Bioprazol bio max

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Package leaflet: Information for the user

Bioprazol Bio Max
20 mg, hard enteric-coated capsules
Omeprazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

1. What Bioprazol Bio Max is and what it is used for

Bioprazol Bio Max in the form of hard enteric-coated capsules contains an active substance called
omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by
reducing the amount of hydrochloric acid produced in the stomach.
Bioprazol Bio Max is used in adults for short-term treatment of symptoms of gastro-oesophageal reflux disease (e.g. heartburn and regurgitation of acidic stomach contents – acid reflux).
Gastro-oesophageal reflux is the backflow of acid from the stomach into the oesophagus (the tube connecting the throat to the stomach), which may lead to inflammation and associated pain. This may cause symptoms such as a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (due to regurgitation of acidic contents). To relieve symptoms, it may be necessary to take the capsules for 2-3 consecutive days.

2. Important information before using Bioprazol Bio Max

When not to use Bioprazol Bio Max

• if the patient is allergic to omeprazole 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 (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing atazanavir or nelfinavir (used to treat HIV infection).

If in any doubt before starting to take Bioprazol Bio Max,
consult your doctor or pharmacist.
Warnings and precautions
Do not take Bioprazol Bio Max for longer than 14 days without consulting a doctor. If symptoms do not improve or worsen, consult a doctor immediately.
Bioprazol Bio Max may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Bioprazol Bio Max, contact a doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• passing black stools (blood-stained faeces);
• severe or persistent diarrhoea, as omeprazole use is associated with a slightly increased risk of infectious diarrhoea;
• previous history of gastric ulcer or gastrointestinal surgery;
• ongoing symptomatic treatment of indigestion or heartburn for 4 or more weeks;
• persistent indigestion or heartburn lasting 4 or more weeks;
• occurrence of jaundice or severe liver disease;
• age over 55 years and new onset of symptoms or recent change in existing symptoms.

Before starting Bioprazol Bio Max, consult a doctor:

• if the patient has ever had a skin reaction to a medicine similar to Bioprazol Bio Max that reduces gastric acid secretion;
• if the patient is scheduled for a specific blood test (chromogranin A level).

If the patient develops a skin rash, especially in sun-exposed areas, inform the doctor immediately, as discontinuation of Bioprazol Bio Max may be necessary. Also report any other adverse effects such as joint pain.
Patients should not take omeprazole preventively.
If treatment with Bioprazol Bio Max exceeds the maximum recommended duration of 14 days, the patient should read the following information.
If Bioprazol Bio Max has been taken for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood.
The doctor may recommend regular blood tests to monitor magnesium levels.
During omeprazole treatment, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in urine and/or allergic reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.
Children and adolescents
Bioprazol Bio Max is not intended for use in children and adolescents.
Bioprazol Bio Max and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use, including those available without prescription. This is important because Bioprazol Bio Max may affect the action of certain other medicines, and some other medicines may affect the action of Bioprazol Bio Max.
Do not take Bioprazol Bio Max if using a medicine containing nelfinavir (used to treat HIV infection).
The patient should inform the doctor or pharmacist if taking clopidogrel (used to prevent blood clots).
Inform the doctor or pharmacist if taking any of the following medicines:

• antifungal and antifungal agents (e.g. ketoconazole, itraconazole, voriconazole);
• digoxin (used to treat heart failure and atrial fibrillation with rapid ventricular response);
• diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy);
• phenytoin (an antiepileptic medicine). If the patient is taking phenytoin, the doctor will monitor the patient's condition when starting and stopping Bioprazol Bio Max;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will monitor the patient's condition when starting and stopping Bioprazol Bio Max;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used in organ transplantation and treatment of atopic dermatitis);
• St John's wort ( Hypericum perforatum ) (used to treat mild depression);
• cilostazol (used to treat symptoms of intermittent claudication in the lower limbs during walking);
• saquinavir (used to treat HIV infection);
• clopidogrel (used to prevent blood clots);
• erlotinib (used to treat cancer);
• methotrexate (a chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue treatment with Bioprazol Bio Max.

Bioprazol Bio Max with food and drink
Bioprazol Bio Max capsules may be taken before meals (on an empty stomach).
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Before starting Bioprazol Bio Max, the patient should inform the doctor whether she is pregnant or trying to become pregnant. The doctor will decide whether she can take Bioprazol Bio Max during this time.
Whether a breastfeeding patient can take Bioprazol Bio Max will be decided by the doctor.
Driving and using machines
Bioprazol Bio Max does not affect the ability to drive or operate tools and machinery.
However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.
Bioprazol Bio Max contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Bioprazol Bio Max

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose is: one 20 mg capsule once daily for 14 days.
If symptoms persist after this time, consult your doctor.
To achieve symptom relief, it may be necessary to continue taking the capsules for another 2-3 days.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules should be taken before food (on an empty stomach).
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain coated pellets that protect the medicine from breakdown by stomach acid. It is essential that the pellets remain intact. These pellets contain the active substance omeprazole and are protected from degradation in the stomach to allow absorption in the intestine. The pellets release the active substance in the intestine, where it is absorbed and then exerts its effect.

What to do if you have difficulty swallowing the capsules

• If the patient has difficulty swallowing the capsules:
• Open the capsule and dissolve its contents in non-carbonated water or mix with any acidic fruit juice (e.g. apple, orange or pineapple juice), or with apple puree.
• Always mix the preparation immediately before consumption (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure the patient receives the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid. Do not use milk or carbonated water. The solid particles contain the medicine – do not chew or crush them.

If you forget to take a dose of Bioprazol Bio Max
Continue taking the medicine as prescribed, following the recommended dosing schedule of Bioprazol Bio Max.
Do not take a double dose to make up for a missed dose.

If you take more Bioprazol Bio Max than you should
If you take more than the recommended dose, seek immediate advice from your doctor or pharmacist.

Stopping Bioprazol Bio Max
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
If you notice any of the following rare but serious adverse effects, you should stop taking Bioprazol Bio Max immediately and contact your doctor without delay:

• occurrence of wheezing, swelling of the lips, tongue or throat or body, rash, fainting or difficulty breathing or swallowing (severe allergic reaction);
• redness of the skin with formation of blisters or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine and fatigue, which may be symptoms of liver disorders.

Other adverse effects include:
Common adverse effects (in 1 to 10 out of 100 people):

• headache,
• effects on the stomach and intestines: diarrhoea, constipation, abdominal pain, gas (bloating),
• nausea or vomiting,
• mild gastric polyps.

Uncommon adverse effects (in 1 to 10 out of 1,000 people):

• swelling of feet and ankles,
• sleep disturbances (insomnia),
• dizziness, tingling and pricking sensations, drowsiness,
• sensation of spinning (dizziness),
• changes in liver function test results,
• skin rash, hives (urticaria), and itching,
• general malaise and weakness.

Rare adverse effects (in 1 to 10 out of 10,000 people):

• blood disorders, such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising or increased likelihood of infection,
• allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing,
• low sodium levels in the blood. This may lead to weakness, vomiting and muscle cramps,
• feeling of restlessness, confusion or depression,
• altered sense of taste,
• vision problems, such as blurred vision,
• sudden sensation of wheezing or shortness of breath (bronchospasm),
• dry mouth,
• inflammation of the mucous membrane of the mouth, fungal infection which may involve the intestines,
• liver disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue,
• hair loss (alopecia),
• skin rash upon exposure to sunlight,
• joint pain (arthralgia) or muscle pain (myalgia),
• severe kidney problems (interstitial nephritis),
• increased sweating.

Very rare adverse effects (less than 1 in 10,000 people):

• changes in blood count including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling or hearing things that are not real (hallucinations),
• severe liver disorders leading to liver failure and encephalopathy,
• sudden onset of severe rash or formation of blisters or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• muscle weakness,
• breast enlargement in males,
• hypomagnesaemia (reduced magnesium levels in the blood).

Frequency not known (cannot be determined from available data):

• intestinal inflammation (leading to diarrhoea),
  • rash which may be accompanied by joint pain.

In very rare cases, Bioprazol Bio Max may affect the number of white blood cells in the blood, which may lead to immunodeficiency. If the patient develops an infection with symptoms such as fever accompanied by severe deterioration in general condition or fever with signs of local infection such as pain in the neck, throat or mouth or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis) based on blood test results. It is important that the patient informs the doctor about the medicine being taken in such a situation.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181C, 02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Bioprazol Bio Max

Keep this medicine out of the sight and reach of children.
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.
PVC-PVDC/Aluminum foil blisters:
Do not store above 25°C.
Aluminum (OPA/Al/PVC)/Aluminum foil blisters:
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bioprazol Bio Max contains

• The active substance is omeprazole. One enteric hard capsule contains 20 mg of omeprazole.
• Other components of the medicine are:
  Enteric pellets: sucrose, sugar spheres (containing sucrose and maize starch); methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30% (containing in composition: methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), hypromellose, type 2910 (E464), talc (E553b), triethyl citrate (E1505), titanium dioxide (E171), disodium phosphate dihydrate (E339ii).
  Hard gelatin capsule:
  Capsule body: gelatin, titanium dioxide (E171)
  Capsule cap: gelatin, titanium dioxide (E171)
  Printing ink (Black Ink SW-9008): black iron oxide (E172), shellac, potassium hydroxide

What Bioprazol Bio Max looks like and contents of the pack
Opaque, hard gelatin enteric capsules (size 3), white in colour, filled with spherical pellets.
The capsules are marked with the letters "OM" (on the cap) and the number "20" (on the body).
The capsules are packed in blisters made of PVC-PVDC/Aluminum or Aluminum (OPA/Al/PVC)/Aluminum, placed in a cardboard box.
Pack contains 7, 10 or 14 hard enteric capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel. +48 61 66 51 500
e-mail: [email protected]

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

Additional information
How to avoid gastric content reflux into the oesophagus and heartburn?
Lifestyle changes may reduce or even eliminate symptoms such as gastric reflux into the oesophagus and heartburn.
Recommended changes include:

• stopping smoking,
• avoiding stress if possible,
• eating small meals low in fat,
• avoiding excessive alcohol consumption,
• avoiding eating meals shortly before bedtime,
• using several pillows when sleeping so that the head is elevated higher than the stomach, which helps prevent acid reflux into the oesophagus.