Bioprazol

Leaflet accompanying the packaging: information for the user

BIOPRAZOL

20 mg, gastro-resistant hard capsules

Omeprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Bioprazol and what is it 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 packaging and other information

1. What is Bioprazol and what is it used for

Bioprazol contains the active substance omeprazole, which belongs to a group of medicines called proton pump inhibitors. These medicines reduce the production of stomach acid, which helps prevent the formation of ulcers and allows existing ones to heal. A single dose of omeprazole inhibits stomach acid secretion for about 24 hours.

Indications for use of Bioprazol:

• gastric or duodenal ulcer disease, including cases with Helicobacter pylori infection,
• reflux esophagitis,
• symptomatic treatment of gastroesophageal reflux disease (heartburn - acid reflux),
• Zollinger-Ellison syndrome,
• prophylaxis of aspiration pneumonia before general anesthesia in patients at risk of acid aspiration,
• symptoms of acid-related dyspepsia,
• treatment and prevention of benign gastric and duodenal ulcers and erosions caused by nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with a history of gastric and duodenal mucosal damage who require NSAID treatment.

2. Important information before taking Bioprazol

When not to take Bioprazol

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

Warnings and precautions

Before starting Bioprazol, discuss it with your doctor or pharmacist. Before starting treatment for gastric or duodenal ulcer disease, or if any disturbing symptoms occur (e.g. significant, unexpected weight loss, recurrent vomiting, difficulty swallowing, vomiting blood, black stools), it is necessary to rule out the possibility of a malignant nature of the disease, as omeprazole treatment may alleviate symptoms and delay diagnosis. Reduced stomach acid, caused by any reason, including proton pump inhibitors, leads to an increase in the number of bacteria normally present in the gastrointestinal tract. Therapy with stomach acid-reducing drugs may lead to an increased risk of Salmonella and Campylobacter infections. If any tests are planned, the doctor should be informed about the use of Bioprazol, as it may affect the results. Before taking the medicine, the doctor should be informed:

• about the planned specific blood test (chromogranin A concentration).

When taking proton pump inhibitors like Bioprazol, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. Patients with diagnosed osteoporosis or taking corticosteroids (which may increase the risk of osteoporosis) should inform their doctor. Patients should consult their doctor if the above warnings apply to their past medical history. Before starting Bioprazol, patients should consult their doctor:

• if they have ever experienced a skin reaction after taking a medicine similar to Bioprazol that reduces stomach acid secretion.

If a skin rash occurs, especially in areas exposed to sunlight, the doctor should be informed as soon as possible, as it may be necessary to discontinue Bioprazol. Patients should also inform their doctor about any other side effects, such as joint pain. During omeprazole treatment, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.

Children and adolescents

Bioprazol is not given to children under 3 years of age. If omeprazole is necessary for children over 3 years of age, a doctor should be consulted (see also section 3. How to take Bioprazol).

Use of Bioprazol in patients with liver function disorders

In patients with liver failure, the daily dose of the medicine should be reduced.

Use of Bioprazol in patients with kidney function disorders

In patients with kidney failure, a dose change is not necessary.

Bioprazol and other medicines

Patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The use of Bioprazol should be discussed with a doctor or pharmacist if the patient is taking any of the following medicines:

• warfarin (an anticoagulant),
• phenytoin (an antiepileptic),
• diazepam, hexobarbital (sedatives and hypnotics),
• atazanavir (a medicine used to treat HIV infection),
• tacrolimus (a medicine used in organ transplantation and for the treatment of atopic dermatitis),
• digoxin (a medicine used to treat heart failure and atrial fibrillation with rapid ventricular action),
• cilostazol (a medicine used to treat symptoms of intermittent claudication),
• antidepressants such as citalopram, imipramine, clomipramine,
• antifungal and antiprotozoal medicines (e.g. ketoconazole, itraconazole, voriconazole).

Bioprazol with food and drink

The capsule should be swallowed whole, washed down with half a glass of water. The capsule can also be opened and its contents swallowed, washed down with half a glass of water. The contents of the capsule can also be suspended, e.g. in fruit juice, yogurt, or non-carbonated mineral water, and taken within 30 minutes of preparation, washed down with half a glass of water.

Pregnancy, breastfeeding, and fertility

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 should only be used during pregnancy if the doctor considers it necessary. It is not recommended to use the medicine during breastfeeding.

Driving and using machines

Omeprazole does not affect mental performance, does not limit the ability to drive vehicles, and does not affect the ability to operate machinery. However, patients should be cautious due to the possibility of side effects such as dizziness, blurred vision, drowsiness. Bioprazol contains sucrose(a sugar used to sweeten e.g. tea). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, which means that the medicine is considered "sodium-free".

3. How to take Bioprazol

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. Gastric ulcer disease The recommended dose of omeprazole is 20 mg once a day. Symptoms usually subside quickly, and in most patients, healing occurs within four weeks. In patients who do not heal within this time, the process usually occurs during the next four weeks of omeprazole treatment. In patients with gastric ulcer disease that is resistant to treatment, omeprazole is used at a dose of 40 mg once a day, and the healing process takes about eight weeks. To prevent recurrence of gastric ulcer disease, omeprazole is recommended at a dose of 20 mg once a day. If necessary, this dose may be increased to 40 mg once a day. Recommended schemes for the treatment of Helicobacter pylori infection Triple therapy - three medicines are given simultaneously according to one of the three schemes below

• 1. Twice a day, 20 mg of omeprazole, 1 g of amoxicillin, and 500 mg of clarithromycin are given for one week.
• 2. Twice a day, 20 mg of omeprazole, 250 mg of clarithromycin, and 400 mg of metronidazole (or 500 mg of tinidazole) are given for one week.
• 3. Once a day, 40 mg of omeprazole and three times a day 500 mg of amoxicillin and 400 mg of metronidazole are given for one week.

Double therapy - two medicines are given simultaneously according to one of the two schemes below

• 1. In divided doses, 40 mg of omeprazole and 1.5 g of amoxicillin are given per day for two weeks. In clinical trials, daily doses of amoxicillin ranged from 1.5 to 3.0 g.
• 2. Once a day, 40 mg of omeprazole and three times a day 500 mg of clarithromycin are given for two weeks.

If, after completing the treatment according to any of the above therapeutic schemes, the patient still has a Helicobacter pylori infection, the treatment can be repeated. Duodenal ulcer disease In patients with active duodenal ulcer disease, the recommended dose of omeprazole is 20 mg once a day. Symptoms usually subside quickly, and in most patients, healing occurs within two weeks. In patients who do not heal within this time, the process usually occurs during the next two weeks of omeprazole treatment. In patients with duodenal ulcer disease that is resistant to treatment, omeprazole is used at a dose of 40 mg once a day, and the healing process takes about four weeks. To prevent recurrence of duodenal ulcer disease, another medicine containing omeprazole is recommended at a dose of 10 mg once a day. If necessary, this dose may be increased to 20-40 mg once a day. Recommended schemes for the treatment of Helicobacter pylori infection co-existing with gastric or duodenal ulcer disease Triple therapy - three medicines are given simultaneously according to one of the three schemes below

• 1. Twice a day, 20 mg of omeprazole, 1 g of amoxicillin, and 500 mg of clarithromycin are given for one week.
• 2. Twice a day, 20 mg of omeprazole, 250 mg of clarithromycin, and 400 mg of metronidazole (or 500 mg of tinidazole) are given for one week.
• 3. Once a day, 40 mg of omeprazole and three times a day 500 mg of amoxicillin and 400 mg of metronidazole are given for one week.

Double therapy - two medicines are given simultaneously according to one of the two schemes below

• 1. In divided doses, 40 mg of omeprazole and 1.5 g of amoxicillin are given per day for two weeks. In clinical trials, daily doses of amoxicillin ranged from 1.5 to 3.0 g.
• 2. Once a day, 40 mg of omeprazole and three times a day 500 mg of clarithromycin are given for two weeks.

If, after completing the treatment according to any of the above therapeutic schemes, the patient still has a Helicobacter pylori infection, the treatment can be repeated. Reflux esophagitis AdultsThe recommended dose of omeprazole is 20 mg once a day. In most patients, symptoms subside after 4 weeks. In patients who are not fully healed after the initial 4 weeks, treatment should be continued for another 4-8 weeks. Bioprazol is also given at a dose of 40 mg per day in patients with severe reflux esophagitis. In long-term treatment of patients, after the reflux esophagitis has subsided, omeprazole is recommended at a dose of 10 mg once a day. If necessary, the dose can be increased to 20-40 mg once a day. ChildrenBioprazol is not given to children under 3 years of age. If omeprazole is necessary for children over 3 years of age with reflux esophagitis, the following dosing is recommended:

• children with a body weight of 10 kg to 20 kg - 10 mg,
• children with a body weight over 20 kg - 20 mg.

Symptomatic treatment of gastroesophageal reflux disease The recommended dose of omeprazole is 10-20 mg once a day - in each case, the dosing should be determined individually. If symptoms do not subside after 4 weeks of treatment with Bioprazol at a dose of 20 mg once a day, further diagnostic tests are recommended. Zollinger-Ellison syndrome In patients with Zollinger-Ellison syndrome, the dose of the medicine should be determined individually. The recommended initial dose of omeprazole is 60 mg once a day. Treatment is continued as long as there are clinical indications. In patients with severe symptoms that respond poorly to other treatments, maintenance treatment with a dose of 20-120 mg once a day is usually effective. Omeprazole at a dose above 80 mg once a day should be given in two divided doses. Prophylaxis of aspiration pneumonia The recommended dose of Bioprazol is 40 mg, given in the evening of the day before surgery and in the same dose in the morning on the day of surgery. Acid-related dyspepsia symptoms The recommended dose of Bioprazol is 20 mg once a day. In some patients, a dose of 10 mg once a day may be sufficient and can be used as an initial dose. If symptoms do not subside after 4 weeks of treatment with Bioprazol at a dose of 20 mg once a day, further diagnostic tests are recommended. Treatment of gastric and duodenal ulcers and erosions caused by nonsteroidal anti-inflammatory drugs The usual dose is 20 mg once a day. The medicine is taken orally, in a single daily dose, at the same time as the NSAID. Prophylaxis of gastric and duodenal ulcers and erosions caused by nonsteroidal anti-inflammatory drugs The usual dose is 20 mg once a day. The medicine is taken orally, in a single daily dose.

Dosing in patients with liver failure

In patients with liver failure, the medicine is given at a dose of 10-20 mg once a day.

Dosing in patients with kidney failure

No dose change is necessary in patients with kidney failure.

Dosing in elderly patients

No dose change is necessary in elderly patients.

Method of administration

The capsule should be swallowed whole. Patients with swallowing disorders can open the capsule and swallow its contents, washed down with half a glass of water. The capsule can also be opened and its contents suspended, e.g. in fruit juice, yogurt, or non-carbonated mineral water, and taken within 30 minutes of preparation, washed down with half a glass of water. The contents of the capsule should not be chewed or crushed before swallowing. If the patient feels that the effect of Bioprazol is too strong or too weak, they should consult their doctor.

Overdose of Bioprazol

In case of overdose, the patient should immediately consult a doctor or pharmacist. Observed symptoms of omeprazole overdose include: nausea, vomiting, dizziness, abdominal pain, diarrhea, headache, apathy, depression, confusion. The observed symptoms of omeprazole overdose were transient and did not require any specific treatment.

Missed dose of Bioprazol

A double dose should not be taken to make up for a missed dose. Treatment should be continued according to the recommended dosing schedule.

Discontinuation of Bioprazol

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bioprazol can cause side effects, although not everybody gets them. During omeprazole treatment, the following have been observed: Common side effects(in more than 1 in 100 people and less than 1 in 10 people): headache, diarrhea, constipation, abdominal pain, nausea, vomiting, bloating with gas, mild gastric polyps. Uncommon side effects(in more than 1 in 1000 people and less than 1 in 100 people): dizziness, paresthesia (abnormal sensation due to changes in nerves or sensory pathways, manifested by spontaneous sensations of burning, tingling, numbness, pain, affecting specific skin areas, depending on the location of the damage), hypersensitivity to light, malaise, drowsiness, insomnia, increased liver enzyme activity, rash, skin inflammation and (or) itching, urticaria, hip, wrist, or spine fractures, malaise. Rare side effects(in more than 1 in 10,000 people and less than 1 in 1000 people): recurring confusion, agitation, aggression, depression, and hallucinations (mainly in severely ill patients), gynecomastia (enlargement of breast tissue in men), dry mouth, gastrointestinal yeast infection, leukopenia (decrease in white blood cell count), thrombocytopenia (decrease in platelet count), agranulocytosis (significant decrease in or absence of a certain type of white blood cell - granulocytes - in the blood), pancytopenia (decrease in the number of all blood cells), encephalopathy (disease or post-traumatic organic brain damage causing many mental and neurological disorders, often central nervous system damage, intellectual and personality disorders) in patients with previously severe liver disease, hepatitis with or without jaundice, liver failure, joint pain, muscle pain, muscle weakness, impotence, hypersensitivity to light, rash, erythema multiforme, Stevens-Johnson syndrome (blisters and erosions with bloody crusts on the mucous membranes of the mouth and nose, conjunctiva, genitals), toxic epidermal necrolysis. The disease is characterized by the occurrence of large, flaccid blisters on erythematous patches, especially in areas exposed to pressure, which quickly rupture, forming extensive erosions), alopecia, hypersensitivity reactions, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock, increased sweating, peripheral edema, blurred vision, taste disorders, hyponatremia (decrease in sodium levels in the blood). Frequency not known(cannot be estimated from the available data): Rash that may be associated with joint pain. If Bioprazol has been taken for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heart rate. If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels can lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell 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 181C, 02-222 Warsaw tel.: +48 22 49 21 301, fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bioprazol

The medicine should be stored out of sight and reach of children. Blister packs of Aluminium/Aluminium foil: Do not store above 25°C. Blister packs of PVC-PVDC/Aluminium foil: Do not store above 25°C. HDPE bottle with HDPE or PP cap There are 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 month. Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Bioprazol contains

• The active substance of the medicine is omeprazole (Omeprazolum). Each gastro-resistant hard capsule contains 20 mg of omeprazole.
• Other ingredients are: capsule filling:sucrose, pellets (containing sucrose and cornstarch), hypromellose 2910, talc, titanium dioxide (E171), disodium phosphate dihydrate, methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion (containing additives: sodium lauryl sulfate, 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, iron oxide black (E172).

What Bioprazol looks like and contents of the pack

Bioprazol are non-transparent, gastro-resistant hard capsules (size 3), white, filled with spherical pellets. The capsules have markings in the form of the letters "OM" (cap) and the number "20" (body), made with black ink. The gastro-resistant hard capsules are packaged in blister packs of PVC-PVDC/Aluminium foil or Aluminium/Aluminium foil or white HDPE bottles with HDPE or PP caps and a child-resistant closure, placed in a cardboard box. Due to the high hygroscopicity of the medicine (in the form of capsules) or bottle (in the form of sachets), a desiccant - silica gel - is placed in the bottle or blister pack. Pack size: 7, 14, 28, or 56 gastro-resistant hard capsules.

Marketing authorization holder

Biofarm Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznań

Manufacturer

Towa Pharmaceutical Europe S.L. C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona Spain For more detailed information, please contact the local representative of the marketing authorization holder:

Poland

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

Date of last revision of the leaflet: