Zalanzo

Package leaflet: Information for the patient

ZALANZO, 15 mg, hard enteric-coated capsules
ZALANZO, 30 mg, hard enteric-coated capsules
Lansoprazole
Please read this 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.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet 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 medical conditions 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 drug (NSAID) therapy in patients requiring long-term NSAID treatment;
• prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk (see section 4.2), who require long-term treatment;
• symptomatic gastroesophageal reflux disease;
• Zollinger-Ellison syndrome.

2. Important 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).
• Do not use lanzoprazole in combination with atazanavir (see section 4.5).

Warnings and precautions
Zalanzo should be used as directed by the doctor.

• As with other anti-ulcer medicines, malignant gastric tumours must be excluded before starting treatment for gastric ulcer with lanzoprazole, because lanzoprazole may mask symptoms and delay diagnosis.
• Treatment with lanzoprazole 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 had a skin reaction due to taking a medicine 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.
During treatment with proton pump inhibitors 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 the patient has been diagnosed with osteoporosis or is taking corticosteroid medicines (which may increase the risk of osteoporosis).
During treatment with lanzoprazole, interstitial nephritis may occur. Symptoms observed by the patient and in laboratory test results may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. Such symptoms should be reported to the treating physician.
Zalanzo and other medicines
Tell the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.
In particular, inform the doctor if the patient is taking medicines containing the following active substances, because Zalanzo may affect their action:

• atazanavir (used in the treatment of HIV infection). Zalanzo should not be used with atazanavir;
• ketoconazole, itraconazole (used in fungal infections);
• rifampicin (used in bacterial infections);
• digoxin (used in the treatment of heart failure);
• theophylline (used in the treatment of asthma);
• tacrolimus (used to prevent transplant rejection);
• fluvoxamine (used in the treatment of depression and psychiatric disorders);
• antacids (used in the treatment of heartburn and acid reflux into the oesophagus);
• sucralfate (used in the treatment of peptic ulcer disease);
• herbal products containing St. John's wort (Hypericum perforatum).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The use of lanzoprazole in pregnant women is not recommended.
Breastfeeding
It is not known whether lanzoprazole passes into human milk.
The doctor will decide whether to continue or discontinue breastfeeding or to continue or discontinue treatment with lanzoprazole, taking into account the benefits of breastfeeding for the child and the benefits of treatment with lanzoprazole for the mother.
Driving and operating machinery
Adverse reactions such as dizziness, impaired balance, visual disturbances and drowsiness may occur. In such cases, the ability to react may be reduced.
Zalanzo contains sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Zalanzo 15 mg contains an azo dye and may cause allergic reactions.
Zalanzo contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule; i.e. the medicine is considered "sodium-free".

3. How to take Zalanzo

This medicine should always be taken as prescribed 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 an additional 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 an additional 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 an additional 4 weeks. Maintenance treatment 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 an additional 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 high-risk patients (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. Symptoms are rapidly relieved. Dosage should be individually adjusted. If symptoms are not relieved after four weeks of treatment with 30 mg once daily, further diagnostic evaluation is recommended.

Zollinger-Ellison syndrome
60 mg daily. Dosage should be individually adjusted, and treatment 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 significant 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 this medicine in children has not been established.

Instructions for use
Capsules should be swallowed whole. If a patient cannot 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.

Use of more than the recommended dose of Zalanzo
Contact your doctor or pharmacist immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Common (occur in no more than 1 in 10 people): 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, mild gastric polyps.
Uncommon (occur in no more than 1 in 100 people): thrombocytopenia (reduced number of blood platelets), eosinophilia (excess of eosinophils - a type of white blood cell - in the blood), leukopenia (reduced number of white blood cells in the blood), depression, joint pain, muscle pain, fractures of the hip, wrist or spine, oedema.
Rare (occur in no more than 1 in 1,000 people): anaemia, insomnia, hallucinations, confusion, restlessness, dizziness with balance disturbances, paraesthesia (sensory disturbances), somnolence, muscle tremors, drowsiness, visual disturbances, glossitis (inflammation of the tongue), oesophageal candidiasis (a type of fungal infection), pancreatitis, taste disturbances, hepatitis, jaundice, petechiae, purpura, hair loss, erythema multiforme, photosensitivity, interstitial nephritis, gynaecomastia (enlargement of breasts in males), galactorrhoea, fever, increased sweating, angioedema, loss of appetite, impotence.
Very rare (occur in fewer than 1 in 10,000 people): agranulocytosis (complete or almost complete absence of granulocytes - a type of white blood cells - in the blood), pancytopenia (deficiency of all types of blood cells), colitis, mucositis (inflammation of the oral mucosa) and black discoloration of the tongue, severe skin reactions with redness, blistering, intense inflammatory changes and loss of skin, 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 (frequency cannot be estimated from available data): rash possibly accompanied by joint pain, visual hallucinations.

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
If Zalanzo has been taken for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, 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 the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Zalanzo

Keep this medicine out of sight and reach of children.
Store at 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 lanzoprazole. Each capsule contains 15 mg or 30 mg of lanzoprazole.
• Other ingredients are:
  Zalanzo 15 mg capsules: sucrose, granules (sucrose, corn starch, purified water), sodium lauryl sulfate, meglumine, mannitol, hypromellose, polyethylene glycol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid copolymer with ethyl acrylate (1:1, 30% suspension, Eudragit L30-D55), opaque hard gelatin capsules (gelatin, quinoline yellow (E 104), titanium dioxide (E 171), purified water).
  Zalanzo 30 mg capsules: sucrose, granules (sucrose, corn starch, purified water), sodium lauryl sulfate, meglumine, mannitol, hypromellose, polyethylene glycol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid copolymer with ethyl acrylate (1:1, 30% suspension, Eudragit L30-D55), opaque hard gelatin capsules (gelatin, titanium dioxide (E 171), purified water).

What Zalanzo looks like and contents of the pack
Zalanzo 15 mg hard enteric capsules are yellow, opaque.
Zalanzo 30 mg hard enteric capsules are white, opaque.
Available pack sizes:
30 mg: 28 hard enteric capsules
15 mg: 28 hard enteric capsules

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Exeltis Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Poland

Manufacturer:
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, No 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

For further information, please contact the local representative of the Marketing Authorisation Holder:
Exeltis Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Phone: 0-22 822 74 31