LANZUL 30 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Lanzul, 30 mg, capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Lanzul and what is it used for
4. Important information before taking Lanzul
   1. When not to take Lanzul
   2. Warnings and precautions
   3. Lanzul and other medicines
   4. Taking Lanzul with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Lanzul contains sugar and sodium
5. How to take Lanzul
   1. Treatment of reflux esophagitis (caused by acid reflux):
   2. Treatment of gastric and duodenal ulcers in patients requiring continuous NSAID treatment:
   3. Prevention of gastric and duodenal ulcers in patients requiring continuous
   4. Taking a higher dose of Lanzul than recommended
   5. Missing a dose of Lanzul
   6. Stopping Lanzul treatment
6. Possible side effects
   1. The patient should stop taking Lanzul and contact their doctor immediately if they experience any of the following symptoms:
   2. Reporting side effects
7. How to store Lanzul
8. Contents of the packaging and other information
   1. What Lanzul contains
   2. What Lanzul looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Lanzul, 30 mg, capsules

Lansoprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lanzul and what is it used for
• 2. Important information before taking Lanzul
• 3. How to take Lanzul
• 4. Possible side effects
• 5. How to store Lanzul
• 6. Contents of the packaging and other information

1. What is Lanzul and what is it used for

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

• Treatment of duodenal and gastric ulcer disease
• Treatment of reflux esophagitis
• Prevention of reflux esophagitis
• Treatment of heartburn and acid reflux
• Treatment of infections caused by the bacterium Helicobacter pyloriin combination with appropriate antibiotics
• Treatment or prevention of duodenal or gastric ulcers in patients requiring continuous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (used to combat pain or inflammation)
• Treatment of Zollinger-Ellison syndrome

The doctor may also prescribe Lanzul for other indications or in different doses than those described in this leaflet. The medicine should be taken according to the doctor's instructions.

2. Important information before taking Lanzul

When not to take Lanzul

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

Warnings and precautions

The patient should inform their doctor if they have severe liver disease. The doctor may then reduce the dose.
To confirm the diagnosis and/or rule out malignant disease, the doctor may have performed or may perform additional tests, such as endoscopy.
If diarrhea occurs during treatment with Lanzul, the patient should inform their doctor as soon as possible, as the use of Lanzul is associated with a slight increase in the frequency of infectious diarrhea.
If the doctor has prescribed Lanzul to the patient together with other medicines (antibiotics) for the treatment of Helicobacter pyloriinfection or anti-inflammatory medicines for pain or rheumatic disease relief: the patient should also carefully read the leaflets of these medicines.
When taking proton pump inhibitors, such as Lanzul, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. The patient should inform their doctor if they have been diagnosed with osteoporosis (reduced bone density) or if the doctor has said that there is a risk of osteoporosis (e.g., if the patient is taking steroid medicines).
Kidney inflammation may occur during lansoprazole treatment. Symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions, such as fever, rash, and joint stiffness. Such symptoms should be reported to the attending physician.
If the patient is taking Lanzul for a longer period (more than 1 year), the doctor will likely regularly monitor their condition. During each visit to the doctor, the patient should report any new and unusual symptoms and circumstances.
Before starting Lanzul treatment, the patient should consult their doctor:

• if the patient has a vitamin B deficiency or risk factors indicating a possible decrease in vitamin B levels, and the patient is being treated with lansoprazole long-term. Like all medicines that reduce gastric acid secretion, lansoprazole may lead to reduced vitamin B absorption.
• if the patient has ever experienced a skin reaction after taking a medicine similar to Lanzul, which reduces gastric acid secretion.
• if a specific blood test (chromogranin A level) is planned.
• if the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue Lanzul treatment. The patient should also inform their doctor about any other side effects, 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 Lanzul treatment. The patient should discontinue Lanzul treatment and contact their doctor immediately if they experience any symptoms associated with severe skin reactions described in section 4.

Lanzul and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor about other medicines containing the following active substances, whose action may be affected by Lanzul:

• HIV protease inhibitors, such as atazanavir and nelfinavir (used to treat HIV infections),
• methotrexate (used to treat autoimmune disease and cancer),
• ketoconazole, itraconazole, rifampicin (used to treat infections),
• digoxin (used to treat heart disease),
• warfarin (used to treat blood clots),
• theophylline (used to treat asthma),
• tacrolimus (used to prevent transplant rejection),
• fluvoxamine (used to treat depression and other mental disorders),
• antacids (used to treat heartburn or acid reflux),
• sucralfate (used to treat stomach and duodenal ulcers),
• medicines containing St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Taking Lanzul with food and drink

To achieve the best treatment results, Lanzul 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Patients taking Lanzul may sometimes experience side effects, such as dizziness, balance disorders, fatigue, and vision disturbances. If the patient experiences such side effects, they should be cautious due to limited reaction ability.
The patient should decide for themselves whether they are able to drive or perform other activities that require attention. Due to the possibility of side effects, the way the patient takes their medicines may negatively affect their ability to perform such activities.
The description of side effects is included in other parts of the leaflet (see section 4).
The patient should read all the information presented in this leaflet.
If the patient has any questions, they should consult their doctor or pharmacist.

Lanzul contains sugar and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Lanzul

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
The dose of Lanzul is determined by the doctor based on the patient's condition. The usual dosing of Lanzul in adults is presented below. The doctor will inform the patient how long the treatment will last. Sometimes the doctor may also prescribe a different dose.
Treatment of heartburn and acid reflux:15 mg or 30 mg once a day for 4 weeks.
If symptoms persist after 4 weeks of treatment, the patient should contact their doctor.
Treatment of duodenal ulcer disease:30 mg once a day for 2 weeks.
Treatment of gastric ulcer disease:30 mg once a day for 4 weeks.

Treatment of reflux esophagitis (caused by acid reflux):

30 mg once a day for 4 weeks.
Long-term prevention of reflux esophagitis:15 mg once a day. The doctor may change the dose and prescribe 30 mg once a day.
Treatment of Helicobacter pyloriinfection:usually 30 mg of lansoprazole in combination with two different antibiotics in the morning and the same dose in the evening. The medicines are usually taken for 7 days.
The following antibiotic combinations are recommended:

• Lanzul, 30 mg with clarithromycin 250-500 mg and amoxicillin 1000 mg.
• Lanzul, 30 mg with clarithromycin 250 mg and metronidazole 400-500 mg.

In patients with ulcer disease who have successfully completed treatment, the risk of recurrence of the infection is low. To ensure the effectiveness of the medicine, it should be taken at the right time and no dose should be missed.

Treatment of gastric and duodenal ulcers in patients requiring continuous NSAID treatment:

30 mg once a day for 4 weeks.

Prevention of gastric and duodenal ulcers in patients requiring continuous

NSAID treatment:15 mg once a day. The doctor may change the dose and prescribe 30 mg once a day.
Zollinger-Ellison syndrome:treatment usually starts with 60 mg once a day; then the doctor will adjust the dose based on the patient's response to treatment.
Use in children and adolescents
Lansoprazole is not recommended for use in children, as its safety and efficacy have not been established in this age group. Lansoprazole should be avoided in young children under 1 year of age, as available data do not show benefits in treating reflux esophagitis.
The capsule should be swallowed whole, with a glass of water. If the patient has difficulty swallowing capsules, the doctor may recommend alternative administration routes. The capsules or their contents should not be crushed or chewed, as this would prevent the medicine from working properly.
If the doctor has prescribed Lanzul to be taken once a day, the patient should take it at the same time every day. The best treatment results can be achieved by taking Lanzul in the morning, before breakfast.
If Lanzul is taken twice a day, the first dose should be taken in the morning, and the second dose in the evening.

Taking a higher dose of Lanzul than recommended

If the patient takes Lanzul in a dose higher than recommended, they should immediately consult their doctor.

Missing a dose of Lanzul

If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is time for the next dose, they should take it at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Lanzul treatment

The patient should not stop treatment too early, even if symptoms have disappeared. If the prescribed treatment period is not completed, the disease may not be fully cured and may recur.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking Lanzul and contact their doctor immediately if they experience any of the following symptoms:

• Red, flat, plate-like, or round spots on the torso, often with centrally located blisters, skin peeling, oral, throat, nose, genital, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Common side effects (may affect up to 1 in 10 people):

• Headache, dizziness.
• Diarrhea, constipation, abdominal pain, nausea or vomiting, gas, dryness or pain in the mouth or throat, mild gastric polyps.
• Changes in liver enzyme test results.
• Skin rash, itching.
• Fatigue.

Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1000 people):

• Anemia (pallor).
• Insomnia, hallucinations, confusion.
• Restlessness, dizziness with balance disorders, tingling and numbness (paresthesia), drowsiness, muscle tremors.
• Vision disturbances.
• Tongue inflammation, oral thrush (fungal infection that can affect the skin or mucous membranes), pancreatitis, taste disturbances.
• Hepatitis (which may be indicated by yellowing of the skin or whites of the eyes).
• Hair loss, increased sensitivity to light.
• Kidney problems.
• Breast swelling in men.
• Fever, loss of appetite, impotence.
• Skin reactions, such as a burning or prickling sensation under the skin, bruising, redness, and excessive sweating.
• Angioedema; the patient should contact their doctor immediately if they experience symptoms of angioedema, such as facial, tongue, or throat swelling, difficulty swallowing, hives, and difficulty breathing.

Very rare side effects (may affect up to 1 in 10,000 people):

• Severe allergic reactions, including anaphylaxis. Symptoms of an allergic reaction may include fever, rash, swelling, and sometimes a decrease in blood pressure.
• Colitis (inflammation of the colon), oral mucositis.
• Abnormal laboratory test results, such as sodium, cholesterol, and triglyceride levels.
• Severe skin reactions with redness, blistering, severe inflammation, and skin loss.
• Lanzul may very rarely cause a decrease in white blood cell count, leading to reduced immunity to infections. The patient should consult their doctor immediately if they develop an infection, which may be indicated by symptoms such as fever, significant deterioration of general health, or fever with symptoms of local infection (e.g., sore throat, pharyngitis, or oral cavity disorders), or difficulties during urination. A blood test will be performed to diagnose possible decreased white blood cell count (agranulocytosis).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• If Lanzul has been taken for more than three months, there is a possibility of decreased magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If the patient experiences any of these symptoms, they should inform their doctor immediately. Low magnesium levels may lead to decreased 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, drowsiness and fatigue, disorientation, weakness or muscle cramps, irritability, seizures, and coma.
• Rash that may be accompanied by joint pain.
• Visual hallucinations.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Lanzul

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, protect from moisture.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lanzul contains

• The active substance of Lanzul is lansoprazole. Each capsule contains 30 mg of lansoprazole.
• Other ingredients are: sugar spheres, hydroxypropyl cellulose, heavy magnesium carbonate, sugar, corn starch, sodium lauryl sulfate, hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, talc, macrogol 6000, titanium dioxide (E 171); capsule shell ingredients: cap:titanium dioxide (E 171), water, gelatin; body:titanium dioxide (E 171), water, gelatin. See section 2 "Lanzul contains sugar and sodium".

What Lanzul looks like and contents of the packaging

The capsules are filled with white to light brown or slightly pink pellets; the capsule cap and body are white.
Packaging: 7, 14, 28, or 56 capsules in blisters in a cardboard box.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: +48 22 57 37 500

Date of last revision of the leaflet: