Zulbex

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Zulbex

10 mg, gastro-resistant tablets
Rabeprazole sodium

You should carefully read the contents of the leaflet before taking 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 pack 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 ulcers (peptic ulcers).
• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) with esophagitis or ulcers, often referred to as acid reflux esophagitis, accompanied by heartburn, or in long-term treatment of GORD.
• Symptomatic treatment of moderate to very severe GORD (symptomatic GORD), also accompanied by heartburn.
• Zollinger-Ellison syndrome, a rare disease characterized by excessive acid production by 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 taking Zulbex

When not to take Zulbex:

• 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:

• about a planned specific blood test (chromogranin A levels).

If you experience a skin rash, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to discontinue treatment with Zulbex. You should also inform your 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 related to blood or liver have been observed, which often resolved after discontinuation of rabeprazole treatment.
If you experience diarrhea (bloody or watery) with high fever and abdominal pain or tenderness during treatment with Zulbex, you should discontinue treatment and contact your 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. You should 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 should not be used in children.

Zulbex and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor or pharmacist:

In case of doubts whether the above situations apply to you, you should consult your doctor or pharmacist before taking Zulbex.

Pregnancy and breastfeeding

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Zulbex should not be taken during pregnancy or if you think you may be pregnant.
Zulbex should not be taken during breastfeeding or if you plan to breastfeed.

Driving and using machines

Taking Zulbex may cause drowsiness. In this case, you should not drive or operate machinery.

3. How to take Zulbex

This medicine should always be taken as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist.
Zulbex is available in the following doses: 10 mg, 20 mg.
ZULBEX TABLETS SHOULD BE SWALLOWED WHOLE.
THE TABLETS SHOULD NOT BE CRUSHED OR CHEWED.
The dosing below is usually used for adults and the elderly. You should 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 Zulbex 20 mg tablet once a day.
In the case of active duodenal ulcer, treatment should be continued for 4 weeks.
After this time, your 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, your doctor may decide to extend treatment for another 6 weeks.
Gastro-oesophageal reflux disease with esophagitis or ulcers
The usual dose is 1 Zulbex 20 mg tablet once a day. Treatment should be continued for 4 weeks. After this time, your 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. Your doctor will decide how long you should take Zulbex. You should regularly consult your 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 resolve after this time, you should consult your doctor. After the first 4 weeks of treatment, in case of symptom recurrence, your 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 your doctor during treatment, depending on your response to treatment. Your doctor will decide on the number of tablets taken and the duration of treatment. You should regularly consult your doctor to control symptoms and dosing.
Treatment of H. pylori infection
The usual dose is Zulbex 20 mg (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 your doctor recommends it. For further information on other medicines used in H. pylori eradication, you should read the leaflet of the respective medicine.

Taking a higher dose of Zulbex than recommended

You should not take more tablets per day than prescribed by your doctor. In case of accidental ingestion of a larger number of tablets, you should consult your doctor or go to the hospital. You should take the tablets and packaging to the hospital so that your doctor can obtain information about the ingested medicine.

Missing a dose of Zulbex

In case of a missed dose, you should take it as soon as possible, and then continue with the normal dosing. If you have not taken the medicine for more than 5 days before taking it again, you should consult your doctor. You should not take a double dose to make up for the missed dose.

Discontinuing Zulbex

You should not change the dose or discontinue treatment without consulting your doctor.
In case of any further doubts related to the use of this medicine, you should consult your 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 resolve without the need to discontinue treatment with Zulbex.
You should discontinue treatment with Zulbex and contact your doctor immediately if you experience the following side effects, as medical attention may be necessary:

• allergic reaction, whose symptoms may include sudden swelling of the face, breathing difficulties, low blood pressure, which can cause fainting or collapse,
• frequent infections such as sore throat or high temperature (fever) or oral or throat ulcers, or
• easy bruising or bleeding; These side effects are rare (may occur in up to 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 up to 1 in 10,000 patients).

Other possible side effects:

Common side effects (may occur in up to 1 in 10 patients):

• Infection
• Insomnia (difficulty sleeping)
• Headache, dizziness
• Cough, sore throat (pharyngitis), runny nose (rhinitis)
• Diarrhea, vomiting, nausea, abdominal pain, constipation (constipation), bloating (flatulence), mild gastric polyps
• Pain without obvious cause, back pain
• Asthenia (weakness), flu-like symptoms

Uncommon side effects (may occur in up to 1 in 100 patients):

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

Rare side effects (may occur in up to 1 in 1000 patients):

• Anorexia (loss of appetite)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Gastritis (stomach upset or pain), stomatitis (pain in the mouth), 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 resolved 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 can cause frequent infections
• Thrombocytopenia (reduced platelet count) - this can cause weakness, easy bruising or bleeding

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 you have taken Zulbex for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If you experience any of these symptoms, you should inform your doctor immediately. Low magnesium levels can lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, 181C Jerozolimskie Avenue, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Zulbex

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zulbex contains

• The active substance of Zulbex is rabeprazole sodium. Each gastro-resistant tablet contains 10 mg of rabeprazole sodium, equivalent to 9.42 mg of rabeprazole.
• The 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: ethylcellulose (E 462), light magnesium oxide (E 530), hypromellose phthalate, diacetylated monoglyceride (E 472a), talc (E 553b), titanium dioxide (E 171), red iron oxide (E 172).

What Zulbex looks like and contents of the pack

Gastro-resistant tablets 10 mg: orange-pink, round, biconvex tablets with beveled edges, tablet diameter approximately 5.7 mm.
Packaging: 14, 28, or 56 gastro-resistant tablets in blisters, in a cardboard box.
For more detailed information, you 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:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 09/986/10-C

Parallel import authorization number: 106/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Approval date of the leaflet: 23.02.2022

[Information about the trademark]