Ozzion

Leaflet attached to the packaging: patient information

Ozzion, 40 mg, gastro-resistant tablets

Pantoprazole

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This leaflet should be kept, so that it can be re-read if necessary.
In case of any doubts, the doctor or pharmacist should be consulted.
This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist.
See section 4.

Table of contents of the leaflet

• 1. What is Ozzion and what is it used for
• 2. Important information before taking Ozzion
• 3. How to take Ozzion
• 4. Possible side effects
• 5. How to store Ozzion
• 6. Contents of the packaging and other information

1. What is Ozzion and what is it used for

Ozzion contains the active substance pantoprazole. Ozzion is a selective proton pump inhibitor, reducing the amount of hydrochloric acid secreted in the stomach. It is used to treat stomach and intestinal diseases related to acid action.

Ozzion 40mg tablets are used

In adults and adolescents aged 12 years and older for the treatment of:

• reflux esophagitis. Esophagitis (a tubular organ connecting the throat to the stomach), accompanied by reflux of acidic stomach contents.

In adults for the treatment of:

• infections caused by the bacterium Helicobacter pyloriin combination with appropriate antibiotic treatment in patients with duodenal or gastric ulcer disease (so-called eradication). The goal of treatment is to eliminate the bacteria and reduce the risk of ulcer recurrence.
• gastric and duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before taking Ozzion

When not to take Ozzion

• if the patient is allergic to pantoprazole, peanuts, soybean oil, or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before starting Ozzion, the patient should discuss with their doctor or pharmacist in the following situations:

• in case of severe liver disease. The patient should inform their doctor about any past liver function disorders. The doctor will decide on more frequent testing of liver enzyme activity, especially in the case of long-term use of Ozzion. If liver enzyme activity increases, treatment should be discontinued.
• in case of reduced vitamin B stores in the body or the presence of risk factors for vitamin B deficiency and concurrent long-term use of pantoprazole. Like all acid-reducing medicines, pantoprazole may lead to reduced vitamin B absorption. The patient should contact their doctor if they notice any of the following symptoms, which may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy,
• numbness or tingling,
• pain or redness of the tongue, oral ulcers,
• muscle weakness,
• vision problems,
• memory problems, disorientation, depression.
• in case of concurrent use of HIV protease inhibitors such as atazanavir (used to treat HIV infection) and pantoprazole, the patient should consult their doctor for detailed advice.
• in case of taking proton pump inhibitors, such as Ozzion, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may slightly increase. The patient should inform their doctor if they have been diagnosed with osteoporosis (reduced bone density) or if their doctor has informed them that they are at risk of osteoporosis (e.g., if they are taking steroid medications).
• in case of taking Ozzion for a period longer than three months, it may lead to a decrease in the patient's blood magnesium level. Low magnesium levels may cause fatigue, involuntary muscle contractions, seizures, disorientation, dizziness, and rapid heartbeat. If any of these symptoms occur, the patient should immediately inform their doctor. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• if the patient has ever experienced a skin reaction after taking a medicine similar to Ozzion that reduces stomach acid.
• if the patient develops a rash on the skin, especially in areas exposed to sunlight, they should immediately inform their doctor, as it may be necessary to stop taking Ozzion. The patient should also mention any other symptoms, such as joint pain.
• severe skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. The patient should stop taking pantoprazole and seek medical advice immediately if they notice any symptoms related to these severe skin reactions described in section 4.
• in case of a planned specific blood test (chromogranin A levels).

The patient should immediately inform their doctorbefore or after taking the medicine if they experience any of the following symptoms, which may be a sign of a more serious illness:

• unintentional weight loss,
• vomiting, especially if it is recurrent,
• bloody vomiting, which may look like coffee grounds,
• blood in the stool, black or tarry stools,
• difficulty swallowing or pain when swallowing,
• pale skin and weakness (anemia),
• chest pain,
• abdominal pain,
• severe and/or persistent diarrhea (as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea).

The doctor may decide to perform additional tests to rule out the presence of malignant disease, as pantoprazole may mask the symptoms of cancer and cause a delay in diagnosis. If the symptoms persist despite the treatment, the doctor will consider further testing.
In case of long-term use of Ozzion (more than 1 year), the doctor will decide on the need for regular health checks. The patient should always inform their doctor about any new or unusual symptoms or circumstances.

Children and adolescents

Ozzion is not recommended for use in children, as its efficacy in children under 12 years of age has not been demonstrated.

Ozzion and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Ozzion may affect the efficacy of other medicines; therefore, the patient should inform their doctor about taking:

• medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Ozzion may make these medicines less effective.
• warfarin and phenprocoumon, which affect blood density and prevent blood clots. Additional tests may be necessary.
• medicines used to treat HIV infection, such as atazanavir.
• methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer) - if the patient is taking methotrexate, the doctor may temporarily discontinue Ozzion treatment, as pantoprazole may increase methotrexate levels in the blood.
• fluvoxamine (a medicine used to treat depression and other mental illnesses) - if the patient is taking fluvoxamine, the doctor may reduce the dose.
• rifampicin (a medicine used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before starting pantoprazole, the patient should discuss with their doctor if they are to undergo a specific urine test (for the presence of tetrahydrocannabinol (THC)).

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of pantoprazole in pregnant women. It has been reported that the medicine is excreted in breast milk. If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The patient should only take this medicine if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus or child.

Driving and using machines

Ozzion has no or negligible influence on the ability to drive and use machines. However, if the patient experiences side effects such as dizziness or vision disturbances, they should not drive or operate any machines.

Ozzion contains soybean lecithin, maltitol, and sodium

In case of an allergy to peanuts or soy, the patient should not take this medicine.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Ozzion

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of any doubts, the patient should consult their doctor or pharmacist.

Method of administration

The tablets should be taken 1 hour before a meal, not chewed or crushed, and swallowed whole with a sufficient amount of water.
Recommended dose

• Adults and adolescents aged 12 years and olderTreatment of reflux esophagitisThe usual dose is 1 tablet per day. The doctor may recommend increasing the dose to 2 tablets per day. Treatment of reflux esophagitis usually lasts 4-8 weeks. The doctor will inform the patient about the recommended treatment duration.
• AdultsTreatment of Helicobacter pylori infections in patients with duodenal or gastric ulcer disease (eradication)in combination with two antibioticsOne tablet twice a day and two antibiotics recommended by the doctor, chosen from the following: amoxicillin, clarithromycin, and metronidazole (or tinidazole), each taken twice a day, simultaneously with pantoprazole. The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet should be taken 1 hour before the evening meal. The patient should follow the doctor's instructions and read the patient information leaflets accompanying the antibiotic packaging. Treatment usually lasts one to two weeks.

Gastric and duodenal ulcer disease
The usual dose is one tablet per day. After consulting the doctor, the dose can be increased to two tablets per day.
The doctor will decide on the required treatment duration. Treatment of gastric ulcer disease usually lasts 4-8 weeks. Treatment of duodenal ulcer disease usually lasts 2-4 weeks.
Long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach
The usual initial dose is two tablets per day.
The patient should take two tablets 1 hour before a meal. The doctor will decide on subsequent dose adjustments based on the amount of hydrochloric acid secreted in the stomach.
If the doctor recommends taking more than two tablets per day, they should be taken twice a day.
If the doctor recommends taking more than four tablets per day, they will inform the patient about the required treatment duration.

Patients with renal impairment

• -in case of kidney disease, Ozzion 40mg should not be used for Helicobacter pylori eradication.

Patients with hepatic impairment

• in case of severe liver disease, the patient should not take more than one 20mg pantoprazole tablet per day (for this reason, 20mg pantoprazole tablets are available).
• in case of moderate or severe liver disease, the patient should not take Ozzion 40mg for Helicobacter pylori eradication.

Use in children and adolescents

The tablets are not recommended for use in children under 12 years of age.

Taking a higher dose of Ozzion than recommended

The patient should inform their doctor or pharmacist. The symptoms of overdose are not known.

Missing a dose of Ozzion

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping Ozzion treatment

The patient should not stop taking the medicine without consulting their doctor or pharmacist.
In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ozzion can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking the medicine and immediately inform their doctor or contact the nearest hospital:

• Severe allergic reactions (frequency: rare:may occur less often than in 1 in 1000 ):swelling of the tongue and/or throat, difficulty swallowing, hives (blistering rash), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with a very fast heartbeat and excessive sweating.
• Severe skin reactions (frequency: unknown:frequency cannot be estimated from the available data ): the patient may notice one or more of the following symptomsblisters on the skin and rapid deterioration of the general condition, peeling of the skin (including minor bleeding) from the eyes, nose, mouth, or genitals, or rash, especially in areas of the skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in some white blood cells or liver enzymes in blood tests may also occur.
• red, non-raised spots or circular patches on the torso, often with blisters, in the center, peeling of the skin, oral ulcers, throat, nose, genitals, and eyes. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Other serious reactions (frequency: unknown):yellowing of the skin or whites of the eyes (caused by severe liver cell damage, jaundice) or fever, rash, kidney enlargement accompanied by painful urination and lower back pain (severe kidney inflammation, which can lead to kidney failure).

Other side effects are as follows:

Common(may occur in less than 1 in 10 people)

• ‒mild gastric polyps.

Uncommon(may occur in less than 1 in 100 people):

• headache, dizziness; diarrhea; nausea, vomiting; bloating and gas, constipation; dry mouth; abdominal pain and discomfort; skin rash, papular rash; itching; weakness, fatigue, or malaise; sleep disturbances; fractures of the hip, wrist, or spine.

Rare(may occur in less than 1 in 1000 people):

• taste disturbances or complete loss of taste; vision disturbances, such as blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; high fever; peripheral edema; allergic reactions; depression; gynecomastia in men.

Very rare(may occur in less than 1 in 10,000 patients):

• disorientation.

Frequency not known(frequency cannot be estimated from the available data):

• hallucinations; confusion (especially in patients who have experienced such symptoms), tingling, numbness, burning, or prickling sensations, rash that may be accompanied by joint pain, colitis that causes persistent, watery diarrhea.

Side effects identified through blood tests:

Uncommon(may occur in less than 1 in 100 people):

• increased liver enzyme activity.

Rare(may occur in less than 1 in 1000 people):

• increased bilirubin levels; increased lipid levels in the blood; sudden decrease in the number of circulating white blood cells, associated with high fever.

Very rare(may occur in less than 1 in 10,000 people):

• decrease in platelet count, which may cause increased tendency to bleeding and bruising; decrease in white blood cell count, which may lead to more frequent infections;
• concomitant decrease in red and white blood cell and platelet counts.

Frequency not known(frequency cannot be estimated from the available data)
Decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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 181 C

• 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 e-mail: [email protected] Side effects can also be reported to the marketing authorization holder or its representative in Poland.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ozzion

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging: Expiry date. The expiry date refers to the last day of the month stated.
HDPE bottle – after opening the bottle, the medicine should be used within 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The medicine should not be stored at temperatures above 25°C.

6. Contents of the packaging and other information

What Ozzion contains

• The active substance of the medicine is pantoprazole. Each gastro-resistant tablet contains 40mg of pantoprazole (equivalent to 45.150mg of pantoprazole sodium sesquihydrate).
• Other ingredients are: o Core: maltitol (E 965), crospovidone, sodium carmellose, anhydrous sodium carbonate (E 500), calcium stearate. o Coating: polyvinyl alcohol, talc (E 533b), titanium dioxide (E 171), macrogol 3350, soybean lecithin (E 322), yellow iron oxide (E 172), anhydrous sodium carbonate (E 500), ethyl acrylate and methyl methacrylate copolymer (1:1) dispersion 30%, triethyl citrate (E 1505).

What Ozzion 40mg looks like and contents of the packaging

Oval, yellow gastro-resistant tablets with dimensions of 10.3 × 5.5 mm.

Packaging type:

Nylon/Aluminum/PVC/Aluminum blisters.
OPA/Aluminum/PVC/Aluminum blisters
HDPE bottle with a PP closure and a desiccant.

Packaging sizes:

14, 28, 56, 84, and 98 gastro-resistant tablets (blisters).
14 and 28 gastro-resistant tablets (HDPE bottles).
Not all packaging sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer/importer

Opella Healthcare Poland Sp. z o.o. Branch in Rzeszów, ul. Lubelska 52, 35-233 Rzeszów, Poland.
SC Zentiva SA, Theodor Pallady Bvd, no 50, 3 district, 032266, Bucharest, Romania
This medicine is authorized in the Member States of the European Economic Area under the following names:

To obtain more detailed information on the medicine, the patient should contact the representative of the marketing authorization holder in Poland:

Zentiva Poland Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:August 2024