Lansoprazole 30mg Orodispersible Tablets
Out of date information, search anotherCUSTOMER: Waymade
PRODUCT: Zoton Fasttab 15mg 30mg
CODE: 6464/2020 2021E
PRE-PRESS NO.: 02-1808
ARTWORKER: DT
DATE OF PROOF: 03/05/12
Q.A.
APPROVED:
PROOF HISTORY:
v.1 - waymade - 03/05/12
CUSTOMER
APPROVED:
DATE:
DATE:
Leaflet Flat Size = 296 x 317 ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO
TRANSTEC 6464/2327 2328 2329
UK PIL DATED JULY 2011
INC BOTH PPI SAFETY WARNINGS
Pg 4
5. How to store Zoton FasTab
Zoton FasTab should not be stored above 25°C. Store in the original packaging.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of the 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.
If the tablets become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
6. Further information
What Zoton FasTabs contain
Zoton FasTabs contain either 15mg or 30mg of the active ingredient lansoprazole.
Zoton FasTabs also contain the following:
Lactose monohydrate, microcrystalline cellulose, magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, polyacrylate dispersion 30%, macrogol 8000, glyceryl monostearate, polysorbate 80, triethyl citrate, citric acid anhydrous, yellow iron oxide (E172), red iron oxide (E172), crospovidone, magnesium stearate, aspartame and strawberry flavouring.
What Zoton FasTabs looks like and contents of the pack
Zoton FasTabs are white, round orodispersible tablets, speckled with orange to dark brown gastro-resistant microgranules.
Zoton FasTabs 15mg are available as blister packs of 14 and 28 orodispersible tablets.
Zoton FasTabs 30mg are available as blister packs of 7, 14 and 28 orodispersible tablets.
Marketing Authorisation Holder and Manufacturer
POM PL No: 6464/2020 Zoton FasTab 15 mg
PL No: 6464/2021 Zoton FasTab 30 mg
These products are manufactured by Takeda Ireland Limited, Kilruddery, Bray, Co. Wicklow, Ireland and are procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.): 3.5.2012
Zoton is a registered trademark of Takeda Chemical Industries Limited
Pg 1
ZOTON® FasTab 15mg /
ZOTON® FasTab 30mg (Lansoprazole)
Patient Information Leaflet
This product is available in two different strengths, 15mg and 30mg, but will be referred to as Zoton FasTab throughout this leaflet.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Zoton FasTab is and what it is used for
2. Before you take Zoton FasTab
3. How to take Zoton FasTab
4. Possible side effects
5. How to store Zoton FasTab
6. Further information
1. What Zoton FasTab is and what it is used for
The active ingredient in Zoton FasTab is lansoprazole, which is a proton pump inhibitor.
Proton pump inhibitors reduce the amount of acid that your stomach makes.
Your doctor may prescribe Zoton FasTab 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 Zoton FasTab 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.
2. Before you take Zoton FasTab
Do not take Zoton FasTab:
• if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Zoton FasTab
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).
Take special care with Zoton FasTab
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 Zoton FasTab contact your doctor immediately, as Zoton FasTab has been associated with a small increase in infectious diarrhoea.
If your doctor has given you Zoton FasTab 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 Zoton FasTab 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 Zoton FasTab 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).
Taking other medicines
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 Zoton FasTab 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).
Pg2 ^
Colour
Swatch
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
DATE:
DATE:
Leaflet Flat Size = 296 x 317 ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO
TRANSTEC 6464/2327 2328 2329
UK PIL DATED JULY 2011
INC BOTH PPI SAFETY WARNINGS
Pg2
Taking Zoton FasTab with food and drink
For the best results from your medicines you should take Zoton FasTab at least 30 minutes before food. Pregnancy and breast-feeding
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 Zoton FasTab. 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.
Important information about some of the ingredients of Zoton FasTab
Zoton FasTab 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.
Zoton FasTab contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
3. How to take Zoton FasTab
Place the tablet on your tongue and suck gently. The tablet rapidly dissolves in the mouth, releasing microgranules which you should swallow without chewing. You can also swallow the tablet whole with a glass of water.
Your doctor might instruct you to take the tablet with an oral syringe, in case you have serious difficulties with swallowing.
The following instructions should be followed if administered via oral syringe:
It is important that the appropriateness of the selected oral syringe is carefully tested.
• Remove the plunger of the syringe (at least 5 ml syringe for the 15 mg tablet and 10ml syringe for the 30 mg tablet)
• Put the tablet into the barrel
• Put the plunger back onto the syringe
• For the 15 mg tablet: Draw 4 ml tap water into the syringe
• For the 30 mg tablet: Draw 10 ml tap water into the syringe
• Invert the syringe and draw an additional 1 ml of air into it
• Shake the syringe gently for 10-20 seconds until the tablet is dispersed
• The contents can be emptied directly into the mouth
• Refill the syringe with 2-5 ml of tap water to flush the remnants out of the syringe into the mouth.
If you are taking Zoton FasTab once a day, try to take it at the same time each day. You may get best results if you take Zoton FasTab first thing in the morning.
If you are taking Zoton FasTab twice a day, you should have the first dose in the morning and the second dose in the evening.
The packaging has been printed with the days of the week to help you keep track of the medicines you have already taken.
The dose of Zoton FasTab depends on your condition. The usual doses of Zoton FasTab 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 oro-dispersible tablet every day for4 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 oro-dispersible tablet every day for 2 weeks
Treatment of stomach ulcer: one 30 mg oro-dispersible tablet every day for 4 weeks
Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg oro-dispersible tablet every day for 4 weeks
Long-term prevention of reflux oesophagitis: one 15 mg oro-dispersible tablet every day, your doctor may adjust your dose to one 30 mg oro-dispersible tablet every day.
Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg oro-dispersible tablet in combination with two different antibiotics in the morning and one 30mg oro-dispersible tablet 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 Zoton FasTab together with 250-500 mg clarithromycin and 1000 mg amoxicillin
• 30 mg Zoton FasTab 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
oro-dispersible tablet every day for 4 weeks.
Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15 mg
oro-dispersible tablet every day, your doctor may adjust your dose to one 30 mg oro-dispersible tablet every day.
Pg 3 ^
Pg 3
Zollinger-Ellison syndrome: The usual dose is two 30 mg oro-dispersible tablets every day to start with, then depending on how you respond to Zoton FasTab the dose that your doctor decides is best for you.
Use in children:
Zoton FasTab 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 Zoton FasTab than prescribed
If you take more Zoton FasTab than you have been told to, seek medical advice quickly.
If you forget to take Zoton FasTab
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 oro-dispersible tablets as normal. Do not take a double dose to make up fora forgotten oro-dispersible tablet.
If you stop taking Zoton FasTab
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.
4. Possible side effects
Like all medicines, Zoton FasTab 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
• diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat
• skin rash, itching
• changes in liver function test values
• tiredness.
The following side effects are uncommon (occur in less than 1 in 100 patients):
• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts
• Musculoskeletal disorders
• Fracture of the hip, wrist or spine.
The following side effects are rare (occur in less than 1 in 1000 patients):
• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)
• skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating
• sensitivity to light
• hair loss
• feelings of ants creeping over the skin (paresthesiae), trembling
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be seen as yellow skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or the mucosa)
• angioedema; 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):
• severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
• inflammation of your mouth (stomatitis)
• colitis (bowel inflammation)
• changes in test values such as sodium, cholesterol and triglyceride levels
• very severe skin reactions with reddening, blistering, severe inflammation and skin loss
• very rarely Zoton FasTab 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).
If diarrhoea occurs during the treatment with Zoton FasTab contact your doctor immediately, as Zoton FasTab has been associated with a small increase in infectious diarrhoea.
If you are on Zoton FasTab 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.
Colour
Swatch
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
DATE:
DATE:
Leaflet Flat Size = 296 x 317 ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO
TRANSTEC 6464/2327 2328 2329
Pg 4
5. How to store Lansoprazole Orodispersible tablets
Lansoprazole Orodispersible tablets should not be stored above 25°C. Store in the original packaging.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to the last day of the 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.
If the tablets become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
6. Further information
What Lansoprazole Orodispersible tablets contain
Lansoprazole Orodispersible tablets contain either 15mg or 30mg of the active ingredient lansoprazole. Lansoprazole Orodispersible tablets also contain the following:
Lactose monohydrate, microcrystalline cellulose, magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, polyacrylate dispersion 30%, macrogol 8000, glyceryl monostearate, polysorbate 80, triethyl citrate, citric acid anhydrous, yellow iron oxide (E172), red iron oxide (E172), crospovidone, magnesium stearate, aspartame and strawberry flavouring.
What Lansoprazole Orodispersible tablets look like and contents of the pack
Lansoprazole Orodispersible tablets are white, round, Orodispersible tablets, speckled with orange to dark brown gastro-resistant microgranules.
Lansoprazole 15mg Orodispersible tablets are available as blister packs of 14 and 28 Orodispersible tablets.
Lansoprazole 30mg Orodispersible tablets are available as blister packs of 7, 14 and 28 Orodispersible tablets.
Marketing Authorisation Holder and Manufacturer
POM PL No: 6464/2020 Lansoprazole 15mg Orodispersible tablets
PL No: 6464/2021 Lansoprazole 30mg Orodispersible tablets
These products are manufactured by Takeda Ireland Limited, Kilruddery, Bray, Co. Wicklow, Ireland and are procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.): 3.5.2012
Pg 1
LANSOPRAZOLE 15mg ORODISPERSIBLE TABLETS/ LANSOPRAZOLE 30mg ORODISPERSIBLE TABLETS
Patient Information Leaflet
This product is available in two different strengths, 15mg and 30mg, but will be referred to as Lansoprazole Orodispersible tablets throughout this leaflet.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Lansoprazole Orodispersible tablets are and what it is used for
2. Before you take Lansoprazole Orodispersible tablets
3. How to take Lansoprazole Orodispersible tablets
4. Possible side effects
5. How to store Lansoprazole Orodispersible tablets
6. Further information
1. What Lansoprazole Orodispersible tablets are and what it is used for
The active ingredient in Lansoprazole Orodispersible tablets 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 Orodispersible tablets 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 Orodispersible tablets 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.
2. Before you take Lansoprazole Orodispersible tablets
Do not take Lansoprazole Orodispersible tablets:
• if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of Lansoprazole Orodispersible tablets
• if you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).
Take special care with Lansoprazole Orodispersible tablets
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 Orodispersible tablets contact your doctor immediately, as Lansoprazole Orodispersible tablets has been associated with a small increase in infectious diarrhoea.
If your doctor has given you Lansoprazole Orodispersible tablets 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 Orodispersible tablets 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 Orodispersible tablets 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).
Taking other medicines
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 Orodispersible tablets 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).
Colour
Swatch
WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
DATE:
DATE:
Leaflet Flat Size = 296 x 317 ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO
TRANSTEC 6464/2327 2328 2329
UK PIL DATED JULY 2011
INC BOTH PPI SAFETY WARNINGS
Pg2
Taking Lansoprazole Orodispersible tablets with food and drink
For the best results from your medicines you should take Lansoprazole Orodispersible tablets at least 30 minutes before food.
Pregnancy and breast-feeding
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 Orodispersible tablets. 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.
Important information about some of the ingredients of Lansoprazole Orodispersible tablets
Lansoprazole Orodispersible tablets 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.
Lansoprazole Orodispersible tablets contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
3. How to take Lansoprazole Orodispersible tablets
Place the tablet on your tongue and suck gently. The tablet rapidly dissolves in the mouth, releasing microgranules which you should swallow without chewing. You can also swallow the tablet whole with a glass of water.
Your doctor might instruct you to take the tablet with an oral syringe, in case you have serious difficulties with swallowing.
The following instructions should be followed if administered via oral syringe:
It is important that the appropriateness of the selected oral syringe is carefully tested.
• Remove the plunger of the syringe (at least 5 ml syringe for the 15 mg tablet and 10ml syringe for the 30 mg tablet)
• Put the tablet into the barrel
• Put the plunger back onto the syringe
• For the 15 mg tablet: Draw 4 ml tap water into the syringe
• For the 30 mg tablet: Draw 10 ml tap water into the syringe
• Invert the syringe and draw an additional 1 ml of air into it
• Shake the syringe gently for 10-20 seconds until the tablet is dispersed
• The contents can be emptied directly into the mouth
• Refill the syringe with 2-5 ml of tap water to flush the remnants out of the syringe into the mouth.
If you are taking Lansoprazole Orodispersible tablets once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole Orodispersible tablets first thing in the morning.
If you are taking Lansoprazole Orodispersible tablets twice a day, you should have the first dose in the morning and the second dose in the evening.
The packaging has been printed with the days of the week to help you keep track of the medicines you have already taken.
The dose of Lansoprazole Orodispersible tablets depends on your condition. The usual doses of Lansoprazole Orodispersible tablets 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 oro-dispersible tablet every day for4 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 oro-dispersible tablet every day for 2 weeks
Treatment of stomach ulcer: one 30 mg oro-dispersible tablet every day for 4 weeks
Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg oro-dispersible tablet every day for 4 weeks
Long-term prevention of reflux oesophagitis: one 15 mg oro-dispersible tablet every day, your doctor may adjust your dose to one 30 mg oro-dispersible tablet every day.
Treatment of infection of Helicobacter pylori: The usual dose is one 30 mg oro-dispersible tablet in combination with two different antibiotics in the morning and one 30mg oro-dispersible tablet 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 Orodispersible tablets together with 250-500 mg clarithromycin and 1000 mg amoxicillin
• 30 mg Lansoprazole Orodispersible tablets 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
oro-dispersible tablet every day for 4 weeks.
Pg 3 ^
Pg 3
Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15 mg oro-dispersible tablet every day, your doctor may adjust your dose to one 30 mg oro-dispersible tablet every day.
Zollinger-Ellison syndrome: The usual dose is two 30 mg oro-dispersible tablets every day to start with, then depending on how you respond to the dose that your doctor decides is best for you.
Use in children:
Lansoprazole Orodispersible tablets 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 Orodispersible tablets than prescribed
If you take more Lansoprazole Orodispersible tablets than you have been told to, seek medical advice quickly. If you forget to take Lansoprazole Orodispersible tablets
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 oro-dispersible tablets as normal. Do not take a double dose to make up fora forgotten oro-dispersible tablet.
If you stop taking Lansoprazole Orodispersible tablets
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.
4. Possible side effects
Like all medicines, Lansoprazole Orodispersible tablets 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
• diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat
• skin rash, itching
• changes in liver function test values
• tiredness.
The following side effects are uncommon (occur in less than 1 in 100 patients):
• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts
• Musculoskeletal disorders
• Fracture of the hip, wrist or spine.
The following side effects are rare (occur in less than 1 in 1000 patients):
• fever
• restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• a change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)
• skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating
• sensitivity to light
• hair loss
• feelings of ants creeping over the skin (paresthesiae), trembling
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be seen as yellow skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or the mucosa)
• angioedema; 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):
• severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
• inflammation of your mouth (stomatitis)
• colitis (bowel inflammation)
• changes in test values such as sodium, cholesterol and triglyceride levels
• very severe skin reactions with reddening, blistering, severe inflammation and skin loss
• very rarely Lansoprazole Orodispersible tablets 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).
If diarrhoea occurs during the treatment with Lansoprazole Orodispersible tablets contact your doctor immediately, as Lansoprazole Orodispersible tablets has been associated with a small increase in infectious diarrhoea.
If you are on Lansoprazole Orodispersible tablets 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.
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