Zulbex

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, the information on the immediate packaging in a foreign language.

Zulbex, 20 mg, gastro-resistant tablets
Rabeprazole sodium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zulbex and what is it 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 packaging and other information

1. What is Zulbex and what is it used for

Zulbex contains the active substance rabeprazole. It belongs to a group of medicines called proton pump inhibitors. The action of the medicine is to reduce the amount of acid produced by the stomach.
Zulbex is indicated for use in:

• Active duodenal or active, benign gastric ulcer (peptic ulcers).
• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) with erosions or ulcers, often called acid reflux, which is accompanied by heartburn, or in long-term treatment of gastro-oesophageal reflux disease.
• Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD), which is also accompanied by heartburn.
• Zollinger-Ellison syndrome, which is a rare disease characterized by the stomach producing too much acid.
• Treatment of H. pylori infection in patients with peptic ulcer disease, in combination with two antibiotics (clarithromycin and amoxicillin).

2. Important information before taking Zulbex

When not to take Zulbex:

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

Warnings and precautions

Before starting treatment with Zulbex, you should discuss it with your doctor or pharmacist.
You should inform your doctor or pharmacist:

• if the patient has been diagnosed with an allergy to other medicines in the group of 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 a vitamin B deficiency or risk factors for reduced vitamin B levels, and the patient is being treated with rabeprazole sodium for a long time; like all medicines that reduce gastric acid secretion, rabeprazole sodium may lead to reduced absorption of vitamin B;
• if the patient has ever had a skin reaction after taking a medicine similar to Zulbex, which reduces stomach acid production;
• about a planned specific blood test (chromogranin A level).

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to discontinue treatment with Zulbex. They should also tell their doctor about any other side effects, such as joint pain.
In the case of long-term use of the medicine, medical supervision may be necessary.
In some patients, problems with blood or liver have been observed, which usually disappeared after discontinuation of rabeprazole treatment.
If the patient experiences diarrhea (bloody or watery) with high fever and abdominal pain or tenderness during treatment with Zulbex, they should discontinue treatment and contact their doctor immediately.
Taking proton pump inhibitors like Zulbex, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Children and adolescents

Zulbex should not be used in children.

Zulbex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor or pharmacist:

• if they are taking ketokonazol or itrakonazol (medicines used to treat fungal infections) at the same time; Zulbex may reduce the levels of these medicines in the blood; the doctor may adjust the dose;
• if they are taking atazanavir (a medicine used to treat HIV infection) at the same time; Zulbex may reduce the levels of this medicine in the blood, so it should not be taken at the same time as Zulbex;
• if they are taking metotreksat (a chemotherapeutic agent used in high doses to treat cancer); if the patient is taking high doses of metotreksat, the doctor may temporarily discontinue treatment with Zulbex.

In case of doubts whether the above situations apply to the patient, they should contact their doctor or pharmacist before taking Zulbex.

Pregnancy and breastfeeding

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Zulbex should not be used during pregnancy or if the patient thinks they may be pregnant.
Zulbex should not be used during breastfeeding or if the patient plans to breastfeed.

Driving and using machines

Taking Zulbex may cause drowsiness. In this case, the patient should not drive or operate machines.

3. How to take Zulbex

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Zulbex is available in 10 mg and 20 mg doses.
ZULBEX TABLETS SHOULD BE SWALLOWED WHOLE.
TABLETS SHOULD NOT BE CRUSHED OR CHEWED.
The dosing below is usually used for adults and the elderly. The patient should not change the dose or duration of treatment on their own.

Children and adolescents

Zulbex should not be used in children.
Active duodenal ulcer and active, benign gastric ulcer
The usual dose is 1 Zulbex 20 mg tablet once a day.
In the case of active duodenal ulcer, treatment should be continued for 4 weeks. After this time, the doctor may decide to extend treatment for another 4 weeks.
In the case of active, benign gastric ulcer, treatment should be continued for 6 weeks. After this time, the doctor may decide to extend treatment for another 6 weeks.
Gastro-oesophageal reflux disease with erosions or ulcers
The usual dose is 1 Zulbex 20 mg tablet once a day. Treatment should be continued for 4 weeks. After this time, the doctor may decide to extend treatment for another 4 weeks.
Long-term treatment of GORD
The usual dose is 1 Zulbex 10 mg or 20 mg tablet once a day. The doctor will decide how long Zulbex should be taken. The patient should regularly consult their doctor to control symptoms and dosing.
Symptomatic treatment of GORD
The usual dose is 1 Zulbex 10 mg tablet once a day. It is recommended to use the established dose for 4 weeks. If symptoms do not disappear after this time, the patient should consult their doctor. After the first 4 weeks of treatment, in case of symptom recurrence, the doctor may recommend taking 1 Zulbex 10 mg tablet as needed to control symptoms.
Zollinger-Ellison syndrome
The usual initial dose is 3 Zulbex 20 mg tablets once a day. The dose may be changed by the doctor during treatment, depending on the patient's response to treatment. The doctor will decide on the number of tablets taken and the duration of treatment. The patient should regularly consult their doctor to control symptoms and dosing.
Treatment of H. pylori infection
The usual dose is 1 Zulbex 20 mg tablet (in combination with two antibiotics - clarithromycin 500 mg and amoxicillin 1 g) twice a day, usually taken for 7 days.
Relief of symptoms usually occurs before the ulcer is completely healed. Therefore, it is essential not to discontinue treatment until the doctor recommends it. For further information on other medicines used in H. pylori eradication, the patient should read the leaflet of the respective medicine.

Taking a higher dose of Zulbex than recommended

The patient should not take more tablets per day than prescribed by the doctor. In case of accidental ingestion of a larger number of tablets, the patient should consult their doctor or go to the hospital. The patient should take the tablets and packaging to the hospital so that the doctor can get information about the taken medicine.

Missing a dose of Zulbex

In case of missing a dose, the patient should take it as soon as possible and then continue with the normal dosing schedule. If the patient has not taken the medicine for more than 5 days before taking it again, they should contact their doctor.
The patient should not take a double dose to make up for the missed dose.

Discontinuing Zulbex

The patient should not change the dose or discontinue treatment without consulting their doctor.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zulbex can cause side effects, although not everybody gets them.
Side effects are usually mild and disappear without the need to discontinue treatment with Zulbex.
The patient should discontinue treatment with Zulbex and contact their doctor immediately if they experience the following side effects, as medical attention may be necessary:

• allergic reaction, 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 throat ulcers,
• easier bleeding or bruising; these side effects are rare (may occur in no more than 1 in 1000 patients).
• severe skin peeling or pain and ulcers in the mouth and throat; these side effects are very rare (may occur in no more than 1 in 10,000 patients).

Other possible side effects:

Common side effects (may occur in no more than 1 in 10 patients):

• infection,
• insomnia (difficulty sleeping),
• headache, dizziness,
• cough, sore throat (throat pain), runny nose (nasal congestion),
• diarrhea, vomiting, nausea, abdominal pain, constipation (constipation), bloating (gas), mild gastric polyps,
• pain without obvious cause, back pain,
• asthenia (weakness), flu-like symptoms.

Uncommon side effects (may occur in no more than 1 in 100 patients):

• nervousness or drowsiness,
• bronchitis, sinusitis,
• dyspepsia (indigestion), dry mouth, belching or regurgitation of gastric 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.

Rare side effects (may occur in no more than 1 in 1000 patients):

• anorexia (loss of appetite),
• depression,
• hypersensitivity (including allergic reactions),
• vision disorders,
• gastritis (stomach upset or pain), stomatitis (mouth pain), taste disorders,
• 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 disappeared after discontinuation of treatment),
• excessive sweating,
• kidney problems, such as interstitial nephritis (kidney tissue disease),
• weight gain,
• changes in white blood cell count (visible in blood tests), which may cause frequent infections,
• thrombocytopenia (reduced platelet count) - this may cause weakness, easier bleeding, or bruising.

Side effects 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 the blood) - symptoms include nausea, muscle weakness, or confusion,
• rash that may be accompanied by joint pain,
• enteritis (leading to diarrhea).

If Zulbex has been taken for a period longer than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should immediately inform their doctor. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Zulbex

The medicine should be stored out of sight and reach of children.
Zulbex should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature below 30°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zulbex contains

• The active substance of Zulbex is rabeprazole sodium. Each gastro-resistant tablet contains 20 mg of rabeprazole sodium, which corresponds to 18.85 mg of rabeprazole.
• The other ingredients are: mannitol (E 421), light magnesium oxide, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose in the tablet core, and magnesium stearate, as well as ethyl cellulose, light magnesium oxide, hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide (E 171), yellow iron oxide (E 172) in the tablet coating.

What Zulbex looks like and what the packaging contains

Gastro-resistant tablets 20 mg: light brown-yellow, round, biconvex tablets, tablet diameter approximately 7.2 mm.
Packaging: 7, 14, 28, or 56 gastro-resistant tablets in blisters of OPA/Al/PVC/Al foil, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, 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:

PharmaVitae Sp. z o.o. Sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CANPOLAND Joint-Stock Company, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Authorization number in the Czech Republic, the country of export:09/987/10-C
Parallel import authorization number:334/17

This medicinal product is authorized for sale in the Member States of the European Economic Area under the following names: Approval date of the leaflet: 26.07.2022

[Information about the trademark]