BIOPRAZOL BIO CONTROL

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Package leaflet: Information for the user

Bioprazol Bio Control
10 mg, hard enteric-coated capsules
Omeprazolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always use this medicine 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 side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, you should consult your doctor.

Table of contents

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

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

Bioprazol Bio Control is available as hard enteric-coated capsules and contains the active substance omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of hydrochloric acid produced in the stomach.
Bioprazol Bio Control is used in adult patients for the short-term treatment of symptoms of gastroesophageal reflux disease (e.g. heartburn and regurgitation of acidic stomach contents – acid regurgitation).
Reflux refers to 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 pain 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 medicine for 2-3 consecutive days.

2. Important information before using Bioprazol Bio Control

When not to use Bioprazol Bio Control

• 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 in the treatment of HIV infection).

If in any doubt, consult your doctor or pharmacist before starting to take Bioprazol Bio Control.

Warnings and precautions

Do not take Bioprazol Bio Control for longer than 14 days without consulting a doctor. If symptoms do not improve or worsen, seek medical advice.

Bioprazol Bio Control may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Bioprazol Bio Control, contact your 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 use of omeprazole is associated with a slight increase in the frequency 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;
• development of jaundice or severe liver disease;
• age over 55 years and occurrence of new symptoms or change in existing symptoms recently.

Before starting to take Bioprazol Bio Control, consult your doctor:

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

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor immediately, as it may be necessary to discontinue Bioprazol Bio Control. Also report any other adverse effects such as joint pain.

Patients should not take omeprazole preventively.

Children and adolescents

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

Bioprazol Bio Control and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take. This is important because Bioprazol Bio Control may affect the action of certain other medicines, and some other medicines may affect the action of Bioprazol Bio Control.

Do not take Bioprazol Bio Control if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

The patient should inform the 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 agents (e.g. ketoconazole, itraconazole, voriconazole);
• digoxin (used in the treatment of heart failure and atrial fibrillation with rapid ventricular response);
• diazepam (used to treat anxiety, reduce muscle tension, or in epilepsy treatment);
• phenytoin (an antiepileptic medicine). If the patient is taking phenytoin, the doctor will monitor the patient's condition when starting and stopping Bioprazol Bio Control;
• 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 Control;
• rifampicin (used in the treatment of tuberculosis);
• atazanavir (used in the treatment of HIV infection);
• tacrolimus (used during organ transplantation and in the treatment of atopic dermatitis);
• St John's wort (Hypericum perforatum) (used in the treatment of mild depression);
• cilostazol (used to treat symptoms of intermittent claudication in the lower limbs during walking);
• saquinavir (used in the treatment of HIV infection).

Bioprazol Bio Control with food and drink

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant or 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 Control, the patient should inform the doctor whether she is pregnant and whether she is trying to become pregnant. The doctor will decide whether she can take Bioprazol Bio Control during this time.

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

Driving and operating machinery

Bioprazol Bio Control does not affect the ability to drive or operate 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 Control contains sacharose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Bioprazol is considered sodium-free

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

3. How to use Bioprazol Bio Control

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose is: two 10 mg capsules once daily for 14 days.
If symptoms do not improve 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 being broken down 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 acts.

What to do if you have difficulty swallowing the capsules

• If you have 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 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 full dose of medicine is taken, 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 Control
Continue taking the medicine as prescribed according to the recommended dosing schedule for Bioprazol Bio Control.
Do not take a double dose to make up for a forgotten dose.

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

Stopping Bioprazol Bio Control
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.
If you notice any of the following rare but serious adverse reactions, stop taking Bioprazol Bio Control immediately and contact your doctor without delay:

• occurrence of wheezing, swelling of the lips, tongue or throat, 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 reactions include:
Common adverse reactions (in 1 to 10 out of 100 people):

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

Uncommon adverse reactions (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 (vertigo),
• changes in liver function test results,
• general malaise and weakness.

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

• blood problems such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising, or increased risk of infection,
• allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing,
• low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps,
• feeling of restlessness, disorientation, 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 affect the intestines,
• liver problems, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue,
• excessive 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 reactions (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 problems leading to liver failure and encephalopathy,
• sudden onset of severe rash or formation of blisters on the skin or skin peeling. 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 blood).

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

• rash which may be accompanied by joint pain.

In very rare cases, Bioprazol Bio Control may affect the number of white blood cells in the blood, which may lead to immunodeficiency. If the patient develops an infection with signs such as fever accompanied by severe deterioration in general condition, or fever with local signs of 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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]
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Bioprazol Bio Control

Keep this medicine out of sight and reach of children.
Blister packs made of OPA/Aluminium/PVC/Aluminium or perforated blisters made of
OPA/Aluminium/PVC/Aluminium
Store below 30°C.
HDPE bottle with a polypropylene (PP) cap
Store below 30°C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Bioprazol Bio Control contains

• The active substance is omeprazole (Omeprazolum). Each enteric hard capsule contains 10 mg of omeprazole.
• Other components of the medicine are:
  pellets: sucrose, granules (containing sucrose and maize starch), povidone K30, sodium lauryl sulfate, sodium carboxymethyl starch (type A), trisodium 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;
  printing 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 is an enteric hard capsule (size 3), opaque, red (cap) – orange (body), containing white to beige pellets.
The capsules are marked with the letter "O" on the cap and the number "10" on the body, printed in white ink.
Enteric capsules are packed in blisters OPA/Aluminium/PVC/Aluminium or perforated blisters OPA/Aluminium/PVC/Aluminium, or in HDPE bottles with PP caps containing a desiccant, all placed together with the patient leaflet in a cardboard box.
Pack sizes:
7, 10, 14, 20 and 28 enteric hard capsules.
Not all pack sizes may be marketed.

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

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

• stopping smoking,
• avoiding stress, if possible,
• eating small meals low in fat,
• avoiding excessive alcohol consumption,
• avoiding eating shortly before bedtime,
• using several pillows while sleeping to keep the head elevated above the stomach, which helps prevent acid reflux into the oesophagus.