Zalanzo

Package Leaflet: Information for the Patient

ZALANZO, 15 mg, Gastro-Resistant Capsules, Hard

ZALANZO, 30 mg, Gastro-Resistant Capsules, Hard

Lansoprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Zalanzo and what is it used for

Zalanzo is a medicine that reduces stomach acid production by inhibiting the action of one of the enzymes involved in acid production. The degree of inhibition depends on the dose of the medicine and the duration of treatment.
The medicine is used in conditions where it is necessary to reduce stomach acid production, such as:

• duodenal ulcer disease;
• gastric ulcer disease;
• treatment of Helicobacter pylori infection (combination therapy with antibiotics);
• gastroesophageal reflux disease - treatment and prevention;
• treatment of mild gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug (NSAID) therapy in patients requiring continuous NSAID therapy;
• prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk (e.g. age over 65, current or past gastric or duodenal disease), requiring continuous NSAID therapy;
• symptomatic gastroesophageal reflux disease;
• Zollinger-Ellison syndrome.

2. Important information before taking Zalanzo

When not to take Zalanzo:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• Zalanzo should not be taken with atazanavir (see section 4.5).

Warnings and precautions

Zalanzo should be taken as directed by your doctor.

• As with other anti-ulcer medicines, before starting treatment for gastric ulcer with lansoprazole, it is necessary to exclude malignant gastric tumor, as lansoprazole may mask symptoms and delay diagnosis.
• Treatment with lansoprazole may increase the risk of gastrointestinal infections, e.g. those caused by bacteria such as Salmonella and Campylobacter.
• -If you experience acute and/or persistent diarrhea, tell your doctor.

Before taking Zalanzo, consult your doctor:

• if you have ever had a skin reaction after taking a medicine similar to Zalanzo that reduces stomach acid production,
• if a specific blood test (chromogranin A level) is planned.

If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Zalanzo. You should also tell your doctor about any other side effects, such as joint pain.
During treatment with proton pump inhibitors, such as Zalanzo, especially for a period longer than one year, the risk of fractures of the hip, wrist, or spine may increase slightly. You should inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
During treatment with lansoprazole, kidney inflammation may occur. Symptoms observed by the patient and in laboratory tests 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.

Zalanzo and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking medicines containing the following active substances, as Zalanzo may affect their action:

• atazanavir (used to treat HIV infection). Zalanzo should not be taken with atazanavir;
• ketokonazole, itraconazole (used to treat fungal infections);
• rifampicin (used to treat bacterial infections);
• digoxin (used to treat heart failure);
• theophylline (used to treat asthma);
• tacrolimus (used to prevent transplant rejection);
• fluvoxamine (used to treat depression and mental disorders);
• antacids (used to treat heartburn and acid reflux);
• sucralfate (used to treat ulcers);
• herbal products containing St. John's Wort (Hypericum perforatum).

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Lansoprazole is not recommended during pregnancy.

Breastfeeding

It is not known whether lansoprazole passes into breast milk.
Your doctor will decide whether to continue or stop breastfeeding or continue or stop lansoprazole treatment, considering the benefits of breastfeeding for the baby and the benefits of lansoprazole for the mother.

Driving and using machines

Some side effects, such as dizziness, impaired balance, impaired vision, and drowsiness, may occur. In such cases, the ability to react may be impaired.

Zalanzo contains sucrose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Zalanzo 15 mg contains the azo dyeand may cause allergic reactions.

Zalanzo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Zalanzo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
For optimal effect, the medicine should be taken once a day (in the morning or evening);
it is recommended to take the medicine on an empty stomach. The capsules should be swallowed whole with a sufficient amount of liquid.
Duodenal ulcer disease
One 30 mg capsule once a day for 2 weeks. In patients who do not heal within this period, treatment may be continued with the same dose for 4 additional weeks.
Gastric ulcer disease
One 30 mg capsule once a day for 4 weeks. If healing is not achieved within this period, treatment may be continued with the same dose for 4 additional weeks.
Treatment of Helicobacter pylori infection
Recommended dosage of Zalanzo 30 mg: twice a day for 7 days in combination with one of the following regimens:

• clarithromycin 250-500 mg twice a day + amoxicillin 1 g twice a day;
• clarithromycin 250 mg twice a day + metronidazole 400-500 mg twice a day.

Gastroesophageal reflux disease
30 mg once a day for 4 weeks. If healing is not achieved within this period, treatment may be continued with the same dose for an additional 4 weeks. Maintenance treatment to prevent relapse of gastroesophageal reflux disease: 15 mg once a day. If necessary, the dose can be increased to 30 mg.
Treatment of mild gastric and duodenal ulcers in patients requiring continuous NSAID therapy
30 mg once a day for 4 weeks. In patients who do not heal within this period, treatment may be continued for an additional 4 weeks. In patients with ulcers that are difficult to heal or at risk of such ulcers, treatment will likely need to be continued for a longer period and/or with higher doses.
Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk (e.g. age over 65, current or past gastric or duodenal disease), requiring continuous NSAID therapy
15 mg once a day. If treatment is ineffective, a dose of 30 mg once a day should be used.
Symptomatic gastroesophageal reflux disease
15 or 30 mg once a day. Rapid relief of symptoms is achieved. The dose should be adjusted individually. If symptoms do not improve after 4 weeks of treatment with a dose of 30 mg once a day, additional diagnostic tests are recommended.
Zollinger-Ellison syndrome
60 mg once a day. The dose should be adjusted individually, and treatment should be continued for as long as necessary. Doses up to 180 mg once a day have been used.
Lansoprazole at a dose greater than 120 mg once a day should be administered in two divided doses.
Elderly patients
In this age group, individual dose adjustment may be necessary. Unless there are significant clinical indications, in the treatment of elderly patients, a dose greater than 30 mg once a day should not be used.
Patients with liver and kidney impairment
In patients with moderate or severe liver impairment, regular monitoring and reduction of the daily dose to 50% are recommended.
No dose adjustment is necessary in patients with kidney impairment.

Use in children

The safety of the medicine in children has not been established.
Method of administration
The capsules should be swallowed whole. If the patient cannot swallow the capsules whole, they can be opened and the contents of the capsule can be sprinkled onto a tablespoon of apple juice and taken immediately (the pH of the apple juice ensures the stability of the medicine). The microgranules should not be chewed or crushed. In patients with a nasogastric tube, the contents of the capsule can be mixed with 40 ml of apple juice and administered through the tube. After administration, the tube should be flushed with an additional portion of apple juice.

Overdose of Zalanzo

Contact your doctor or pharmacist immediately.

Missed dose of Zalanzo

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (occurring in less than 1 in 10 people): headaches and dizziness, nausea, diarrhea, constipation, vomiting, bloating with gas, dryness of the mouth or throat, increased liver enzyme activity, hives, itching, rash, fatigue, mild gastric polyps.
Uncommon (occurring in less than 1 in 100 people): thrombocytopenia (decreased platelet count), eosinophilia (increased eosinophil count), leukopenia (decreased white blood cell count), depression, joint pain, muscle pain, fractures of the hip, wrist, or spine, swelling.
Rare (occurring in less than 1 in 1000 people): anemia, insomnia, hallucinations, confusion, anxiety, dizziness with impaired balance, paresthesia (sensory disturbances), drowsiness, muscle tremors, somnolence, visual disturbances, inflammation of the tongue, esophageal candidiasis (a type of fungal infection), pancreatitis, taste disturbances, liver inflammation, jaundice, purpura, petechiae, hair loss, erythema multiforme, photosensitivity, interstitial nephritis, gynecomastia (breast enlargement in men), galactorrhea, fever, increased sweating, angioedema, anorexia, impotence.
Very rare (occurring in less than 1 in 10,000 people): agranulocytosis (severe decrease in granulocyte count), pancytopenia (decrease in all blood cell types), colitis, stomatitis, black tongue, severe skin reactions with redness, blistering, inflammation, and skin loss, anaphylactic shock (with symptoms such as facial swelling, tongue or throat swelling, difficulty swallowing, hives, and difficulty breathing), increased cholesterol and triglyceride levels, decreased sodium levels in the blood.
Frequency not known (frequency cannot be estimated from available data): rash that may be associated with joint pain, visual hallucinations.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.
If you have taken Zalanzo for a period longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat.
If you observe any of these symptoms, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Zalanzo

Keep the medicine out of the sight and reach of children.
Store in a temperature not exceeding 25°C, in the original packaging, protected from moisture.
Do not use this medicine after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Zalanzo contains

• The active substance of the medicine is lansoprazole. One capsule contains 15 mg or 30 mg of lansoprazole.
• The other ingredients are: Zalanzo 15 mg capsules: sucrose, pellets (sucrose, corn starch, purified water), sodium lauryl sulfate, meglumine, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid - ethyl acrylate copolymer (1:1, 30% dispersion, Eudragit L30-D55), hard, non-transparent gelatin capsules (gelatin, quinoline yellow (E 104), titanium dioxide (E 171), purified water). Zalanzo 30 mg capsules: sucrose, pellets (sucrose, corn starch, purified water), sodium lauryl sulfate, meglumine, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid - ethyl acrylate copolymer (1:1, 30% dispersion, Eudragit L30-D55), hard, non-transparent gelatin capsules (gelatin, titanium dioxide (E 171), purified water).

What Zalanzo looks like and contents of the pack

Zalanzo 15 mg gastro-resistant, hard capsules are yellow, non-transparent.
Zalanzo 30 mg gastro-resistant, hard capsules are white, non-transparent.
Pack sizes:
30 mg: 28 gastro-resistant, hard capsules
15 mg: 28 gastro-resistant, hard capsules

Marketing authorization holder and manufacturer

Marketing authorization holder:
Exeltis Poland Sp. z o.o.
Szamocka Street 8
01-748 Warsaw
Manufacturer:
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, No 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
For more detailed information, please contact the local representative of the marketing authorization holder:
Exeltis Poland Sp. z o.o.
Szamocka Street 8
01-748 Warsaw
Phone: 0-22 822 74 31

Date of last revision of the leaflet: