Lanzul S

Leaflet accompanying the packaging: patient information

Lanzul S, 15 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 them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Lansoprazole, the active substance of Lanzul S, is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid produced in the stomach.
The doctor may prescribe Lanzul S 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 who require 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 S for other indications or in different doses than those described in this leaflet. The medicine should be taken as directed by the doctor.

2. Important information before taking Lanzul S

When not to take Lanzul S

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

Warnings and precautions

Tell your doctor if you 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 S, tell your doctor as soon as possible, as the use of Lanzul S is associated with a slight increase in the frequency of infectious diarrhea.
If the doctor has prescribed Lanzul S with other medicines (antibiotics) for Helicobacter pyloriinfection or anti-inflammatory medicines that relieve pain or symptoms of rheumatic disease: also read the leaflets of these medicines carefully.
Taking proton pump inhibitors, such as Lanzul S, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have been diagnosed with osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g., if you are taking steroid medicines).
If you are taking Lanzul S for a long period (more than 1 year), your doctor will probably regularly check your condition. During each visit to the doctor, report any new or unusual symptoms and circumstances.
Nephritis (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. Report such symptoms to your doctor.
Before taking Lanzul S, consult your doctor:

• if you have a vitamin B12 deficiency or risk factors for vitamin B12 deficiency, and you are being treated with lansoprazole for a long time. Like all medicines that reduce gastric acid secretion, lansoprazole may lead to reduced vitamin B12 absorption.
• if you have ever had a skin reaction after taking a medicine similar to Lanzul S that reduces gastric acid secretion.
• if a specific blood test (chromogranin A level) is planned.
• if you have had a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Lanzul S. Also, tell your 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 S. Stop taking Lanzul S and contact your doctor immediately if you experience any of the symptoms associated with severe skin reactions described in section 4.

Lanzul S and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor about other medicines containing the following active substances, whose action may be affected by Lanzul S:

• 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 S with food and drink

To get the best results from the treatment, Lanzul S should be taken at least 30 minutes before a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Patients taking Lanzul S may sometimes experience side effects, such as dizziness, balance disorders, fatigue, and vision disturbances. If you experience such side effects, be cautious due to impaired reaction ability.
You should decide yourself whether you are able to drive or perform other activities that require attention. Due to the possibility of side effects, the way you take your medicines may negatively affect your ability to perform such activities safely.
The description of side effects is included in other parts of the leaflet (see section 4).
Read all the information presented in this leaflet.
If you have any questions, consult your doctor or pharmacist.

Lanzul S contains sugar and sodium

If you have been diagnosed with intolerance to some sugars, consult your 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 S

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
The dose of Lanzul S will be determined by your doctor, depending on your condition. The usual dosing of Lanzul S in adults is described below. Your doctor will tell you how long the treatment will last. Sometimes your 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, consult your 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. Your 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:

• lansoprazole 30 mg with clarithromycin 250-500 mg and amoxicillin 1000 mg,
• lansoprazole 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, take it at the right time and do not miss any dose.

Treatment of gastric and duodenal ulcers in patients who require continuous treatment with NSAIDs:

30 mg once a day for 4 weeks.

Prevention of gastric and duodenal ulcers in patients who require continuous

treatment with NSAIDs:15 mg once a day. Your 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 according to the patient's response to treatment.
Use in children and adolescents
Lansoprazole is not recommended for use in children, as the safety and efficacy of its use have not been established in this age group. Avoid giving lansoprazole to 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 you have difficulty swallowing capsules, your doctor may recommend a different route of administration. Do not crush or chew the capsules or their contents, as this will prevent the medicine from working properly.
If your doctor has told you to take Lanzul S once a day, you should take it at the same time every day. The best results can be achieved by taking Lanzul S in the morning, before breakfast.
If Lanzul S 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 S than recommended

If you take more Lanzul S than recommended, seek medical advice immediately.

Missing a dose of Lanzul S

If you forget to take a dose, take it as soon as you remember. However, if it is time for your next dose, take it at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Lanzul S

Do not stop treatment too early, even if your symptoms have improved. If you do not complete the prescribed treatment period, your disease may not be fully cured and may recur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Lanzul S and contact your doctor immediately if you experience any of the following symptoms:

• Red, flat, target-like, or circular patches on the torso, often with central blisters, skin peeling, oral, throat, nose, genital, and eye ulcers. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Appearance of a 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.
• Anxiety, dizziness with balance disorders, tingling and numbness (paresthesia), drowsiness, muscle tremors.
• Visual disturbances.
• Tongue inflammation, candidiasis (fungal infection that can affect the skin or mucous membranes), pancreatitis, taste disorders.
• Hepatitis (which may be indicated by yellowing of the skin or whites of the eyes).
• Hair loss, hypersensitivity 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; you should contact your doctor immediately if you 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 S can very rarely cause a reduction in the number of white blood cells, leading to reduced immunity to infections. You should consult your doctor immediately if you get an infection, with symptoms such as fever, severe deterioration of general health, or fever with symptoms of local infection (e.g., sore throat, pharynx, or mouth), or urinary problems. A blood test will be performed to diagnose any possible reduction in the number of white blood cells (agranulocytosis).

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

• If you have taken Lanzul S for more than three months, there is a possibility of reduced magnesium levels in the blood. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can lead to reduced potassium or calcium levels in the blood. Your 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lanzul S

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, protected 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 stated.
The batch number is stated on the packaging after "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your 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 S contains

• The active substance of Lanzul S is lansoprazole. Each capsule contains 15 mg of lansoprazole.
• Other ingredients are: sugar, pellets, hydroxypropyl cellulose, heavy magnesium carbonate, sugar, cornstarch, 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), iron oxide red (E 172), water, gelatin; body:titanium dioxide (E 171), water, gelatin. See section 2 "Lanzul S contains sugar and sodium".

What Lanzul S looks like and what the packaging contains

The capsules are filled with white to light brown or slightly pink pellets; the capsule cap is reddish-brown, and the capsule body is white.
Packaging: 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, 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 the last update of the leaflet: