15 mg and 30 mg orodispersible tablets
lansoprazole
What Lanzo is and what it is used for
The active substance in Lanzo is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced in the stomach.
Your doctor may prescribe Lanzo for the following indications:
- 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 Lanzo 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 using Lanzo
Do not take Lanzo
- 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 malignant disease.
If diarrhea occurs during treatment with Lanzo, you should contact your doctor immediately, as Lanzo has been associated with a slightly increased incidence of infectious diarrhea.
In microscopic colitis, treatment with Lanzo should be discontinued.
If your doctor has prescribed you, Lanzo, in addition to other medicines intended for the treatment of infection with Helicobacter pylori ( 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.
The use of a proton pump inhibitor such as Lanzo, especially for more than one year, may increase the risk of fracture of the hip, wrist, or spine. Tell your doctor if you have osteoporosis (reduced bone density called osteoporosis ), or if your doctor has told you that you are at risk of developing osteoporosis (eg if you are taking corticosteroids.
If you are taking Lanzo 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.
Talk to your doctor before taking Lanzo:
- if you have low levels of vitamin B12 or risk factors for low levels of vitamin B12 and are on long-term treatment with Lanzo. As with all antacids, medication with Lanzo may lead to reduced vitamin B12 uptake .
- if you are going to have a specific blood test (chromogranin A)
- if you have ever had a skin reaction after treatment with a medicine similar to Lanzo 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 treatment with Lanzo. Also remember to mention any other side effects, such as joint pain.
Other drugs and Lanzo
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 Lanzo may affect the way these medicines work:
- HIV protease inhibitors such as atazanavir or nelfinavir (used to treat 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 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).
Lanzo with food, drink and alcohol
For best results with this medicine, you should take Lanzo 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 Lanzo. 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 attention. 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.
Lanzo contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Lanzo contains aspartame
One Lanzo 15 mg orodispersible tablet contains 4.5 mg of aspartame.
One Lanzo 30 mg orodispersible tablet contains 9.0 mg of aspartame.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
How to use Lanzo
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Place the tablet on the tongue and let it slowly melt. The tablet dissolves quickly in the mouth and releases micro granules grains, which you should swallow without chewing. You can also swallow the tablet whole with 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 administration is by syringe:
The suitability of the selected syringe must be carefully tested.
- Remove the plunger from the syringe (at least 5 ml syringe for 15 mg tablet and 10 ml syringe for 30 mg tablet)
- Place the tablet in the syringe barrel
- 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 upside down and also 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 residue out of the syringe into the mouth.
If you are taking Lanzo once a day, try to take the medicine at the same time each day. You can get the best results if you take Lanzo immediately in the morning.
If you take Lanzo twice a day, you should take the first dose one in the morning and the second dose one in the evening.
Dose one of Lanzo depends on your condition. The usual dose of Lanzo for adults is given 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): one 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 with Helicobacter pylori: the usual 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 Lanzo together with 250-500 mg clarithromycin and 1,000 mg amoxicillin.
- 30 mg Lanzo 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 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 usual dose is two 30 mg orodispersible tablets each day, to begin with, then depending on how you respond to Lanzo, your doctor will decide which dose is best for you.
Use for children
Lanzo should not be given to children.
If you take more Lanzo than you should
If you forget to take Lanzo
If you forget to take a dose, take it as soon as you remember unless it is time to take your next dose. If this happens, skip the missed dose and take the other orodispersible tablets as usual. Do not take a double dose to make up for a forgotten mouth-watering tablet.
If you stop taking Lanzo
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.
Common side effects are (may affect up to 1 in 10):
- 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.
Less common side effects are (may affect up to 1 in 100):
- Depression
- joint or muscle pain
- fluid retention or swelling
- altered blood cell count .
Rare side effects are (may affect up to 1 in 1000 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.
Very rare side effects are (may affect up to 1 in 10 000 users):
- 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, Lanzo can 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 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 ).
Has been reported (occurs in an unknown number of users):
- if you take Lanzo for more than three months, it is possible that the levels of magnesium in your blood may decrease. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, confusion, cramps, dizziness and increased heart rate. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide that regular blood tests are needed to check your magnesium levels .
- kutan lupus erythematosus
- skin rash, possibly with joint pain
- visual hallucinations
How to store Lanzo
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
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 15 mg or 30 mg.
Other ingredients are:
lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, titanium dioxide (E 171), talc, mannitol, methacrylic acid ethyl acrylate copolymer (1: 1) dispersion 30%, polyacrylate dispersion 30%, macrogol Monate, poly color Monate anhydrous citric acid, crospovidone, magnesium stearate, aspartame (E 951) (see section 2 “Lanzo contains aspartame”), strawberry flavor, red iron oxide (E 172) and yellow iron oxide (E 172).
What the medicine looks like and contents of the pack
Lanzo 15 mg and 30 mg are white to yellow-white orodispersible tablets. Each orodispersible tablet contains orange to dark brown dots, which consist of microencapsulated enteric granules. Lanzo 15 mg is labeled “15” on one side of the tablet and Lanzo 30 mg is labeled “30”.
Mouthwash tablets 15 mg and 30 mg: 7, 14, 28, 56, or 98 tablets in aluminum blister packs
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Pfizer AB
191 90 Sollentuna
Tel: 08 – 550 520 00
Email: eumedinfo@pfizer.com