Ozzion

Package leaflet: Information for the patient

Ozzion, 20 mg, enteric-coated tablets
Pantoprazole
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
Keep this leaflet for future reference.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 package 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 that reduces the amount of hydrochloric acid secreted in the stomach. It is used in the treatment of gastrointestinal disorders associated with acid secretion.

Ozzion 20 mg tablets are used in:
Adults and adolescents aged 12 years and older:

• Treatment of symptoms (e.g. heartburn, regurgitation of acidic stomach contents, pain during swallowing) associated with gastroesophageal reflux disease (GERD) caused by backflow of acidic stomach contents into the oesophagus.
• Long-term treatment of reflux oesophagitis (inflammation of the oesophagus accompanied by regurgitation of acidic stomach contents) and prevention of its recurrence.

Ozzion is used in adults for:

• Prevention of gastric and duodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require long-term NSAID therapy.

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 treatment with Ozzion, talk to your doctor or pharmacist if:

• you have severe liver disease. Inform your doctor about any history of liver function disorders. Your doctor may decide to monitor liver enzyme activity more frequently, especially during long-term treatment with Ozzion. If increased liver enzyme activity occurs, treatment should be discontinued.

• long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) is required alongside Ozzion, due to an increased risk of gastrointestinal complications. The potential risk should be individually assessed based on risk factors such as age (over 65 years), history of gastric or duodenal ulcer, or previous gastrointestinal bleeding.

• you have low vitamin B₁₂ levels or risk factors for vitamin B₁₂ deficiency and are undergoing long-term pantoprazole therapy. Like all medicines that reduce gastric acid secretion, pantoprazole may impair vitamin B₁₂ absorption. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B₁₂ levels:

• extreme fatigue or lack of energy,

• numbness or tingling sensations,

• pain or redness of the tongue, oral ulcers,

• muscle weakness,

• vision disturbances,

• memory problems, disorientation, depression.

• you are taking protease inhibitors for HIV, such as atazanavir (used in HIV treatment), together with pantoprazole. Please consult your doctor for detailed advice.

• you are taking proton pump inhibitors such as Ozzion, especially for longer than one year, as there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have been diagnosed with osteoporosis (reduced bone density) or if you have been told you are at risk of developing osteoporosis (e.g. if you are taking steroid medicines).

• you have been taking Ozzion for longer than three months, as this may lead to low magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, seizures, confusion, dizziness, or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

• you have previously experienced a skin reaction to a medicine similar to Ozzion that reduces stomach acid secretion.

• you develop a skin rash, especially on sun-exposed areas, inform your doctor immediately, as this may require discontinuation of Ozzion. 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 use. Discontinue pantoprazole and seek immediate medical advice if you notice any symptoms related to these serious skin reactions described in section 4.

• you are scheduled for a specific blood test (chromogranin A levels).

Contact your doctor immediately before or after taking this medicine if you experience any of the following symptoms, which may indicate a more serious underlying condition:

• unintentional weight loss,
• vomiting, especially recurrent,
• vomiting blood, which may look like dark coffee grounds,
• presence of blood in stool, black or tarry stools,
• difficulty swallowing or pain when swallowing,
• paleness and weakness (anaemia),
• chest pain,
• abdominal pain,
• severe and/or persistent diarrhoea, as use of Ozzion is associated with a slightly increased risk of infectious diarrhoea.

Your doctor may decide to perform tests to rule out cancer, as pantoprazole may mask symptoms of malignancy and delay diagnosis. If symptoms persist despite treatment, your doctor will consider further investigations.
If Ozzion is used long-term (longer than 1 year), your doctor will decide whether regular health monitoring is necessary. Always inform your 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 demonstrated in children under 12 years of age.

Ozzion with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines. Ozzion may affect the effectiveness of other medicines. Inform your doctor if you are 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 reduce their effectiveness.
• warfarin or phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be required.
• medicines used to treat HIV infection, such as atazanavir.
• methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue Ozzion, as pantoprazole may increase methotrexate blood levels.
• fluvoxamine (a medicine used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce the dose.
• rifampicin (a medicine used to treat infections).
• St John's wort (Hypericum perforatum) (used to treat mild depression).

Discuss with your doctor before starting pantoprazole if you are scheduled for a specific urine test (for tetrahydrocannabinol, THC).

Pregnancy, breastfeeding and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion of the drug in breast milk has been reported. If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine. This medicine should only be used if your doctor considers that the benefits to the mother outweigh the possible risks to the foetus or child.

Driving and operating machinery
Ozzion has no or negligible effect on the ability to drive and operate machinery. However, if you experience adverse effects such as dizziness or visual disturbances, do not drive or operate machinery.

Ozzion contains soya lecithin, maltitol and sodium
Do not take this medicine if you are allergic to peanuts or soya.

Patients with known intolerance to certain sugars should consult their doctor before starting this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet; therefore, it is considered "sodium-free".

3. How to take Ozzion

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Method of administration
The tablets should be taken 1 hour before a meal. Do not chew or crush the tablets; swallow them whole with a sufficient amount of water.
Recommended dose

• Adults and adolescents aged 12 years and older
  Treatment of symptoms (e.g. heartburn, regurgitation of acid stomach contents, pain during swallowing) associated with gastroesophageal reflux disease
  The usual dose is one tablet per day. Symptoms usually resolve within 2–4 weeks, but no later than after an additional 4 weeks. Your doctor will decide how long you should continue treatment. After a defined treatment period, if symptoms recur, one tablet per day may be taken as needed.

Long-term treatment and prevention of relapse of reflux esophagitis
The usual dose is one tablet per day. If the disease recurs, your doctor may decide to increase the dose to twice the amount and prescribe Ozzion 40 mg, once daily.
After healing, the dose may be reduced again to one 20 mg tablet per day.

• Adults
  Prevention of gastric and duodenal ulcers in patients on long-term non-steroidal anti-inflammatory drugs (NSAIDs)
  The usual dose is one tablet per day.

Patients with impaired liver function
In case of severe liver disease, do not take more than one 20 mg tablet per day.
Use in children and adolescents
Ozzion is not recommended for use in children under 12 years of age.
Taking more Ozzion than recommended
Inform your doctor or pharmacist. Symptoms of overdose are not known.
If you forget to take Ozzion
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
Stopping Ozzion
Do not stop taking this medicine without consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop using the medicine immediately and contact your doctor or go to the nearest hospital:

• Serious allergic reactions (frequency: rare: may occur in fewer than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (blistering rash), breathing difficulties, allergic facial swelling (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.
• Serious skin reactions (frequency unknown: frequency cannot be estimated from available data): the patient may notice one or more of the following symptoms: blisters on the skin and rapid deterioration in general condition, peeling of the skin (including minor bleeding) around the eyes, nose, mouth, or genital organs, or a rash, particularly on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, and swollen glands (e.g., under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• Red, non-raised spots or circular patches on the trunk, often with blisters in the center, skin peeling, and ulceration of the mouth, throat, nose, genital organs, and eyes. The onset of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious reactions (frequency unknown): yellowing of the skin or whites of the eyes (due to severe liver cell damage, jaundice), or fever, rash, and enlarged kidneys, sometimes associated with painful urination and lower back pain (severe kidney inflammation, which may lead to kidney failure).

Other adverse reactions are as follows:
Common (may occur in fewer than 1 in 10 people)

• Benign gastric polyps.

Uncommon (may occur in fewer than 1 in 100 people)

• Headache, dizziness; diarrhoea; nausea, vomiting; bloating and flatulence, constipation; dryness of the mouth; abdominal pain and discomfort; skin rash, papular rash; itching; weakness, fatigue or malaise; sleep disorders; fractures of the hip, wrist or spine.

Rare (may occur in fewer than 1 in 1,000 people)

• Taste disturbances or complete loss of taste; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; limb swelling (peripheral oedema); allergic reactions; depression; gynaecomastia (breast enlargement) in males.

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

• Disorientation.

Frequency unknown (frequency cannot be estimated from available data):

• Hallucinations; confusion (particularly in patients who have previously experienced such symptoms), sensations of tingling, pricking, burning, or numbness; rash possibly associated with joint pain; inflammation of the large intestine causing persistent, watery diarrhoea.

Adverse reactions identified by blood tests:
Uncommon (may occur in fewer than 1 in 100 people)

• Increased liver enzyme activity.

Rare (may occur in fewer than 1 in 1,000 people)

• Increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating white blood cells associated with high fever.

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

• Decreased platelet count, which may lead to increased tendency to bleeding and bruising; decreased white blood cell count, which may increase susceptibility to infections;
• Concurrent marked decrease in red blood cells, white blood cells, and platelets.

Frequency unknown (frequency cannot be estimated from available data)
Decreased blood sodium, magnesium, calcium, or potassium levels (see section 2).
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Faks: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ozzion

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
date. The expiry date refers to the last day of the stated month.
HDPE bottle – after opening the bottle, the medicine should be used within 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.
Do not store above 25°C.

6. Contents of the packaging and other information

What Ozzion contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (corresponding to 22.5755 mg of sodium pantoprazole monohydrate).
• Other ingredients are:
  Core: maltitol (E 965), crospovidone, sodium carmellose, anhydrous sodium carbonate (E 500), calcium stearate.
  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),
  copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30%, triethyl citrate
  (E 1505),

What Ozzion 20 mg looks like and contents of the pack
Oval, yellow enteric-coated tablets of size 8.2 × 4.4 mm.

Type of container:
Blister packs: Nylon/Aluminium/PVC/Aluminium.
Blister packs: OPA/Aluminium/PVC/Aluminium.
HDPE bottle with PP closure and desiccant.

Pack sizes:
14, 28, 56, 84 and 98 enteric-coated tablets (blister packs).
14 and 28 enteric-coated tablets (HDPE bottles).
Not all pack 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 medicinal product is authorized for marketing in the European Economic Area under the following names:

For more detailed information about the medicine, please contact the
responsible entity's representative in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
___________________________________________________________________________
The following lifestyle recommendations and dietary changes may also help alleviate heartburn
or other symptoms related to gastric acid:

• avoiding large meals;
• eating slowly;
• stopping smoking;
• limiting alcohol and caffeine intake;
• reducing body weight (in case of overweight);
• avoiding tight clothing or belts;
• avoiding eating meals less than three hours before lying down;
• sleeping with the head elevated (in case of nighttime symptoms);
• limiting consumption of foods that commonly trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, spicy and acidic foods, citrus fruits and fruit juices, tomatoes.