Package leaflet: Information for the patient

Lanzul S, 15 mg, capsules
Lansoprazole
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Lanzul S is and what it is used for
Important information before taking Lanzul S
How to take Lanzul S
Possible side effects
How to store Lanzul S
Contents of the pack and other information

1. What Lanzul S is and what it is used for

Lansoprazole, the active substance in Lanzul S, is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced in the stomach.
Your doctor may prescribe Lanzul S for adult patients for the following indications:

Treatment of duodenal and gastric ulcers
Treatment of reflux esophagitis
Prevention of reflux esophagitis
Treatment of heartburn and acid regurgitation into the oesophagus
Treatment of infections caused by Helicobacter pylori bacteria in combination with appropriate antibiotic therapy
Treatment or prevention of duodenal or gastric ulcers in patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain or inflammation)
Treatment of Zollinger-Ellison syndrome

Your doctor may also prescribe Lanzul S for other indications or at doses different from those described in this leaflet. Always take the medicine as directed by your doctor.

2. Important information before using Lanzul S

When not to use Lanzul S

if the patient is allergic (hypersensitive) to lanzoprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Inform the doctor if the patient has severe liver disease. The doctor may then reduce the dose.
To confirm the diagnosis and (or) exclude malignant tumour, the doctor has performed or may perform an additional examination, known as endoscopy.
If diarrhoea occurs during treatment with Lanzul S, the doctor should be informed as soon as possible, as use of Lanzul S is associated with a small increased risk of infectious diarrhoea.
If the doctor has prescribed Lanzul S together with other medicines (antibiotics) against Helicobacter pylori infection or anti-inflammatory medicines relieving pain or symptoms of rheumatic disease: also carefully read the package leaflets of these medicines.
Taking proton pump inhibitors such as Lanzul S, especially for over one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform the doctor if osteoporosis (reduced bone density) has been diagnosed or if the doctor has indicated a risk of osteoporosis (for example, if the patient is taking steroid medicines).
If the patient is taking Lanzul S for a prolonged period (over 1 year), the doctor will likely monitor the patient regularly. During each visit to the doctor, report any new or unusual symptoms or circumstances.
While taking lanzoprazole, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in the urine and (or) hypersensitivity reactions such as fever, rash and joint stiffness. The patient should report such symptoms to the treating doctor.
Before starting treatment with Lanzul S, consult a doctor:

if the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and the patient is being treated long-term with lanzoprazole. Like all medicines reducing gastric acid secretion, lanzoprazole may lead to reduced absorption of vitamin B₁₂.
if the patient has ever experienced a skin reaction due to taking a medicine similar to Lanzul S that reduces gastric acid secretion.
if a specific blood test (chromogranin A levels) is planned.
if the patient develops a skin rash, especially in areas exposed to sunlight, the doctor should be informed immediately, as discontinuation of Lanzul S may be necessary. Also report any other adverse reactions occurring, such as joint pain.
severe skin reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)] have been reported in association with taking Lanzul S. Treatment with Lanzul S should be discontinued and immediate medical advice sought if any of the symptoms related to serious skin reactions described in section 4 occur.

Lanzul S and other medicines
Tell the doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
In particular, inform the doctor about other medicines containing the following active substances, whose action may be disturbed during treatment with Lanzul S:

HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of HIV infection),
methotrexate (used in the treatment of autoimmune disease and cancer),
ketoconazole, itraconazole, rifampicin (used in the treatment of infections),
digoxin (used in the treatment of heart conditions),
warfarin (used in the treatment of blood clots),
theophylline (used in the treatment of asthma),
tacrolimus (used to prevent transplant rejection),
fluvoxamine (used in the treatment of depression and other psychiatric disorders),
medicines that neutralize gastric hydrochloric acid (used in the treatment of heartburn or acid reflux),
sucralfate (used in the treatment of gastric and duodenal ulcers),
medicines containing St. John's wort (Hypericum perforatum) (used in the treatment of mild depression).

Taking Lanzul S with food and drink
For optimal treatment results, Lanzul S should be taken at least 30 minutes before a meal, with a glass of water.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Patients taking Lanzul S may occasionally experience adverse effects such as dizziness, impaired balance, fatigue, and visual disturbances. If such adverse effects occur, the patient should exercise caution due to reduced reaction ability. The patient should personally decide whether he or she is able to drive or perform other tasks requiring concentration. Due to the possibility of adverse effects, the way the medicine is taken may negatively affect the ability to safely perform such activities.
A description of adverse effects is provided in other sections of this leaflet (see section 4).
Please read all the information provided in this leaflet.
If you have any questions, consult your doctor or pharmacist.
Lanzul S contains sucrose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Lanzul S

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
your doctor.
The dose of Lanzul S is individually adjusted by the doctor according to the patient's condition. Below
are the usual dosage recommendations for Lanzul S in adults. The doctor will inform the patient
how long the treatment should last. Sometimes the doctor may prescribe a different dose.
Treatment of heartburn and acid regurgitation: 15 mg or 30 mg once daily for 4 weeks.
If symptoms persist after 4 weeks of treatment, consult your doctor.
Treatment of duodenal ulcer: 30 mg once daily for 2 weeks.
Treatment of gastric ulcer: 30 mg once daily for 4 weeks.
Treatment of reflux oesophagitis (caused by acid regurgitation):
30 mg once daily for 4 weeks.
Long-term prevention of reflux oesophagitis: 15 mg once daily. The doctor may
adjust the dose and prescribe 30 mg once daily.
Treatment of Helicobacter pylori infection: usually 30 mg of lanzoprazole in combination with
two different antibiotics, taken in the morning and the same dose in the evening. The treatment is
usually administered for 7 days.
The following antibiotic combinations are recommended:

lanzoprazole 30 mg with clarithromycin 250–500 mg and amoxicillin 1000 mg,
lanzoprazole 30 mg with clarithromycin 250 mg and metronidazole 400–500 mg.

In patients with peptic ulcer disease who have successfully completed treatment, the risk of
recurrence of infection is low. To ensure effective action of the medicine, it must be taken at the
correct time and no dose should be missed.
Treatment of gastric and duodenal ulcers in patients requiring continuous NSAID therapy:
30 mg once daily for 4 weeks.
Prevention of gastric and duodenal ulcers in patients requiring continuous
NSAID therapy: 15 mg once daily. The doctor may adjust the dose and prescribe 30 mg once
daily.
Zollinger-Ellison syndrome: treatment is usually initiated with 60 mg once daily; thereafter, the
doctor will adjust the dose according to the patient's response to treatment.
Use in children and adolescents
Lanzoprazole is not recommended for use in children, as its safety and efficacy have not been
established in this age group. Lanzoprazole should be avoided in infants under 1 year of age, as
available data do not demonstrate benefit in treating reflux oesophagitis in this population.
The capsule should be swallowed whole with a glass of water. If the patient has difficulty swallowing
capsules, the doctor may recommend an alternative method of administration. Do not crush or
chew the capsules or their contents, as this would impair the proper functioning of the medicine.
If the doctor has prescribed Lanzul S once daily, the patient should take it at the same time each
day, if possible. Optimal treatment results are achieved when Lanzul S is taken in the morning,
before breakfast.
If Lanzul S is prescribed twice daily, the first dose should be taken in the morning and the second
in the evening.
Taking more Lanzul S than prescribed
If the patient takes more Lanzul S than recommended, medical advice should be sought
immediately.
Missed dose of Lanzul S
If the patient forgets to take a dose, it should be taken as soon as remembered. However, if it is
almost time for the next dose, the missed dose should be skipped. Do not take a double dose to
make up for a missed dose.
Stopping Lanzul S treatment
The patient should not stop treatment prematurely, even if symptoms have improved. If the
prescribed course of treatment is not completed, the condition may not be fully cured and may
recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Lanzul S and contact your doctor immediately
if any of the following symptoms occur:

Reddish, flat, disc-shaped or circular rashes on the trunk, often with centrally located blisters, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Development of rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Common adverse reactions (may occur in up to 1 in 10 patients):

Headache, dizziness.
Diarrhoea, constipation, abdominal pain, nausea or vomiting, flatulence, dryness or pain in the mouth or throat, mild gastric polyps.
Changes in liver enzyme test results.
Skin rash, itching of the skin.
Fatigue.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

Changes in blood cell count.
Depression.
Joint or muscle pain.
Fluid retention or oedema.

Rare adverse reactions (may occur in up to 1 in 1000 patients):

Anaemia (pallor).
Insomnia, hallucinations, confusion.
Restlessness, dizziness with balance disturbances, tingling and numbness (paraesthesiae), somnolence, muscle tremor.
Visual disturbances.
Inflammation of the tongue, candidiasis (fungal infection which may affect the skin or mucous membranes), pancreatitis, taste disturbances.
Hepatitis (which may manifest as yellowing of the skin or the whites of the eyes).
Hair loss, photosensitivity.
Kidney-related disorders.
Breast enlargement in men.
Fever, loss of appetite, impotence.
Skin reactions, e.g. burning or pricking sensation under the skin, bruising, redness and excessive sweating.
Angioedema; patients should contact their doctor immediately if symptoms of angioedema occur, e.g. swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

Very severe hypersensitivity reactions, including anaphylactic shock. Symptoms of hypersensitivity reactions may include fever, rash, swelling and sometimes a drop in blood pressure.
Inflammation of the large intestine (colitis), inflammation of the oral mucosa.
Laboratory test abnormalities, e.g. levels of sodium, cholesterol and triglycerides.
Very severe skin reactions with redness, blistering, intense inflammatory changes and skin loss.
Very rarely, Lanzul S may cause a reduction in white blood cell count, leading to decreased patient immunity to infections. The patient should immediately consult a doctor if an infection develops, with symptoms such as fever, significant deterioration in general health or fever with local infection symptoms (e.g. sore throat, larynx or oral cavity), or discomfort during urination. A blood test will be performed to diagnose possible reduction in white blood cell count (agranulocytosis).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

If Lanzul S has been taken for longer than three months, there may be a decrease in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle cramps, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
Low sodium levels in the blood. Typical symptoms include nausea and vomiting, headache, somnolence and fatigue, disorientation, weakness or muscle cramps, irritability, seizures, coma.
Rash possibly accompanied by joint pain.
Visual hallucinations.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lanzul S

Keep this medicine out of sight and reach of children.
Store below 25°C and protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the packaging and other information

What Lanzul S contains

The active substance is lanzoprazole. Each capsule contains 15 mg of lanzoprazole.
The other ingredients are: sucrose, granules, hydroxypropylcellulose, heavy magnesium carbonate, sucrose, corn starch, sodium lauryl sulfate, hypromellose, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, talc, macrogol 6000, titanium dioxide (E 171); capsule shell ingredients: cap: titanium dioxide (E 171), red iron oxide (E 172), water, gelatin; body: titanium dioxide (E 171), water, gelatin. See section 2 "Lanzul S contains sucrose and sodium".

What Lanzul S looks like and contents of the pack
The capsules are filled with white to light brown or slightly pinkish pellets; the capsule cap is reddish-brown, the body is white.
Pack sizes: 28 or 56 capsules in blisters packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Tel. +48 22 57 37 500