Ozzion

Leaflet attached to the packaging: patient information

Ozzion, 20 mg, gastro-resistant tablets

Pantoprazole

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.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What Ozzion is and what it is 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 pack and other information

1. What Ozzion is and what it is 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 gastrointestinal diseases related to acid action.

Ozzion, 20mg tablets are used

in adults and adolescents aged 12 years and older:

• to treat symptoms (e.g., heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux into the esophagus.
• for long-term treatment of reflux esophagitis (esophagitis accompanied by acid reflux) and prevention of its recurrence.

Ozzion is used in adults:

• to prevent stomach and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require long-term NSAID use.

2. Important information before taking Ozzion

When not to take Ozzion

• if the patient is allergic to pantoprazole, peanuts, soy, 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 talk to their doctor or pharmacist in the following situations:

• in case of severe liver disease. The patient should tell their doctor about any past liver function disorders. The doctor will decide whether to perform more frequent liver enzyme tests, especially during long-term Ozzion treatment. If liver enzymes increase, treatment should be discontinued.

in case of the need for long-term use of NSAIDs and taking Ozzion, due to the increased risk of gastrointestinal complications. The potential risk should be assessed individually, depending on risk factors such as age (over 65 years), a history of stomach or duodenal ulcers, or gastrointestinal bleeding.

• 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 disturbances,
• 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 more than one year, there may be a slightly increased risk of hip, wrist, or spine fractures. 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 medicines).
• in case of taking Ozzion for more than three months, there may be a decrease in the patient's blood magnesium level. Low magnesium levels can cause fatigue, involuntary muscle contractions, seizures, disorientation, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should immediately inform their doctor. Low magnesium levels can 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 tell 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, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with pantoprazole. 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 disease:

• unintentional weight loss,
• vomiting, especially if it recurs,
• 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 Ozzion treatment is associated with a small increased risk of infectious diarrhea.

The doctor may decide to perform tests to rule out cancer, as pantoprazole can mask cancer symptoms and delay diagnosis. If symptoms persist despite treatment, the doctor will consider further tests.
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 has not been proven in children under 12 years of age.

Ozzion and other medicines

The patient should tell 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, so the patient should tell 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 stop Ozzion treatment, as pantoprazole may increase methotrexate levels in the blood.
• fluvoxamine (a medicine used to treat depression and other mental health conditions) - 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 it with their doctor if they are to undergo a specific urine test (for tetrahydrocannabinol (THC)).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Ozzion contains soy 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 doubts, the patient should consult their doctor or pharmacist.

Method of administration

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 symptoms (e.g., heartburn, acid reflux, pain when swallowing)associated with gastroesophageal reflux diseaseThe usual dose is one tablet per day. Symptom relief is usually achieved within 2-4 weeks, but no later than after another 4 weeks. The doctor will decide how long to take the medicine. After a certain period of treatment, in case of symptom recurrence, the patient can take one tablet per dayas needed.

Long-term treatment and prevention of reflux esophagitis recurrence
The usual dose is one tablet per day. In case of disease recurrence, the doctor may decide to use a twice higher dose and take Ozzion 40 mg once a day.
After healing, the dose can be reduced back to one 20 mg tablet per day.

• AdultsPrevention of stomach and duodenal ulcers in patients taking long-term non-steroidal anti-inflammatory drugs (NSAIDs)The usual dose is one tablet per day.

Patients with liver function disorders

In case of severe liver disease, the patient should not take more than one 20 mg tablet per day.

Use in children and adolescents

The medicine is 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, pharmacist, or nurse.

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 facial edema (Quincke's edema/anaphylactic shock), severe dizziness with very rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency: unknown:frequency cannot be estimated from available data ): the patient may notice one or more of the following symptomsblisters on the skin and rapid deterioration of general condition, skin peeling (including minor bleeding) around the eyes, nose, mouth, or genitals, or rash, especially on sun-exposed skin areas. Joint pain or flu-like symptoms, fever, swelling of glands (e.g., under the arms), and changes in blood test results may also occur.
• red, unraised spots or round patches on the torso, often with blisters, in the center, peeling skin, oral ulcers, throat, nose, genitals, and eye lesions. 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 severe reactions (frequency: unknown):yellowing of the skin or whites of the eyes (due to severe liver cell damage, jaundice) or fever, rash, kidney enlargement accompanied by sometimes 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 stomach 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; hip, wrist, or spine fractures.

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 people)

• disorientation.

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

• hallucinations; confusion (especially in patients who have experienced such symptoms), feeling of tingling, prickling, burning, or numbness, 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 white blood cell count, associated with high fever.

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

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

Frequency not known(frequency cannot be estimated from 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 not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date. The expiry date refers to the last day of the month.
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 they no longer use. This will help protect the environment.
Do not store above 25°C.

6. Contents of the pack and other information

What Ozzion contains

• The active substance of the medicine is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (equivalent to 22.5755 mg 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, soy lecithin (E 322), yellow iron oxide (E 172), anhydrous sodium carbonate (E 500),

methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate (E 1505),

What Ozzion 20 mg looks like and what the pack contains

Oval, yellow gastro-resistant tablets with dimensions of 8.2 × 4.4 mm.

Types of packaging:

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

Package sizes:

14, 28, 56, 84, and 98 gastro-resistant tablets (blisters).
14 and 28 gastro-resistant tablets (HDPE bottles).
Not all package 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 Polska 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
___________________________________________________________________________
The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms:

• avoiding large meals;
• eating slowly;
• quitting smoking;
• reducing alcohol and caffeine consumption;
• losing weight (in case of overweight);
• avoiding tight clothing or belts;
• avoiding eating meals later than three hours before bedtime;
• sleeping with the head elevated (in case of nighttime symptoms);

• reducing consumption of foods that usually cause heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits and juices, tomatoes.