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LANSOPRAZOLE 30MG CAPSULES

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Lansoprazole 30mg Capsules/ Ogast 30mg Capsules
(lansoprazole)





Patient Information Leaflet
This medicine is available using the above names but will be
referred to as Lansoprazole throughout this leaflet. This leaflet
has been written to help you get the best effect from your
medicine.
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.
In this leaflet:
1) What Lansoprazole is and what it is used for
2) Before you take Lansoprazole
3) How to take Lansoprazole
4) Possible side effects
5) How to store Lansoprazole
6) Further information
1) WHAT LANSOPRAZOLE IS AND WHAT IT IS USED FOR
The active ingredient in your medicine is Lansoprazole which is
a proton pump inhibitor. Proton pump inhibitors reduce the
amount of acid that your stomach makes.
Your doctor may prescribe Lansoprazole for the following
indications:

Treatment of duodenal and stomach ulcer

Treatment of inflammation in your oesophagus (reflux
oesophagitis)

Prevention of reflux oesophagitis

Treatment of heartburn and acid regurgitation

Treatment of infections caused by the bacteria
Helicobacter pylori when given in combination with
antibiotic therapy

Treatment or prevention of duodenal or stomach ulcer
in patients requiring continued NSAID treatment
(NSAID treatment is used against pain or
inflammation)

Treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Lansoprazole for another
indication or with a dose different from that which is written in
this information leaflet. Please follow your doctor’s instructions
for taking your medicine.
2) BEFORE YOU TAKE LANSOPRAZOLE
Do not take Lansoprazole:

If you are allergic (hypersensitive) to lansoprazole or
any of the other ingredients of these capsules

You are taking a medicine containing the active
substance atazanavir (used in the treatment of HIV).
Take special care with Lansoprazole
Please tell your doctor if you have serious liver disease. The
doctor may have to adjust your dosage.
Your doctor may perform or have performed an additional
investigation called an endoscopy in order to diagnose your
condition and/or exclude malignant disease.
If diarrhoea occurs during the treatment with Lansoprazole
contact your doctor immediately, as Lansoprazole has been
associated with a small increase in infectious diarrhoea.
If your doctor has given you Lansoprazole in addition to other
medicines intended for the treatment of Helicobacter pylori
infection (antibiotics) or together with anti-inflammatory
medicines to treat your pain or rheumatic disease: please also
read the package leaflets of these medicines carefully.
Taking a proton pump inhibitor like Lansoprazole, especially
over a period of more than one year, may slightly increase your
risk of fracture in the hip, wrist or spine. Tell your doctor if you
have osteoporosis or if you are taking corticosteroids (which
can increase the risk of osteoporosis).
If you take Lansoprazole on a long-term basis (longer than 1
year) your doctor will probably keep you under regular
surveillance. You should report any new and exceptional
symptoms and circumstances whenever you see your doctor.
Taking other medicines
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
In particular, tell your doctor if you are taking medicines
containing any of the following active substances as
Lansoprazole may affect the way these drugs work:

ketoconazole, itraconazole, rifampicin (used to treat
infections)

digoxin (used to treat heart problems)
Product: Lansoprazole 30mg Capsules
Colours: Black





theophylline (used to treat asthma)
tacrolimus (used to prevent transplant rejection)
fluvoxamine (used to treat depression and other
psychiatric diseases)
antacids (used to treat heartburn or acid regurgitation)
sucralfate (used for healing ulcers)
St John’s wort (Hypericum perforatum) (used to treat
mild depression)

Taking Lansoprazole with food and drink
For the best results from your medicine you should take
Lansoprazole at least 30 minutes before food.
Pregnancy and breast-feeding
If you are pregnant, breast-feeding or if there is a chance you
might be pregnant ask your doctor 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.
Important information about some of the ingredients of
Lansoprazole
Lansoprazole contains sucrose. If you have been told by your
doctor that you have an intolerance to some sugars, talk to your
doctor before taking this medicine.
3) HOW TO TAKE LANSOPRAZOLE
Swallow the capsule whole with a glass of water. If you find the
capsules difficult to swallow your doctor may advise on
alternative ways to take your medicine. Do not crush or chew
these capsules or the content of an emptied capsule because
this will stop them from working properly.
If you are taking Lansoprazole once a day, try to take it at the
same time each day. You may get best results if you take
Lansoprazole first thing in the morning.
If you are taking Lansoprazole twice a day, you should have the
first dose in the morning and the second dose in the evening.
The packaging has been printed with the days of the week to
help you keep track of the medicines you have already taken.
The dose of Lansoprazole depends on your condition. The
usual doses of Lansoprazole for adults are given below. Your
doctor will sometimes prescribe you a different dose and will tell
you how long your treatment will last.
Treatment of heartburn and acid regurgitation: one 15 mg
or 30 mg capsule every day for 4 weeks. If symptoms persist
you should report to your doctor. If your symptoms are not
relieved within 4 weeks, please contact your doctor.
Treatment of duodenal ulcer: one 30 mg capsule every day
for 2 weeks
Treatment of stomach ulcer: one 30 mg capsule every day
for 4 weeks
Treatment of inflammation in your oesophagus (reflux
oesophagitis): one 30 mg capsule every day for 4 weeks
Long-term prevention of reflux oesophagitis: one 15 mg
capsule every day, your doctor may adjust your dose to one 30
mg capsule every day.
Treatment of infection of Helicobacter pylori: The usual
dose is one 30 mg capsule in combination with two different
antibiotics in the morning and one 30 mg capsule in
combination with two different antibiotics in the evening.
Treatment will usually be every day for 7 days.
The recommended combinations of antibiotics are:

30 mg Lansoprazole together with 250-500 mg
clarithromycin and 1000 mg amoxicillin

30 mg Lansoprazole together with 250 mg
clarithromycin and 400-500 mg metronidazole

If you are being treated for infection because you have an
ulcer, it is unlikely that your ulcer will return if the infection is
successfully treated. To give your medicine the best chance of
working, take it at the right time and do not miss a dose.

PLPI: 17211/0537
Item Code: LAN2007F/E

Dimensions: 210mm x 400mm
Proof: 2

Treatment of duodenal or stomach ulcer in patients
requiring continued NSAID treatment: one 30 mg capsule
every day for 4 weeks.



Prevention of duodenal or stomach ulcer in patients
requiring continued NSAID treatment: one 15 mg capsule
every day, your doctor may adjust your dose to one 30 mg
capsule every day.
Zollinger-Ellison syndrome: The usual dose is two 30 mg
capsules every day to start with, then depending on how you
respond to Lansoprazole the dose that your doctor decides is
best for you.
Use in children:
Lansoprazole should not be given to children.
Take your medicine exactly as your doctor has told you. You
should check with your doctor if you are not sure how to take
your medicine.
If you take more Lansoprazole than prescribed
If you take more Lansoprazole than you have been told to, seek
medical advice quickly.
If you forget to take Lansoprazole
If you forget to take a dose, take it as soon as you remember,
unless it is nearly time for your next dose. If this happens skip
the missed dose and take the remaining capsules as normal.
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Lansoprazole
Do not stop treatment early because your symptoms have got
better. Your condition may not have been fully healed and may
reoccur if you do not finish your course of treatment.
If you have any further questions on the use of this product, ask
your doctor.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Lansoprazole 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
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 (paresthesiae),
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.

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
If you are on Lansoprazole for more than three months it is
possible that the levels of magnesium in your blood may fall.
Low levels of magnesium can be seen as fatigue, involuntary
muscle contractions, disorientation, convulsions, dizziness,
increased heart rate. If you get any of these symptoms, please
tell your doctor promptly. Low levels of magnesium can also
lead to a reduction in potassium or calcium levels in the blood.
Your doctor may decide to perform regular blood tests to
monitor your levels of magnesium.
If any of the side effects gets serious, or if you notice any side
effects not listed in the leaflet, please tell your doctor.
5) STORING LANSOPRAZOLE CAPSULES
Keep out of the sight and reach of children.
Store at room temperature (15-25°C) and keep it in the
packaging that it came in to help protect it from moisture. Do
not keep it in the fridge.
Do not use this medicine after the expiry date which you will
find on the pack.
If your capsules become discoloured or show any sign of
deterioration, return them to your 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 to
protect the environment.
6) FURTHER INFORMATION
What Lansoprazole capsules contain
Each capsule contains 30mg of the active ingredient
lansoprazole.
The inactive ingredients are magnesium carbonate heavy,
sucrose, maize starch, low substitution hydroxypropylcellulose,
methacrylic acid and ethyl acrylate copolymer, talc, macrogol
6000, titanium dioxide (E171), polysorbate 80 and colloidal
anhydrous silica, gelatin.
The capsule shell also contains the following inactive
ingredients erythrosine (E127) and yellow iron oxide (E172).
What Lansoprazole capsules look like and contents of the
pack
Lansoprazole capsules are half-white and half-orange coloured
capsules.
They are available in blister packs of 14 capsules
Manufacturer
This product is manufactured by Usiphar, F. 60200 Compiegne,
France and procured from within the EU by the Product Licence
Holder Polyfarma Ltd and repackaged by Kent Pharmaceuticals
Ltd both at Repton Road, Measham, DE12 7DT, UK.
POM
Lansoprazole 30mg Capsules
Ogast 30mg Capsules

PL No: 17211/0537

Leaflet revision and issue date: 10.10.2012
This leaflet does not contain all the information about your
medicine. If you have any questions or you are not sure about
anything ask your doctor or pharmacist.

The following side effects are very rare (occur in less than
1 in 10,000 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

Product: Lansoprazole 30mg Capsules
Colours: Black

PLPI: 17211/0537
Item Code: LAN2007F/E

Dimensions: 210mm x 400mm
Proof: 2

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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