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LANSOPRAZOL 30 MG CAPSULES GASTRO-RESISTANT CAPSULES

Active substance(s): LANSOPRAZOLE

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PATIENT LEAFLET: INFORMATION FOR THE
USER

LANSOPRAZOLE
15 mg & 30 mg
GASTRO-RESISTANT
CAPSULES
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 become
serious, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist.
.

IN THIS LEAFLET

1. What Lansoprazole is for
2. Before you take Lansoprazole
3. How to take Lansoprazole
4. Possible side effects
5. How to store Lansoprazole
6. Further information
1. WHAT LANSOPRAZOLE IS FOR

The active ingredient in Lansoprazole
15 mg and 30 mg gastro-resistant capsules
is lansoprazole, which is a proton pump
inhibitor. Proton pump inhibitors reduce the
amount of acid that your stomach makes.
Your doctor may prescribe Lansoprazole
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 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 LANSOPRAZOLE

Do not take Lansoprazole and tell your
doctor if you:
 are allergic (hypersensitive) to
lansoprazole or any of the other
ingredients of these capsules, (listed in
section 6 of this leaflet)
 are taking a medicine containing the
active substance atazanavir (used in the
treatment of HIV).
Do not take this medicine if any of the
above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking
Lansoprazole.
Warning and precautions
Talk to your doctor before taking
lansoprazole:
 if you have ever had a skin reaction
after treatment with a medicine similar
to lansoprazole 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.
Remember to also mention any other
ill-effect like pain in your joints.
Take special care with Lansoprazole
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 contact your doctor
immediately, as Lansoprazole has been
associated with a small increase in
infectious diarrhoea.
If your doctor has given you Lansoprazole
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, 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 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.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking Lansoprazole.
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 Lansoprazole may
affect the way these drugs work, and these
medicines may affect the way
Lansoprazole works:
 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 Lansoprazole with food and
drink
For the best results from your medicines
you should take Lansoprazole 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 or pharmacist for advice
before taking any medicine.
Driving and using machines
Side effects such as dizziness, vertigo,
tiredness and visual disturbances
sometimes occur in patients taking
Lansoprazole. 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 Lansoprazole
capsules
Lansoprazole capsules contain sucrose. If
you have been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking this
medicine.
3. HOW TO TAKE LANSOPRAZOLE

Swallow the capsule whole with a glass of
water. If you find the capsules difficult to
swallow your doctor may advise on
alternative ways to take your medicine. Do
not crush or chew these capsules or the
content of an emptied capsule because this
will stop them from working properly.
If you are taking Lansoprazole once a
day, try to take it at the same time each
day. You may get best results if you
take Lansoprazole first thing in the
morning.
If you are taking Lansoprazole twice a day,
you should have the first dose in the
morning and the second dose in the
evening.
The dose of Lansoprazole depends on your
condition. The usual doses of Lansoprazole
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 capsule 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 capsule every day for 2 weeks
Treatment of stomach ulcer:
one 30 mg capsule every day for 4 weeks
Treatment of inflammation in your
oesophagus (reflux oesophagitis):
one 30 mg capsule every day for 4 weeks
Long-term prevention of reflux
oesophagitis:
one 15 mg capsule every day, your doctor
may adjust your dose to one 30 mg capsule
every day.
Treatment of infection of Helicobacter
pylori:
The usual dose is one 30 mg capsule in
combination with two different antibiotics in
the morning and one 30 mg capsule 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 together with
250-500 mg clarithromycin and 1000 mg
amoxicillin
 30 mg Lansoprazole 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 capsule every day for 4 weeks.
Prevention of duodenal or stomach
ulcer in patients requiring continued
NSAID treatment:
one 15 mg capsule every day, your doctor
may adjust your dose to one 30 mg capsule
every day.
Zollinger-Ellison syndrome:
The usual dose is two 30 mg capsules
every day to start with, then depending on
how you respond to Lansoprazole the dose
that your doctor decides is best for you.
Use in Children
Lansoprazole 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 than
prescribed
If you take more Lansoprazole than you
have been told to, seek medical advice
quickly. Contact your doctor or the nearest
hospital casualty department immediately.
Take this leaflet and the package with you
so they know what has been taken.
If you forget to take Lansoprazole
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
capsules as normal. Do not take a double
dose to make up for a forgotten capsule.
If you stop taking Lansoprazole
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, Lansoprazole capsules
can cause side effects, although not
everybody gets them.
If you get any of the following side
effects, STOP TAKING Lansoprazole
and tell your doctor immediately or go
to the nearest hospital emergency
department:
 an allergic reaction to Lansoprazole.
You may experience some of the
following symptoms; swelling of the
face, tongue or throat which may cause
difficulty swallowing or breathing, red,
raised, lumpy rash (hives)
 reddening of the skin with blisters or
peeling. There may also be severe
blisters and bleeding in the lips, eyes,
mouth, nose and genitals you may also
have a high temperature swollen glands
or joint pain. This could be
‘Stevens-Johnson syndrome’ or ‘toxic
epidermal necrolysis’.
Talk to your doctor straight away if
you notice any of the following
serious side effects:
 Blood problems such as a reduced
number of white cells or platelets. This
can cause weakness, bruising or make
infections more likely. A blood test can
be taken to check.
 Severe kidney problems (interstitial
nephritis)
 Severe stomach or back pain. These
could be signs of pancreatitis, (an
inflammation of the pancreas).
 High temperature, tiredness, loss of
appetite, stomach pain, feeling sick
(nausea), yellowing of the skin or eyes
(jaundice) and liver failure. These are
symptoms of hepatitis (inflammation of
the liver).
Tell your doctor or pharmacist if you
notice any of the following side
effects:
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
shown by a blood test
 tiredness
The following side effects are uncommon
(occur in less than 1 in 100 patients):
 depression
 joint or muscle pain
 fluid retention or swelling
 fracture of the hip, wrist or spine
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
 anaemia (paleness)
 feelings of ants creeping over the skin
(paresthesia), trembling
 breast swelling in males, impotence
 candidiasis (fungal infection, may affect
skin or the mucosa)
The following side effects are very rare
(occur in less than 1 in 10000 patients):
 inflammation of your mouth (stomatitis)
 colitis (bowel inflammation)
 changes in test values such as sodium,
cholesterol and triglyceride levels
Frequency not known
 rash, possibly with pain in the joints
 If you are on lansoprazole 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 any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor.
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
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

Keep out of the sight and reach of
children.
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.
Store below 25ºC.
Store in the original package to help protect
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 Lansoprazole capsules contains
The active substance is lansoprazole. Each
capsule contains either 15 mg or 30 mg of
lansoprazole.
The other ingredients are:
- Capsule content: Sugar spheres
(sucrose and maize starch), Sodium
laurylsulphate, Meglumine, Mannitol
(E421), Hypromellose, Macrogol, Talc,
Polysorbate 80, Titanium dioxide
(E171), Methacrylic Acid-Ethyl Acrylate
Copolymer (1:1), Dispersion 30%
- Capsule shell: Gelatine, Titanium
dioxide (E171)
Capsule shell of 15 mg also contains:
Quinoline yellow (E104)
What Lansoprazole capsules looks
like and contents of the pack
Lansoprazole 15 mg gastro-resistant
capsules: opaque yellow cap and body
capsules.
Lansoprazole 30 mg gastro-resistant
capsules: opaque white cap and body
capsules.
Each capsule contains white or almost
white spherical microgranules.
These capsules are available in blister
packs containing 7, 14, 28, 56 or 98
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
P.C. 1060, Nicosia
CYPRUS
Manufacturer
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, Nº 7,
Polígono Industrial Miralcampo,
19200 Azuqueca de Henares
(Guadalajara)
SPAIN
This leaflet was last revised in
10/2015.
A0037&0038/O/PIL/A4

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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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