Package leaflet: Information for the patient

Lansoprazole 15 mg gastro-resistant capsules, hard

Lansoprazole 30 mg gastro-resistant capsules, hard
lansoprazole

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 or nurse.
- 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 side effects, talk to your doctor or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Lansoprazole is and what it is used for

2. What you need to know before you take Lansoprazole
3. How to take Lansoprazole
4. Possible side effects
5. How to store Lansoprazole
6. Contents of the pack and other information

1. What Lansoprazole is and what it is used for

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 in adults:
- 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.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
2. What you need to know before you take Lansoprazole

Do not take Lansoprazole:

- if you are allergic (hypersensitive) to lansoprazole or any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Lansoprazole.

Please tell your doctor if you have serious liver disease. The doctor may have to adjust your
dosage.

If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole
that reduces stomach acid talk to your doctor before taking Lansoprazole.

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.

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.

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 a proton pump inhibitor like < Invented name >, 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).

Tell your doctor before taking this medicine, if you are due to have a specific blood test
(Chromogranin A).

Talk to your doctor before taking lansoprazole if you have low vitamin B12 levels or have
risk factors for low vitamin B12 levels and receive long-term treatment with lansoprazole. As
with all acid reducing agents, lansoprazole may lead to a reduced absorption of vitamin B12.

Other medicines and Lansoprazole

Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.

In particular tell your doctor or pharmacist if you are taking medicines containing any of the
following active substances as Lanzul may affect the way these medicines work:
- HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
- methotrexate (used to treat autoimmune disease and cancer)
- ketoconazole, itraconazole, rifampicin (used to treat infections)
- digoxin (used to treat heart problems)
- warfarin (used to treat blood clots)
- 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 and alcohol

For the best results from your medicines you should take Lansoprazole at least 30 minutes
before food.

Pregnancy and breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant or are 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.

Invented name contains sucrose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially
‘sodium-free’.

3. How to take Lansoprazole

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

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

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.

Treatment of duodenal or stomach ulcer in patients requiring continued NSAID

treatment: one 30 mg capsule every day for 4 weeks.
Prevention of duodenal or stomach ulcer in patients requiring continued NSAID
treatment: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg
capsule every day.

Zollinger-Ellison syndrome: The usual dose is two 30 mg capsules every day to start with,
then depending on how you respond to Lansoprazole the dose that your doctor decides is best
for you.

Use in children
Lansoprazole should not be given to children.

If you take more Lansoprazole than you should

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 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

Do not stop treatment early because your symptoms have got better. Your condition may not
have been fully healed and may reoccur if you do not finish your course of treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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
- feeling or being sick, diarrhoea, stomach pains, constipation, wind, dry or sore mouth or
throat, benign polyps in the stomach
- changes in liver function test values
- skin rash, itching
- tiredness.

The following side effects are uncommon (occur in less than 1 in 100 patients):
- changes in blood cell counts
- depression
- joint or muscle pain, fracture of the hip, wrist or spine
- fluid retention or swelling.

The following side effects are rare (occur in less than 1 in 1000 patients):
- anaemia (paleness)
- insomnia, hallucinations, confusion
- restlessness, vertigo, feelings of ants creeping over the skin (paresthesiae), drowsiness,
trembling
- visual disturbances
- inflammation of your tongue (glossitis), candidiasis (fungal infection, may affect skin or
the mucosa), pancreatitis, a change in the way things taste
- inflammation of the liver (may be seen as yellow skin or eyes)
- skin reactions such as burning or pricking feeling under the skin, bruising, reddening,
hair loss, sensitivity to light
- kidney problems
- breast swelling in males
- fever, excessive sweating, angioedema, loss of appetite, impotence; 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):
- 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)
- colitis (bowel inflammation), inflammation of your mouth (stomatitis)
- very severe skin reactions with reddening, blistering, severe inflammation and skin loss
- severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity
reaction may include fever, rash, swelling and sometimes a fall in blood pressure
- changes in test values such as sodium, cholesterol and triglyceride levels.

The occurrence of following side effects is not known (cannot be estimated from the
available data):
- 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.
- Visual hallucinations.
- Rash, possibly with pain in the joints.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lansoprazole

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package. Keep the container (bottle) tightly closed,
in order to protect from moisture.

Use the contents within 3 months of opening the container.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information

What Lansoprazole contains

- The active substance is lansoprazole.

Each capsule contains 15 milligram or 30 milligram of lansoprazole.
- The capsules also contain sugar granules (sucrose, maize starch), povidone, disodium
hydrogen phosphate dihydrate, sodium laurylsulphate, methacrylic acid - ethyl acrylate
copolymer (1:1) dispersion 30 per cent, talc, macrogol, titanium dioxide (E 171),
polysorbate 80.Capsule shell: gelatin, titanium dioxide (E171). The 15 mg capsule also
contains red iron oxide (E172). See section 2: “Lansoprazole contains sucrose and
sodium”.

What Lansoprazole looks like and contents of the pack

Capsules 15 mg: white/red-brownish gelatine capsule containing white or light brown or

lightly pink enteric-coated pellets.
Capsules 30 mg: white gelatine capsule containing white, light brown or lightly pink enteric-
coated pellets.

Pack sizes:
A plastic container of 14, 28, 56 and 98 capsules. Containers for 14, 28 or 56 capsules
contain a desiccant. The container for 98 capsules contains two desiccants.
Boxes of 7, 14, 28, 49, 56 and 98 capsules in blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This leaflet was last revised in 01/2020