Lansoprazole 15 Mg Orodispersible Tablets
7505xxxx 7505xxxx
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANSOPRAZOLE 15 mg ORODISPERSIBLE TABLETS LANSOPRAZOLE 30 mg ORODISPERSIBLE TABLETS
(lansoprazole)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
' What is in this leaflet:
11. What Lansoprazole is and what it is used for.
2. What you need to know before you take Lansoprazole.
3. How to take Lansoprazole.
4. Possible side effects.
5. How to store Lansoprazole.
6. Contents of the pack and other information.
1. WHAT LANSOPRAZOLE IS 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 for the following indications:
• Treatment of duodenal and stomach ulcers.
• 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 ulcers 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 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLE
Do not take Lansoprazole:
• If you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are taking a medicine containing the active substance atazanavir (used in the treatment of HIV).
Warnings and precautions
Talk to your doctor before taking Lansoprazole.
Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.
Please tell your doctor if you have serious liver disease.
The doctor may have to adjust your dosage.
If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as Lansoprazole has been associated with a small increase in infectious diarrhoea.
If your doctor has given you Lansoprazole 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.
Taking a proton pump inhibitor like Lansoprazole, 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).
If you take Lansoprazole 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.
Other medicines and Lansoprazole
Tell your doctor 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 containing any of the following active substances as Lansoprazole 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).
Lansoprazole with food and drink
For the best results from your medicines you should take Lansoprazole at least 30 minutes before food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby 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. 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.
Lansoprazole 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.
Lansoprazole contains aspartame (E951).
Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
3. HOW TO TAKE LANSOPRAZOLE
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The dose of Lansoprazole depends on your condition. The usual doses of Lansoprazole 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 orodispersible tablet every day for 4 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 orodispersible tablet every day for 2 weeks. Treatment of stomach ulcer
One 30 mg orodispersible tablet every day for 4 weeks.
Treatment of inflammation in your oesophagus (reflux oesophagitis)
One 30 mg orodispersible tablet every day for 4 weeks.
Long-term prevention of reflux oesophagitis
One 15 mg orodispersible tablet every day, your doctor may adjust your dose to one 30 mg orodispersible tablet every day.
Treatment of infection of 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. Treatment will usually be every day for 7 days.
The recommended combinations of antibiotics are:
• 30 mg Lansoprazole together with 250-500 mg clarithromycin and 1000 mg amoxicillin
• 30 mg Lansoprazole 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 ulcers in patients requiring continued non-steroidal anti-inflammatory drug (NSAID) treatment
One 30 mg orodispersible tablet every day for 4 weeks.
Prevention of duodenal or stomach ulcers in patients requiring continued NSAID treatment
One 15 mg orodispersible tablet every day, your doctor may adjust your dose to one 30 mg orodispersible tablet every day.
Zollinger-Ellison syndrome
The usual dose is two 30 mg orodispersible tablets every day to start with, then depending on how you respond to Lansoprazole the dose that your doctor decides is best for you.
Method of administration:
1. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
2. Peel off the backing.
3. Carefully take out the tablet from the packaging (do not push it through).
4. 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.
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Your doctor might instruct you to take the tablet with a 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 10 ml 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.
• Repeat the precedent step if necessary.
The following instructions should be followed if the tablet is administered with a syringe by nasogastric tube:
• Remove the plunger of the syringe (at least 5 ml syringe for the 15 mg tablet and 10 ml 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
• Join the syringe to the tube and empty the syringe content in the nasogastric tube.
• Refill the syringe with 2-5 ml of tap water and administer the content in the tube.
If you are taking Lansoprazole once a day, try to take it at the same time each day. You may get best results if you take Lansoprazole first thing in the morning.
If you are taking Lansoprazole twice a day, you should have the first dose in the morning and the second dose in the evening.
Use in children
Lansoprazole should not be given to children.
If you take more Lansoprazole than you should
If you take more Lansoprazole than you have been told to, seek medical advice quickly or quickly consult the Toxicological Information Service.
If you forget to take Lansoprazole
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 orodispersible tablets as normal. Do not take a double dose to make up for a forgotten orodispersible tablet.
If you stop taking Lansoprazole
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 medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lansoprazole can cause side effects, although not everybody gets them.
If you think you may have any of the following side effects, stop taking this medicine and contact your doctor or go to your nearest hospital emergency room immediately.
• Pancreatitis which would involve the sudden onset of a severe dull pain around the top of your stomach.
The ache may travel to your back and may feel worse after you have eaten (rare, may affect up to 1 in 1,000 people).
• Inflammation of the liver, which may be seen as yellow skin or eyes (rare, may affect up to 1 in 1,000 people).
• Angioedema, with symptoms such as: swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath (rare, may affect up to 1 in 1,000 people).
• Severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure (very rare, may affect up to 1 in 10,000 people).
• Very severe skin reactions with reddening, blistering, severe inflammation and skin loss (very rare, may affect up to 1 in 10,000 people).
• Very rarely lansoprazole may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. This can cause 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. In such case a blood test will be taken to check possible reduction of white blood cells (very rare, may affect up to 1 in 10,000 people).
• Diarrhoea (common, may affect up to 1 in 10 people).
This side effect should be reported to your doctor as the medicine has been associated with a small increase in infectious diarrhoea.
Other possible side effects:
Common (may affect up to 1 in 10 people):
• headache, dizziness
• constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat
• skin rash, itching
• changes in liver function test values
• tiredness.
Uncommon (may affect up to 1 in 100 people):
• depression
• joint or muscle pain
• fracture of the hip, wrist or spine
• fluid retention or swelling
• changes in blood cell counts.
Rare (may affect up to 1 in 1,000 people):
• 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
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or the mucosa).
Very rare (may affect up to 1 in 10,000 people):
• inflammation of your mouth (stomatitis)
• colitis (bowel inflammation)
• changes in test values such as sodium, cholesterol and triglyceride levels.
Frequency not known (frequency cannot be estimated from the available data):
If you are on Lansoprazole 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 you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE LANSOPRAZOLE
Keep out of the sight and reach of children.
Store in the original container in order to protect from moisture.
Bottles: Use within 100 days of opening. Once open keep bottle tightly closed.
Do not use Lansoprazole after the expiry date which is stated on the blister, carton, bottle after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lansoprazole contains
• The active substance is lansoprazole.
• The other ingredients are: sugar spheres, magnesium carbonate, light (E504); crospovidone (E1202); hydroxypropylcellulose (E463); methacrylic acid - ethyl acrylate, copolymer (1:1) type A; triethyl citrate (E1505); sodium hydroxide (E524); methacrylic acid - ethyl acrylate, copolymer (1:1) dispersion 30 per cent; talc (E553b); polysorbate 80 (E433); macrogol 6000; iron oxide red (E172); iron oxide yellow (E172); mannitol (E421); cellulose, microcrystalline (E460); sodium starch glycolate (type A); crospovidone (E1202); aspartame (E951); sodium laurilsulfate; sodium hydrogen carbonate (E500); citric acid monohydrate (E330); strawbery flavour; magnesium stearate.
What Lansoprazole looks like and contents of the pack
Your medicine is in the form of orodispersible tablets (solid oral dosage form).
Lansoprazole 15 mg Orodispersible Tablets are white to yellowish white, round, 11 mm in diameter, flat-faced beveled edged tablet engraved with 'LP1' on one side and 'M' on other side with orange to dark brown speckles.
Lansoprazole 30 mg Orodispersible Tablets are white to yellowish white, round, 12.7 mm in diameter, flat-faced beveled edged tablet engraved with 'LP2' on one side and 'M' on other side with orange to dark brown speckles.
Lansoprazole 15 mg and 30 mg Orodispersible Tablets are available in:
• perforated blister packs of 7, 14, 28, 30, 56, 90, 98 tablets
• perforated unit-dose blister packs containing 28 x 1 tablets
• bottles of 30, 100, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.
This leaflet was last revised in: 07/2012 10003947 - 450895
CODE No.: MH/DRUGS/25/NKD/89 750ixoixo
Lansoprazole ODT 15 & 30 mg
Component Type
Affiliate Item Code
Superceded Affiliate Item Code
TrackWise PR No.
421571
Packing Site/Printer
Nashik
TBC
Leaflet
10003 947 - 4 50895
04569/1306, 1307
10003947
TBC
N/A
N/A
1
UK
N/A
N/A
Date: 29 JUN 2014
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