LANSOPRAZOLE 30MG GASTRO-RESISTANT CAPSULES HARD

Active substance: LANSOPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lansoprazole 15mg Gastro-Resistant Capsules, Hard
Lansoprazole 30mg Gastro-Resistant Capsules, Hard
(Referred to as Lansoprazole Gastro-Resistant Capsules in the remainder of the leaflet)

Taking Lansoprazole Gastro-Resistant
Capsules with food and drink
Taking Lansoprazole Gastro-Resistant Capsules
with food can reduce its effect. Take this
medicine before meals.

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Take your medicine in the morning before eating.
If you are taking the medicine twice a day, take
the second dose in the evening before you eat.
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, please 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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
In this leaflet:
1. What Lansoprazole Gastro-Resistant
Capsules are and what they are used for
2. What you need to know before you take
Lansoprazole Gastro-Resistant Capsules
3. How to take Lansoprazole Gastro-Resistant
Capsules
4. Possible side effects
5. How to store Lansoprazole Gastro-Resistant
Capsules
6. Contents of the pack and other information
1. What Lansoprazole Gastro-Resistant
Capsules are and what they are used for

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The active ingredient in your medicine is
lansoprazole. Lansoprazole belongs to a group
of medicines called proton-pump inhibitors
(PPIs), which are used to lower the amount of
acid that your stomach produces.
Lansoprazole Gastro-Resistant Capsules are
used:
• to treat ulcers in the stomach or the upper part
of the gut (duodenum)
• to treat and relieve the symptoms of a condition
where acid and food from the stomach escapes
into your food pipe (reflux oesophagitis) and to
prevent this condition from coming back
• to treat stomach and duodenal ulcers caused
by medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) and to stop
you getting an ulcer while you are taking an
NSAID
• to treat an infection caused by Helicobacter
pylori. This is a bacterial infection which can
cause inflammation of the stomach and can
also cause ulcers
• to treat problems in your gut (pancreas and/or
intestine) caused by your stomach producing
too much acid (Zollinger-Ellison syndrome).

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2. What you need to know before you take
Lansoprazole Gastro-Resistant Capsules

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If you are breastfeeding check with your doctor
before taking this medicine. Your doctor will
decide if you should take it.
Ask your doctor for advice before taking any
medicine.
Driving and using machinery
You may feel dizzy, sleepy, or have problems
with your eyesight whilst taking Lansoprazole
Gastro-Resistant Capsules. If this happens do
not drive, use tools or machines until you feel
normal.
Important information about some of the
ingredients of Lansoprazole Gastro-Resistant
Capsules
This medicine 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.
Lansoprazole15mg Gastro-Resistant Capsules
contain carmoisine (E122) and tartrazine (E102),
which may cause allergic reactions.

The name of your medicine is Lansoprazole
Gastro-Resistant Capsules, Hard.

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Pregnancy and breast-feeding
Do not take Lansoprazole Gastro-Resistant
Capsules if you are pregnant, think you may be
pregnant or are planning to get pregnant.

Do not take Lansoprazole Gastro-Resistant
Capsules if you:
• are allergic (hypersensitive) to lansoprazole or
to any of the other ingredients in this medicine
(listed in section 6)
• are taking a medicine called atazanavir (used
to treat HIV).
Talk to your doctor before taking
Lansoprazole Gastro-Resistant Capsules if
you:
• have liver problems
• are currently receiving treatment for infections
in the stomach or intestine
• are taking antibiotics
• know you are going to be treated with this
medicine for more than a year.
Taking other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.
The following medicines can affect or can be
affected by Lansoprazole Gastro-Resistant
Capsules:
• ketoconazole, itraconazole, and rifampicin,
used to treat various types of infection
• fluvoxamine, used to treat depression and
other psychiatric problems
• tacrolimus, used to prevent transplant rejection
• digoxin, used to treat various heart conditions
• theophyllin, used to treat asthma
• St John’s wort, used to treat mild depression.
• Methotrexate, used to treat a number of
conditions including cancer, arthritis and psoriasis
Take Lansoprazole Gastro-Resistant Capsules at
least an hour before or after you take the
following medicines:
• antacids, used to treat indigestion or heartburn
• sucralfate, used to treat intestinal ulcers or
gastritis.

3. How to take Lansoprazole
Gastro-Resistant Capsules
Always take Lansoprazole Gastro-Resistant
Capsules exactly as your doctor has told you.
Check with your doctor or pharmacist if you are
not sure.
Take Lansoprazole Gastro-Resistant Capsules at
least 30 minutes before meals. Take your
medicine in the morning before eating. If you are
taking the medicine twice a day, take the second
dose in the evening before you eat.
Swallow the capsules whole or empty the
capsules and swallow the contents with a glass
of water (do not crush or chew the
capsules/contents of the capsule).
Your doctor will decide the right dose and
duration of treatment for you. This information
will be on the pharmacist’s label.
Adults
This medicine may be given to you in different
doses depending on the illness being treated.
The usual doses for adults are:
• ulcers in the upper part of the gut (duodenal
ulcers): 30mg once daily for two weeks. Your
doctor may then decide you need to take the
medicine for another two weeks
• ulcers in the stomach (gastric ulcers): 30mg
once daily for four weeks. Your doctor may
then decide you need to take the medicine for
another four weeks
• treatment and relief of symptoms of a condition
where acid and food from the stomach escapes
into the food pipe (reflux oesophagitis): 15mg
or 30mg once daily for four weeks.
• prevention of reflux oesophagitis: 15mg once
daily, which may be increased to 30mg
• treatment of gastric and duodenal ulcers
caused by an NSAID: 30mg once daily for four
weeks. Your doctor may then decide you need
to take the medicine for another four weeks
• Prevention of an ulcer while taking an NSAID:
15mg or 30mg once daily.
• treatment of an infection caused by
Helicobacter pylori: 30mg twice a day for one
week in combination with antibiotics
• problems in the gut (pancreas and/or intestine)
caused by your stomach producing too much
acid (Zollinger-Ellison Syndrome): your
treatment may begin with a dose of 60mg
taken once daily. Your doctor may decide to
increase the daily dose up to a maximum of
180mg to stop your illness coming back.
Patients with liver problems
Your doctor may reduce your dose if you have
moderate or severe liver problems.
Elderly patients
Your doctor may decide to change your dose, but
it should not be more than a maximum daily
amount of 30mg.
Children
Lansoprazole Gastro-Resistant Capsules are not
recommended for use in children.
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Black

Lansoprazole Capsules 15mg & 30mg - 28 tab
Wockhardt UK
FP3860 / FP3861
L1
(w)148 x (h)420mm
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 1st PDF sent on - 29TH JAN. 2013
 2nd PDF sent on - 30TH JUNE 2014
 3rd PDF sent on - 1ST JULY 2014

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Uncommon (affecting at least 1 in 1000 but
less than 1 in 100 patients)
• changes to various types of blood cells (shown
in blood tests)
• feeling depressed
• pain in your muscles or joints.
Common (affecting at least 1 in 100 but less
than 1 in 10 patients)
• feeling sick or being sick
• wind, diarrhoea, stomach pain, difficulty in
passing stools/constipation
• feeling dizzy, headache, feeling tired
• dry mouth or throat
• changes in the way your liver works
• itching or skin rash
• hives.
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.

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Both strengths of capsules are available in
aluminium blister strips, in pack sizes of 14, 28,
49, 56 and 98 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK

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Lansoprazole 30mg Gastro-Resistant Capsules,
Hard are white gelatin gastro-resistant capsule
imprinted with ‘W761’ in black ink, filled with
white, off-white to bluish pellets.

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What Lansoprazole Gastro-Resistant
Capsules look like and the contents of the
pack
Lansoprazole 15mg Gastro-Resistant Capsules,
Hard are white /red-brownish gelatin
gastro-resistant capsules imprinted with ‘W760’
in black ink, filled with white, off-white to bluish
pellets.

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Capsule shell printing ink:
shellac (E904), dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene glycol (E1520),
strong ammonium solution, iron oxide black
(E172), potassium hydroxide (E525), and
purified.water.

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Rare (affecting at least 1 in 10,000 but less
than 1 in 1000 patients)
• itchy pink/red rash (erythema multiforme)
• being more sensitive to the sun than usual
• changes in the way things taste, or mouth
infections
• inflammation of your tongue (glossitis)
• red spots under the skin, red or purple
discolouration of the skin
• hair loss
• restlessness, difficulty sleeping, sleepiness,
strange sounds or visions (hallucinations),
feeling confused
• feeling of extreme dizziness
• shaking
• liver problems including yellowing of your skin
or whites of your eyes (jaundice)
• swelling of the ankles, feet or fingers
• tingling or numbness in the hands or feet (“pins
and needles”)
• kidney problems
• severe stomach pain which may reach through
to the back. This could be a sign of pancreatitis
• blurred vision
• swelling of one or both breasts in men
• fever
• sweating
• feeling tired, faint, dizzy, having pale skin.
These could be symptoms of anaemia
• loss of appetite
• being unable to achieve an erection
(impotence).

Capsule shell:
Body: gelatin, titanium dioxide (E171), purified
water
Cap: gelatin, titanium dioxide (E171), purified
water. Lansoprazole 15mg Gastro-Resistant
Capsules, Hard also contain carmoisine (E122),
tartrazine (E102) and brilliant blue (E133) in the
capsule shells.

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Other very rare side effects are:
• a very severe form of allergic skin reaction
causing blistering of the skin, mouth, eyes and
genitals (Stevens-Johnson syndrome and toxic
epidermal necrolysis)
• abdominal pain and diarrhoea
• sore mouth
• increase in your blood cholesterol and fat
levels
• low blood levels of sodium which can cause
tiredness and confusion, muscle twitching, fits
and coma.

The other ingredients are:
sugar spheres, opadry clear {hypromellose
(E464), talc (E553b), Macrogol (PEG 400 and
6000)}, magnesium carbonate light (E504),
hypromellose, Macrogol (PEG 6000), sucrose,
purified talc (E553b), methacrylic acid-ethyl
acrylate copolymer, titanium dioxide (E171),
polysorbate 80, and colloidal anhydrous silica.

Manufacturer:
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:
0800 198 5000 (UK Only)

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If you experience any severe allergic
reaction, contact your doctor or nearest
hospital casualty department immediately.

Each Lansoprazole 30mg Gastro-Resistant
Capsule, Hard contains 30mg of lansoprazole.

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Very rare (affecting less than 1 in 10,000
patients)
• a severe form of allergic reaction
(anaphylactic/anaphylactoid reaction).
Symptoms of a severe allergic reaction include
rash, swelling of the face and difficulty
breathing.

Each Lansoprazole 15mg Gastro-Resistant
Capsule, Hard contains 15mg of lansoprazole.

Please be ready to give the following information:
Product name

Reference
number

Lansoprazole 15mg
Gastro-Resistant Capsules, Hard 29831/0533
Lansoprazole 30mg
Gastro-Resistant Capsules, Hard 29831/0534
This is a service provided by the Royal National
Institute of Blind People.
Leaflet Prepared: July 2014

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Like all medicines, Lansoprazole
Gastro-Resistant Capsules can cause side
effects, although not everybody gets them. The
following side effects may be experienced:

What Lansoprazole Gastro-Resistant
Capsules contain
The active ingredient is lansoprazole.

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4. Possible side effects

6. Contents of the pack and other information

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If you have any further questions on the use of
Lansoprazole Gastro-Resistant Capsules, ask
your doctor or pharmacist.

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
protect the environment.

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If you forget to take Lansoprazole
Gastro-Resistant Capsules
If you forget a dose, take it as soon as you
remember. However, if it is almost time for your
next dose, then do not take the missed dose at
all. NEVER take a double dose to make up for
the one missed.

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The symptoms of an overdose are not known.
However, you may suffer from one of the side
effects listed in section 4 (Possible side effects).

• Do not store above 25°C.
• Store in the original packaging in order to
protect from moisture.
• Do not take Lansoprazole Gastro-Resistant
Capsules after
the expiry date
stated on the
packaging. The
expiry date
refers to the last
day of the
month.

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If you take more Lansoprazole
Gastro-Resistant Capsules than you should
Tell your doctor or go to your nearest hospital
straight away. Remember to take with you any
Lansoprazole Gastro-Resistant Capsules that
are left and this leaflet. This is so the doctor
knows what you have taken.

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5. How to store Lansoprazole
Gastro-Resistant Capsules
• Keep out of the reach and sight of children.

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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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