Zulbex

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Zulbex (Rabeprazole Krka 10 mg)

10 mg, gastro-resistant tablets

Rabeprazole sodium
Zulbex and Rabeprazole Krka 10 mg are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 medicine works by reducing the amount of acid produced by the stomach.
Zulbex is used for:

• Active duodenal or benign gastric ulcers (peptic ulcers).
• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) with esophagitis or ulcers, often called acid reflux, which causes heartburn, or for long-term treatment of GORD.
• Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD), which is also accompanied by heartburn.
• Zollinger-Ellison syndrome, a rare condition where the stomach produces 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 you are allergic to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6),
• in pregnancy, suspected pregnancy, or during breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting treatment with Zulbex, discuss it with your doctor or pharmacist.
Tell your doctor or pharmacist:

• if you have ever had an allergy to other proton pump inhibitor medicines,
• if you have ever had stomach cancer,
• if you have a history of liver disease,
• if you are taking atazanavir (a medicine used to treat HIV infection);
• if you have a vitamin B12 deficiency or risk factors for reduced vitamin B12 levels and are taking long-term rabeprazole sodium; like all medicines that reduce stomach acid, rabeprazole sodium may lead to reduced absorption of vitamin B12,
• if you have ever had a skin reaction after taking a medicine that reduces stomach acid,
• about any planned specific blood test (chromogranin A levels).

If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Zulbex. Also, tell 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 with blood or liver have been observed, which usually disappeared after stopping treatment with rabeprazole.
If you experience diarrhea (bloody or watery) with high fever and abdominal pain or tenderness during treatment with Zulbex, stop taking the medicine and contact your doctor immediately.
When taking proton pump inhibitors like Zulbex, especially for a period longer than one year, the risk of bone fractures in the hip, wrist, or spine may increase slightly. Tell your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
During treatment with rabeprazole, kidney inflammation may occur. Signs and symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. Report such symptoms to your doctor.

Children and adolescents

Zulbex should not be used in children.

Zulbex and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor or pharmacist:

• if you are taking ketoconazole or itraconazole (medicines used to treat fungal infections); Zulbex may reduce the levels of these medicines in the blood; your doctor may adjust the dose;
• if you are taking atazanavir (a medicine used to treat HIV infection); Zulbex may reduce the levels of this medicine in the blood, so it should not be taken at the same time as Zulbex;
• if you are taking methotrexate (a chemotherapy medicine used in high doses to treat cancer); if you are taking high doses of methotrexate, your doctor may temporarily stop treatment with Zulbex.

If you are unsure whether the above situations apply to you, consult your doctor or pharmacist before taking Zulbex.

Pregnancy and breastfeeding

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

Driving and using machines

Taking Zulbex may cause drowsiness. In this case, do not drive or operate machines.

Zulbex contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "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 below is usually used for adults and the elderly. Do not change the dose or duration of treatment yourself.
Zulbex is available in 10 mg and 20 mg strengths.

Children and adolescents

Zulbex should not be used in children.
Active duodenal and benign gastric ulcers
The usual dose is 1 Zulbex 20 mg tablet once a day.
For active duodenal ulcers, treatment should be continued for 4 weeks. After this time, your doctor may decide to extend treatment for another 4 weeks.
For active, benign gastric ulcers, 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 dosage.
Symptomatic treatment of GORD
The usual dose is 1 Zulbex 10 mg tablet once a day. It is recommended to use the established dosage for 4 weeks. If symptoms do not disappear after this time, consult your doctor. After the first 4 weeks of treatment, if symptoms recur, your doctor may recommend taking 1 Zulbex 10 mg tablet on demand 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 and duration of treatment. You should regularly consult your doctor to control symptoms and dosage.
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 for 7 days. Relief of symptoms usually occurs before complete healing of the ulcer. Therefore, it is essential not to stop treatment until your doctor recommends it. For further information on other medicines used in H. pylori eradication, refer to the leaflet of the respective medicine.

Taking a higher dose of Zulbex than recommended

Do not take more tablets per day than your doctor has prescribed. If you have taken more tablets than prescribed, consult your doctor or go to the hospital. Take the tablets and packaging with you to the hospital, so your doctor can get information about the medicine you have taken.

Missing a dose of Zulbex

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

Stopping treatment with Zulbex

Do not change the dose or stop treatment without consulting your doctor.
If you have any further doubts about taking this medicine, 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 disappear without the need to stop treatment with Zulbex.
Stop taking Zulbex and contact your doctor immediately if you experience the following side effects, as medical attention may be necessary:

• allergic reaction, which may include sudden swelling of the face, problems with breathing, low blood pressure, which may cause fainting or collapse,
• frequent infections such as sore throat or high temperature (fever) or oral or throat ulcers,
• easier bleeding or bruising; 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, bloating (flatulence), mild gastric polyps
• Pain without clear 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 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 showing 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 (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 disappeared after stopping treatment)
• Excessive sweating
• Kidney problems, such as interstitial nephritis (kidney tissue disease)
• Weight gain
• Changes in white blood cell count (seen in blood tests), which may cause frequent infections
• Thrombocytopenia (reduced platelet count) - 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) - may cause 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 may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heart rate. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels may 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, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store 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 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 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 rabeprazole sodium. Each gastro-resistant tablet contains 10 mg of rabeprazole sodium, which corresponds to 9.42 mg of rabeprazole.
• The other ingredients are: mannitol (E 421), light magnesium oxide, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose in the tablet core, and ethyl cellulose, light magnesium oxide, hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide (E 171), red iron oxide (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 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, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Italy, 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Italian, country of export marketing authorization number: 041591052
041591037
041591076

Parallel import authorization number:

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

Date of leaflet approval: 14.05.2024

[Information about the trademark]