline (used to treat asthma )
- tacrolimus (used to prevent transplant rejection )
- fluvoxamine (used to treat depression and other psychiatric disorders)
- antacids (antacids used to treat heartburn or acid reflux)
- sucralfate (used to heal stomach ulcers )
- St. John’s wort ( Hypericum perforatum ) (used to treat mild depression)
Lansoprazole Krka with food, drink and alcohol
For best results with this medicine, you should take Lansoprazole Krka at least 30 minutes before eating.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Side effects such as dizziness, dizziness, fatigue, and visual disturbances sometimes occur in patients taking Lansoprazole Krka. If you get such side effects, you should be careful, as your ability to react may be impaired.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance.
If you are not sure, talk to your doctor or pharmacist.
Lansoprazole Krka contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free.
How to use Lansoprazole Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Swallow the capsule whole with a glass of water. If you find it difficult to swallow the capsules, your doctor may advise you on other ways to take the medicine. Do not crush or chew these capsules or the contents of an emptied capsule, as this will prevent them from working properly.
If you are taking Lansoprazole Krka once a day, try to take the medicine at the same time each day. For best results, take Lansoprazole Krka immediately in the morning.
If you are taking Lansoprazole Krka twice a day, you should take the first dose one in the morning and the second dose one in the evening.
The dose of Lansoprazole Krka depends on your condition. Usual doses of Lansoprazole Krka for adults are listed below. Your doctor will sometimes prescribe a different dose and will tell you how long your treatment should last.
Treatment of heartburn and acid reflux: one 15 mg or 30 mg capsule daily for 4 weeks. If symptoms persist, tell your doctor. If symptoms do not resolve within 4 weeks, consult a physician.
Treatment of duodenal ulcers: one 30 mg capsule daily for 2 weeks.
Treatment of ulcers in the stomach: one 30 mg capsule daily for 4 weeks.
Treatment of inflammation of the esophagus ( reflux esophagitis ) a 30 mg capsule daily for 4 weeks.
Long-term prevention of reflux oesophagitis: one 15 mg capsule daily, the doctor may adjust the dose to one 30 mg capsule daily.
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. The treatment usually lasts every day for 7 days.
Recommended combinations of antibiotics are:
- 30 mg Lansoprazole Krka with 250-500 mg clarithromycin and 1000 mg amoxicillin
- 30 mg Lansoprazole Krka together with 250 mg clarithromycin and 400-500 mg metronidazole.
If you are being treated for infection because you have a stomach ulcer, it is unlikely that the stomach ulcer will return if the treatment of the infection is successful. For the medicine to have the best possible effect, you should take it at the right time and not miss a dose.
Treatment of ulcers in duodenum one or stomach of patients who require continued NSAID treatment: one 30 mg capsule every day for 4 weeks.
Prevention of ulcers in duodenum one or stomach of patients who require continued NSAID treatment: one 15 mg capsule every day, the physician may adjust the dose of one to one 30 mg capsule every day.
Zollinger-Ellison syndrome: The usual dose is two 30 mg capsules each day, to begin with, then depending on how you respond to Lansoprazole Krka, your doctor will decide which dose is best for you.
Use for children and adolescents
Lansoprazole Krka should not be given to children.
If you use more Lansoprazole Krka than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) by mistake for assessment of the risk and advice.
If you forget to use Lansoprazole Krka
If you forget to take a dose, take it as soon as you remember unless it is time to take the next dose. If this happens, skip the missed dose and take the other capsules as usual. Do not take a double dose to make up for a forgotten capsule.
If you stop using Lansoprazole Krka
Do not stop treatment prematurely if your symptoms have improved. You may not be fully recovered and the disease may return if you do not complete the course of treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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
- nausea, vomiting, diarrhea, abdominal pain, constipation, nausea, vomiting, gas, dry mouth or sore throat, benign polyps in the stomach
- altered values from liver function tests
- rash, itching
- fatigue
The following side effects are uncommon (may affect up to 1 in 100 people):
- changed number blood s
- Depression
- joint or muscle pain, hip, wrist or vertebral fractures
- fluid retention or swelling
The following side effects are rare (may affect up to 1 in 1,000 people):
- anemia (pallor)
- insomnia, hallucinations, confusion
- restlessness, dizziness, ant crawling ( paresthesia ), drowsiness, trembling
- visual disturbances
- inflammation of the tongue ( glossitis ) candida infection (fungal infection, can affect skin or mucous membranes), pancreatitis, taste changes
- hepatitis (may manifest as yellowing of the skin or eyes)
- skin reactions such as burning or stinging sensation under the skin, bruising, redness , hair loss, photosensitivity
- kidney problems
- breast swelling in men
- fever, excessive sweating, angioedema , loss of appetite, impotence; You should see a doctor immediately if you get symptoms of angioedema , such as swollen face, tongue or throat, difficulty swallowing, hives and difficulty breathing.
The following side effects are very rare (may affect up to 1 in 10,000 people):
- In very rare cases, Lansoprazole Krka may cause a decrease in the number of white blood cells so that the defense of the infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat / throat / mouth or difficulty urinating, you should see a doctor immediately. A blood sample will be taken to check if the number of white blood cells has decreased ( agranulocytosis ).
- colitis ( inflammation of the intestines), inflammation of the mouth ( stomatitis )
- very severe skin reactions with redness , blistering, severe inflammation and skin waste
- severe hypersensitivity reaction including shock . Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a drop in blood pressure.
- altered test values such as sodium , cholesterol and triglyceride levels
The following side effects have been reported (affects an unknown number of users):
- if you use lansoprazole for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
- visual hallucinations.
- skin rash, possibly with joint pain.
How to store Lansoprazole Krka
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 can, blister, and carton. The expiration date is the last day of the specified month.
Store in the original package. Do not store above 25 ° C. Close the package (jar) tightly. Moisture sensitive.
The shelf life of broken packaging is 3 months.
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.
Contents of the package and other information
Content declaration
- The active substance is lansoprazole.
- Each capsule contains 15 mg or 30 mg of lansoprazole.
- The other ingredients are sugar spheres (sucrose and maize starch), povidone, disodium hydrogen phosphate dihydrate, sodium lauryl sulphate, methacrylic acid-ethyl acrylate copolymer (1: 1) -dispersion 30%, talc, macrogol, titanium dioxide (E171 oil) ), in 15 mg also red iron oxide (E172).See section 2 “Lansoprazole Krka contains sucrose and sodium”.
What the medicine looks like and contents of the pack
15 mg: White/red/brownish gelatin capsule, filled with white/light brown or pink enteric-coated granules.
30 mg: White gelatin capsule, filled with white/light brown or pink enteric-coated granules.
Pack sizes:
A plastic jar with 14, 28, 56, and 98 capsules. Jars with 14, 28, or 56 capsules contain a drying capsule. The 98 container contains two drying capsules.
Cartons of 7, 14, 28, 49, 56, and 98 capsules in blister packs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
KRKA dd Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia