ZULBEX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Zulbex, 10 mg, gastro-resistant tablets
3. Zulbex, 20 mg, gastro-resistant tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
4. What is Zulbex and what is it used for
5. Important information before taking Zulbex
   1. When not to take Zulbex
   2. Warnings and precautions
   3. Children and adolescents
   4. Zulbex and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Zulbex contains sodium
6. How to take Zulbex
   1. Children and adolescents
   2. Taking a higher dose of Zulbex than recommended
   3. Missing a dose of Zulbex
   4. Stopping treatment with Zulbex
7. Possible side effects
   1. Common side effects (may affect up to 1 in 10 patients):
   2. Uncommon side effects (may affect up to 1 in 100 patients):
   3. Rare side effects (may affect up to 1 in 1000 patients):
   4. Side effects with unknown frequency (frequency cannot be estimated from available data):
   5. Reporting side effects
8. How to store Zulbex
9. Contents of the pack and other information
   1. What Zulbex contains
   2. What Zulbex looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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 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 leaflet, please inform your doctor or pharmacist. See section 4.

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 action of the medicine is to reduce the amount of acid produced by the stomach.

Zulbex is indicated for use in:

• Active duodenal ulcer or active, benign gastric ulcer (peptic ulcers)
• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) with esophagitis or ulceration, often called acid reflux, which causes heartburn, or in 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 taking Zulbex, discuss it with your doctor or pharmacist.

Inform your doctor or pharmacist:

• if you have ever had an allergy to other proton pump inhibitor medicines;
• if you have ever had a stomach tumor;
• 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 you 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, you should inform your doctor as soon as possible, as it may be necessary to stop taking 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 with blood or liver have been observed, which usually disappeared after stopping treatment with rabeprazole.

If, during treatment with Zulbex, you experience diarrhea (bloody or watery) with high fever and abdominal pain or tenderness, you should 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. You should inform 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. Such symptoms should be reported to the treating physician.

Children and adolescents

Zulbex should not be used in children.

Zulbex and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

Inform 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, you should consult your doctor or pharmacist before taking Zulbex.

Pregnancy and breastfeeding

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might 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.

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 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, you should consult your doctor. After the first 4 weeks of treatment, in case of symptom recurrence, your doctor may recommend taking one 10 mg Zulbex tablet on demand to control symptoms.

Zollinger-Ellison syndrome

The usual initial dose is three 20 mg Zulbex tablets 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 the 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 for 7 days. Relief of symptoms usually occurs before complete healing of the ulcer. Therefore, it is important not to stop treatment until your doctor recommends it. For further information on other medicines used in H. pylori eradication, you should read 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. In case of accidental ingestion of a larger number of tablets, you should 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 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, you should 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 the use of 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.

You should 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 can 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 affect 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 obvious cause, back pain
• Asthenia (weakness), flu-like symptoms

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

• Nervousness or drowsiness
• Bronchitis, sinusitis
• Dyspepsia (indigestion), dry mouth, belching (eructation) with 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 showing liver function

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

• 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 (yellowing of the skin and whites of the eyes), hepatic encephalopathy (brain damage caused by liver disease)
• Itching, sweating, skin blisters (reactions that 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 can 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 heartbeat. If you experience any of these symptoms, you should 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 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 batch number is stated on the packaging after "Lot".

Store in the original package 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. 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. 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, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate in the tablet core, and ethylcellulose, 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 leaflet: 07.04.2023