ZALANZO 30 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. ZALANZO, 15 mg, Gastro-Resistant Capsules, Hard
3. ZALANZO, 30 mg, Gastro-Resistant Capsules, Hard
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
4. What is Zalanzo and What is it Used For
5. Important Information Before Taking Zalanzo
   1. When Not to Take Zalanzo:
   2. Warnings and Precautions
   3. Other Medicines and Zalanzo
   4. Driving and Operating Machines
6. How to Take Zalanzo
   1. Use in Children
   2. Overdose of Zalanzo
   3. Missed Dose of Zalanzo
7. Possible Side Effects
   1. Reporting Side Effects
8. How to Store Zalanzo
9. Contents of the Pack and Other Information
   1. What Zalanzo Contains
   2. What Zalanzo Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer

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.

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 treatment;
• prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk (see section 4.2), requiring continuous treatment;
• 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).

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 cause a slight increase in the risk of gastrointestinal infections, e.g. those caused by bacteria such as Salmonella and Campylobacter.
• - If you experience acute and/or persistent diarrhea, please tell your doctor.

Before taking Zalanzo, consult your doctor:

• if you have ever had a skin reaction after taking a medicine similar to Zalanzo, which 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, please tell your doctor as soon as possible, as it may be necessary to discontinue Zalanzo. You should also tell your doctor about any other side effects, such as joint pain.

Other Medicines and Zalanzo

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Lansoprazole may increase the blood levels of medicines metabolized by the CYP3A4 enzyme, such as warfarin (a medicine used to treat deep vein thrombosis and pulmonary embolism), antipyrine (a medicine used to treat pain and reduce fever), indomethacin (a medicine used to treat pain and inflammation), ibuprofen (a medicine used to treat pain and inflammation), phenytoin (an antiepileptic medicine), propranolol (a medicine used to treat heart rhythm disorders), prednisolone (a corticosteroid), diazepam (a sedative, anxiolytic, and anticonvulsant medicine), clarithromycin (a macrolide antibiotic used to treat various infections, including Helicobacter pylori), and terfenadine (an antihistamine and anti-allergic medicine).
Lansoprazole may reduce the expected clinical efficacy of theophylline (a medicine used to treat asthma and chronic obstructive pulmonary disease), as it reduces its blood levels. Caution is advised when taking both medicines together.
Concomitant use of lansoprazole and oral contraceptives may slow down their elimination.
Lansoprazole may reduce the bioavailability of medicines whose absorption depends on gastric juice pH (ketoconazole - an antifungal medicine, and itraconazole - an antifungal medicine, ampicillin esters - penicillin antibiotics used to treat various infections, iron salts - used to prevent iron deficiency, digoxin - a cardiac medicine used to treat heart failure). Medicines that neutralize stomach acid and sucralfate (a protective medicine used to treat gastric and duodenal ulcers) may reduce lansoprazole absorption, and therefore these medicines should be taken at least 1 hour before taking lansoprazole.

• During treatment with proton pump inhibitors, such as Zalanzo, especially for a period longer than one year, the risk of hip, wrist, or spine fractures 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).

When taking medicines containing proton pump inhibitors, such as Zalanzo, especially for a period longer than one year, the risk of hip, wrist, or spine fractures 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).

Driving and Operating Machines

Side effects such as dizziness, balance disorders, vision disturbances, and drowsiness may occur. In such cases, the ability to react may be impaired.
Zalanzo contains sucrose.If you have intolerance to sugars, consult your doctor before taking Zalanzo.
Zalanzo 15 mg contains the azo dyeand may cause allergic reactions.

3. How to Take Zalanzo

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
To achieve 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 achieve healing 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 recurrence 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 treatment
30 mg once a day for 4 weeks. In patients who do not achieve healing 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 ulcers, treatment may need to be continued for a longer period and/or with higher doses.
Prevention of gastric and duodenal ulcers associated with NSAID treatment in patients at risk (e.g. age over 65, current or past gastric or duodenal disease), requiring continuous NSAID treatment
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 individualized. If symptoms do not improve after 4 weeks of treatment with a dose of 30 mg once a day, additional diagnostic tests should be performed.
Zollinger-Ellison syndrome
60 mg once a day. The dose should be individualized, 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 is unable to swallow the capsules whole, they can be opened and the contents of the capsule can be poured into 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

Immediately contact your doctor or pharmacist.

Missed Dose of Zalanzo

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (in more than 1 in 100, less than 1 in 10 patients): headache and dizziness, nausea, diarrhea, constipation, vomiting, bloating with gas, dryness in the throat or mouth, increased liver enzyme activity, urticaria, itching, rash, fatigue, mild gastric polyps.
Uncommon (in more than 1 in 1000, less than 1 in 100 patients): thrombocytopenia (reduced platelet count), eosinophilia (increased number of eosinophils in the blood), leukopenia (reduced white blood cell count), depression, joint pain, muscle pain, edema.
Rare (in more than 1 in 10,000, less than 1 in 1000 patients): anemia, insomnia, hallucinations, confusion, anxiety, dizziness with balance disorders, paresthesia (sensory disturbances), drowsiness, muscle tremors, vision disturbances, stomatitis, esophageal candidiasis, pancreatitis, taste disturbances, hepatitis, jaundice, purpura, petechiae, hair loss, erythema multiforme, photosensitivity, interstitial nephritis, gynecomastia (breast enlargement in men), fever, increased sweating, angioedema, anorexia, impotence.
Very rare (in less than 1 in 10,000 patients): agranulocytosis (severe reduction or absence of granulocytes in the blood), pancytopenia (reduction of all blood cell types), colitis, stomatitis, severe skin reactions with redness, blistering, and peeling, anaphylactic shock (characterized by facial, tongue, or throat edema, difficulty swallowing, urticaria, and difficulty breathing), increased cholesterol and triglyceride levels, reduced sodium levels in the blood.
Frequency not known: 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 more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heart rate. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may lead to reduced 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to Store Zalanzo

The medicine should be stored out of 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 is 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 capsules, hard, are light yellow, non-transparent.
Zalanzo 30 mg gastro-resistant capsules, hard, are white, non-transparent.
Available packs:
30 mg: 28 gastro-resistant capsules, hard
15 mg: 28 gastro-resistant capsules, hard

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
Manufacturer:
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, No 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
To obtain more detailed information, please contact the local representative of the Marketing Authorization Holder:
Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
phone: +48 22 822 74 31
Date of Last Revision of the Leaflet:09.08.2018