Zulbex

Package leaflet: Information for the patient

Caution! Keep the leaflet. Information on the immediate packaging in a foreign language.
Zulbex (Rabeprazolo Krka 20 mg)
20 mg, enteric-coated tablets
Rabeprazolum natricum
Zulbex and Rabeprazolo Krka 20 mg are different brand names for the same medicine.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of 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.
• Treatment of symptomatic moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD), which is 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 this with your doctor or pharmacist.
You should inform your doctor or pharmacist:

• if the patient has had an allergic reaction 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 currently taking atazanavir (a medicine used to treat HIV infection);
• if the patient has vitamin B__ deficiency or risk factors for reduced vitamin B__ levels, and is being treated long-term with sodium rabeprazole; like all medicines that reduce (inhibit) gastric acid secretion, sodium rabeprazole may lead to reduced absorption of vitamin B__,
• if the patient has ever experienced a skin reaction while taking a medicine similar to Zulbex that reduces gastric acid secretion,
• about planned specific blood tests (chromogranin A levels).

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as this may require discontinuation of Zulbex. You should also report any other adverse reactions 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 watery or bloody diarrhoea with high fever and abdominal pain or tenderness occurs during treatment with Zulbex, the treatment should be stopped and the patient should contact the doctor immediately.
Taking proton pump inhibitors such as Zulbex, particularly for longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if the patient has been diagnosed with osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).
While taking rabeprazole, interstitial nephritis (inflammation of the kidneys) may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or allergic reactions such as fever, rash and joint stiffness. Such symptoms should be reported to the treating physician.

Children and adolescents
Zulbex must not be used in children.

Zulbex with other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken or might take any other medicines.
You should inform your doctor or pharmacist:

• if the patient is taking ketoconazole or itraconazole (medicines used to treat fungal infections); Zulbex may reduce blood levels of these medicines; the doctor may adjust the dose accordingly;
• if the patient is 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 taking methotrexate (a chemotherapeutic agent used in high doses for cancer treatment); if the patient is receiving high-dose methotrexate, the doctor may temporarily interrupt treatment with Zulbex.

If in doubt whether any of the above situations apply, consult your doctor or pharmacist before taking Zulbex.

Pregnancy and breastfeeding
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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 the patient plans to breastfeed.

Driving and operating machinery
Zulbex may cause drowsiness. In such cases, do not drive or operate machinery.

Zulbex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Zulbex

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
ZULBEX TABLETS SHOULD BE SWALLOWED WHOLE.
DO NOT CRUSH OR CHEW THE TABLETS.
The dosages described below are generally recommended for adults and elderly patients. Do not alter the dosage or duration of treatment without medical advice.
Zulbex is available in 10 mg and 20 mg tablets.

Children and adolescents
Zulbex should not be used in children.

Active duodenal ulcer and active, mild gastric ulcer
The usual dose is 1 tablet of Zulbex 20 mg once daily.
For active duodenal ulcer, treatment should continue for 4 weeks. After this period, your doctor may decide to extend treatment for another 4 weeks.
For active, mild 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 determine how long Zulbex should be taken. Regular consultations with your doctor are necessary to monitor symptoms and adjust dosage as needed.

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 persist 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 physician. 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) twice daily, usually for 7 days. Symptom relief may occur before complete healing of the ulcer. Therefore, it is important not to discontinue treatment unless instructed by your doctor. For further information on other medicines used in H. pylori eradication, refer to the respective product leaflet.

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 the hospital immediately. Bring the medicine and its packaging with you so the doctor can obtain information about the medicine taken.

Missed dose of Zulbex
If you miss a dose, take it as soon as possible and then continue with your regular 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 dosage 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 intervention may be required:

• allergic reaction, symptoms of which may include sudden facial swelling, breathing difficulties, low blood pressure which may cause fainting or collapse,
• frequent infections such as sore throat or high temperature (fever), or mouth or throat ulcers,
• 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 ulceration of the mouth or throat; 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, pharyngitis (sore throat), rhinitis (nasal congestion)
• Diarrhea, vomiting, nausea, abdominal pain, constipation, flatulence (gas), mild gastric polyps
• Pain without obvious cause, back pain
• Asthenia (weakness), influenza-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
• Gastritis (stomach upset or pain), stomatitis (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 available data):

• Confusion
• Swelling of feet or ankles
• Breast enlargement in males
• Hyponatremia (low sodium levels in blood) – symptoms include nausea, muscle weakness or feeling disoriented.
• Rash accompanied by joint pain
• Colitis (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 manifest as fatigue, involuntary muscle cramps, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, the doctor should be informed immediately. Low magnesium levels may lead to reduced potassium or calcium levels in blood. The doctor may recommend regular blood tests to monitor magnesium levels.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Zulbex contains

• The active substance is sodium rabeprazole. Each enteric-coated tablet contains 20 mg of sodium rabeprazole, equivalent to 18.85 mg of rabeprazole.
• Other ingredients are: mannitol (E 421), light magnesium oxide, hydroxypropylcellulose, low-substituted hydroxypropylcellulose in the tablet core; ethylcellulose, light magnesium oxide, hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide (E 171), yellow iron oxide (E 172) in the tablet coating. See section 2 "Zulbex contains sodium".

What Zulbex looks like and contents of the pack
Light brownish-yellow, round, biconvex tablets, approximately 7.2 mm in diameter.
Pack: 14, 28 or 56 enteric-coated tablets in blisters, packed in a cardboard carton.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Italy, the 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Italy, the country of export: 041591165
Parallel import authorization number: 198/24
This medicinal product is authorized in the European Economic Area member states under the following names: