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LANSOPRAZOLE 15 MG ORODISPERSIBLE TABLETS

Active substance(s): LANSOPRAZOLE / LANSOPRAZOLE / LANSOPRAZOLE

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TEVA UK Ref:

Version:

231-30-86802-ZC LEA LANSOPRAZOLE OD AS TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
380 mm
190 mm
N/A
N/A

6

22 March 2017

Colours Used:

BLACK
PANTONE® GREEN C
Template

In particular tell your doctor if you are taking medicines
containing any of the following active substances as
Lansoprazole orodispersible tablet may affect the way these
medicines work:
Lansoprazole
• 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. Pregnancy and breast-feeding
This includes any possible side effects not listed in this
If you are pregnant or breast-feeding, think you may be
leaflet. See section 4.
pregnant or planning to have a baby, ask your doctor or
WHAT IS IN THIS LEAFLET:
pharmacist for advice before taking this medicine.

Lansoprazole 15 & 30 mg
Orodispersible Tablets

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

Driving and using machines
Side effects such as dizziness, vertigo, tiredness and visual
disturbances sometimes occur in patients taking Lansoprazole
orodispersible tablet . 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.

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. Descriptions of these effects can be found in other sections.
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

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).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole
orodispersible tablets
• if you are due to have a specific blood test (Chromogranin A).
• 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.

Read all the information in this leaflet for guidance.
Discuss with your doctor, nurse or pharmacist if you are
unsure about anything.
Lansoprazole orodispersible tablet contain lactose and
sucrose and aspartame
Lansoprazole orodispersible tablet contains lactose and
sucrose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.
Lansoprazole 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.
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.
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.

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
Please tell your doctor if you have serious liver disease. The
• Put the plunger back onto the syringe
doctor may have to adjust your dosage.
• For the 15 mg tablet: Draw 4 ml tap water into the syringe
Your doctor may perform or have performed an additional
• For the 30 mg tablet: Draw 10 ml tap water into the syringe
investigation called an endoscopy in order to diagnose your
• Invert the syringe and draw an additional 1 ml of air into it
condition and/or exclude malignant disease.
• Shake the syringe gently for 10-20 seconds until the tablet is
• If diarrhoea occurs during the treatment with Lansoprazole
dispersed
orodispersible tablet contact your doctor immediately, as
Lansoprazole orodispersible tablet has been associated with • The contents can be emptied directly into the mouth
• Refill the syringe with 2-5 ml of tap water to flush the
a small increase in infectious diarrhoea.
remnants out of the syringe into the mouth.
• If your doctor has given you Lansoprazole orodispersible
tablet in addition to other medicines intended for the
If you are taking Lansoprazole orodispersible tablet once a
treatment of Helicobacter pylori infection (antibiotics) or
day, try to take it at the same time each day. You may get best
together with anti-inflammatory medicines to treat your pain
results if you take Lansoprazole orodispersible tablet first
or rheumatic disease: please also read the package leaflets
thing in the morning.
of these medicines carefully.
• If you take Lansoprazole orodispersible tablet on a
If you are taking Lansoprazole orodispersible tablet twice a
long-term basis (longer than 1 year) your doctor will
day, you should have the first dose in the morning and the
probably keep you under regular surveillance. You should
second dose in the evening.
report any new and exceptional symptoms and
For the best results from your medicine you should take
circumstances whenever you see your doctor.
Lansoprazole orodispersible tablet at least 30 minutes before
Taking a proton pump inhibitor like Lansoprazole
food.
orodispersible tablets, especially over a period of more than
one year, may slightly increase your risk of fracture in the hip, The dose of Lansoprazole orodispersible tablet depends on
your condition. The recommended doses of Lansoprazole
wrist or spine. Tell your doctor if you have osteoporosis or if
orodispersible tablet for adults are given below. Your doctor
you are taking corticosteroids (which can increase the risk of
will sometimes prescribe you a different dose and will tell you
osteoporosis).
how long your treatment will last.
Children
Treatment of heartburn and acid regurgitation: one 15 mg or
The use of Lansoprazole orodispersible tablet is not
30 mg orodispersible tablet for 4 weeks. If symptoms persist
recommended in children as clinical data are limited.
you should report to your doctor. If your symptoms are not
Treatment of small children below one year of age should be
avoided as available data have not shown beneficial effects in relieved within 4 weeks, please contact your doctor.
the treatment of gastro-oesophageal reflux disease.
Treatment of duodenal ulcer: one 30 mg orodispersible tablet
every day for 2 weeks
Other medicines and Lansoprazole orodispersible tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Treatment of stomach ulcer: one 30 mg orodispersible tablet
every day for 4 weeks

TEVA UK Ref:

Version:

231-30-86802-ZC LEA LANSOPRAZOLE OD AS TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
380 mm
190 mm
N/A
N/A

6

22 March 2017

Colours Used:

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
recommended 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 orodispersible tablet together with
250-500 mg clarithromycin and 1000 mg amoxicillin
• 30 mg Lansoprazole orodispersible tablet 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.

BLACK
PANTONE® GREEN C
Template

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
• rash, possibly with pain in the joints
These are very serious side effects. You may need urgent
medical attention or hospitalisation.
The following side effects have been reported at the
approximate frequencies shown:
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, benign polyps in the stomach
• skin rash, itching
• changes in liver function test values
• tiredness.
Uncommon: may affect up to 1 in 100 people
• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts
• slight increase in the risk of hip, wrist or spine fractures if
you take Lansoprazole orodispersible tablets over a period
of more than one year.

Rare: may affect up to 1 in 1000 people
• fever
Prevention of duodenal or stomach ulcer in patients requiring • restlessness, drowsiness, confusion, hallucinations,
continued NSAID treatment: one 15 mg orodispersible tablet
insomnia, visual disturbances, vertigo
every day, your doctor may adjust your dose to one 30 mg
• a change in the way things taste, loss of appetite,
orodispersible tablet every day.
inflammation of your tongue (glossitis)
Zollinger-Ellison syndrome: The recommended dose is two 30 mg • skin reactions such as burning or pricking feeling under the
skin, bruising, reddening and excessive sweating
orodispersible tablet every day to start with, then depending
on how you respond to Lansoprazole orodispersible tablet the • sensitivity to light
• hair loss
dose that your doctor decides is best for you.
• feelings of ants creeping over the skin (paresthesiae),
Children: Lansoprazole orodispersible tablet should not be
trembling
given to children.
• anaemia (paleness)
Take your medicine exactly as your doctor has told you. You
• breast swelling in males, impotence
should check with your doctor if you are not sure how to take
Very rare: may affect up to 1 in 10,000 people
your medicine.
• inflammation of your mouth (stomatitis)
If you take more Lansoprazole orodispersible tablet than you
• colitis (bowel inflammation)
should
• changes in test values such as sodium, cholesterol and
triglyceride levels
If you take more Lansoprazole orodispersible tablet than you
have been told to, contact your doctor, pharmacist or your
Reporting of side effects
nearest hospital emergency department.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
If you forget to take Lansoprazole orodispersible tablet
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
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 By reporting side effects you can help provide more
the missed dose and take the remaining orodispersible tablets information on the safety of this medicine.
as normal.
HOW TO STORE LANSOPRAZOLE ORODISPERSIBLE
Do not take a double dose to make up for a forgotten dose.

5

TABLETS

If you stop taking Lansoprazole orodispersible tablet
Keep this medicine out of the sight and reach of children.
Do not stop treatment early because your symptoms have got Do not store above 25°C. Store in the original package to
better. Your condition may not have been fully healed and may protect from moisture.
reoccur if you do not finish your course of treatment.
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
If you have any further questions on the use of this medicine,
of that month.
ask your doctor or pharmacist.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
POSSIBLE SIDE EFFECTS
medicines you no longer use. These measures will help protect
the environment.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
CONTENTS OF THE PACK AND OTHER

4

6

The following side effects are allergic reactions which need
immediate medical attention:
• 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
• severe hypersensitivity reactions including shock.
Symptoms of a hypersensitivity reaction may include fever,
rash, swelling and sometimes a fall in blood pressure
• very severe skin reactions with reddening, blistering, severe
inflammation and skin loss
If you suffer from any of the following at any time during your
treatment STOP TAKING your tablets and contact your doctor
immediately:
Common: may affect up to 1 in 10 people
• diarrhoea
Rare: may affect up to 1 in 1,000 people
• kidney problems
• pancreatitis
• inflammation of the liver (may be seen as yellow skin or eyes)
• candidiasis (fungal infection, may affect skin or the mucosa)
Very rare: may affect up to 1 in 10,000 people
• Lansoprazole orodispersible tablet 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)
Not known: frequency cannot be estimated from the available
data
• if you are on Lansoprazole orodispersible tablet 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

INFORMATION

What Lansoprazole Orodispersible Tablets contain
• The active substance is lansoprazole.
Each 15 mg orodispersible tablet contains 15 mg of
lansoprazole.
Each 30 mg orodispersible tablet contains 30 mg of
lansoprazole.
• The other ingredients are sugar spheres (sucrose and maize
starch), hypromellose, talc, magnesium carbonate,
methacrylic acid-ethyl acrylate copolymer (1:1) triethyl
citrate, titanium dioxide (E 171), colloidal anhydrous silica,
lactose monohydrate, maize starch, aspartame, strawberry
flavour and magnesium stearate.
What Lansoprazole Orodispersible Tablets looks like and
contents of the pack
Lansoprazole 15 mg Orodispersible Tablets: White to off-white,
flat beveled round tablet debossed with "15" on one side of the
tablet and plain on the other side. Each orodispersible tablet
contains white to greyish gastroresistant granules.
Lansoprazole 30 mg Orodispersible Tablets: White to off white,
flat beveled round tablet debossed with "30" on one side of the
tablet and plain on the other side. Each orodispersible tablet
contains white to greyish gastroresistant granules.
Lansoprazole Orodispersible Tablets are available in
aluminium – aluminium blister packs:
15 mg: 1, 7, 14, 28, 30, 30 (3 x 10), 50, 56, 98 & 100
orodispersible tablets
30 mg: 1, 2, 7, 14, 28, 30, 30 (3 x 10), 50, 56, 98 & 100
orodispersible tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer :
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in 03/2017
PL 00289/1048
PL 00289/1049
86802-ZC
322K403560716

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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