Zalanzo

Package leaflet: Information for the patient

ZALANZO, 15 mg, hard enteric capsules
ZALANZO, 30 mg, hard enteric capsules
Lansoprazole
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Table of contents

1. What Zalanzo is and what it is 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 Zalanzo is and what it is used for

Zalanzo is a medicine that reduces gastric acid secretion by inhibiting one of the enzymes involved in acid production. The degree of inhibition depends on the dose and duration of treatment.
The medicine is used in diseases where reduction of gastric acid secretion is required, such as:

• duodenal ulcer;
• gastric ulcer;
• treatment of Helicobacter pylori infection (in combination therapy with antibiotics);
• gastroesophageal reflux disease – treatment and prevention;
• treatment of mild gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs) in patients requiring continuous NSAID therapy;
• 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. Information before using Zalanzo

When not to use Zalanzo:

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

Warnings and precautions
Zalanzo should be used according to the doctor's instructions.

• As with other anti-ulcer drugs, before starting treatment for gastric ulcer with lansoprazole, malignant gastric tumour should be excluded, because lansoprazole may mask symptoms and delay diagnosis.
• Treatment with lansoprazole may slightly increase the risk of gastrointestinal infections, e.g. those caused by bacteria such as Salmonella and Campylobacter.
• If acute and/or persistent diarrhoea occurs, inform the doctor.

Before starting treatment with Zalanzo, consult a doctor:

• if the patient has ever experienced a skin reaction while taking a drug similar to Zalanzo 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, inform the doctor as soon as possible, as discontinuation of Zalanzo may be necessary. Also report any other adverse reactions occurring, such as joint pain.
Other medicines and Zalanzo
Inform the doctor about all medicines currently used, recently taken, or planned for use.
Lansoprazole may increase plasma concentrations of drugs metabolized by the so-called CYP3A4 isoenzyme, such as: warfarin (a drug used in the treatment of deep vein thrombosis and pulmonary embolism), antipyrine (an antipyretic, analgesic and anti-inflammatory drug), indomethacin (an analgesic and anti-inflammatory drug), ibuprofen (an analgesic and anti-inflammatory drug), phenytoin (an anticonvulsant), propranolol (a drug used in cardiac disorders), prednisolone (a corticosteroid), diazepam (a hypnotic, sedative and anticonvulsant), clarithromycin (a macrolide antibiotic used in various infections including Helicobacter pylori), and terfenadine (an antihistamine and antiallergic drug).
Lansoprazole may reduce the expected clinical efficacy of theophylline (a drug used in asthma and chronic bronchitis) due to decreased plasma concentration. Caution is advised when using both drugs concomitantly.
Concomitant use of lansoprazole and oral contraceptives may slow their elimination.
Lansoprazole may reduce the bioavailability of drugs whose absorption depends on gastric pH (ketoconazole – an antifungal drug, and itraconazole – an antifungal drug, ampicillin esters – penicillin antibiotics used in various infections, iron salts – used to prevent iron deficiency, digoxin – a cardiac drug used in heart failure). Medicines that neutralize gastric hydrochloric acid and sucralfate (a protective agent used in gastric and duodenal ulcer disease) may reduce lansoprazole absorption; therefore, these medicines should be taken at least 1 hour before taking lansoprazole.

During treatment with proton pump inhibitor-containing preparations such as Zalanzo, especially for periods longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform the doctor if osteoporosis has been diagnosed or if corticosteroids (which may increase the risk of osteoporosis) are being taken.
Driving and operating machinery
Adverse effects such as dizziness, impaired balance, visual disturbances, and drowsiness may occur. In such cases, the ability to react may be impaired.
Zalanzo contains sucrose. In case of sugar intolerance, consult a doctor before taking Zalanzo.
Zalanzo 15 mg contains an azo dye and may cause allergic reactions.

3. How to use Zalanzo

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
To achieve optimal effect, the medicine should be taken once daily (in the morning or evening); it is recommended to take the medicine on an empty stomach. The capsules should be swallowed whole with an adequate amount of liquid.

Duodenal ulcer
One 30 mg capsule once daily for 2 weeks. In patients not healed within this period, treatment may be continued at the same dose for a further 4 weeks.

Gastric ulcer
One 30 mg capsule once daily for 4 weeks. If healing has not occurred within this period, treatment may be continued at the same dose for a further 4 weeks.

Treatment of Helicobacter pylori infection
Recommended dosage of Zalanzo 30 mg: twice daily for 7 days in combination with one of the following regimens:

• clarithromycin 250–500 mg twice daily + amoxicillin 1 g twice daily;
• clarithromycin 250 mg twice daily + metronidazole 400–500 mg twice daily.

Reflux esophagitis
30 mg once daily for 4 weeks. If healing has not occurred within this period, treatment may be continued at the same dose for a further 4 weeks. Maintenance therapy to prevent relapse of reflux esophagitis: 15 mg once daily. If necessary, the dose may be increased to 30 mg.

Treatment of mild gastric and duodenal ulcers in patients requiring continuous NSAID therapy
30 mg once daily for 4 weeks. In patients not healed within this period, treatment may be continued for a further 4 weeks. In patients with difficult-to-heal ulcers or at risk of such ulcers, longer treatment duration and/or higher doses may be required.

Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk (e.g. age over 65 years, current or previous gastric or duodenal disease), requiring continuous NSAID therapy
15 mg once daily. If treatment is ineffective, 30 mg once daily should be used.

Symptomatic gastroesophageal reflux disease (GERD)
15 or 30 mg once daily. Symptom relief is usually rapid. Dosage should be individualized. If symptoms have not improved after four weeks of treatment with 30 mg once daily, further diagnostic evaluation is recommended.

Zollinger-Ellison syndrome
60 mg once daily. Dosage should be individualized, and treatment should be continued as long as necessary. Doses up to 180 mg daily have been used.
Lansoprazole doses exceeding 120 mg daily should be administered in two divided doses.

Elderly patients
Individual dose adjustment may be necessary in this age group. Unless there are compelling clinical indications, doses exceeding 30 mg daily should not be used in elderly patients.

Patients with hepatic or renal impairment
In patients with moderate or severe hepatic impairment, regular monitoring is recommended and the daily dose should be reduced by 50%.
No dosage adjustment is necessary in patients with renal impairment.

Use in children
The safety of Zalanzo in children has not been established.

Instructions for use
The capsules should be swallowed whole. If a patient is unable to swallow the capsules whole, they may be opened and the contents mixed with one tablespoon of apple juice and taken immediately (the pH of apple juice ensures drug stability). The microgranules must not be chewed or crushed. In patients with a nasogastric tube, the capsule contents may 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
Seek immediate medical advice from a doctor or pharmacist.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common (in more than 1 in 100, less than 1 in 10 patients): headaches and dizziness, nausea, diarrhoea,
constipation, vomiting, bloating with flatulence, dryness of the throat or oral cavity, increased
liver enzyme activity, urticaria, itching, rash, fatigue, benign gastric polyps.
Uncommon (in more than 1 in 1,000, less than 1 in 100 patients): thrombocytopenia (reduced
platelet count), eosinophilia (excess of eosinophils - a type of white blood cells - in blood), leukopenia (reduced number of white blood cells in blood), depression, joint pain, muscle pain, oedema.
Rare (in more than 1 in 10,000, less than 1 in 1,000 patients): anaemia, insomnia, hallucinations, confusion, restlessness, dizziness with balance disturbances, paraesthesia (sensory disturbances), somnolence, muscle twitching, visual disturbances, glossitis, oesophageal candidiasis (a type of fungal infection), pancreatitis, taste disturbances, hepatitis, jaundice, petechiae, purpura, hair loss, erythema multiforme, photosensitivity, interstitial nephritis, gynaecomastia (breast enlargement in males), fever, increased sweating, angioedema, loss of appetite, impotence.
Very rare (in less than 1 in 10,000 patients): agranulocytosis (complete or near-complete absence of granulocytes - a type of white blood cells - in blood), pancytopenia (deficiency of all blood cell types), colitis, stomatitis, severe cutaneous reactions with redness, blistering, extensive inflammatory changes and skin loss, anaphylactic shock (symptoms include swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties), increased cholesterol and triglyceride levels, decreased blood sodium concentration.
Frequency not known: rash possibly accompanied by joint pain, visual hallucinations.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
If Zalanzo has been taken for longer than three months, there may be a risk of decreased magnesium levels in blood. Low magnesium levels may present as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, and rapid heartbeat.
If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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].
Reporting adverse reactions helps provide more information on the safety of the medicine. Adverse reactions can also be reported to the responsible entity.

5. How to store Zalanzo

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

6. Contents of the package and other information

What Zalanzo contains

• The active substance is lansoprazole.
• The other ingredients are:
  Zalanzo 15 mg capsules: sucrose, granules (sucrose, corn starch, purified water), sodium lauryl sulfate, meglumine, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid copolymer with ethyl acrylate (1:1, 30% dispersion, Eudragit L30-D55), opaque hard gelatin capsules (gelatin, quinoline yellow (E 104), titanium dioxide (E 171), purified water).
  Zalanzo 30 mg capsules: suc游戏副本