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LANSOPRAZOLE 30 MG ORODISPERSIBLE TABLETS

Active substance(s): LANSOPRAZOLE

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Lansoprazole 15 & 30 mg
Orodispersible Tablets

Lansoprazole orodispersible tablet may affect the way these
drugs work:
• ketoconazole, itraconazole, rifampicin (used to treat
infections)
PACKAGE LEAFLET: INFORMATION
• digoxin (used to treat heart problems)
FOR THE USER
• theophylline (used to treat asthma)
Read all of this leaflet carefully before you start taking this
• tacrolimus (used to prevent transplant rejection)
medicine because it contains important information for you.
• fluvoxamine (used to treat depression and other psychiatric
• Keep this leaflet. You may need to read it again.
diseases)
• If you have any further questions, ask your doctor or
• antacids (used to treat heartburn or acid regurgitation)
pharmacist.
• sucralfate (used for healing ulcers)
• This medicine has been prescribed for you only. Do not pass • St John´s wort (Hypericum perforatum) (used to treat mild
it on to others. It may harm them, even if their signs of
depression)
illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. Lansoprazole orodispersible tablet with food and drink
This includes any possible side effects not listed in this
For the best results from your medicines you should take
leaflet. See Section 4.
Lansoprazole orodispersible tablet at least 30 minutes before
WHAT IS IN THIS LEAFLET:
food.
1. What Lansoprazole Orodispersible Tablets are and what they
Pregnancy and breast-feeding
are used for
2. What you need to know before you take Lansoprazole
If you are pregnant or breast-feeding, think you may be
Orodispersible Tablets
pregnant or planning to have a baby, ask your doctor or
3. How to take Lansoprazole Orodispersible Tablets
pharmacist for advice before taking this medicine.
4. Possible side effects
5. How to store Lansoprazole Orodispersible Tablets
Driving and using machines
6. Contents of the pack and other information
Side effects such as dizziness, vertigo, tiredness and visual
WHAT LANSOPRAZOLE ORODISPERSIBLE TABLETS disturbances sometimes occur in patients taking Lansoprazole
orodispersible tablet . If you experience side effects like these
ARE AND WHAT THEY ARE USED FOR
you should take caution as your ability to react may be
The active ingredient in Lansoprazole Orodispersible Tablets is decreased.
lansoprazole, which is a proton pump inhibitor. Proton pump
inhibitors reduce the amount of acid that your stomach makes. You alone are responsible to decide if you are in a fit condition
to drive a motor vehicle or perform other tasks that demand
Your doctor may prescribe Lansoprazole Orodispersible Tablets increased concentration. Because of their effects or
undesirable effects, one of the factors that can reduce your
for the following indications:
ability to do these things safely is your use of medicines.
• Treatment of duodenal and stomach ulcer
• Treatment of inflammation in your oesophagus (reflux
Descriptions of these effects can be found in other sections.
oesophagitis)
• Prevention of reflux oesophagitis
Read all the information in this leaflet for guidance.
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacteria Helicobacter Discuss with your doctor, nurse or pharmacist if you are
unsure about anything.
pylori when given in combination with antibiotic therapy
• Treatment or prevention of duodenal or stomach ulcer in
Lansoprazole orodispersible tablet contains lactose, sucrose
patients requiring continued NSAID treatment (NSAID
and aspartame
treatment is used against pain or inflammation)
• Treatment of Zollinger-Ellison syndrome.
Lansoprazole orodispersible tablet contains lactose and
Your doctor may have prescribed Lansoprazole Orodispersible sucrose. If you have been told by your doctor that you have an
Tablets for another indication or with a dose different from that intolerance to some sugars, contact your doctor before taking
this medicine.
which is written in this information leaflet. Please follow your

1

doctor’s instructions for taking your medicine.

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LANSOPRAZOLE ORODISPERSIBLE TABLET

Do not take Lansoprazole orodispersible tablet
• 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).

Lansoprazole orodispersible tablet contains aspartame.
Aspartame is a source of phenylalanine, which may be harmful
for people with phenylketonuria.

3

HOW TO TAKE LANSOPRAZOLE ORODISPERSIBLE
TABLET

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The orodispersible tablets are for oral use.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole
orodispersible tablets
• If you have ever had a skin reaction after treatment with a
medicine similar to Lansoprazole orodispersible tablet that
reduces stomach acid.
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
tablet. Remember to also mention any other ill-effects like pain
in your joints.

The tablets break easily, so you should handle the tablets
carefully. Do not handle the tablets with wet hands as the
tablets may break up.

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 tablet contact your doctor immediately, as
Lansoprazole orodispersible tablet has been associated with
a small increase in infectious diarrhoea.
• If your doctor has given you Lansoprazole orodispersible
tablet 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 tablet 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.

The following instructions should be followed if administered
via syringe:
It is important that the appropriateness of the selected 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.

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).
Children
The use of Lansoprazole orodispersible tablet is not
recommended in children as clinical data are limited.
Treatment of small children below one year of age should be
avoided as available data have not shown beneficial effects in
the treatment of gastro-oesophageal reflux disease.

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 a
syringe, in case you have serious difficulties with swallowing.

If you are taking Lansoprazole orodispersible tablet once a
day, try to take it at the same time each day. You may get best
results if you take Lansoprazole orodispersible tablet first
thing in the morning.
If you are taking Lansoprazole orodispersible tablet twice a
day, you should have the first dose in the morning and the
second dose in the evening.
The dose of Lansoprazole orodispersible tablet depends on
your condition. The usual doses of Lansoprazole
orodispersible tablet for adults are given below. Your doctor
will sometimes prescribe you a different dose and will tell you
how long your treatment will last.

Other medicines and Lansoprazole orodispersible tablets

Treatment of heartburn and acid regurgitation: one 15 mg or
30 mg orodispersible tablet 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.

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Treatment of duodenal ulcer: one 30 mg orodispersible tablet
every day for 2 weeks

In particular tell your doctor if you are taking medicines
containing any of the following active substances as

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

• colitis (bowel inflammation)
• changes in test values such as sodium, cholesterol and
triglyceride levels
• very severe skin reactions with reddening, blistering, severe
Long-term prevention of reflux oesophagitis: one 15 mg
inflammation and skin loss.
orodispersible tablet every day, your doctor may adjust your
• very rarely Lansoprazole orodispersible tablet may cause a
dose to one 30 mg orodispersible tablet every day.
reduction in the number of white blood cells and your
resistance to infection may be decreased. If you experience
Treatment of infection of Helicobacter pylori: The usual dose is
an infection with symptoms such as fever and serious
one 30 mg orodispersible tablet in combination with two
deterioration of your general condition, or fever with local
different antibiotics in the morning and one 30 mg
infection symptoms such as sore throat/pharynx/mouth or
orodispersible tablet in combination with two different
urinary problems you should see your doctor immediately.
antibiotics in the evening. Treatment will usually be every day
A blood test will be taken to check possible reduction of
for 7 days.
white blood cells (agranulocytosis).
The recommended combinations of antibiotics are:
Not
known: frequency cannot be estimated from the available
• 30 mg Lansoprazole orodispersible tablet together with
data
250-500 mg clarithromycin and 1000 mg amoxicillin
• if you are on Lansoprazole orodispersible tablets for more
• 30 mg Lansoprazole orodispersible tablet together with
than three months it is possible that the levels of
250 mg clarithromycin and 400-500 mg metronidazole
magnesium in your blood may fall. Low levels of
If you are being treated for infection because you have an
magnesium can be seen as fatigue, involuntary muscle
ulcer, it is unlikely that your ulcer will return if the infection is
contractions, disorientation, convulsions, dizziness,
successfully treated. To give your medicine the best chance of
increased heart rate. If you get any of these symptoms,
working, take it at the right time and do not miss a dose.
please tell your doctor promptly. Low levels of magnesium
can also lead to a reduction in potassium or calcium levels
Treatment of duodenal or stomach ulcer in patients requiring
in the blood. Your doctor may decide to perform regular
continued NSAID treatment: one 30 mg orodispersible tablet
blood tests to monitor your levels of magnesium.
every day for 4 weeks.
• rash, possibly with pain in the joints
Prevention of duodenal or stomach ulcer in patients requiring Reporting of side effects
continued NSAID treatment: one 15 mg orodispersible tablet
If you get any side effects, talk to your doctor or pharmacist.
every day, your doctor may adjust your dose to one 30 mg
This includes any possible side effects not listed in this leaflet.
orodispersible tablet every day.
You can also report side effects directly via the Yellow Card
Zollinger-Ellison syndrome: The usual dose is two 30 mg
orodispersible tablet every day to start with, then depending
on how you respond to Lansoprazole orodispersible tablet the
dose that your doctor decides is best for you.
Children: Lansoprazole orodispersible tablet 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 tablet than you
should
If you take more Lansoprazole orodispersible tablet than you
have been told to, seek medical advice quickly
If you forget to take Lansoprazole orodispersible tablet
If you forget to take a dose, take it as soon as your 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 dose.

Scheme at: 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 store above 25°C. Store in the original package to
protect from moisture.
Do not use this medicine after the expiry date which is stated
on the blister and carton. 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 protect
the environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Lansoprazole Orodispersible Tablets contains

The active substance is lansoprazole.
Each 15 mg orodispersible tablet contains 15 mg of
Do not stop treatment early because your symptoms have got lansoprazole.
better. Your condition may not have been fully healed and may Each 30 mg orodispersible tablet contains 30 mg of
lansoprazole.
reoccur if you do not finish your course of treatment.
The other ingredients are sugar spheres (sucrose and maize
If you have any further questions on the use of this medicine,
starch), hypromellose, talc, magnesium carbonate, methacrylic
ask your doctor or pharmacist.
acid-ethyl acrylate copolymer (1:1) triethyl citrate, titanium
dioxide (E 171), colloidal anhydrous silica, lactose
POSSIBLE SIDE EFFECTS
monohydrate, maize starch, aspartame, strawberry flavour and
magnesium stearate.
Like all medicines, this medicine can cause side effects,
What Lansoprazole Orodispersible Tablets looks like and
although not everybody gets them.
contents of the pack
Common: may affect up to 1 in 10 people
Lansoprazole 15 mg Orodispersible Tablets: White to off-white,
• headache, dizziness
• diarrhoea, constipation, stomach pains, feeling or being sick, flat beveled round tablet debossed with "15" on one side of the
tablet and plain on the other side. Each orodispersible tablet
wind, dry or sore mouth or throat
contains white to greyish gastroresistant granules.
• skin rash, itching
Lansoprazole 30 mg Orodispersible Tablets: White to off white,
• changes in liver function test values
flat beveled round tablet debossed with "30" on one side of the
• tiredness.
tablet and plain on the other side. Each orodispersible tablet
Uncommon: may affect up to 1 in 100 people
contains white to greyish gastroresistant granules.
• depression
Lansoprazole Orodispersible Tablets are available in
• joint or muscle pain
aluminium – aluminium blister packs:
• fluid retention or swelling
15 mg: 1, 7, 14, 28, 30, 30 (3 x 10), 50, 56, 98 & 100
• changes in blood cell counts
orodispersible tablets
• slight increase in the risk of hip, wrist or spine fractures if
30 mg: 1, 2, 7, 14, 28, 30, 30 (3 x 10), 50, 56, 98 & 100
you take Lansoprazole orodispersible tablets over a period
orodispersible tablets
of more than one year.
Not all pack sizes may be marketed.
If you stop taking Lansoprazole orodispersible tablet

4

Rare: may affect up to 1 in 1000 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.
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)

Marketing Authorisation Holder and Manufacturer :
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in 12/2015
PL 00289/1048
PL 00289/1049

86802-ZB
322K403560715

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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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