15 mg and 30 mg orodispersible tablets, respectively
lansoprazole
What Lansoprazole Teva is and what it is used for
The active substance in Lansoprazole Teva 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 Teva for the following indications in adults:
- treatment of duodenal and gastric ulcers
- 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 duodenal or gastric ulcer in patients requiring continued NSAID therapy ( NSAID therapy is used for pain or inflammation )
- treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Lansoprazole Teva for a different use or at a different dose than the one given in this leaflet. Always take this medicine exactly as your doctor has told you.
You must contact a doctor if you do not feel better or if you feel worse after 14 days.
Lansoprazole contained in Lansoprazole Teva 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.
What you need to know before you take Lansoprazole Teva
Do not take Lansoprazole Teva
- if you are allergic 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 Teva:
- if you have severe liver disease. Your doctor may need to adjust your dose .
- if you have low levels of vitamin B12 or risk factors for low levels of vitamin B12 and are on long-term treatment with Lansoprazol Teva. As with all antacids, treatment with Lansoprazol Teva 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 Lansoprazol Teva 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 Teva. 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 Lansoprazol Teva, you should contact your doctor immediately, as Lansoprazol Teva has been associated with a slightly increased incidence of infectious diarrhea.
- If your doctor has prescribed you Lansoprazole Teva 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.
The use of a proton pump inhibitor such as Lansoprazole Teva, especially for more than one year, may increase the risk of 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.
If you are taking Lansoprazole Teva 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.
If you are treated with Lansoprazole Teva for more than three months, the levels of magnesium in your blood may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness, increased heart rate. 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 decide to take regular blood tests to check the levels of magnesium in your blood.
Other medicines and Lansoprazole Teva
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 Teva 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)
- theophylline (used to treat asthma )
- warfarin (used to treat blood clots)
- tacrolimus (used to prevent transplant rejection )
- fluvoxamine (used to treat depression and other psychiatric disorders)
- 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 Teva with food and drink
For best results, take Lansoprazole Teva at least 30 minutes before a meal.
Pregnancy and breastfeeding
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. 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 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.
Lansoprazole Teva contains lactose, sucrose and aspartame.
Lansoprazole Teva contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Lansoprazole Teva 15 mg orodispersible tablets contain 6.5 mg of aspartame in each tablet.
Lansoprazole Teva 30 mg orodispersible tablets contain 13 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. This 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 take Lansoprazole Teva
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The tablets break easily, so you should handle the tablets carefully. Do not take the tablets with wet hands as the tablets may dissolve.
Place the tablet on the tongue and suck gently. The tablet dissolves quickly in the mouth and releases micro granule 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 must be followed if administration by syringe:
The suitability of the selected syringe must be carefully tested.
- remove the plunger from the syringe (at least 5 ml syringe for the 15 mg tablet and 10 ml syringe for the 30 mg tablet)
- place the tablet in the syringe barrel
- put the plunger back in the syringe
- for the 15 mg tablet: draw 4 ml of tap water into the syringe
- for the 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
- Shake the syringe gently 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 out the residue from the syringe into the mouth.
If you are taking Lansoprazole Teva once a day, try to take the medicine at the same time each day. You can get the best results if you take Lansoprazole Teva immediately in the morning.
If you are taking Lansoprazole Teva twice a day, you should take the first dose in the morning and the second dose in the evening.
For best results with this medicine, you should take Lansoprazole Teva at least 30 minutes before eating.
The dose of Lansoprazole Teva depends on your condition. The recommended dose of Lansoprazole Teva for adults is 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: 15 mg or 30 mg lansoprazole daily for 4 weeks. If your symptoms persist, tell your doctor. If symptoms persist within 4 weeks, consult a physician.
Treatment of duodenal ulcers: 30 mg lansoprazole daily for 2 weeks.
Treatment of gastric ulcers: 30 mg lansoprazole daily for 4 weeks.
Treatment of inflammation of the esophagus ( reflux esophagitis ): 30 mg lansoprazole daily for 4 weeks.
Long-term prevention of reflux oesophagitis: 15 mg lansoprazole daily, your doctor may adjust the dose to one to 30 mg lansoprazole.
Treatment of infection of Helicobacter pylori: The recommended dose is 30 mg of lansoprazole in combination with two different antibiotics in the morning and 30 mg of lansoprazole 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 Teva with 250-500 mg clarithromycin and 1,000 mg amoxicillin
- 30 mg Lansoprazole Teva tablet 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 the duodenum one or stomach ulcer in patients requiring continued NSAID treatment: 30 mg lansoprazole daily for 4 weeks.
Prevention of ulcers in the duodenum one or stomach ulcer in patients requiring continued NSAID treatment: 15 mg lansoprazole daily, your doctor may adjust the dose of one 30 mg lansoprazole daily.
Zollinger-Ellison syndrome: The recommended dose is 60 mg lansoprazole every day, to begin with, and then depending on how you respond to Lansoprazole Teva, your doctor will decide which dose is best for you.
Children: Lansoprazole Teva tablets should not be given to children.
If you forget to take Lansoprazole Teva
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 tablets as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lansoprazole Teva
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.
If you get any of the following side effects, stop taking Lansoprazole Teva and contact your doctor or emergency department immediately:
- Angioedema : symptoms may include swollen face, tongue or throat, difficulty swallowing, hives and difficulty breathing (rare – may affect up to 1 in 1,000 people)
- severe hypersensitivity reactions including anaphylactic shock : symptoms may include fever, rash, swelling and sometimes drop in blood pressure (very rare – may affect up to 1 in 10,000 users)
- very severe skin reactions with redness , blistering, severe inflammation and skin waste: Steven-Johnson syndrome, toxic epidermal necrolysis (very rare – may affect up to 1 in 10,000 people) and erythema multiforme (rare – may affect up to 1 in 1 in 1 000 users)
hepatitis : may manifest as yellowing of the skin or eyes (rare – may affect up to 1 in 1,000 people).
The following side effects are common (may affect up to 1 in 10 people):
- headache, dizziness
- diarrhea, constipation, abdominal pain, nausea or vomiting, gas, dry mouth or sore mouth, benign polyps in the stomach
- rash, itching
- altered values from liver function tests
- fatigue.
The following side effects are uncommon (may affect up to 1 in 100 people):
- Depression
- joint or muscle pain
- fluid retention or swelling ( edema )
- changed number blood s
- hip, wrist or vertebral fractures (see section 2 “Warnings and Precautions”).
The following side effects are rare (may affect up to 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 ( pancreatitis )
- breast swelling in men, impotence
- candida infection (fungal infection, may affect skin or mucous membranes).
The following side effects are very rare (may affect up to 1 in 10,000 people):
- inflammation of the mouth ( stomatitis )
- colitis ( inflammation of the intestine)
- altered test values such as sodium , cholesterol and triglyceride levels
- decreased number of white blood cells that can lead to a weakening of the immune system. 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 urinary tract problems, you should see a doctor immediately. A blood sample will be taken to check if the number of white blood cells has decreased ( agranulocytosis ).
The following side effects have been reported (affects an unknown number of users):
- skin rash, possibly with joint pain
- low levels of magnesium in the blood ( hypomagnesaemia ) (see section 2 “Warnings and precautions”), severe hypomagnesaemia can lead to low levels of calcium in your blood (hypocalcaemia)
- visual hallucinations.
How to store Lansoprazol Teva
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the blister and carton. 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.
Each 15 mg orodispersible tablet contains 15 mg of lansoprazole.
Each 30 mg orodispersible tablet contains 30 mg of lansoprazole. - The other ingredients are sugar spheres (sucrose and maize starch), hypromellose, talc, magnesium carbonate, methacrylic acid-ethyl acrylate copolymer (1: 1), triethyl citrate, titanium dioxide (E 171), colloidal anhydrous silica, lactose monohydrate , maize starch, magnesium starch and magnesium starch.
What the medicine looks like and contents of the pack
Lansoprazole Teva 15 mg orodispersible tablets: White to off-white, round, flat tablet with beveled edges. Marked with “15” on one side of the tablet and is unmarked on the other side. Each orodispersible tablet contains white to greyish stomach-resistant granules.
Lansoprazole Teva 30 mg orodispersible tablets: White to off-white, round, flat tablet with beveled edges. Marked with “30” on one side of the tablet and is unmarked on the other side. Each orodispersible tablet contains white to greyish stomach-resistant granules.
Lansoprazole Teva is available in aluminum-aluminum blister packs :
Lansoprazole Teva 15 mg orodispersible tablets : 1, 7, 14, 28, 30, 30 (3 x 10), 50, 56, 98 & 100 orodispersible tablets. Lansoprazole Teva 30 mg orodispersible tablets : 1, 2, 7, 14, 28, 30, 30 (3 x 10), 50, 56, 98 & 100 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Debrecen, Hungary
Teva Czech Industries sro
Opava, Czech Republic
Pharmachemie BV
Haarlem, The Netherlands
Balkanpharma Dupnitsa-AD
Dupnitsa, Bulgaria
Merckle GmbH
Ulm, Germany