Bioprazol Bio Max

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

Bioprazol Bio Max in the form of gastro-resistant hard capsules contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of hydrochloric acid secreted in the stomach.
Bioprazol Bio Max is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn and acid regurgitation).
Reflux occurs when stomach acid flows back into the esophagus (which connects the throat to the stomach), which can lead to the development of inflammation and accompanying pain. This can cause symptoms such as a burning sensation in the chest rising to the throat (heartburn) and a sour taste in the mouth (due to acid regurgitation). To relieve symptoms, it may be necessary to take capsules for 2-3 consecutive days.

2. Important information before taking Bioprazol Bio Max

When not to take Bioprazol Bio Max

In case of any doubts before starting to take Bioprazol Bio Max, consult a doctor or pharmacist.

Warnings and precautions

Do not take Bioprazol Bio Max for more than 14 days without consulting a doctor. In case of no improvement and in case of worsening symptoms, consult a doctor.
Bioprazol Bio Max may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Bioprazol Bio Max, consult a doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting blood or black tarry stools;
• severe or persistent diarrhea, as the use of omeprazole is associated with a slight increase in the frequency of infectious diarrhea;
• previous stomach ulcer or gastrointestinal surgery;
• continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks;
• persistent indigestion or heartburn for 4 or more weeks;
• jaundice or severe liver disease;
• age over 55 and new or recently changed symptoms.

Before starting to take Bioprazol Bio Max, consult a doctor:

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to stop taking Bioprazol Bio Max. The patient should also inform their doctor about any other side effects, such as joint pain.
Patient should not take omeprazole as a preventive measure.
If the patient has been taking Bioprazol Bio Max for more than the recommended maximum period of 14 days, they should read the following information.
If Bioprazol Bio Max has been taken for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, the patient should inform their doctor immediately. Low magnesium levels can lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
During treatment with omeprazole, 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. The patient 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

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, including those obtained without a prescription. This is important because Bioprazol Bio Max may affect the way some other medicines work, and some other medicines may affect the way Bioprazol Bio Max works.
Do not take Bioprazol Bio Max if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
The patient should tell their doctor or pharmacist if they are taking clopidogrel (used to prevent blood clots).
Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• antifungal and antifungal medicines (e.g., ketoconazole, itraconazole, voriconazole);
• digoxin (used to treat heart failure and atrial fibrillation with rapid ventricular rate);
• diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy);
• phenytoin (an antiepileptic drug). 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 after organ transplantation and to treat atopic dermatitis);
• St. John's Wort (Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat symptoms of intermittent claudication);
• 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 methotrexate in high doses, the doctor may temporarily discontinue Bioprazol Bio Max.

Bioprazol Bio Max with food and drink

Bioprazol Bio Max capsules can be taken before meals (on an empty stomach).

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 a doctor or pharmacist before taking this medicine.
Before starting to take Bioprazol Bio Max, the patient should inform their doctor if they are pregnant or trying to become pregnant. The doctor will decide if the patient can take Bioprazol Bio Max at that time.
The doctor will decide if a breastfeeding patient can take Bioprazol Bio Max.

Driving and using machines

Bioprazol Bio Max does not affect the ability to drive or use machines.
However, it is possible to experience side effects such as dizziness and visual disturbances (see section 4). If these occur, the patient should not drive or operate machinery.

Bioprazol Bio Max contains sucrose

If the patient has 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 sodium per capsule, which means it is considered "sodium-free".

3. How to take Bioprazol Bio Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The usual dose is: one 20 mg capsule once a dayfor 14 days.
If symptoms do not improve after this time, consult a doctor.
To relieve symptoms, it may be necessary to take capsules for 2-3 consecutive days.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules should be taken before meals (on an empty stomach).
• The capsules should be swallowed whole, with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain enteric-coated pellets that prevent the medicine from being broken down by the acid in the stomach. It is essential not to damage the pellets. These pellets contain the active substance omeprazole and are protected from breakdown in the stomach to allow it to be absorbed from the intestine. The pellets release the active substance in the intestine, where it is absorbed and then acts.

What to do if the patient has difficulty swallowing the capsules

• If the patient has difficulty swallowing the capsules:
• Open the capsule and mix its contents with water or a slightly acidic fruit juice (e.g., apple, orange, or pineapple) or with applesauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose of the medicine, rinse the glass with half a glass of water and drink the liquid. Do not usemilk or carbonated water. The solid particles contain the medicine - do not chew or crush them.

Missed dose of Bioprazol Bio Max

Continue taking the medicine, following the dosing instructions for Bioprazol Bio Max.
Do not take a double dose to make up for a missed dose.

Taking more than the recommended dose of Bioprazol Bio Max

In case of taking a higher dose than recommended, consult a doctor or pharmacist immediately.

Stopping treatment with Bioprazol Bio Max

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of any of the following rare but serious side effects, stop taking Bioprazol Bio Max and contact a doctor immediately:

• appearance of wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty breathing or swallowing (severe allergic reaction);
• redness of the skin with blistering or peeling. It is also possible to develop large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver disorders.

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

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

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

• swelling of the feet and ankles,
• sleep disturbance (insomnia),
• dizziness, feeling of tingling and prickling, feeling of drowsiness,
• feeling of spinning (dizziness),
• changes in liver function test results,
• skin rash, papular rash (hives) and itching of the skin
• general malaise and weakness.

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

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

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

• changes in blood morphology, including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling, or hearing things that do not exist (hallucinations),
• severe liver problems leading to liver failure and brain inflammation,
• sudden onset of severe rash or blisters on the skin or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• muscle weakness,
• breast enlargement in men,
• hypomagnesemia (low magnesium levels in the blood).

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

• •enteritis (leading to diarrhea)
• rash that may be accompanied by joint pain.

In very rare cases, Bioprazol Bio Max may affect the number of white blood cells in the blood, leading to a lack of immunity. If the patient experiences an infection with symptoms such as fever with a serious deterioration in general condition or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, they should consult a doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential for the patient to inform their doctor about the medicine they are taking.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform 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 Bio Max

Keep the 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 month.
PVC-PVDC/Aluminum blisters:
Do not store above 25°C.
Aluminum (OPA/Al/PVC)/Aluminum blisters:
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bioprazol Bio Max contains

• The active substance of the medicine is omeprazole. One gastro-resistant hard capsule contains 20 mg of omeprazole.
• The other ingredients of the medicine are: Enteric-coated pellets: sucrose, sugar spheres (containing sucrose and cornstarch); methacrylic acid and ethyl acrylate copolymer (1:1), dispersion, 30% (containing 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: Body of the capsule: gelatin, titanium dioxide (E171) Cap of the capsule: gelatin, titanium dioxide (E171), Printing ink (Black Ink SW-9008): iron oxide black (E172), shellac, potassium hydroxide

What Bioprazol Bio Max looks like and contents of the pack

Opaque, hard gelatin capsules (size 3), white, filled with spherical pellets.
The capsules are marked with the letters "OM" (cap) and the number "20" (body).
The capsules are packaged in PVC-PVDC/Aluminum or Aluminum (OPA/Al/PVC)/Aluminum blisters, placed in a cardboard box.
The pack contains 7, 10, or 14 hard gastro-resistant capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel. +48 61 66 51 500
e-mail: biofarm@biofarm.pl

Manufacturer

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

Date of last revision of the leaflet:

Additional information

How can gastroesophageal reflux and heartburn be avoided?
Changes in lifestyle can reduce or even eliminate symptoms such as gastroesophageal reflux and heartburn.
Changes to consider include:

• stopping smoking,
• avoiding stress if possible,
• eating small portions of low-fat foods,
• avoiding excessive alcohol consumption,
• avoiding eating meals shortly before bedtime,
• using several pillows to sleep, which will keep the head higher than the stomach, preventing stomach acid from flowing back into the esophagus.