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LANSOPRAZOLE 15MG GASTRO-RESISTANT CAPSULES

Active substance(s): LANSOPRAZOLE

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TEVA UK Ref:

Version:

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

2

6 November 2015

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 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

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.

What Lansoprazole Capsules are and what they
Pregnancy and breast-feeding
are used for
If you are pregnant or breast-feeding, think you may be

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

surveillance. You should report any new and exceptional
symptoms and circumstances whenever you see your
doctor.

What you need to know before you take
Lansoprazole Capsules

Do not take Lansoprazole if you are:
• allergic to lansoprazole or any of the other ingredients of
Lansoprazole (listed in section 6)
• taking a medicine containing the active substance
atazanavir (used in the treatment of HIV).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lansoprazole
Capsules
• 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-effects like pain in your joints.
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).
If you take Lansoprazole on a long-term basis (longer than 1
year) your doctor will probably keep you under regular

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.

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.
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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
recommended dose of Lansoprazole is 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.
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.

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

LANSOPRAZOLE 15 MG & 30 MG
GASTRO-RESISTANT CAPSULES

TEVA UK Ref:

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

Version:

2

6 November 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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,
If you are being treated for infection because you have an
severe inflammation and skin loss.
ulcer, it is unlikely that your ulcer will return if the infection
• very rarely Lansoprazole may cause a reduction in the
is successfully treated. To give your medicine the best
number of white blood cells and your resistance to
chance of working, take it at the right time and do not miss a
infection may be decreased. If you experience an infection
dose.
with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection
Treatment of duodenal or stomach ulcer in patients
symptoms such as sore throat/pharynx/mouth or urinary
requiring continued NSAID treatment: one 30 mg capsule
problems you should see your doctor immediately. A
every day for 4 weeks.
blood test will be taken to check possible reduction of
Prevention of duodenal or stomach ulcer in patients
white blood cells (agranulocytosis).
requiring continued NSAID treatment: one 15 mg capsule
Frequency not known
every day, your doctor may adjust your dose to one 30 mg
capsule every day.
• an autoimmune disease of the skin known as Cutaneous
lupus erythematosus
Zollinger-Ellison syndrome: The usual dose is two 30 mg
capsules every day to start with, then depending on how you • rash, possibly with pain in the joints
respond to Lansoprazole the dose that your doctor decides is If you are on Lansoprazole Capsules for more than three
best for you.
months it is possible that the levels of magnesium in your
blood may fall. Low levels of magnesium can be seen as
Use in children
fatigue, involuntary muscle contractions, disorientation,
Lansoprazole should not be given to children.
convulsions, dizziness, increased heart rate. If you get any of
these symptoms, please tell your doctor promptly. Low
If you take more Lansoprazole Capsules than you should
levels of magnesium can also lead to a reduction in
If you take more Lansoprazole than you have been told to,
potassium or calcium levels in the blood. Your doctor may
seek medical advice quickly.
decide to perform regular blood tests to monitor your levels
If you forget to take Lansoprazole Capsules
of magnesium.
If you forget to take a dose, take it as soon as your
Reporting of side effects
remember unless it is nearly time for your next dose. If this
If you get any side effects, talk to your doctor, pharmacist or
happens skip the missed dose and take the remaining
nurse. This includes any possible side effects not listed in
capsules as normal. Do not take a double dose to make up
this leaflet. You can also report side effects directly via the
for a forgotten capsule.
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
If you stop taking Lansoprazole Capsules
By reporting side effects you can help provide more
Do not stop treatment early because your symptoms have
information on the safety of this medicine.
got better. Your condition may not have been fully healed
and may reoccur if you do not finish your course of
5 How to store Lansoprazole Capsules
treatment. If you have any further questions on the use of
this,medicine ask your doctor or pharmacist.
Keep this medicine out of the sight and reach of children.
Store below 30ºC.
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

4

Possible side effects

Do not use this medicine 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.
Do not throw away any medicines via wastewater or
The following side effects are common (occur in more than 1 household waste.
in 100 patients):
Ask your pharmacist how to throw away medicines you no
• headache, dizziness
longer use. These measures will help to protect the
• diarrhoea, constipation, stomach pains, feeling or being
environment.
sick, wind, dry or sore mouth or throat
• skin rash, itching
6 Contents of the pack and other information
• changes in liver function test values
• tiredness.
What Lansoprazole Capsules contains
The following side effects are uncommon (occur in less than • The active substance is lansoprazole.
1 in 100 patients):
• The other ingredients are:
• depression
sugar spheres (sucrose and maize starch), sodium starch
• joint or muscle pain
glycolate (type A), sodium laurilsulfate (type A), povidone
• fluid retention or swelling
(K30), potassium oleate, oleic acid, hypromellose,
• changes in blood cell counts.
methacrylic acid - ethyl acrylate copolymer 1:1, triethyl
• fracture of the hip, wrist or spine.
citrate, titanium dioxide (E171), talc, carrageenan, Potassium
chloride and carnauba wax.. The printing ink on the capsules
The following side effects are rare (occur in less than 1 in
contains the following additional ingredients: shellac (lacca),
1000 patients):
propylene glycol, ammonium hydroxide, potassium
• fever
hydroxide, black iron oxide (E172).
• restlessness, drowsiness, confusion, hallucinations,
insomnia, visual disturbances, vertigo
What Lansoprazole Capsules look like and contents of the
• a change in the way things taste, loss of appetite,
pack
inflammation of your tongue (glossitis)
Each hard, cellulose capsule has a white cap marked with
• skin reactions such as burning or pricking feeling under
the letter L and a white body marked with the numbers 15 or
the skin, bruising, reddening and excessive sweating
30, depending on the product strength. The capsules contain
• sensitivity to light
white to beige gastro-resistant micropellets containing either
• hair loss
15 mg or 30 mg lansoprazole.
• feelings of ants creeping over the skin (paraesthesia),
Lansoprazole Capsules are supplied in
trembling
Aluminium/Aluminium blisters of 7, 14, 28, 30, 56 and 98
• anaemia (paleness)
capsules*.
• kidney problems
*Not all pack sizes may be marketed.
• pancreatitis
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

• 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

Marketing Authorisation Holder and Manufacturer
TEVA UK Limited
Brampton Road, Hampden Park
Eastbourne
East Sussex BN22 9AG
This leaflet was last updated November 2015

69714-Z
200 X 323

TEVA UK Ref:

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:
Package Leaflet:
Information For the patient
• ketoconazole, itraconazole, rifampicin (used
to treat infections)
Read all of this leaflet carefully before you
start taking this medicine because it contains • digoxin (used to treat heart problems)
• theophylline (used to treat asthma)
important information for you.
• tacrolimus (used to prevent transplant
• Keep this leaflet. You may need to read it
rejection)
again.
• If you have any further questions, ask your • fluvoxamine (used to treat depression and
other psychiatric diseases)
doctor or pharmacist.
• This medicine has been prescribed for you • antacids (used to treat heartburn or acid
regurgitation)
only. Do not pass it on to others. It may
harm them, even if their signs of illness are • sucralfate (used for healing ulcers)
• St John’s wort (Hypericum perforatum)
the same as yours.
(used to treat mild depression)
• If you get any of the side effects, talk to
your doctor or pharmacist . This includes
Lansoprazole Capsules with food and drink
any possible side effects not listed in this
For the best results from your medicines you
leaflet. See section 4.
should take Lansoprazole at least 30 minutes
before food.
What in this leaflet

LANSOPRAZOLE 15 MG & 30 MG
GASTRO-RESISTANT CAPSULES

25 mm.

2

What you need to know before you
take Lansoprazole Capsules

Do not take Lansoprazole if you are:
• allergic to lansoprazole or any of the other
ingredients of Lansoprazole (listed in
section 6)
• taking a medicine containing the active
substance atazanavir (used in the treatment
of HIV).

25 mm.

LAETUS

DIR. LECTURA

Warnings and precautions
Talk to your doctor or pharmacist before
taking Lansoprazole Capsules
• if you have ever had a skin reaction after
treatment with a medicine similar to
Lansoprazole that reduces stomach acid.

Doble a 154 mm.

6 November 2015

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

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.

5 mm.

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.

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.
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.

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 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 recommended dose of
Lansoprazole is given below. Your doctor will
sometimes prescribe you a different dose
and will tell you how long your treatment will
last.

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 Treatment of heartburn and acid
to also mention any other ill-effects like pain regurgitation: one 15 mg or 30 mg capsule
in your joints.
for 4 weeks. If symptoms persist you should
report to your doctor. If your symptoms are
Please tell your doctor if you have serious
not relieved within 4 weeks, please contact
liver disease. The doctor may have to adjust
your doctor.
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.

Treatment of duodenal ulcer: one 30 mg
capsule every day for 2 weeks.

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

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
If you take Lansoprazole on a long-term basis
metronidazole
(longer than 1 year) your doctor will probably
If you are being treated for infection because
keep you under regular surveillance. You
you have an ulcer, it is unlikely that your
should report any new and exceptional
ulcer will return if the infection is successfully
symptoms and circumstances whenever you
treated. To give your medicine the best
see your doctor.
chance of working, take it at the right time
Children
and do not miss a dose.
Lansoprazole should not be given to children.
Treatment of duodenal or stomach ulcer in
Other medicines and Lansoprazole Capsules patients requiring continued NSAID
Tell your doctor or pharmacist if you are
treatment: one 30 mg capsule every day for 4
taking have recently taken or might take any weeks.
other medicines.
25 mm.

Cara A 160 x 470

LAETUS

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).

Treatment of stomach ulcer: one 30 mg
capsule every day for 4 weeks.

DIR. LECTURA

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.

Version:

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.

Doble a 114 mm.

LAETUS

What Lansoprazole Capsules are
and what 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 caution as your ability to react may be
decreased.

DIR. LECTURA

1

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.

LAETUS

LAETUS

DIR. LECTURA

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

Doble a 74 mm.

DIR. LECTURA

LAETUS

DIR. LECTURA

5 mm.

231-30-11112-E LEA LANSOPRAZOLE A/S CAPS TUK
Posición de Laetus 6

25 mm.

TEVA UK Ref:

the blood. Your doctor may decide to
perform regular blood tests to monitor your
levels of magnesium.

LAETUS

DIR. LECTURA

231-30-11112-E LEA LANSOPRAZOLE A/S CAPS TUK
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.

25 mm.

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
Use in children
provide more information on the safety of
Lansoprazole should not be given to children. this medicine.
If you take more Lansoprazole Capsules than
to store Lansoprazole
you should
5 How
Capsules
If you take more Lansoprazole than you have
been told to, seek medical advice quickly.
Keep this medicine out of the sight and reach
If you forget to take Lansoprazole Capsules
of children.
If you forget to take a dose, take it as soon as Store below 30ºC.
your remember unless it is nearly time for
Do not use this medicine after the expiry date
your next dose. If this happens skip the
that is stated on the label and carton after
missed dose and take the remaining capsules
‘EXP:’. The expiry date refers to the last day
as normal. Do not take a double dose to make
of that month.
up for a forgotten capsule.
Do not throw away any medicines via
If you stop taking Lansoprazole Capsules
wastewater or household waste.
Do not stop treatment early because your
Ask your pharmacist how to throw away
symptoms have got better. Your condition
medicines you no longer use. These
may not have been fully healed and may
measures will help to protect the
reoccur if you do not finish your course of
environment.
treatment. If you have any further questions
on the use of this,medicine ask your doctor or 6 Contents of the pack and other
pharmacist.
information
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.

What Lansoprazole Capsules contains
- 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),
The following side effects are common (occur potassium oleate, oleic acid, hypromellose,
in more than 1 in 100 patients):
methacrylic acid - ethyl acrylate copolymer
• headache, dizziness
1:1, triethyl citrate, titanium dioxide (E171),
• diarrhoea, constipation, stomach pains,
talc, carrageenan, Potassium chloride and
feeling or being sick, wind, dry or sore
carnauba wax.. The printing ink on the
mouth or throat
capsules contains the following additional
• skin rash, itching
ingredients: shellac (lacca), propylene glycol,
• changes in liver function test values
ammonium hydroxide, potassium hydroxide,
• tiredness.
black iron oxide (E172).
The following side effects are uncommon
What Lansoprazole Capsules look like and
(occur in less than 1 in 100 patients):
contents of the pack
• depression
Each hard, cellulose capsule has a white cap
• joint or muscle pain
marked with the letter L and a white body
• fluid retention or swelling
marked with the numbers 15 or 30,
• changes in blood cell counts.
depending on the product strength. The
• fracture of the hip, wrist or spine.
capsules contain white to beige gastroresistant micropellets containing either 15 mg
The following side effects are rare (occur in
or 30 mg lansoprazole.
less than 1 in 1000 patients):
• fever
Lansoprazole Capsules are supplied in
• restlessness, drowsiness, confusion,
Aluminium/Aluminium blisters of 7, 14, 28,
hallucinations, insomnia, visual
30, 56 and 98 capsules*.
disturbances, vertigo
*Not all pack sizes may be marketed.
• a change in the way things taste, loss of
Marketing Authorisation Holder and
appetite, inflammation of your tongue
Manufacturer
(glossitis)
Marketing Authorisation Holder
• skin reactions such as burning or pricking
feeling under the skin, bruising, reddening TEVA UK Limited
Brampton Road, Hampden Park
and excessive sweating
Eastbourne
• sensitivity to light
East Sussex BN22 9AG
• hair loss
• feelings of ants creeping over the skin
Manufacturer:
(paraesthesia), trembling
Teva Pharma S.L.U.
• anaemia (paleness)
Poligono Industrial Malpica,
• kidney problems
calle C, Numero 4,
• pancreatitis
50016 Zaragoza,
• inflammation of the liver (may be seen as
Spain
yellow skin or eyes)
Telephone: 00 34 976 57 17 84
• breast swelling in males, impotence
Telefax: 00 34 976 57 26 63
• candidiasis (fungal infection, may affect
This leaflet was last updated November 2015
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.

4

Possible side effects

Version:

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

2
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Pre-plegado a
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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).
Frequency not known

LAETUS

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
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DIR. LECTURA

• an autoimmune disease of the skin known
as Cutaneous lupus erythematosus
• rash, possibly with pain in the joints

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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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