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ZOTON FASTAB 15MG

Active substance(s): 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.
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.
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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.
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.
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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.
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.

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 gastroresistant 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
or
Pfizer Manufacturing Deutschland GmbH,
Betriebsstätte, Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
This leaflet was last revised in 02/2015.
* 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 the following
numbers: 00057/1296 or
00057/1297.
Ref: ZT 7_0

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.

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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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