ZOTON FASTAB 15MG

Active substance: LANSOPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoton FasTab* 15 mg oro-dispersible tablets
Zoton FasTab* 30 mg oro-dispersible tablets
lansoprazole

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.
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).
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 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)
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.

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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 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
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 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
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 30 mg
oro-dispersible tablet in combination with two
different antibiotics in the evening. Treatment
will usually be every day for 7 days.
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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.
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 for a forgotten oro- dispersible tablet.

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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.
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).
Frequency not known
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 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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.
5. HOW TO STORE ZOTON FasTab
Keep out of the reach and sight of children.
Do not use Zoton FasTab 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 store above 25°C. Do not keep it in the
fridge. Keep your medicine in the packaging
that it came in to help protect it from moisture.
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.
6. FURTHER INFORMATION
What Zoton FasTab contains
- The active substance is lansoprazole
- The other ingredients are lactose
monohydrate, microcrystalline cellulose,
magnesium carbonate, low-substituted
hydroxypropyl cellulose, hydroxypropyl
cellulose, hypromellose, titanium dioxide,
talc, mannitol, methacrylic acid – ethyl
acrylate copolymer, polyacrylate dispersion,
macrogol 8000, glyceryl monostearate,
polysorbate 80, triethyl citrate, citric acid
anhydrous, crospovidone, magnesium
stearate, aspartame, strawberry flavour and
iron oxide red and yellow (E172).
What Zoton FasTab looks like and contents
of the pack
Zoton FasTab 15 mg and 30 mg are white to
yellowish white oro-dispersible tablets speckled
with orange to dark brown gastro-resistant
microgranules. Zoton FasTab 15 mg have
“15” imprinted on one side of the tablets and
Zoton FasTab 30 mg have “30” imprinted on
one side of the tablets. Each Zoton FasTab
oro- dispersible tablet is strawberry flavoured.
Zoton FasTab 15 mg and 30 mg are available in
packs of 28 tablets.
Marketing Authorisation Holder and
Manufacturer
The marketing authorisation holder is:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom.
The manufacturer is:
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge
County Kildare
Ireland
This leaflet was last approved in MM/YYYY
* Trademark of, and under
licence agreement with, Takeda
Pharmaceutical Company
Limited, Japan.

This leaflet can be made
available in large print, audio or
Braille on request.
Contact 0800 198 5000 to
request this, quoting one of the
following numbers: 00057/1296
or 00057/1297.
Ref: ZT 5_0
334466

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P229

ZOTON 30 MG 28 TB FDDF LEAFLET
LEAFLET (Back)
NEWBRIDGE
334466
N/A
N/A

Job No.
Pass No.
Date last modified

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MRP Component Description:
Component
Packaging Plant
Item Code
Pharma Code
Barcode No.

334466A01
1
05 May 12

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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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