15 mg, 30 mg orodispersible tablet
lansoprazole
What Lansoprazole SUN is and what it is used for
The active substance in Lansoprazole SUN 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 SUN for the following:
- treatment of ulcers in the stomach and duodenum
- treatment of inflammation of the esophagus ( reflux esophagitis )
- prevention of reflux oesophagitis
- 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 SUN may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 SUN
Do not take Lansoprazole SUN:
- if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Tell your doctor if you have severe liver disease. Your doctor may need to adjust your dose.
Your doctor may or may have done another test called an endoscopy to diagnose your disease and/or rule out malignancy.
If diarrhea occurs during treatment with Lansoprazole SUN, you should contact your doctor immediately, as Lansoprazole SUN has been associated with a slightly increased incidence of infectious diarrhea.
If your doctor has prescribed you Lansoprazole SUN in addition to other medicines intended 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.
Using proton pump inhibitors such as Lansoprazole SUN and especially if you use Lansoprazol SUN for more than one year may increase the risk of hip, wrist, or vertebral fractures. Tell your doctor if you have osteoporosis ( osteoporosis ) or if you use medicines called corticosteroids because they may increase the risk of osteoporosis.
If you are taking Lansoprazole SUN for a long time (longer than 1 year), your doctor will probably check you regularly. Report any new and unusual symptoms and details when you see your doctor.
Talk to your doctor before taking Lansoprazole SUN:
- you have low vitamin B12 levels or risk factors for low vitamin B12 levels and are on long-term treatment with Lansoprazole SUN. As with all antacids, medication with Lansoprazole SUN may reduce vitamin B12 uptake .
- you should undergo a specific blood test (chromogranin A).
- if you have ever had a skin reaction after treatment with a medicine similar to Lansoprazol SUN 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 SUN. Also remember to mention any other side effects , such as joint pain.
Other medicines and Lansoprazole SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking medicines that contain any of the following active substances, as Lansoprazole SUN may affect the way these medicines work:
- HIV – protease inhibitor atazanavir or nelfinavir (for the treatment of HIV )
- 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 cells )
- 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 SUN with food and drink
For best results with this medicine, you should take Lansoprazole SUN 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 for advice before using this medicine.
Driving and using machines
Side effects such as dizziness, fatigue, and visual disturbances sometimes occur in patients taking Lansoprazole SUN. If you get such side effects, 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, nurse, or pharmacist.
Lansoprazole SUN 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 SUN
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Place the tablet on the tongue and let it melt slowly. The tablet dissolves rapidly in the mouth and releases micro granules. Do not chew these but swallow the micro granules using a glass of water.
Your doctor may instruct you to take the tablet with a syringe if you have severe difficulty swallowing.
The following instructions should be followed if the tablet is to be given with a dosing syringe.
The suitability of the selected syringe must be carefully tested.
- Remove the plunger from the syringe (at least one 5 ml syringe for the 15 mg tablet and 10 ml syringe for the 30 mg tablet).
- Place the tablet in the syringe.
- Put the plunger back in the syringe.
- For a 15 mg tablet: Drain 4 ml of tap water into the syringe.
- For 30 mg tablet: Draw 10 ml of tap water into the syringe.
- Turn the syringe over and draw 1 ml of air into it.
- Gently shake the syringe for 10-20 seconds until the tablet is dissolved.
- The contents can be emptied directly into the mouth.
- Refill the syringe with 2-5 ml of tap water to flush the remnants of the syringe into your mouth.
- Repeat the previous step if necessary.
If you are taking Lansoprazole SUN once a day, try to take the medicine at the same time each day. You can get the best results if you take Lansoprazole SUN immediately in the morning.
If you take Lansoprazole SUN twice a day, you should take the first dose in the morning and the second dose in the evening.
Dosing one of Lansoprazole SUN depends on your condition. Usual doses of Lansoprazole SUN 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: a 15 mg or 30 mg orodispersible tablet for 4 weeks. If symptoms persist, tell your doctor. If symptoms persist within 4 weeks, consult a physician.
Treatment of duodenal ulcers: one 30 mg orodispersible tablet every day for 2 weeks.
Treatment of ulcers in the stomach: one 30 mg orodispersible tablet every day for 4 weeks.
Treatment of inflammation of the esophagus ( reflux esophagitis ) a 30 mg orodispersible tablet every day for 4 weeks.
Long-term prevention of reflux oesophagitis: one 15 mg orodispersible tablet every day, the doctor may adjust the dose one to one 30 mg orodispersible tablet every day.
Treatment of infection of Helicobacter pylori: The recommended dose is one 30 mg orodispersible tablet in combination with two different antibiotics in the morning and one 30 mg orodispersible tablet 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 SUN with 250-500 mg clarithromycin and 1000 mg amoxicillin
- 30 mg Lansoprazole SUN 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 ulcer will return if the treatment of the infection is successful. For the medicine to work best, 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 orodispersible tablet every day for 4 weeks.
Prevention of ulcers in duodenum one or stomach of patients who require continued NSAID treatment: one 15 mg orodispersible tablet every day, the physician may adjust the dose of one to 30 mg orodispersible tablet every day.
Zollinger-Ellison Syndrome: The recommended dose is two 30 mg orodispersible tablets each day, to begin with, then depending on how you respond to Lansoprazole SUN, your doctor will decide which dose is best for you.
Use for children
Lansoprazole SUN should not be given to children.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are common (affects more than 1 patient in 100):
- headache, dizziness
- diarrhea, constipation, abdominal pain, nausea, vomiting, gas, dry mouth or mouth or throat pain
- rash, itching
- altered values from liver function tests
- fatigue
- benign polyps in the stomach.
The following side effects are uncommon (affects less than 1 in 100 people):
- Depression
- joint or muscle pain
- fluid retention or swelling
- changed number blood s
- risk of hip, wrist or vertebral fracture.
The following side effects are rare (affects less than 1 in 1,000 people):
- fever
- restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, dizziness
- taste changes, loss of appetite, inflammation of the tongue ( glossitis )
- skin reactions such as burning or stinging sensation under the skin, bruising, redness and excessive sweating
- photosensitivity
- hair loss
- ant crawling ( paresthesia ), trembling
- anemia (pallor)
- kidney problems
- pancreatitis
- hepatitis (may manifest as yellowing of the skin or eyes)
- breast swelling in men, impotence
- candida infection (fungal infection, may affect skin or mucous membranes)
- angioedema . 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 (affects less than 1 in 10,000 patients):
- severe hypersensitivity reaction including shock . Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a drop in blood pressure.
- inflammation of the mouth ( stomatitis )
- colitis ( inflammation of the intestine)
- altered test values such as sodium , cholesterol and triglyceride levels
- very severe skin reactions with redness , blistering, severe inflammation and skin waste
- In very rare cases, Lansoprazole SUN may cause a decrease in the number of white blood cells , which may reduce the risk of infection. If you get an infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection 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 ).
Occurs in an unknown number of users:
- If you use Lansoprazole SUN 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.
- skin rash, possibly with joint pain
- visual hallucinations
How to store Lansoprazole SUN
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 carton and blister after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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 pack and other information
Content declaration
- The active substance is lansoprazole.
- The other ingredients are sugar spheres (containing sucrose and maize starch), magnesium carbonate, hypromellose, polysorbate 80, macrogol 6000, triethyl citrate, talc, copolymer of methacrylic acid and ethyl acrylate, copolymer of methyl acrylate, methyl methacrylate, microcrystalline acrylic acrylate , tropical flavors, malic acid , magnesium stearate.
What the medicine looks like and contents of the pack
Lansoprazole SUN 15 mg: Smooth, round, whitish tablets with microgranular spots.
Lansoprazole SUN 30 mg: Smooth, round, whitish tablets with microgranular spots.
Lansoprazole SUN 15 mg and 30 mg are available in packs of 14, 28, 56, or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
SUN Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH, Hoofddorp
Netherlands
Manufacturer
Laboratorios SALVAT, SA
Gall 30-36 – 08950
Llobregat jobs
Barcelona
Spain
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH, Hoofddorp
Netherlands