Bioprazol

Package leaflet: Information for the user

BIOPRAZOL
20 mg, enteric hard capsules
Omeprazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Bioprazol is and what it is used for
Bioprazol contains omeprazole as the active substance, which belongs to a group of medicines called
proton pump inhibitors. These medicines reduce the production of hydrochloric acid in the stomach, thereby preventing
ulcer formation and allowing healing of existing ulcers.
A single dose of omeprazole inhibits gastric acid secretion for approximately
24 hours.
Indications for Bioprazol:

• Gastric or duodenal ulcer disease, including cases associated with Helicobacter pylori infection,
• Reflux oesophagitis,
• Symptomatic treatment of gastro-oesophageal reflux disease (heartburn),
• Zollinger-Ellison syndrome,
• Prevention of aspiration pneumonitis prior to general anaesthesia in patients at risk of aspiration of acidic gastric contents,
• Acid-related dyspeptic symptoms,
• Treatment and prevention of mild gastric and duodenal ulcers and erosions caused by non-steroidal anti-inflammatory drugs (NSAIDs) in patients with a history of gastric or duodenal mucosal injury who require NSAID therapy.

2. Important information before taking Bioprazol

When not to take Bioprazol

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6),
• if you are taking atazanavir (a medicine used to treat HIV infection) at the same time.

Warnings and precautions
Before starting Bioprazol, discuss it with your doctor or pharmacist.
Before starting treatment for gastric ulcer or if any worrying symptoms occur (e.g. significant, unexpected weight loss, recurrent vomiting, difficulty swallowing, vomiting blood, tarry stools), the possibility of a malignant condition should be ruled out, as omeprazole treatment may relieve symptoms and delay diagnosis.
Reduced gastric acidity, due to any cause including proton pump inhibitors, may lead to an increase in bacteria normally present in the gastrointestinal tract. Therapy with acid-reducing medicines may increase the risk of Salmonella and Campylobacter infections.
If you are planning to undergo any tests, inform your doctor that you are taking Bioprazol, as it may affect test results.
Before taking the medicine, inform your doctor:

• about planned specific blood tests (chromogranin A levels).

Long-term use of proton pump inhibitors such as Bioprazol, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
Consult your doctor even if the above warnings relate to conditions that occurred in the past.
Before starting Bioprazol, consult your doctor:

• if you have ever had a skin reaction to a medicine similar to Bioprazol that reduces gastric acid secretion.

If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor immediately, as discontinuation of Bioprazol may be necessary. Also report any other adverse effects, such as joint pain.
Renal inflammation may occur during omeprazole treatment. Symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Such symptoms should be reported to your doctor.
Children and adolescents
Bioprazol should not be given to children under 3 years of age. If omeprazole treatment is necessary in children over 3 years of age, consult your doctor (see also section 3. How to take Bioprazol).
Use of Bioprazol in patients with liver function disorders
In patients with hepatic impairment, the daily dose should be reduced.
Use of Bioprazol in patients with kidney function disorders
In patients with renal impairment, dose adjustment is not required.
Bioprazol with other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
The use of Bioprazol should be discussed with your doctor or pharmacist if you are taking any of the following medicines:

• warfarin (anticoagulant),
• phenytoin (antiepileptic),
• diazepam, hexobarbital (sedatives and hypnotics),
• atazanavir (used in the treatment of HIV infection),
• tacrolimus (used in organ transplantation and treatment of atopic dermatitis),
• digoxin (used in heart failure and atrial fibrillation with rapid ventricular response),
• cilostazol (used to treat intermittent claudication causing cramping pain in the lower limbs during walking),
• antidepressants such as: citalopram, imipramine, clomipramine,
• antifungal and antiprotozoal medicines (e.g. ketoconazole, itraconazole, voriconazole).

Bioprazol with food and drink
Swallow the capsule whole with half a glass of water.
The capsule may also be opened and its contents swallowed with half a glass of water.
Alternatively, the capsule contents may be suspended in fruit juice, yoghurt, or still mineral water, and consumed within 30 minutes of preparation, followed by half a glass of water.
Pregnancy, breastfeeding, and fertility
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 may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Use of this medicine during breastfeeding is not recommended.
Driving and using machines
Omeprazole does not impair psychomotor performance and does not limit the ability to drive or operate machinery.
However, exercise caution due to the possibility of adverse effects such as dizziness, blurred vision, or drowsiness.
Bioprazol contains sucrose (sugar used, for example, to sweeten tea).
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose, meaning the medicine is considered "sodium-free".

3. How to use Bioprazol

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Peptic ulcer of the stomach
The recommended dose of omeprazole is 20 mg once daily. Symptoms usually improve quickly,
and healing occurs within four weeks in most patients. In patients who have not healed within this
time, healing usually occurs during the next four weeks of omeprazole treatment.
For patients with treatment-resistant gastric ulcer disease, omeprazole is administered at a dose of 40 mg
once daily, and the healing process takes approximately eight weeks.
To prevent recurrence of gastric ulcer disease, omeprazole is recommended at a dose of
20 mg once daily. If necessary, this dose may be increased to 40 mg once
daily.
Regimens recommended for eradication of Helicobacter pylori infection
Triple therapy – three drugs are administered simultaneously according to one of the three
regimens below:

1. 20 mg omeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily for one week.
2. 20 mg omeprazole, 250 mg clarithromycin, and 400 mg metronidazole (or 500 mg tinidazole) twice daily for one week.
3. 40 mg omeprazole once daily and 500 mg amoxicillin and 400 mg metronidazole three times daily for one week.

Dual therapy – two drugs are administered simultaneously according to one of the two
regimens below:

1. Divided doses of 40 mg omeprazole and 1.5 g amoxicillin per day for two weeks. In clinical trials, daily doses of amoxicillin ranging from 1.5 to 3.0 g were used.
2. 40 mg omeprazole once daily and 500 mg clarithromycin three times daily for two weeks.

If, after completion of treatment according to any of the above therapeutic regimens,
Helicobacter pylori infection persists, treatment may be repeated.
Duodenal ulcer disease
For patients with active duodenal ulcer disease, the recommended dose of omeprazole is 20 mg
once daily. Symptoms usually improve quickly, and healing occurs in most patients
within two weeks. In patients who have not healed within this time, healing usually
occurs during the next two weeks of omeprazole treatment.
For patients with treatment-resistant duodenal ulcer disease, omeprazole is administered at a dose of
40 mg once daily, and the healing process takes approximately four weeks.
To prevent recurrence of duodenal ulcer disease, another omeprazole-containing medicine is recommended
at a dose of 10 mg once daily. If necessary, this dose may be
increased to 20–40 mg daily.
Regimens recommended for eradication of Helicobacter pylori infection coexisting with
gastric or duodenal ulcer disease
Triple therapy – three drugs are administered simultaneously according to one of the three
regimens below:

1. 20 mg omeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily for one week.
2. 20 mg omeprazole, 250 mg clarithromycin, and 400 mg metronidazole (or 500 mg tinidazole) twice daily for one week.
3. 40 mg omeprazole once daily and 500 mg amoxicillin and 400 mg metronidazole three times daily for one week.

Dual therapy – two drugs are administered simultaneously according to one of the two
regimens below:

1. Divided doses of 40 mg omeprazole and 1.5 g amoxicillin per day for two weeks. In clinical trials, daily doses of amoxicillin ranging from 1.5 to 3.0 g were used.
2. 40 mg omeprazole once daily and 500 mg clarithromycin three times daily for two weeks.

If, after completion of treatment according to any of the above therapeutic regimens,
Helicobacter pylori infection persists, treatment may be repeated.
Reflux esophagitis
Adults
The recommended dose of omeprazole is 20 mg once daily. In the vast majority of patients,
symptoms resolve within 4 weeks. In patients not fully healed after the initial
4 weeks, treatment should be continued for an additional 4–8 weeks.
Bioprazol may also be administered at 40 mg daily in patients with severe reflux esophagitis. For long-term treatment, after resolution of reflux esophagitis, omeprazole is recommended at a dose of 10 mg once daily. If necessary, the dose
may be increased to 20–40 mg once daily.
Children
Bioprazol should not be administered to children under 3 years of age. When omeprazole is required
in children over 3 years of age with reflux esophagitis, the following dosing is recommended:

• children weighing 10 to 20 kg – 10 mg,
• children weighing over 20 kg – 20 mg.

Symptomatic treatment of gastroesophageal reflux disease
The recommended dose of omeprazole is 10 mg to 20 mg daily – dosing should be individualized in each case.
If symptoms do not resolve after four weeks of treatment with Bioprazol at a dose of 20 mg daily,
further diagnostic evaluation is recommended.
Zollinger–Ellison syndrome
For patients with Zollinger–Ellison syndrome, the dose should be individually adjusted. The recommended
initial dose of omeprazole is 60 mg once daily. Treatment continues as long as clinically indicated. In patients with severe symptoms poorly responsive to other treatments, maintenance therapy with doses ranging from 20 mg to 120 mg daily is usually effective.
Omeprazole doses exceeding 80 mg daily should be administered in two divided doses.
Prophylaxis of aspiration pneumonia
Bioprazol is recommended at a dose of 40 mg, administered in the evening of the day before
surgery and in the same dose on the morning of the surgical procedure.
Acid-related dyspeptic symptoms
The recommended dose of Bioprazol is 20 mg once daily. In some patients, a dose of 10 mg daily is sufficient and may therefore be considered as the initial dose. If symptoms do not resolve after 4 weeks of treatment with Bioprazol at a dose of 20 mg daily, further diagnostic evaluation is recommended.
Treatment of gastric and duodenal ulcers and erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs).
The usual dose is 20 mg once daily. The medicine is taken orally as a single daily dose, administered concurrently with NSAIDs.
Prophylaxis of gastric and duodenal ulcers and erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs).
The usual dose is 20 mg once daily. The medicine is taken orally as a single daily dose.
Dosage in patients with hepatic impairment
In patients with liver impairment, the dose should be 10 to 20 mg daily.
Dosage in patients with renal impairment
No dosage adjustment is necessary in patients with renal impairment.
Dosage in elderly patients
No dosage adjustment is necessary in elderly patients.
Method of administration
The capsule should be swallowed whole.
Patients with swallowing difficulties may open the capsule and swallow the contents with
half a glass of water. Alternatively, the capsule may be opened, and the contents suspended in, for example, fruit juice, yogurt, or non-carbonated mineral water, and consumed within 30 minutes of preparation, followed by half a glass of water.
The capsule contents should not be chewed or crushed before swallowing.
If you feel that the effect of Bioprazol is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Bioprazol
In case of accidental overdose, seek immediate medical advice from a doctor
or pharmacist.
Observed symptoms of omeprazole overdose include: nausea, vomiting, dizziness, abdominal
pain, diarrhea, headache, apathy, depression, and confusion. Symptoms of omeprazole overdose were transient, and no specific treatment was required.
Missed dose of Bioprazol
Do not take a double dose to make up for a missed dose.
Continue treatment as prescribed.
Discontinuation of Bioprazol
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following have been observed during treatment with omeprazole:

Common adverse reactions (in more than 1 in 100 people and less than 1 in 10 people):
headache, diarrhoea, constipation, abdominal pain, nausea, vomiting, flatulence,
benign gastric polyps.

Uncommon adverse reactions (in more than 1 in 1000 people and less than 1 in 100 people):
dizziness, paraesthesia (abnormal sensation due to changes in nerves or sensory pathways. It manifests as spontaneous sensations such as burning, pricking, tingling, or stinging affecting specific areas of the skin, depending on the site of damage), photosensitivity, malaise, somnolence, insomnia, increased liver enzyme activity, rash, dermatitis and (or) pruritus, urticaria, fracture of the hip, wrist or spine, malaise.

Rare adverse reactions (in more than 1 in 10,000 people and less than 1 in 1000 people):
recurrent confusion, agitation, aggression, depression and hallucinations (especially in severely ill patients), gynaecomastia (enlargement of breast tissue in males), dry mouth, gastrointestinal candidiasis, leucopenia (reduced number of white blood cells in blood), thrombocytopenia (reduced number of platelets in blood), agranulocytosis (marked decrease or absence of a certain type of white blood cells – granulocytes – in blood), pancytopenia (reduction in all blood cells), encephalopathy (disease-related or post-traumatic organic brain damage causing multiple psychiatric and neurological disorders, often involving damage to the central nervous system, intellectual and personality disturbances) in patients with pre-existing severe liver disease, hepatitis with or without jaundice, liver failure, arthralgia, myalgia, muscle weakness, impotence, photosensitivity, rash, erythema multiforme, Stevens-Johnson syndrome (blisters and erosions with haemorrhagic crusts on mucous membranes of the mouth, nose, conjunctiva, and genital organs), toxic epidermal necrolysis. A disease characterized by the occurrence of large flaccid blisters on erythematous patches, especially in areas prone to pressure, which rapidly rupture leading to extensive erosions), alopecia, hypersensitivity reactions, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock, increased sweating, peripheral oedema, blurred vision, taste disturbances, hyponatraemia (reduced sodium concentration in blood).

Frequency not known (cannot be estimated from available data):
Rash accompanied by joint pain.

If Bioprazol has been taken for longer than three months, there is a possibility of decreased magnesium levels in blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to reduced potassium or calcium levels in blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Bioprazol

Keep this medicine out of the sight and reach of children.
Aluminum/Aluminum foil blisters:
Do not store above 25°C.
PVC-PVDC/Aluminum foil blisters:
Do not store above 25°C.
HDPE bottle with HDPE or PP cap:
No special storage requirements.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
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.

6. Contents of the pack and other information

What Bioprazol contains

• The active substance is omeprazole (Omeprazolum). Each enteric hard gelatin capsule contains 20 mg of omeprazole.
• The other components are: capsule contents: sucrose, pellets (containing sucrose and maize starch), hypromellose 2910, talc, titanium dioxide (E171), disodium hydrogen phosphate dihydrate, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion (containing the excipients: sodium lauryl sulphate, polysorbate 80), triethyl citrate; capsule body: titanium dioxide (E171), gelatin; capsule cap: titanium dioxide (E171), gelatin; printing ink (Black ink; SW - 9008): shellac, potassium hydroxide, black iron oxide (E172).

What Bioprazol looks like and contents of the pack
Bioprazol is an opaque, white, enteric hard gelatin capsule (size 3) filled with spherical pellets.
The capsules are marked with the letters "OM" (on the cap) and the number "20" (on the body) printed in black ink.
The enteric capsules are packed in PVC-PVDC/Aluminium blisters or Aluminium/Aluminium blisters or in white HDPE bottles with HDPE or PP caps and child-resistant closure, placed in a cardboard box. Due to the high hygroscopicity of the medicinal product, a desiccant (silica gel) is placed in the cap (in the form of capsules) or in the bottle (in the form of sachets).
Pack sizes:
7, 14, 28 or 56 enteric hard capsules.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland

Manufacturer
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona
Spain

For further information, please contact the local representative of the Marketing Authorisation Holder:

Poland
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500