LANSOPRAZOLE 15MG GASTRO-RESISTANT CAPSULES

Active substance: LANSOPRAZOLE

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Ref:

231-30-69714-X LEA LANSOPRAZOLE A/S CAPS TUK

Version:

1

15 August 2012

PL Number(s),
PL 00289/1358-9. Teva UK Ltd Licence. (Responsible Regulatory Dept = Post-licence Regulatory Team),
MA Holder & Packer: MA Holder: TEVA UK Limited. Packed at TEVA UK Ltd, Eastbourne, Packing line: UHLMANN.
Reason for revision: Version 1: Regulatory text updates from Reg. Affairs 15/05/12 12:23. V2: Remove personal details from Header Box.

PAGE 1: FRONT FACE (INSIDE OF REEL)

Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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).

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
or pharmacist.
IN THIS LEAFLET:

1. What Lansoprazole Capsules are and what they are used
for
2. Before you take Lansoprazole Capsules
3. How to take Lansoprazole Capsules
4. Possible side effects
5. How to store Lansoprazole Capsules
6. Further information

1

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
WHAT LANSOPRAZOLE CAPSULES ARE AND WHAT taking this medicine.

THEY ARE USED FOR

Pharma code 524

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
written in this information leaflet. Please follow your
doctor’s instructions for taking your medicine.

2

Taking Lansoprazole Capsules with food and drink
For the best results from your medicines you should take
Lansoprazole at least 30 minutes before food.

BEFORE YOU TAKE LANSOPRAZOLE CAPSULES

Do not take Lansoprazole if you are:
• allergic (hypersensitive) to lansoprazole or any of the other
ingredients of Lansoprazole
• taking a medicine containing the active substance
atazanavir (used in the treatment of HIV).
Take special care with Lansoprazole Capsules
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 Capsules,
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).

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 contains 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 CAPSULES

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 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.

If you take Lansoprazole on a long-term basis (longer than 1 Treatment of inflammation in your oesophagus (reflux
oesophagitis): one 30 mg capsule every day for 4 weeks.
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. 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.

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

LANSOPRAZOLE
15 mg and 30 mg
GASTRO-RESISTANT CAPSULES

Ref:

231-30-69714-X LEA LANSOPRAZOLE A/S CAPS TUK

Version:

1

15 August 2012

PL Number(s),
PL 00289/1358-9. Teva UK Ltd Licence. (Responsible Regulatory Dept = Post-licence Regulatory Team),
MA Holder & Packer: MA Holder: TEVA UK Limited. Packed at TEVA UK Ltd, Eastbourne, Packing line: UHLMANN.
Reason for revision: Version 1: Regulatory text updates from Reg. Affairs 15/05/12 12:23. V2: Remove personal details from Header Box.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Treatment of infection of Helicobacter pylori: The usual dose is • breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or the
one 30 mg capsule in combination with two different
mucosa)
antibiotics in the morning and one 30 mg capsule in
• angioedema; You should see your doctor immediately if
combination with two different antibiotics in the evening.
you experience symptoms of angioedema, such as swollen
Treatment will usually be every day for 7 days.
face, tongue or pharynx, difficulty to swallow, hives and
The recommended combinations of antibiotics are:
difficulties to breath.
• 30 mg Lansoprazole together with 250-500 mg
The following side effects are very rare (occur in less than 1
clarithromycin and 1000 mg amoxicillin
in 10000 patients):
• 30 mg Lansoprazole together with 250 mg clarithromycin
• severe hypersensitivity reactions including shock.
and 400-500 mg metronidazole
Symptoms of a hypersensitivity reaction may include
If you are being treated for infection because you have an
fever, rash, swelling and sometimes a fall in blood
ulcer, it is unlikely that your ulcer will return if the infection is
pressure
successfully treated. To give your medicine the best chance of • inflammation of your mouth (stomatitis)
working, take it at the right time and do not miss a dose.
• colitis (bowel inflammation)
• changes in test values such as sodium, cholesterol and
Treatment of duodenal or stomach ulcer in patients requiring
triglyceride levels
continued NSAID treatment: one 30 mg capsule every day for • very severe skin reactions with reddening, blistering,
4 weeks.
severe inflammation and skin loss.
• very rarely Lansoprazole may cause a reduction in the
Prevention of duodenal or stomach ulcer in patients requiring
number of white blood cells and your resistance to
continued NSAID treatment: one 15 mg capsule every day,
infection may be decreased. If you experience an infection
your doctor may adjust your dose to one 30 mg capsule every
with symptoms such as fever and serious deterioration of
day.
your general condition, or fever with local infection
symptoms such as sore throat/pharynx/mouth or urinary
Zollinger-Ellison syndrome: The usual dose is two 30 mg
problems you should see your doctor immediately. A
capsules every day to start with, then depending on how you
blood test will be taken to check possible reduction of
respond to Lansoprazole the dose that your doctor decides is
white blood cells (agranulocytosis).
best for you.
Frequency not known
If you are on Lansoprazole Capsules for more than three
Lansoprazole should not be given to children.
months it is possible that the levels of magnesium in your
blood may fall. Low levels of magnesium can be seen as
Take your medicine exactly as your doctor has told you. You
should check with your doctor if you are not sure how to take fatigue, involuntary muscle contractions, disorientation,
convulsions, dizziness, increased heart rate. If you get any of
your medicine.
these symptoms, please tell your doctor promptly. Low levels
of magnesium can also lead to a reduction in potassium or
If you take more Lansoprazole Capsules than you should
calcium levels in the blood. Your doctor may decide to perform
If you take more Lansoprazole than you have been told to,
regular blood tests to monitor your levels of magnesium.
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 product, ask your
doctor.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Lansoprazole 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.
• 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
• feelings of ants creeping over the skin (paraesthesia),
trembling
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be seen as yellow skin or eyes)

If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.

5

HOW TO STORE LANSOPRAZOLE CAPSULES

Keep out of the reach and sight of children.
Store below 30ºC.
Do not use Lansoprazole Capsules after the expiry date that
is stated on the label and carton after ‘EXP:’. The expiry date
refers to the last day of that month.
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 contain
• The active substance is lansoprazole.
• The other ingredients are:
sugar spheres (sucrose and maize starch), sodium starch
glycolate (type A), sodium laurilsulfate (type A), povidone
(K30), potassium oleate, oleic acid, hypromellose,
methacrylic acid - ethyl acrylate copolymer 1:1, triethyl
citrate, titanium dioxide (E171), talc, carrageenan, Potassium
chloride and carnauba wax. The printing ink on the capsules
contains the following additional ingredients: shellac (lacca),
propylene glycol, ammonium hydroxide, potassium
hydroxide, black iron oxide (E172).
What Lansoprazole Capsules look like and contents of the
pack
Each hard, cellulose capsule has a white cap marked with the
letter L and a white body marked with the numbers 15 or 30,
depending on the product strength. The capsules contain
white to beige gastro-resistant micropellets containing either
15 mg or 30 mg lansoprazole.
Lansoprazole Capsules are supplied in
Aluminium/Aluminium blisters of 7, 14, 28, 30, 56 and 98
capsules*.
*Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park,
Eastbourne, East Sussex, BN22 9AG, United Kingdom.
This leaflet was last updated May 2012
PL 00289/1358-9
69714-X

Posición de Laetus 6
Taking other medicines
Please tell your doctor if you are taking
or have recently taken any other
medicines, including medicines
obtained without a prescription.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Version:

2

14 August 2012

5 mm.

Reason for revision: Version 1: Regulatory text updates - 15/05/12 12:23.
V2: Removal of name from Header box (14/08/12 12:07)

PL Number(s),
PL 00289/1358-9. (Responsible Regulatory Officer = Yogesh Toraskar),
MA Holder & Packer: Packed at Zaragosa

LAETUS

Ref:

25 mm.

DIR. LECTURA

231-30-11112-B LEA LANSOPRAZOLE A/S CAPS TUK
25 mm.

Your doctor may perform or have
performed an additional investigation
called an endoscopy in order to
diagnose your condition and/or
exclude malignant disease.

LAETUS

Doble a 154 mm.

Pre-plegado a 235 mm.

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 diarrhoea occurs during the
treatment with Lansoprazole contact
your doctor immediately, as
Lansoprazole has been associated with
a small increase in infectious
diarrhoea.

DIR. LECTURA

Pregnancy and breast-feeding
If you are pregnant, breast-feeding or if
The active ingredient in Lansoprazole
there is a chance you might be
is lansoprazole, which is a proton
pregnant ask your doctor for advice
pump inhibitor. Proton pump inhibitors before taking this medicine.
reduce the amount of acid that your
stomach makes.
Driving and using machines
Side effects such as dizziness, vertigo,
Your doctor may prescribe
tiredness and visual disturbances
Lansoprazole for the following
sometimes occur in patients taking
indications:
Lansoprazole. If you experience side
• Treatment of duodenal and stomach effects like these you should take
ulcer
caution as your ability to react may be
• Treatment of inflammation in your
decreased.
oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
You alone are responsible to decide if
• Treatment of heartburn and acid
you are in a fit condition to drive a
regurgitation
motor vehicle or perform other tasks
• Treatment of infections caused by
that demand increased concentration.
the bacteria Helicobacter pylori when Because of their effects or undesirable
given in combination with antibiotic effects, one of the factors that can
therapy
reduce your ability to do these things
• Treatment or prevention of duodenal safely is your use of medicines.
or stomach ulcer in patients
Descriptions of these effects can be
requiring continued NSAID
found in other sections.
treatment (NSAID treatment is used Read all the information in this leaflet
against pain or inflammation)
for guidance.
• Treatment of Zollinger-Ellison
syndrome.
Discuss with your doctor, nurse or
pharmacist if you are unsure about
Your doctor may have prescribed
Lansoprazole for another indication or anything.
with a dose different from that which is
Important information about some of
written in this information leaflet.
the ingredients of Lansoprazole
Please follow your doctor’s
Capsules
instructions for taking your medicine.
Lansoprazole contains sucrose. If you
have been told by your doctor that you
BEFORE YOU TAKE
2 LANSOPRAZOLE CAPSULES
have an intolerance to some sugars,
contact your doctor before taking this
medicine.
Do not take Lansoprazole if you are:
• allergic (hypersensitive) to
lansoprazole or any of the other
3 HOW TO TAKE LANSOPRAZOLE
CAPSULES
ingredients of Lansoprazole
• taking a medicine containing the
active substance atazanavir (used in Swallow the capsule whole with a
glass of water. If you find the capsules
the treatment of HIV).
difficult to swallow your doctor may
advise on alternative ways to take your
Take special care with Lansoprazole
medicine. Do not crush or chew these
Capsules
capsules or the content of an emptied
Please tell your doctor if you have
capsule because this will stop them
serious liver disease. The doctor may
from working properly.
have to adjust your dosage.

Doble a 114 mm.

LAETUS

CAPSULES ARE AND WHAT
THEY ARE USED FOR

Doble a 74 mm.

DIR. LECTURA

LAETUS

DIR. LECTURA

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.
Lansoprazole may affect the way these
• Keep this leaflet. You may need to
drugs work:
read it again.
• ketoconazole, itraconazole,
• If you have any further questions,
rifampicin (used to treat infections)
ask your doctor or pharmacist.
• digoxin (used to treat heart
• This medicine has been prescribed
problems)
for you. Do not pass it on to others. It • theophylline (used to treat asthma)
may harm them, even if their
• tacrolimus (used to prevent
symptoms are the same as yours.
transplant rejection)
• If any of the side effects get serious, • fluvoxamine (used to treat
or if you notice any side effects not
depression and other psychiatric
listed in this leaflet, please tell your
diseases)
doctor or pharmacist.
• antacids (used to treat heartburn or
acid regurgitation)
IN THIS LEAFLET:
• sucralfate (used for healing ulcers)
1. What Lansoprazole Capsules are
• St John´s wort (Hypericum
and what they are used for
perforatum) (used to treat mild
2. Before you take Lansoprazole
depression).
Capsules
3. How to take Lansoprazole Capsules Taking Lansoprazole Capsules with
4. Possible side effects
food and drink
5. How to store Lansoprazole Capsules For the best results from your
6. Further information
medicines you should take
Lansoprazole at least 30 minutes
before food.
1 WHAT LANSOPRAZOLE

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.

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 Treatment of heartburn and acid
also read the package leaflets of these regurgitation: one 15 mg or 30 mg
capsule for 4 weeks. If symptoms
medicines carefully.
persist you should report to your
doctor. If your symptoms are not
Taking a proton pump inhibitor like
Lansoprazole Capsules, especially over relieved within 4 weeks, please contact
your doctor.
a period of more than one year, may
slightly increase your risk of fracture in
the hip, wrist or spine. Tell your doctor Treatment of duodenal ulcer: one 30 mg
capsule every day for 2 weeks.
if you have osteoporosis or if you are
taking corticosteroids (which can
Treatment of stomach ulcer: one 30 mg
increase the risk of osteoporosis).
capsule every day for 4 weeks.
If you take Lansoprazole on a
Treatment of inflammation in your
long-term basis (longer than 1 year)
oesophagus (reflux oesophagitis): one
your doctor will probably keep you
under regular surveillance. You should 30 mg capsule every day for 4 weeks.
report any new and exceptional
Long-term prevention of reflux
symptoms and circumstances
oesophagitis: one 15 mg capsule every
whenever you see your doctor.
day, your doctor may adjust your dose
to one 30 mg capsule every day.
25 mm.

Cara A 140 x 470

LAETUS

LAETUS

DIR. LECTURA

5 mm.

LANSOPRAZOLE
15 mg and 30 mg
GASTRO-RESISTANT
CAPSULES

DIR. LECTURA

25 mm.

25 mm.

LAETUS

DIR. LECTURA

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.

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.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Lansoprazole 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.
• 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
• feelings of ants creeping over the
skin (paraesthesia), 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.

Do not use Lansoprazole Capsules
after the expiry date that is stated on
the label and carton after ‘EXP:’. The
expiry date refers to the last day of that
month.

6

Pre-plegado a 235 mm.

FURTHER INFORMATION

What Lansoprazole Capsules contain
• The active substance is lansoprazole.
• The other ingredients are:
sugar spheres (sucrose and maize
starch), sodium starch glycolate (type
A), sodium laurilsulfate (type A),
povidone (K30), potassium oleate,
oleic acid, hypromellose, methacrylic
acid - ethyl acrylate copolymer 1:1,
triethyl citrate, titanium dioxide (E171),
talc, carrageenan, Potassium chloride
and carnauba wax. The printing ink on
the capsules contains the following
additional ingredients: shellac (lacca),
propylene glycol, ammonium
hydroxide, potassium hydroxide, black
iron oxide (E172).
What Lansoprazole Capsules look like
and contents of the pack
Each hard, cellulose capsule has a
white cap marked with the letter L and
a white body marked with the
numbers 15 or 30, depending on the
product strength. The capsules contain
white to beige gastro-resistant
micropellets containing either 15 mg
or 30 mg lansoprazole.
Lansoprazole Capsules are supplied in
Aluminium/Aluminium blisters of 7, 14,
28, 30, 56 and 98 capsules*.
*Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
TEVA UK Limited, Brampton Road,
Hampden Park, Eastbourne,
East Sussex, BN22 9AG, United
Kingdom.
Manufacturer:
Teva Pharma S.L.U.
Poligono Industrial Malpica, calle C,
Numero 4, 50016 Zaragoza, Spain
Telephone: 00 34 976 57 17 84
Telefax: 00 34 976 57 26 63
This leaflet was last updated May 2012
PL 00289/1358-9
LAETUS

Reason for revision: Version 1: Regulatory text updates - 15/05/12 12:23.
V2: Removal of name from Header box (14/08/12 12:07)

PL Number(s),
PL 00289/1358-9. (Responsible Regulatory Officer = Yogesh Toraskar),
MA Holder & Packer: Packed at Zaragosa

Keep out of the reach and sight of
children.
Store below 30ºC.

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 product, ask your doctor.

2

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.

11112-B

25 mm.

000000000/P0

Cara B 140 x 470

DIR. LECTURA

14 August 2012

Frequency not known
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
Zollinger-Ellison syndrome: The usual magnesium can be seen as fatigue,
dose is two 30 mg capsules every day involuntary muscle contractions,
disorientation, convulsions, dizziness,
to start with, then depending on how
you respond to Lansoprazole the dose increased heart rate. If you get any of
that your doctor decides is best for you. these symptoms, please tell your doctor
promptly. Low levels of magnesium can
Lansoprazole should not be given to
also lead to a reduction in potassium or
children.
calcium levels in the blood. Your doctor
may decide to perform regular blood
Take your medicine exactly as your
tests to monitor your levels of
doctor has told you. You should check
magnesium.
with your doctor if you are not sure
If any of the side effects become
how to take your medicine.
serious, or if you notice any side
effects not listed in this leaflet, please
If you take more Lansoprazole
tell your doctor.
Capsules than you should
If you take more Lansoprazole than
you have been told to, seek medical
5 HOW TO STORE CAPSULES
LANSOPRAZOLE
advice quickly.

Version:

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

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 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).

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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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