BIOPRAZOL 10 mg Capsules

Contents of the leaflet

1. What is Bioprazol Bio Control and what is it used for
2. Important information before taking Bioprazol Bio Control
   1. When not to take Bioprazol Bio Control
   2. Warnings and precautions
   3. Children and adolescents
   4. Bioprazol Bio Control with other medicines
   5. Bioprazol Bio Control with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Bioprazol Bio Control contains sucrose
   9. Bioprazol is considered sodium-free
3. How to take Bioprazol Bio Control
   1. How to take this medicine
   2. What to do if you have difficulty swallowing the capsules
   3. Missed dose of Bioprazol Bio Control
   4. Taking more than the recommended dose of Bioprazol Bio Control
   5. Stopping treatment with Bioprazol Bio Control
4. Possible side effects
   1. If you notice any of the following rare but serious side effects, stop taking Bioprazol Bio Control and contact your doctor immediately:
   2. Reporting side effects
5. How to store Bioprazol Bio Control
6. Contents of the pack and other information
   1. What Bioprazol Bio Control contains
   2. What Bioprazol Bio Control looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:
   6. Additional information

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

Bioprazol Bio Control, 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 acid produced in the stomach.

Bioprazol Bio Control is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (such as 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 inflammation and 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 tablets for 2-3 consecutive days.

2. Important information before taking Bioprazol Bio Control

When not to take Bioprazol Bio Control

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if you are taking a medicine containing atazanavir or nelfinavir (used to treat HIV infection).

If you have any doubts before taking Bioprazol Bio Control, you should talk to your doctor or pharmacist.

Warnings and precautions

You should not take Bioprazol Bio Control for more than 14 days without consulting a doctor. If there is no improvement and if symptoms worsen, you should consult a doctor.

Bioprazol Bio Control may mask the symptoms of other diseases. Therefore, if you experience any of the following conditions before or while taking Bioprazol Bio Control, you should contact your 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 incidence 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 taking Bioprazol Bio Control, you should consult your doctor:

• If you have ever had a skin reaction after taking a medicine that reduces stomach acid;
• If you are planning to have a specific blood test (chromogranin A levels).

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Bioprazol Bio Control. You should also tell your doctor about any other side effects, such as joint pain.

Patients should not take omeprazole as a preventive measure.

Children and adolescents

Bioprazol Bio Control is not intended for use in children and adolescents.

Bioprazol Bio Control with other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. This is important because Bioprazol Bio Control may affect the way some other medicines work, and some other medicines may affect the way Bioprazol Bio Control works.

You should not take Bioprazol Bio Control if you are taking a medicine containing nelfinavir(used to treat HIV infection).

The patient should tell the doctor or pharmacist if they are taking clopidogrel (used to prevent blood clots).

You should inform your doctor or pharmacist if you are taking any of the following medicines:

• antifungal and antiprotozoal 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 medicine). If you are taking phenytoin, your doctor will monitor your condition when starting and stopping Bioprazol Bio Control;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will monitor your condition when starting and stopping Bioprazol Bio Control;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used during 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).

Bioprazol Bio Control with food and drink

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Before taking Bioprazol Bio Control, the patient should inform the doctor if she is pregnant or trying to become pregnant. The doctor will decide if the patient can take Bioprazol Bio Control at that time.

Whether a breastfeeding patient can take Bioprazol Bio Control will be decided by the doctor.

Driving and using machines

Bioprazol Bio Control does not affect the ability to drive or use machines.

However, it is possible to experience side effects such as dizziness and blurred vision (see section 4). If these occur, you should not drive or operate machinery.

Bioprazol Bio Control contains sucrose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Bioprazol is considered sodium-free

The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., per two capsules, which means that the medicine is considered "sodium-free".

3. How to take Bioprazol Bio Control

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

The usual dose is: two 10 mg capsules once a dayfor 14 days.

If symptoms do not improve after this time, you should contact your 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 important that the pellets are not damaged. 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 you have difficulty swallowing the capsules

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

Missed dose of Bioprazol Bio Control

You should continue taking the medicine, following the dosing instructions for Bioprazol Bio Control.

Do not take a double dose to make up for a missed dose.

Taking more than the recommended dose of Bioprazol Bio Control

If you have taken more than the recommended dose, you should contact your doctor or pharmacist immediately.

Stopping treatment with Bioprazol Bio Control

If you have any further doubts about taking this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following rare but serious side effects, stop taking Bioprazol Bio Control and contact your 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 have large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine, and fatigue, which can be signs of liver problems.

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 gastric polyps.

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

• swelling of the feet and ankles,
• sleep disturbance (insomnia),
• dizziness, tingling, and numbness, feeling of drowsiness,
• feeling of spinning (vertigo of labyrinthine origin),
• changes in liver function test results,
• general feeling of being unwell 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, easy bruising, or 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, disorientation, 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,
• excessive hair loss (alopecia),
• skin rash on exposure to sunlight,
• 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 cell counts, 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 encephalopathy,
• sudden onset of severe rash or blistering of the skin or peeling. This may 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(frequency cannot be estimated from the available data):

• rash that may be associated with joint pain.

In very rare cases, Bioprazol Bio Control may affect the number of white blood cells in the blood, which can lead to a lack of immunity. If you experience an infection with symptoms such as fever with a serious deterioration in general health or fever with symptoms of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, you 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 important for the patient to inform the doctor about the medicine being taken.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bioprazol Bio Control

The medicine should be stored out of sight and reach of children.

Blisters of OPA/Aluminum/PVC/Aluminum or perforated blisters of OPA/Aluminum/PVC/Aluminum

Store in a temperature below 30°C.

HDPE bottle with a polypropylene (PP) cap

Store in a temperature below 30°C.

Store the bottle tightly closed to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bioprazol Bio Control contains

• The active substance of the medicine is omeprazole ( Omeprazolum). Each gastro-resistant hard capsule contains 10 mg of omeprazole.
• The other ingredients of the medicine are: pellets:sucrose, spheres (containing sucrose and cornstarch), povidone K30, sodium lauryl sulfate, sodium carboxymethyl starch (type A), disodium phosphate dodecahydrate, hypromellose 6 cP, triethyl citrate, methacrylic acid, and ethyl acrylate copolymer (1:1), sodium hydroxide, titanium dioxide (E171), talc; capsule cap:iron oxide red (E172), erythrosine (E127), titanium dioxide (E171), purified water, gelatin;

capsule body:quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171),
purified water, gelatin;
ink(TekPrint SB-0007P White Ink): shellac, propylene glycol, povidone, sodium hydroxide,
titanium dioxide (E171).

What Bioprazol Bio Control looks like and contents of the pack

Bioprazol Bio Control are gastro-resistant hard capsules (size 3), opaque, red (cap) - orange (body), containing white to beige pellets.

The capsules are marked with the letter "O" (cap) and the number "10" (body), printed with white ink.

The gastro-resistant hard capsules are packaged in OPA/Aluminum/PVC/Aluminum blisters or perforated OPA/Aluminum/PVC/Aluminum blisters or an HDPE bottle with a PP cap containing a desiccant, placed together with the patient leaflet in a cardboard box.

Package sizes:

7, 10, 14, 20, and 28 gastro-resistant hard capsules.

Not all package sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

tel. +48 61 66 51 500

fax: +48 61 66 51 505

[email protected]

Manufacturer

TEVA Pharma S.L.U.

Polígono Industrial Malpica calle C4

50016 Zaragoza

Spain

Date of last revision of the leaflet:

Additional information

How can you avoid reflux and heartburn?

Changing your lifestyle can reduce or even eliminate symptoms such as 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 your head higher than your stomach, preventing stomach acid from flowing back into the esophagus.