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LANSOPRAZOLE 15MG GASTRO-RESISTANT CAPSULES

Active substance(s): LANSOPRAZOLE

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Ref:

2231-30-69714-Y LEA LANSOPRAZOLE A/S CAPS TUK

Version:

3

Trackwise Parent:

142117

PL Number(s),
MA Holder & Packer:

PL 00289/1358-9. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-01133 / 231-10-01136
524 (000001101)
Univers

Base Font Size:

9 Pt

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

323 mm
200 mm
-

01 July2013
Child:

210013

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)
Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

PANTONE® GREEN C
BLACK
Template

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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 only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:

1. What Lansoprazole Capsules are and what they are used
for
2. What you need to know before you take Lansoprazole
Capsules
3. How to take Lansoprazole Capsules
4. Possible side effects
5. How to store Lansoprazole Capsules
6. Contents of the pack and other information

1 WHAT LANSOPRAZOLE CAPSULES ARE AND
Pharma code 524

WHAT THEY ARE USED FOR

Children
Lansoprazole should not be given to children.
Other medicines and Lansoprazole Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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:
• 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).
Lansoprazole Capsules 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 or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor or
pharmacist 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
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.
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.

The active ingredient in Lansoprazole 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
3 HOW TO TAKE LANSOPRAZOLE CAPSULES
written in this information leaflet. Please follow your
doctor’s instructions for taking your medicine.
Swallow the capsule whole with a glass of water. If you
find the capsules difficult to swallow your doctor may
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE advise on alternative ways to take your medicine. Do not
LANSOPRAZOLE CAPSULES
crush or chew these capsules or the content of an emptied
capsule because this will stop them from working properly.
Do not take Lansoprazole if you are:
• allergic to lansoprazole or any of the other ingredients of Always take this medicine exactly as your doctor or
Lansoprazole (listed in section 6)
pharmacist has told you. Check with your doctor or
• taking a medicine containing the active substance
pharmacist if you are not sure.
atazanavir (used in the treatment of HIV).
If you are taking Lansoprazole once a day, try to take it at
Warnings and precautions
the same time each day. You may get best results if you
Talk to your doctor or pharmacist before taking
take Lansoprazole first thing in the morning.
Lansoprazole Capsules
If you are taking Lansoprazole twice a day, you should
Please tell your doctor if you have serious liver disease.
have the first dose in the morning and the second dose in
The doctor may have to adjust your dosage.
the evening.
Your doctor may perform or have performed an additional
The dose of Lansoprazole depends on your condition. The
investigation called an endoscopy in order to diagnose
recommended dose of Lansoprazole is given below. Your
your condition and/or exclude malignant disease.
doctor will sometimes prescribe you a different dose and
If diarrhoea occurs during the treatment with Lansoprazole will tell you how long your treatment will last.
contact your doctor immediately, as Lansoprazole has been
Treatment of heartburn and acid regurgitation: one 15 mg
associated with a small increase in infectious diarrhoea.
or 30 mg capsule for 4 weeks. If symptoms persist you
If your doctor has given you Lansoprazole in addition to
should report to your doctor. If your symptoms are not
other medicines intended for the treatment of Helicobacter relieved within 4 weeks, please contact your doctor.
pylori infection (antibiotics) or together with
Treatment of duodenal ulcer: one 30 mg capsule every day
anti-inflammatory medicines to treat your pain or
for 2 weeks.
rheumatic disease: please also read the package leaflets of
Treatment of stomach ulcer: one 30 mg capsule every day
these medicines carefully.
for 4 weeks.
Taking a proton pump inhibitor like Lansoprazole Capsules,
Treatment of inflammation in your oesophagus (reflux
especially over a period of more than one year, may
oesophagitis): one 30 mg capsule every day for 4 weeks.
slightly increase your risk of fracture in the hip, wrist or
spine. Tell your doctor if you have osteoporosis or if you
Long-term prevention of reflux oesophagitis: one 15 mg
are taking corticosteroids (which can increase the risk of
capsule every day, your doctor may adjust your dose to
osteoporosis).
one 30 mg capsule every day.
If you take Lansoprazole on a long-term basis (longer than Treatment of infection of Helicobacter pylori: The usual
1 year) your doctor will probably keep you under regular
dose is one 30 mg capsule in combination with two
surveillance. You should report any new and exceptional
different antibiotics in the morning and one 30 mg capsule
symptoms and circumstances whenever you see your
in combination with two different antibiotics in the
doctor.
evening. Treatment will usually be every day for 7 days.

Top of page cut-off to middle of registration mark: 44 mm.

LANSOPRAZOLE
15 mg and 30 mg
GASTRO-RESISTANT CAPSULES

Ref:

2231-30-69714-Y LEA LANSOPRAZOLE A/S CAPS TUK

Version:

3

Trackwise Parent:

142117

PL Number(s),
MA Holder & Packer:

PL 00289/1358-9. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-01133 / 231-10-01136
524 (000001101)
Univers

Base Font Size:

9 Pt

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

323 mm
200 mm
-

01 July2013
Child:

210013

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)
Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

PANTONE® GREEN C
BLACK
Template

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.
If you take more Lansoprazole Capsules than you should
If you take more Lansoprazole than you have been told to,
seek medical advice quickly.
If you forget to take Lansoprazole Capsules
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 Capsules
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 medicine ask your doctor or pharmacist.

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 Lansoprazole 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
• an autoimmune disease of the skin known as Cutaneous
lupus erythematosus
If you are on Lansoprazole Capsules 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card 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 CAPSULES

Keep this medicine out of the sight and reach of children.
Store below 30ºC.
Like all medicines, this medicine can cause side effects,
Do not use this medicine after the expiry date that is stated
although not everybody gets them.
on the label and carton after ‘EXP:’. The expiry date refers
The following side effects are common (occur in more than to the last day of that month.
Do not throw away any medicines via wastewater or
1 in 100 patients):
household waste.
• headache, dizziness
• diarrhoea, constipation, stomach pains, feeling or being Ask your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the
sick, wind, dry or sore mouth or throat
environment.
• skin rash, itching
• changes in liver function test values
6 CONTENTS OF THE PACK AND OTHER
• tiredness.
INFORMATION
The following side effects are uncommon (occur in less
What
Lansoprazole Capsules contains
than 1 in 100 patients):
• The active substance is lansoprazole.
• depression
• The other ingredients are:
• joint or muscle pain
sugar spheres (sucrose and maize starch), sodium starch
• fluid retention or swelling
glycolate (type A), sodium laurilsulfate (type A), povidone
• changes in blood cell counts.
(K30), potassium oleate, oleic acid, hypromellose,
• fracture of the hip, wrist or spine.
methacrylic acid - ethyl acrylate copolymer 1:1, triethyl
The following side effects are rare (occur in less than 1 in
citrate, titanium dioxide (E171), talc, carrageenan,
1000 patients):
Potassium chloride and carnauba wax. The printing ink on
• fever
the capsules contains the following additional ingredients:
• restlessness, drowsiness, confusion, hallucinations,
shellac (lacca), propylene glycol, ammonium hydroxide,
insomnia, visual disturbances, vertigo
potassium hydroxide, black iron oxide (E172).
• a change in the way things taste, loss of appetite,
What Lansoprazole Capsules look like and contents of the
inflammation of your tongue (glossitis)
pack
• skin reactions such as burning or pricking feeling under
Each hard, cellulose capsule has a white cap marked with
the skin, bruising, reddening and excessive sweating
the letter L and a white body marked with the numbers 15
• sensitivity to light
or 30, depending on the product strength. The capsules
• hair loss
contain white to beige gastro- resistant micropellets
• feelings of ants creeping over the skin (paraesthesia),
containing either 15 mg or 30 mg lansoprazole.
trembling
• anaemia (paleness)
Lansoprazole Capsules are supplied in
• kidney problems
Aluminium/Aluminium blisters of 7, 14, 28, 30, 56 and 98
• pancreatitis
capsules*.
• inflammation of the liver (may be seen as yellow skin or *Not all pack sizes may be marketed.
eyes)
Marketing Authorisation Holder and Manufacturer
• breast swelling in males, impotence
Marketing Authorisation Holder
• candidiasis (fungal infection, may affect skin or the
TEVA UK Limited
mucosa)
Brampton Road, Hampden Park
• angioedema; You should see your doctor immediately if
Eastbourne
you experience symptoms of angioedema, such as
East Sussex BN22 9AG
swollen face, tongue or pharynx, difficulty to swallow,
This leaflet was last updated June 2013
hives and difficulties to breath.

4 POSSIBLE SIDE EFFECTS

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

69714-Y

200 X 323

25 mm.

LANSOPRAZOLE
15 mg and 30 mg
GASTRO-RESISTANT
CAPSULES

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

9 Pt
Base Font Size:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

BLACK

Template

470 mm
140 mm
L:
W:
D:
Foil Width:
Perforated:

Dimensions:

231-10-01133 / 231-10-01136
Univers
F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

5 mm.

25 mm.

Trackwise Parent:

PL 00289/1358-9. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at: Zaragosa.
PL Number(s),
MA Holder & Packer:

3
Version:

142117

231-30-11112-C LEA LANSOPRAZOLE A/S CAPS TUK Ref:

Child:

210013

25 mm.

25 mm.

LAETUS

01 July2013

5 mm.
DIR. LECTURA

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

In particular tell your doctor if you are
taking medicines containing any of the
Read all of this leaflet carefully before following active substances as
you start taking this medicine because Lansoprazole may affect the way these
it contains important information for
drugs work:
you.
• ketoconazole, itraconazole,
• Keep this leaflet. You may need to
rifampicin (used to treat infections)
read it again.
• digoxin (used to treat heart
• If you have any further questions,
problems)
ask your doctor or pharmacist.
• theophylline (used to treat asthma)
• This medicine has been prescribed
• tacrolimus (used to prevent
for you only. Do not pass it on to
transplant rejection)
others. It may harm them, even if
• fluvoxamine (used to treat
their signs of illness are the same as
depression and other psychiatric
yours.
diseases)
• If you get any of the side effects, talk • antacids (used to treat heartburn or
to your doctor or pharmacist . This
acid regurgitation)
includes any possible side effects not • sucralfate (used for healing ulcers)
listed in this leaflet. See section 4.
• St John´s wort (Hypericum
perforatum) (used to treat mild
WHAT IS IN THIS LEAFLET:
depression)
1. What Lansoprazole Capsules are and
Lansoprazole
Capsules with food and
what they are used for
2. What you need to know before you drink
For the best results from your medicines
take Lansoprazole Capsules
3. How to take Lansoprazole Capsules you should take Lansoprazole at least
30 minutes before food.
4. Possible side effects
5. How to store Lansoprazole Capsules Pregnancy and breast-feeding
6. Contents of the pack and other
If you are pregnant or breast-feeding,
information
think you may be pregnant or planning
to have a baby, ask your doctor or
WHAT
LANSOPRAZOLE
1 CAPSULES ARE AND WHAT
pharmacist for advice before taking
this medicine.
THEY ARE USED FOR

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
Your doctor may prescribe Lansoprazole caution as your ability to react may be
for the following indications:
decreased.
• Treatment of duodenal and stomach You alone are responsible to decide if
ulcer
you are in a fit condition to drive a
• Treatment of inflammation in your
motor vehicle or perform other tasks
oesophagus (reflux oesophagitis)
that demand increased concentration.
• Prevention of reflux oesophagitis
Because of their effects or undesirable
• Treatment of heartburn and acid
effects, one of the factors that can
regurgitation
reduce your ability to do these things
• Treatment of infections caused by
safely is your use of medicines.
the bacteria Helicobacter pylori when Descriptions of these effects can be
given in combination with antibiotic found in other sections.
therapy
Read all the information in this leaflet
• Treatment or prevention of duodenal for guidance.
or stomach ulcer in patients
Discuss with your doctor, nurse or
requiring continued NSAID
• treatment (NSAID treatment is used pharmacist if you are unsure about
anything.
against pain or inflammation)
• Treatment of Zollinger-Ellison
Lansoprazole Capsules contain sucrose
syndrome.
If you have been told by your doctor
that you have an intolerance to some
Your doctor may have prescribed
Lansoprazole for another indication or sugars, contact your doctor before
with a dose different from that which is taking this medicine.
written in this information leaflet.
TO TAKE
3 HOW
Please follow your doctor’s
LANSOPRAZOLE CAPSULES
instructions for taking your medicine.
Swallow the capsule whole with a
YOU NEED TO KNOW
glass of water. If you find the capsules
2 WHAT
BEFORE YOU TAKE
difficult to swallow your doctor may
LANSOPRAZOLE CAPSULES
advise on alternative ways to take your
medicine. Do not crush or chew these
Do not take Lansoprazole if you are:
• allergic to lansoprazole or any of the capsules or the content of an emptied
capsule because this will stop them
other ingredients of Lansoprazole
from working properly.
(listed in section 6)
• taking a medicine containing the
Always take this medicine exactly as
active substance atazanavir (used in your doctor or pharmacist has told
the treatment of HIV).
you. Check with your doctor or
pharmacist if you are not sure.
Warnings and precautions
Talk to your doctor or pharmacist
If you are taking Lansoprazole once a
before taking Lansoprazole Capsules
day, try to take it at the same time each
Please tell your doctor if you have
day. You may get best results if you
serious liver disease. The doctor may
take Lansoprazole first thing in the
have to adjust your dosage.
morning.
Your doctor may perform or have
If you are taking Lansoprazole twice a
performed an additional investigation day, you should have the first dose in
called an endoscopy in order to
the morning and the second dose in
diagnose your condition and/or
the evening.
exclude malignant disease.
The dose of Lansoprazole depends on
If diarrhoea occurs during the treatment your condition.The recommended
with Lansoprazole contact your doctor dose of Lansoprazole is given below.
immediately, as Lansoprazole has
Your doctor will sometimes prescribe
been associated with a small increase you a different dose and will tell you
in infectious diarrhoea.
how long your treatment will last.
If your doctor has given you
Treatment of heartburn and acid
Lansoprazole in addition to other
regurgitation: one 15 mg or 30 mg
medicines intended for the treatment
capsule for 4 weeks. If symptoms
of Helicobacter pylori infection
persist you should report to your
(antibiotics) or together with
doctor. If your symptoms are not
anti-inflammatory medicines to treat
relieved within 4 weeks, please contact
your pain or rheumatic disease: please your doctor.
also read the package leaflets of these
Treatment of duodenal ulcer: one
medicines carefully.
30 mg capsule every day for 2 weeks.
Taking a proton pump inhibitor like
Lansoprazole Capsules, especially over Treatment of stomach ulcer: one
30 mg capsule every day for 4 weeks.
a period of more than one year, may
slightly increase your risk of fracture in Treatment of inflammation in your
the hip, wrist or spine. Tell your doctor oesophagus (reflux oesophagitis): one
if you have osteoporosis or if you are
30 mg capsule every day for 4 weeks.
taking corticosteroids (which can
Long-term prevention of reflux
increase the risk of osteoporosis).
oesophagitis: one 15 mg capsule every
If you take Lansoprazole on a
day, your doctor may adjust your dose
long-term basis (longer than 1 year)
to one 30 mg capsule every day.
your doctor will probably keep you
Treatment of infection of Helicobacter
under regular surveillance. You should
pylori: The usual dose is one 30 mg
report any new and exceptional
capsule in combination with two
symptoms and circumstances
different antibiotics in the morning and
whenever you see your doctor.
one 30 mg capsule in combination
Children
with two different antibiotics in the
Lansoprazole should not be given to
evening. Treatment will usually be
children.
every day for 7 days.
The active ingredient in Lansoprazole
is lansoprazole, which is a proton
pump inhibitor. Proton pump
inhibitors reduce the amount of acid
that your stomach makes.

Cara A 140 x 470

Doble a 74 mm.

Doble a 114 mm.

Doble a 154 mm.

Pre-plegado a
235 mm.

9 Pt
Base Font Size:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

BLACK

Template

L:
W:
D:
Foil Width:
Perforated:

231-10-01133 / 231-10-01136
Univers
210013

PL Number(s),
MA Holder & Packer:

Trackwise Parent:

PL 00289/1358-9. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at: Zaragosa.

Child:

3
Version:

142117

231-30-11112-C LEA LANSOPRAZOLE A/S CAPS TUK Ref:

• very severe skin reactions with
reddening, blistering, severe
inflammation and skin loss.
• very rarely Lansoprazole 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
If you are being treated for infection
deterioration of your general
because you have an ulcer, it is
condition, or fever with local
unlikely that your ulcer will return if
infection symptoms such as sore
the infection is successfully treated. To
throat/pharynx/mouth or urinary
give your medicine the best chance of
problems you should see your
working, take it at the right time and
doctor immediately. A blood test will
do not miss a dose.
be taken to check possible reduction
Treatment of duodenal or stomach
of white blood cells
ulcer in patients requiring continued
(agranulocytosis).
NSAID treatment: one 30 mg capsule
Frequency not known
every day for 4 weeks.
• an autoimmune disease of the skin
Prevention of duodenal or stomach
known as Cutaneous lupus
ulcer in patients requiring continued
erythematosus
NSAID treatment: one 15 mg capsule
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

every day, your doctor may adjust your If you are on Lansoprazole Capsules
dose to one 30 mg capsule every day. for more than three months it is
Zollinger-Ellison syndrome: The usual possible that the levels of magnesium
dose is two 30 mg capsules every day in your blood may fall. Low levels of
magnesium can be seen as fatigue,
to start with, then depending on how
you respond to Lansoprazole the dose involuntary muscle contractions,
that your doctor decides is best for you. disorientation, convulsions, dizziness,
increased heart rate. If you get any of
Use in children
these symptoms, please tell your
Lansoprazole should not be given to
doctor promptly. Low levels of
children.
magnesium can also lead to a
reduction in potassium or calcium
If you take more Lansoprazole
levels in the blood. Your doctor may
Capsules than you should
decide to perform regular blood tests
If you take more Lansoprazole than
to monitor your levels of magnesium.
you have been told to, seek medical
advice quickly.
Reporting of side effects
If you get any side effects, talk to your
If you forget to take Lansoprazole
doctor, pharmacist or nurse. This
Capsules
includes any possible side effects not
If you forget to take a dose, take it as
listed in this leaflet. You can also
soon as your remember unless it is
report side effects directly via the
nearly time for your next dose. If this
happens skip the missed dose and take Yellow Card Scheme at:
the remaining capsules as normal. Do www.mhra.gov.uk/yellowcard
not take a double dose to make up for By reporting side effects you can help
provide more information on the
a forgotten capsule.
safety of this medicine.
If you stop taking Lansoprazole
TO STORE
Capsules
5 HOW
LANSOPRAZOLE CAPSULES
Do not stop treatment early because
your symptoms have got better. Your
Keep this medicine out of the sight and
condition may not have been fully
reach of children.
healed and may reoccur if you do not
finish your course of treatment. If you Store below 30ºC.
have any further questions on the use Do not use this medicine after the
of this medicine ask your doctor or
expiry date that is stated on the label
pharmacist.
and carton after ‘EXP:’. The expiry date
refers to the last day of that month.
4 POSSIBLE SIDE EFFECTS
Do not throw away any medicines via
wastewater or household waste.
Like all medicines, this medicine can
Ask your pharmacist how to throw
cause side effects, although not
away medicines you no longer use.
everybody gets them.
These measures will help to protect
The following side effects are common the environment.
(occur in more than 1 in 100 patients):
OF THE PACK AND
6 CONTENTS
• headache, dizziness
OTHER INFORMATION
• diarrhoea, constipation, stomach
pains, feeling or being sick, wind, dry What Lansoprazole Capsules contains
• The active substance is lansoprazole.
or sore mouth or throat
• The other ingredients are:
• skin rash, itching
• changes in liver function test values sugar spheres (sucrose and maize
starch), sodium starch glycolate (type
• tiredness.
A), sodium laurilsulfate (type A),
The following side effects are
uncommon (occur in less than 1 in 100 povidone (K30), potassium oleate,
oleic acid, hypromellose, methacrylic
patients):
acid - ethyl acrylate copolymer 1:1,
• depression
triethyl citrate, titanium dioxide (E171),
• joint or muscle pain
talc, carrageenan, Potassium chloride
• fluid retention or swelling
and carnauba wax. The printing ink on
• changes in blood cell counts.
the capsules contains the following
• fracture of the hip, wrist or spine.
additional ingredients: shellac (lacca),
The following side effects are rare
propylene glycol, ammonium
(occur in less than 1 in 1000 patients): hydroxide, potassium hydroxide, black
• fever
iron oxide (E172).
• restlessness, drowsiness, confusion,
What Lansoprazole Capsules look like
hallucinations, insomnia, visual
and contents of the pack
disturbances, vertigo
Each hard, cellulose capsule has a
• a change in the way things taste,
white cap marked with the letter L and
loss of appetite, inflammation of
a white body marked with the numbers
your tongue (glossitis)
15 or 30, depending on the product
• skin reactions such as burning or
strength. The capsules contain white to
pricking feeling under the skin,
beige gastro- resistant micropellets
bruising, reddening and excessive
containing either 15 mg or 30 mg
sweating
lansoprazole.
• sensitivity to light
Lansoprazole Capsules are supplied in
• hair loss
Aluminium/Aluminium blisters of 7, 14,
• feelings of ants creeping over the
28, 30, 56 and 98 capsules*.
skin (paraesthesia), trembling
*Not all pack sizes may be marketed.
• anaemia (paleness)
• kidney problems
Marketing Authorisation Holder and
• pancreatitis
Manufacturer
• inflammation of the liver (may be
Marketing Authorisation Holder
seen as yellow skin or eyes)
• breast swelling in males, impotence TEVA UK Limited
Brampton Road, Hampden Park
• candidiasis (fungal infection, may
Eastbourne
affect skin or the mucosa)
East Sussex BN22 9AG
• angioedema; You should see your
doctor immediately if you experience Manufacturer:
symptoms of angioedema, such as
Teva Pharma S.L.U.
swollen face, tongue or pharynx,
Poligono Industrial Malpica,
difficulty to swallow, hives and
calle C, Numero 4,
difficulties to breath.
50016 Zaragoza,
The following side effects are very rare Spain
(occur in less than 1 in 10000 patients): Telephone: 00 34 976 57 17 84
Telefax: 00 34 976 57 26 63
• severe hypersensitivity reactions
including shock. Symptoms of a
This leaflet was last updated June 2013
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
11112-C

01 July2013

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

Dimensions:

470 mm
140 mm
-

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C

25 mm.

140 x 470

25 mm.

000000000/P0

Cara B 140 x 470

Pre-plegado a
235 mm.

Expand view ⇕

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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