Zulbex

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Zulbex (Rabeprazolo Krka 10 mg)
10 mg, enteric-coated tablets
Rabeprazolum natricum
Zulbex and Rabeprazolo Krka 10 mg are different brand names of the same medicine.
Please read this 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 of the leaflet

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 secretion 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 production of stomach acid.
• 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.
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 concurrently 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 undergoing long-term treatment 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 previously experienced a skin reaction due to treatment with 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, inform the doctor immediately, as it may be necessary to discontinue Zulbex. Also report any other adverse effects such as joint pain.
In case of long-term treatment, medical monitoring may be required.
Some patients have experienced blood or liver problems, which usually resolved after stopping treatment with rabeprazole.
If, during treatment with Zulbex, the patient develops diarrhoea (bloody or watery) accompanied by high fever and abdominal pain or tenderness, treatment should be stopped immediately and the doctor contacted without delay.
Taking proton pump inhibitors such as Zulbex, especially for periods 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 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 about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform your doctor or pharmacist:

• if the patient is concurrently 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 concurrently taking atazanavir (a medicine used to treat HIV infection); Zulbex may reduce blood levels of this medicine, and therefore should not be used together with Zulbex;
• if the patient is concurrently taking methotrexate (a chemotherapeutic agent used in high doses for cancer treatment); if the patient is receiving high doses of methotrexate, the doctor may temporarily interrupt treatment with Zulbex.

If in doubt whether any of the above situations apply, contact 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. it is considered "sodium-free".

3. How to take Zulbex

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
ZULBEX TABLETS SHOULD BE SWALLOWED WHOLE.
DO NOT CRUSH OR CHEW THE TABLETS.
The dosing recommendations below usually apply to adults and elderly patients. Do not change the dose or duration of treatment on your own.
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, benign 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, benign gastric ulcer, treatment should continue for 6 weeks. After this period, your doctor may decide to extend treatment for another 6 weeks.

Reflux esophagitis 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 GORD
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. Regular consultations with your doctor are necessary to monitor symptoms and dosage.

Symptomatic treatment of GORD
The usual dose is 1 tablet of Zulbex 10 mg once daily. A fixed dosing regimen 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 taken 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. Symptom relief usually occurs before complete ulcer healing. Therefore, it is important not to interrupt 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 hospital immediately. Take the tablets and 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, 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 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 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 ulceration,
• 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 apparent 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, belching with 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 (decreased platelet count) – this may cause weakness, increased tendency to bleed or bruise

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

• Confusion
• Swelling of the 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 the blood. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The 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 a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. 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.
• The other ingredients are: mannitol (E 421), light magnesium oxide, hydroxypropylcellulose, low-substituted hydroxypropylcellulose in the tablet core; and ethylcellulose, light magnesium oxide, hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide (E 171), iron oxide red (E 172) in the tablet coating. See section 2 "Zulbex contains sodium".

What Zulbex looks like and contents of the pack
Orange-pink, round, biconvex tablets with bevelled edges, approximately 5.7 mm in diameter.
Pack: 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 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: 197/24
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 Authorisation number in Italy, the country of export: 041591052
Parallel Import Licence number:
This medicinal product is authorised in the European Economic Area countries under the following names: