Zulbex

Package Leaflet: Information for the Patient

Zulbex, 10 mg, gastro-resistant tablets

Zulbex, 20 mg, gastro-resistant tablets

rabeprazole sodium

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 gastric ulcer (peptic ulcer disease)
• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) with esophagitis or ulceration, often called acid reflux disease, accompanied by heartburn, or for 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 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 taking Zulbex

When not to take Zulbex

• during pregnancy, suspected pregnancy, or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before taking Zulbex, discuss it with your doctor or pharmacist.

Tell your doctor or pharmacist:

• 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, inform your doctor about any other side effects, such as joint pain.

Long-term use of the medicine may require medical supervision.

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 while taking Zulbex, stop taking the medicine and contact your doctor immediately.

When taking proton pump inhibitors like Zulbex, especially for more than one year, the risk of bone fractures in the hip, wrist, or spine may increase slightly. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

While taking 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 or have recently taken, as well as any medicines you plan to take.

Tell your doctor or pharmacist:

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 or have recently taken, 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 machinery.

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, ask your doctor or pharmacist.

ZULBEX TABLETS SHOULD BE SWALLOWED WHOLE.

ZULBEX TABLETS SHOULD NOT BE CRUSHED OR CHEWED.

The dosing below is usually used for adults and the elderly. Do not change the dose or duration of treatment yourself.

Children and adolescents

Zulbex should not be used in children.

Active duodenal ulcer and active, benign gastric ulcer

The usual dose is one 20 mg Zulbex tablet per day.

For active duodenal ulcer, 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 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 ulceration

The usual dose is one 20 mg Zulbex tablet per 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 one 10 mg or 20 mg Zulbex tablet per 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 one 10 mg Zulbex tablet per day. It is recommended to use a fixed dose 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 one 10 mg Zulbex tablet on demand to control symptoms.

Zollinger-Ellison syndrome

The usual initial dose is 3 tablets of 20 mg Zulbex per 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 20 mg Zulbex (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 complete healing of the ulcer. Therefore, it is essential not to stop treatment until your doctor tells you to. For further information on other medicines used in H. pylori eradication, refer to the package leaflet of the respective medicine.

Taking a higher dose of Zulbex than recommended

Do not take more tablets per day than prescribed by your doctor. If you accidentally take more tablets, consult your doctor or go to the hospital. Take the tablets and packaging with you to the hospital so that the 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 questions about taking this medicine, ask 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 any of the following side effects, as medical attention may be necessary:

• allergic reaction, whose symptoms 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 mouth ulcers, or throat ulcers,
• easy bruising or bleeding; These side effects are rare (may affect up to 1 in 1000 people).
• severe skin peeling or pain and ulcers in the mouth and throat; These side effects are very rare (may affect up to 1 in 10,000 people).

Other possible side effects:

Common side effects (may affect up to 1 in 10 people):

• 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 affect up to 1 in 100 people):

• Nervousness or drowsiness
• Bronchitis, sinusitis
• Dyspepsia (indigestion), dry mouth, belching (eructation) with regurgitation of gastric contents or gas
• Rash, redness of the skin
• 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 affect up to 1 in 1000 people):

• Anorexia (loss of appetite)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Gastritis (upset or stomach pain), stomatitis (pain in the mouth), taste disturbances
• Liver problems, such as hepatitis and jaundice (yellow color 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, easy bruising or bleeding

Side effects with unknown frequency (frequency cannot be estimated from the 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 heartbeat. If you experience any of these symptoms, inform 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 package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zulbex

Keep this medicine out of the 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 stated.

The batch number is stated on the packaging after "Lot".

Store in the original packaging to protect from moisture and light.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, equivalent to 9.42 mg of rabeprazole. Each gastro-resistant tablet contains 20 mg of rabeprazole sodium, equivalent to 18.85 mg of rabeprazole.
• The other ingredients are: mannitol (E 421), light magnesium oxide, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate in the tablet core, and ethyl cellulose, light magnesium oxide, hypromellose phthalate, diacetylated monoglyceride, talc, titanium dioxide (E 171), red iron oxide (E 172) - only in 10 mg tablets, and yellow iron oxide (E 172) - only in 20 mg tablets, in the tablet coating. See section 2 "Zulbex contains sodium".

What Zulbex looks like and contents of the pack

10 mg gastro-resistant tablets: orange-pink, round, biconvex tablets with beveled edges, tablet diameter approximately 5.7 mm

20 mg gastro-resistant tablets: light brown-yellow, round, biconvex tablets, tablet diameter approximately 7.2 mm

Packaging: 7, 14, 28, or 56 gastro-resistant tablets in blisters, in a cardboard box

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

Date of last revision of the package leaflet: 07.04.2023