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

20 mg, gastro-resistant tablets

Rabeprazole sodium

You should carefully read the contents of this 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.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 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 used for:

• Active duodenal or benign gastric ulcers (peptic ulcers)
• Symptomatic treatment of gastro-oesophageal reflux disease (GORD) with oesophagitis or ulcers, often called acid reflux disease, accompanied by heartburn, or in long-term treatment of GORD
• Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD), 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, you should discuss it with your doctor or pharmacist.

You should inform 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 a vitamin B12 deficiency and are taking rabeprazole sodium for a long time; like all medicines that reduce stomach acid, rabeprazole sodium may lead to reduced vitamin B12 absorption;
• if you have ever had a skin reaction with a medicine that reduces stomach acid, similar to Zulbex;
• about a planned specific blood test (chromogranin A levels).

If you get a rash on your skin, especially in areas exposed to sunlight, you should contact your doctor as soon as possible, as it may be necessary to stop taking Zulbex. You should also tell your doctor about any other side effects, such as joint pain.

In 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 diarrhoea (bloody or watery) with high fever and abdominal pain or tenderness while taking Zulbex, 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 can 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. Such symptoms should be reported to the treating doctor.

Children and adolescents

Zulbex should not be used in children.

Zulbex and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take.

You should inform your doctor or pharmacist:

• if you are taking ketokonazole 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 contact your doctor or pharmacist before taking Zulbex.

Pregnancy and breastfeeding

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the 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.

Zulbex contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially 'sodium-free'.

3. How to take Zulbex

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Zulbex is available in the following strengths: 10 mg, 20 mg.

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.

Duodenal and benign gastric ulcers

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

In the case of duodenal ulcers, treatment should be continued for 4 weeks. After this time, your doctor may decide to extend the treatment for another 4 weeks. In the case of benign gastric ulcers, treatment should be continued for 6 weeks. After this time, your doctor may decide to extend the treatment for another 6 weeks.

Gastro-oesophageal reflux disease with oesophagitis or ulcers

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 the 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 check your symptoms and dosage.

Symptomatic treatment of GORD

The usual dose is one 10 mg Zulbex tablet per day. It is recommended to use the 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, 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 x 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 to take and the duration of treatment. You should regularly consult your doctor to check your 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 the ulcer is completely healed. Therefore, it is important not to stop treatment until your doctor tells you to. For further information on other medicines used in H. pylori eradication, you should read the leaflet for the relevant medicine.

Taking a higher dose of Zulbex than recommended

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

Missing a dose of Zulbex

If you miss a dose, you should 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 contact your doctor. You should not take a double dose to make up for a missed dose.

Stopping treatment with Zulbex

You should not change the dose or stop treatment without consulting your doctor.

If you have any further questions on 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 taking Zulbex.

You should stop taking Zulbex and contact your doctor immediately if you experience any of the following side effects, as you may need medical attention:

• 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 mouth ulcers, or throat ulcers,
• easier bleeding or bruising; these side effects are rare (may affect up to 1 in 1000 people).
• severe skin blistering 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 (throat pain), runny nose (rhinitis)
• Diarrhoea, vomiting, nausea, abdominal pain, constipation (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 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 people):

• Anorexia (loss of appetite)
• Depression
• Hypersensitivity (including allergic reactions)
• Visual disturbances
• Gastritis (disorder or stomach pain), stomatitis (mouth pain), taste disturbances
• Liver problems, such as hepatitis and jaundice (yellow colour 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 cells (visible in blood tests), which can cause frequent infections
• Thrombocytopenia (reduced platelet count) - this can cause weakness, easier bleeding or bruising

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Confusion
• Swelling of the feet or ankles
• Breast enlargement in men
• Hyponatraemia (low sodium levels in the blood) - symptoms include nausea, muscle weakness or confusion
• Rash that may be accompanied by joint pain
• Enteritis (leading to diarrhoea) 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 tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction 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

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

5. How to store Zulbex

The medicine should be stored 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 stated.

The batch number is stated on the packaging.

Store 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. 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 of Zulbex is rabeprazole sodium. 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 (E 463), low-substituted hydroxypropyl cellulose (E 463), magnesium stearate in the tablet core and ethyl cellulose (E 462), light magnesium oxide, hypromellose phthalate, diacetylated monoglyceride (E 472a), talc (E 553b), titanium dioxide (E 171), yellow iron oxide (E 172) in the tablet coating. See section 2 "Zulbex contains sodium".

What Zulbex looks like and contents of the pack

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

Packaging: 28 gastro-resistant tablets in blisters, in a cardboard box.

For more detailed information, you should contact the marketing authorisation holder or parallel importer.

Marketing authorisation 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.

ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Marketing authorisation number in the Czech Republic, the country of export: 09/987/10-C

Parallel import authorisation number: 379/19

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

Date of revision of the leaflet: 04.10.2024

[Information about the trademark]