Zulbex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Zulbex
10 mg, enteric-coated tablets
Rabeprazolum natricum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Zulbex is and what it is used for

Zulbex contains the active substance rabeprazole. It belongs to a group of medicines called proton pump inhibitors. The medicine works by reducing the amount of acid produced by the stomach.

Zulbex is indicated for:

• Active duodenal ulcer or active, benign gastric ulcer (peptic ulcers).
• Treatment of symptomatic gastro-oesophageal reflux disease (GORD) with erosions or ulcers, often referred to as acid-induced oesophagitis, associated with heartburn, or for long-term treatment of gastro-oesophageal reflux disease.
• Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD), also associated with heartburn.
• Zollinger-Ellison syndrome, a rare condition characterized by excessive acid production in the stomach.
• Treatment of H. pylori infection in patients with peptic ulcer disease, in combination with two antibiotics (clarithromycin and amoxicillin).

2. Important information before using Zulbex

When not to use Zulbex:

• if the patient is allergic to sodium rabeprazole or any of the other ingredients of this medicine (listed in section 6),
• during pregnancy, suspected pregnancy, or while breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Zulbex, discuss it with your doctor or pharmacist.
Inform your doctor or pharmacist:

• if the patient has had an allergy to other proton pump inhibitors;
• if the patient has been diagnosed with stomach cancer;
• if the patient has a history of liver disease;
• if the patient is taking atazanavir (a medicine used to treat HIV infection) at the same time;
• if the patient has vitamin B12 deficiency or risk factors for reduced vitamin B12 levels, and is being treated long-term with sodium rabeprazole; like all medicines that reduce (inhibit) gastric acid secretion, sodium rabeprazole may lead to decreased absorption of vitamin B12;
• if the patient has ever experienced a skin reaction while taking a medicine similar to Zulbex that reduces gastric acid secretion;
• about any planned specific blood test (chromogranin A levels).

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor immediately, as it may be necessary to discontinue Zulbex. Also report any other adverse effects such as joint pain.
Long-term use of the medicine may require medical monitoring.
Some patients have experienced blood or liver problems, which often resolved after stopping treatment with rabeprazole.
If the patient develops diarrhoea (bloody or watery) with high fever and abdominal pain or tenderness during treatment with Zulbex, stop taking the medicine and contact the doctor immediately.
Taking proton pump inhibitors such as Zulbex, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Children and adolescents
Zulbex must not be used in children.

Zulbex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor or pharmacist:

• if the patient is also taking ketoconazole or itraconazole (medicines used to treat fungal infections); Zulbex may reduce blood levels of these medicines; the doctor may adjust the dose;
• if the patient is also taking atazanavir (a medicine used to treat HIV infection); Zulbex may reduce blood levels of this medicine, therefore it should not be used together with Zulbex;
• if the patient is also taking methotrexate (a chemotherapeutic agent used in high doses to treat cancer); if the patient is receiving high doses of methotrexate, the doctor may temporarily interrupt treatment with Zulbex.

If you are unsure whether any of the above situations apply to the patient, contact your doctor or pharmacist before taking Zulbex.

Pregnancy and breastfeeding
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Zulbex during pregnancy or if the patient suspects she may be pregnant.
Do not use Zulbex while breastfeeding or if planning to breastfeed.

Driving and using machines
Taking Zulbex may cause drowsiness. In such a case, do not drive or operate machinery.

3. How to use Zulbex

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Zulbex is available in the following strengths: 10 mg, 20 mg.
ZULBEX TABLETS SHOULD BE SWALLOWED WHOLE.
DO NOT CRUSH OR CHEW THE TABLETS.
The dosages given below are generally recommended for adults and elderly patients. Do not change the dose or duration of treatment on your own.

Children and adolescents
Zulbex should not be used in children.

Active duodenal ulcer and active, benign gastric ulcer
The usual dose is 1 tablet of Zulbex 20 mg once daily.
In the case of active duodenal ulcer, treatment should continue for 4 weeks. After this period, your doctor may decide to extend treatment for another 4 weeks.
In the case of active, benign gastric ulcer, treatment should continue for 6 weeks. After this period, your doctor may decide to extend treatment for another 6 weeks.

Gastroesophageal reflux disease (GERD) with erosions or ulcers
The usual dose is 1 tablet of Zulbex 20 mg once daily. Treatment should continue for 4 weeks. After this period, your doctor may decide to extend treatment for another 4 weeks.

Long-term treatment of GERD
The usual dose is 1 tablet of Zulbex 10 mg or 20 mg once daily. Your doctor will decide how long Zulbex should be taken. You should have regular consultations with your doctor to monitor symptoms and dosage.

Symptomatic treatment of GERD
The usual dose is 1 tablet of Zulbex 10 mg once daily. A fixed dosage is recommended for 4 weeks. If symptoms do not improve after this time, consult your doctor. After the initial 4 weeks of treatment, if symptoms recur, your doctor may recommend taking 1 tablet of Zulbex 10 mg as needed to control symptoms.

Zollinger-Ellison syndrome
The usual initial dose is 3 tablets of Zulbex 20 mg once daily. The dose may be adjusted by your doctor during treatment depending on the patient's response. The number of tablets and duration of treatment are determined by the doctor. Regular consultations with your doctor are necessary to monitor symptoms and dosage.

Treatment of H. pylori infection
The usual recommended dose is Zulbex 20 mg (in combination with two antibiotics – clarithromycin 500 mg and amoxicillin 1 g), taken twice daily, usually for 7 days.
Improvement of 4 symptoms usually occurs before complete ulcer healing. Therefore, it is important not to interrupt treatment unless otherwise advised by your doctor. For further information on other medicines used in H. pylori eradication, refer to the package leaflet of the respective medicine.

Taking more Zulbex than prescribed
Do not take more tablets per day than prescribed by your doctor. If you accidentally take more tablets than recommended, consult your doctor or go to hospital. Take the medicine and its packaging with you so the doctor can obtain information about the medicine taken.

Missing a dose of Zulbex
If you miss a dose, take it as soon as possible, then continue with your normal dosing schedule. If you have not taken the medicine for more than 5 days, contact your doctor before restarting treatment. Do not take a double dose to make up for a missed dose.

Stopping Zulbex treatment
Do not change the dose or stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are usually mild and resolve without the need to discontinue treatment with
Zulbex.
Treatment with Zulbex should be discontinued and medical advice should be sought immediately if the following adverse reactions occur, as medical assistance may be required:

• allergic reaction, symptoms of which may include sudden swelling of the face, breathing difficulties, low blood pressure which may cause fainting or collapse,
• frequent infections such as sore throat or high temperature (fever) or mouth ulcers or sore throat,
• increased tendency to bleed or bruise; These adverse reactions are rare (may occur in no more than 1 in 1,000 patients).
• severe skin peeling or pain and mouth and throat ulcers; These adverse reactions are very rare (may occur in no more than 1 in 10,000 patients).

Other possible adverse reactions:
Common adverse reactions (may occur in no more than 1 in 10 patients):

• Infection
• Insomnia (difficulty sleeping)
• Headache, dizziness
• Cough, sore throat, nasal mucosal inflammation (nasal congestion)
• Diarrhea, vomiting, nausea, abdominal pain, constipation, bloating (gas), mild gastric polyps
• Pain without obvious cause, back pain
• Asthenia (weakness), flu-like symptoms

Uncommon adverse reactions (may occur in no more than 1 in 100 patients):

• Nervousness or drowsiness
• Bronchitis, sinusitis
• Dyspepsia (indigestion), dry mouth, regurgitation of stomach contents or gas
• Rash, skin redness
• Muscle and joint pain, leg cramps, fractures of the hip, wrist or spine
• Urinary tract infections
• Chest pain
• Chills, fever
• Changes in blood test results indicating liver function abnormalities

Rare adverse reactions (may occur in no more than 1 in 1,000 patients):

• Anorexia (loss of appetite)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Gastric mucosal inflammation (stomach upset or pain), oral mucosal inflammation (mouth pain), taste disturbances
• Liver problems, such as hepatitis and jaundice (yellowing of the skin and whites of the eyes), hepatic encephalopathy (brain damage caused by liver disease)
• Itching, sweating, skin blisters (these reactions usually resolve after discontinuation of treatment)
• Excessive sweating
• Kidney problems, such as interstitial nephritis (connective tissue disease of the kidneys)
• Weight gain
• Changes in white blood cells (visible in blood tests), which may lead to frequent infections
• Thrombocytopenia (reduced platelet count) – this may cause weakness, increased bleeding or bruising

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• Confusion
• Swelling of feet or ankles
• Breast enlargement in men
• Hyponatremia (low sodium levels in blood) – symptoms include nausea, muscle weakness or disorientation
• Rash associated with joint pain
• Inflammation of the intestine (leading to diarrhea) If Zulbex 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 cramps, disorientation, seizures, dizziness, rapid heartbeat. If any of the above symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to decreased potassium or calcium levels in blood. The doctor may recommend regular blood tests to monitor magnesium levels.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Zulbex

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light and moisture.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Zulbex contains

• The active substance is sodium rabeprazole. Each enteric-coated tablet contains 10 mg of sodium rabeprazole, equivalent to 9.42 mg of rabeprazole.
• Other ingredients are: mannitol (E 421), light magnesium oxide (E 530), hydroxypropyl cellulose (E 463), low-substituted hydroxypropyl cellulose (E 463), magnesium stearate (E 470b). Coating: ethyl cellulose (E 462), light magnesium oxide (E 530), hypromellose phthalate, diacetylated monoglyceride (E 472a), talc (E 553b), titanium dioxide (E 171), iron oxide red (E 172).

What Zulbex looks like and contents of the pack
Enteric-coated tablets 10 mg: orange-pink, round, biconvex tablets with bevelled edges, approximately 5.7 mm in diameter.
Packaging: 14, 28 or 56 enteric-coated tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Manufacturer:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in the Czech Republic, country of export: 09/986/10-C
Parallel Import Licence Number: 106/22
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names: