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LANSOPRAZOLE 15MG ORODISPERSIBLE TABLETS

Active substance(s): LANSOPRAZOLE / LANSOPRAZOLE / LANSOPRAZOLE

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Lansoprazole 15mg Orodispersible Tablets/
Lansoprazole 30mg Orodispersible Tablets
252126

4299

Package leaflet: Information for the user
Lansoprazole 15mg Orodispersible Tablets
Lansoprazole 30mg Orodispersible Tablets
Lansoprazole
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you
Ÿ Keep this leaflet. You may need to read it again.
Ÿ If you have any further questions, ask your doctor or pharmacist.
Ÿ 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.
Ÿ If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet
1. What Lansoprazole orodispersible tablets are and what they are used
for
2. What you need to know 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. Contents of the pack and other information
1. What Lansoprazole orodispersible tablets are and what they are
used for
The active ingredient in Lansoprazole 15mg and 30mg orodispersible
tablets is lansoprazole, which is a proton pump inhibitor. Proton pump
inhibitors reduce the amount of acid that your stomach makes.
Lansoprazole orodispersible tablets are used to treat adults
Your doctor may prescribe Lansoprazole orodispersible tablets for the
following indications:
Ÿ Treatment of duodenal and stomach ulcer
Ÿ Treatment of inflammation in your oesophagus (reflux oesophagitis)
Ÿ Prevention of reflux oesophagitis
Ÿ Treatment of heartburn and acid regurgitation
Ÿ Treatment of infections caused by the bacteria Helicobacter pylori
when given in combination with antibiotic therapy
Ÿ Treatment or prevention of duodenal or stomach ulcer in patients
requiring continued NSAID treatment (NSAID treatment is used
against pain or inflammation)
Ÿ 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. What you need to know before you take Lansoprazole orodispersible
tablets
Do not take Lansoprazole orodispersible tablets:
Ÿ If you are allergic to lansoprazole or any of the other ingredients of
this medicine (listed in section 6).
Ÿ If you are taking a medicine containing the active substance
atazanavir (used in the treatment of HIV).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole
orodispersible tablets;
Ÿ If you have serious liver disease. The doctor may have to adjust your
dosage.
Ÿ If you have ever had a skin reaction after treatment with a medicine
similar to Lansoprazole orodispersible tablets that reduces stomach
acid.

Ÿ If you are due to have a specific blood test (Chromogranin A)
If you get a rash on your skin, especially in areas exposed to the sun tell
your doctor as soon as you can, as you may need to stop your treatment
with Lansoprazole orodispersible tablets.
Remember to also mention any other ill-effects like pain in your joints.
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 have 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.
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).
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.
Other medicines and Lansoprazole orodispersible tablets
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 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)
§ diuretics (used to elevate the rate of urination)
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might 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, 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.
Lansoprazole orodispersible tablets contain aspartame
Lansoprazole orodispersible tablets contain aspartame. Aspartame
contains a source of phenylalanine, which may be harmful for people with
phenylketonuria.
3. How to take Lansoprazole orodispersible tablets
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Place the tablet on your tongue and suck gently. The tablet rapidly
dissolves in the mouth, releasing pellets 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 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 water into the syringe
§ For the 30 mg tablet: Draw 10 ml 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
§ After the tablet has dispersed, administer the contents within 15
minutes
§ The contents can be emptied directly into the mouth
§ Refill the syringe with approximately 2 ml (5 ml for the 30 mg tablet)
of water, shake gently, and administer any remaining contents.
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 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
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

235 mm

350 mm

252126 INS LANSOPRZOL OD TABS UK R3 (FRONT)
Market/Customer :

UK

Location :

Pithampur

Prepared On :

23/05/2017

Version No. :

03

Product Name :

INS LANSOPRZOL OD TABS UK R3

Material Code :

252126

Supersedes Material code :

249084

Open Size :

350 x 235 mm (L x W)

Pharma Code :

4299

Folded Size :

60 x 30 mm ( (L x W)

No. of pages or Leafs/PAD

NA

Substrate :

GSM : 40 gsm

Component :

Pack Insert

Paper : Bible Paper

Gluing :

Yes

Font Name :

Helvetica Condensed

Perforation :

NA

Font Size :

9 pt.

Cover Page Substrate :

NA

Pantone Colour :
Reason for Change :

Black
Change in textmatter

Unicorn Creation
D/Lupin/Regulatory/UK/Lansoprazole Orodispersible Tablets/

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 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 orodispersible tablet every day for 4 weeks.
Prevention of duodenal or stomach ulcer 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 orodispersible tablets the dose that your doctor decides is
best for you.
Use in children and adolescents
Lansoprazole orodispersible tablets should not be given to children.
If you take more Lansoprazole orodispersible tablets than you should
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 orodispersible tablets as normal. Do not take a double
dose to make up for a forgotten orodispersible 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 medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If diarrhoea occurs during the treatment with Lansoprazole orodispersible
tablets contact your doctor immediately, as Lansoprazole orodispersible
tablets have been associated with a small increase in infectious diarrhoea.
The following side effects are common (may affect up to 1 in 10 people):
§ headache, dizziness
§ diarrhoea, constipation, stomach pains, benign polyps in the
stomach, 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 (may affect up to 1 in 100
people):
§ depression
§ joint or muscle pain
§ fluid retention or swelling
§ changes in blood cell counts.
§ risk of fracture in the hip, wrist or spine
The following side effects are 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
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 (may affect up to 1 in 10,000
people):
§ 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).
The following side effect occurs with frequency not known (frequency
cannot be estimated from the available data):
Ÿ hypomagnesaemia (abnormally low levels of magnesium in the
blood)
Ÿ rash, possibly with pain in the joints
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Lansoprazole orodispersible tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the
carton and blister. The expiry date refers to the last day of that month.
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Store below 25°C. Keep your medicine in the packaging that it came in to
help protect it from moisture.
Do not throw away any medicines via waste water or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Lansoprazole orodispersible tablets contain
- The active substance is lansoprazole. One (1) 15mg orodispersible tablet
contains 15mg of lansoprazole, one (1) 30mg orodispersible tablet
contains 30mg of lansoprazole.
- The other ingredients are:
Tablet core: microcrystalline cellulose, light magnesium carbonate, lowsubstituted hydroxypropyl cellulose, hydroxypropyl cellulose (E463).
Coating: hypromellose 3 cps (E464), low substituted hydroxypropyl
cellulose, talc (E553b), titanium dioxide (E171), mannitol (E421),
methacrylic acid ethyl acrylate copolymer dispersion (1:1), polyacrylate
dispersion, glycerol monostearate, polyethylene glycol 6000, triethyl
citrate, polysorbate 80, anhydrous citric acid (E330), ferric oxide yellow
(E172), ferric oxide red (E172), talc (E553b),
F-melt type C,
crospovidone, microcrystalline cellulose, aspartame(E951), strawberry
flavour, magnesium stearate (vegetable grade) (E470b).
What Lansoprazole orodispersible tablets look like and contents of the
pack
Lansoprazole 15mg and 30mg orodispersible tablets are white to
yellowish white uncoated tablets, speckled with orange to dark brown
pellets. Lansoprazole 15mg orodispersible tablets are debossed with “I5”
on one side of the tablet and Lansoprazole 30mg orodispersible tablets are
debossed with “30” on one side of the tablet. Each Lansoprazole 15mg
and 30mg orodispersible tablet is strawberry flavoured.
Lansoprazole 15mg and 30mg orodispersible tablets are available in
packs of 7, 14, 28, 56, and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
Wa16 0PF
United Kingdom
This medicinal product is authorised in the Member States of the EEA
under the following names:
Ireland:
Lansoprazole 15mg and 30mg Orodispersible Tablets
Italy:
Lansoprazolo Sandoz GmbH
Spain:
Lansoprazol Flas Sandoz 15mg, 30mg Comprimidos
bucodispersables EFG
United Kingdom: Lansoprazole 15mg and 30mg Orodispersible Tablets
This leaflet was last revised in 05/2017.
Code No. MP/DRUGS/25/8/2010
ID#: 252126

235 mm

350 mm

252126 INS LANSOPRZOL OD TABS UK R3 (BACK)
Market/Customer :

UK

Location :

Pithampur

Prepared On :

23/05/2017

Version No. :

03

Product Name :

INS LANSOPRZOL OD TABS UK R3

Material Code :

252126

Supersedes Material code :

249084

Open Size :

350 x 235 mm (L x W)

Pharma Code :

4299

Folded Size :

60 x 30 mm ( (L x W)

No. of pages or Leafs/PAD

NA

Substrate :

GSM : 40 gsm

Component :

Pack Insert

Paper : Bible Paper

Gluing :

Yes

Font Name :

Helvetica Condensed

Perforation :

NA

Font Size :

9 pt.

Cover Page Substrate :

NA

Pantone Colour :
Reason for Change :

Black
Change in textmatter

Unicorn Creation
D/Lupin/Regulatory/UK/Lansoprazole Orodispersible Tablets/

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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