Bioprazol

Package leaflet: Information for the user

BIOPRAZOL
40 mg, hard enteric-coated capsules
Omeprazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Bioprazol is and what it is 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 package and other information

1. What Bioprazol is and what it is used for

Bioprazol contains the active substance called omeprazole, which belongs to a group of medicines known as proton pump inhibitors (PPIs). These medicines reduce the amount of hydrochloric acid produced in the stomach.

Bioprazol is used to treat the following conditions:

In adults:

• Gastro-oesophageal reflux disease (GORD). In this condition, acidic stomach fluid flows back into the oesophagus (the part of the digestive tract connecting the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or in the stomach (gastric ulcers).
• Ulcers associated with infection by the bacterium Helicobacter pylori. In this case, your doctor may also prescribe antibiotics to eradicate the infection and help heal the ulcers.
• Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Bioprazol may also be used to prevent the development of ulcers during treatment with NSAIDs.
• Zollinger-Ellison syndrome, a condition in which excessive amounts of hydrochloric acid are produced in the stomach due to the presence of a tumour (gastrinoma) in the pancreas.

In children:
Children aged over 1 year and weighing ≥ 10 kg

• Gastro-oesophageal reflux disease. In this condition, acidic stomach fluid flows back into the oesophagus (the part of the digestive tract connecting the throat to the stomach), causing pain, inflammation and heartburn. In children, symptoms of reflux disease may include regurgitation of stomach contents into the mouth (spitting up/food coming back), vomiting and poor weight gain.

Children and adolescents aged over 4 years

• Ulcers caused by infection with the bacterium Helicobacter pylori. In this case, your doctor may also prescribe antibiotics for the child to eradicate the infection and help heal the ulcer.

2. Important information before using Bioprazol

When not to use 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 allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

If there are any doubts, the patient should consult a doctor or pharmacist before using Bioprazol.

Warnings and precautions

Before starting treatment with Bioprazol, discuss the following with a doctor or pharmacist:

• if the patient has ever had a skin reaction to a medicine similar to Bioprazol 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, they should inform their doctor immediately, as discontinuation of Bioprazol may be necessary. The patient should also report any other adverse effects, such as joint pain.

Bioprazol may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Bioprazol, the patient should contact their doctor without delay:

• unexplained weight loss and difficulty swallowing,
• stomach pain or indigestion,
• vomiting of food or blood,
• passing black stools (blood-discoloured faeces),
• severe or persistent diarrhoea, as use of omeprazole is associated with a slightly increased risk of infectious diarrhoea,
• severe liver problems.

If Bioprazol is used long-term (longer than 1 year), the patient will likely require close and regular medical monitoring. Any new or unusual symptoms or circumstances should be reported during visits to the doctor.

Taking proton pump inhibitors such as Bioprazol, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

While taking omeprazole, interstitial nephritis (inflammation of the kidneys) may occur. Symptoms may include reduced urine volume or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.

Children and adolescents

Detailed information on the use of Bioprazol in children and adolescents is provided in section 3, "How to take Bioprazol".

Other medicines and Bioprazol

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

Do not take Bioprazol if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• ketoconazole, itraconazole, or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or in the treatment of epilepsy);
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient's condition when starting and stopping Bioprazol.
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient's condition when starting and stopping Bioprazol.
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used following organ transplantation);
• St John's wort (Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat intermittent claudication);
• saquinavir (used to treat HIV infection);
• clopidogrel (used to prevent blood clots).

If the doctor has prescribed antibiotics—amoxicillin and clarithromycin—along with Bioprazol for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about any other medicines they are taking.

Food and drink

The capsules can be taken with food or 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 baby, she should consult her doctor or pharmacist before using this medicine.

Before starting Bioprazol, the patient should inform her doctor whether she is pregnant or trying to become pregnant. The doctor will decide whether she can take Bioprazol during this time.

The decision on whether a breastfeeding woman can take Bioprazol will be made by the doctor.

Driving and using machines

Bioprazol has no influence on the ability to drive or use tools and machines. However, adverse effects such as dizziness and visual disturbances may occur (see section 4 of this leaflet). If these occur, the patient should not drive or operate machinery.

Bioprazol contains sucrose

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

Bioprazol is considered sodium-free

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Bioprazol

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will depend on your medical condition and age.
The usual doses of Bioprazol are given below.

Adults

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of
gastric acid:

• If your doctor has diagnosed mild damage to your oesophagus, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend taking 40 mg once daily for an additional 8 weeks if the oesophagus has not yet healed.
• The usual dose after healing of the oesophagus is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

Treatment of duodenal ulcers (ulcers in the upper part of the intestine):

• The usual dose is 20 mg once daily for 2 weeks. Your doctor may recommend continuing the same dose for another 2 weeks if the ulcers have not healed by then.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers (ulcers in the stomach):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for another 4 weeks if the ulcers have not healed by then.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of duodenal and gastric ulcers:

• The usual dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of duodenal and gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once daily for 4 to 8 weeks.

Prevention of recurrence of duodenal and gastric ulcers during NSAID treatment:

• The usual dose is 20 mg once daily.

Treatment of ulcers associated with infection by Helicobacter pylori bacteria and prevention of
their recurrence:

• The usual dose of Bioprazol is 20 mg twice daily for 1 week.
• Your doctor will also prescribe two antibiotics (amoxicillin, clarithromycin or metronidazole).

Treatment of Zollinger-Ellison syndrome (a condition in which excessive hydrochloric acid is produced in the stomach due to a tumour in the pancreas):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and determine how long Bioprazol should be taken.

Children and adolescents

Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of
gastric acid:

• Children above 1 year of age and weighing more than 10 kg may take Bioprazol. The dose for children depends on body weight and will be determined by the doctor.

Treatment of ulcers associated with infection by Helicobacter pylori bacteria and prevention of
their recurrence:

• Children above 4 years of age may take Bioprazol. The dose for children depends on body weight and will be determined by the doctor.
• Your doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take Bioprazol capsules

• It is recommended to take the capsules in the morning.
• Capsules may be taken with or without food.
• 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.

What to do if you have difficulty swallowing capsules (in adults or children)

• If an adult or child has difficulty swallowing capsules:
• Open the capsule and swallow the contents directly with a glass of water, or mix the contents with a glass of non-carbonated water, 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). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the full dose of Bioprazol is taken, rinse the glass thoroughly with half a glass of water and drink this liquid as well. The solid particles contain the medicine – do not chew or crush them before swallowing.
• DO NOT USE carbonated water or milk.

If you take more Bioprazol than you should
If you take more Bioprazol than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Bioprazol
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Stopping Bioprazol
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 any of the following rare but serious adverse reactions occur,
discontinue taking Bioprazol immediately and contact a doctor without delay:

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blister formation 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 indicate liver function disorders.

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

• headache
• effects on stomach or intestine: diarrhoea, stomach pain, constipation, bloating with gas release
• nausea or vomiting
• mild gastric polyps

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

• swelling of feet and ankles
• sleep disturbances (insomnia)
• dizziness, tingling or prickling sensations, drowsiness
• sensation of spinning (vertigo)
• changes in liver function test results
• skin rash, nodular rash (urticaria), and skin itching
• general malaise and lack of energy

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

• blood-related problems, such as reduced number of white blood cells or platelets, which may lead to weakness, 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, which may lead to weakness, vomiting, and muscle cramps
• agitation, confusion, or depression
• altered taste sensation
• vision problems (e.g. blurred vision)
• sudden sensation of wheezing or breathlessness (bronchospasm)
• dry mouth
• inflammation of the oral mucosa
• fungal infection ("thrush"), which may affect the intestines and is caused by fungi
• liver function disorders, including jaundice with yellowing of the skin, dark urine, and feeling of weakness
• 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 (occur less frequently than in 1 out of 10,000 people):

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

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

• rash that may be accompanied by joint pain.

If Bioprazol has been taken for longer than three months, there may be a risk of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms are observed, a doctor should be informed 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.
In very rare cases, Bioprazol may affect the number of white blood cells in the blood, leading to immunodeficiency. If a 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 neck, throat or mouth pain, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible white blood cell deficiency (agranulocytosis), confirmed by blood tests. It is important that the patient informs the doctor about the medicine being taken.
Patients should not be alarmed by the list of adverse reactions listed above. It is possible that none of them will occur.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Reactions of Medicinal Products at 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bioprazol

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the outer carton and blister. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Bioprazol contains

• The active substance is omeprazole (omeprazolum). Each enteric hard capsule contains 40 mg of omeprazole.
• Other components of the medicine are: capsule fill: sucrose, pellets (containing sucrose and maize starch), copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion, 30% (containing: copolymer of methacrylic acid and ethyl acrylate, polysorbate 80, sodium lauryl sulfate), hypromellose, type 2910 (E464), talc (E553b), triethyl citrate (E1505), disodium phosphate dihydrate (E339ii), titanium dioxide (E171); capsule body: gelatin, purified water, titanium dioxide (E171); capsule cap: gelatin, purified water, titanium dioxide (E171); printing ink (Black Ink SW-9008): black iron oxide (E172), shellac, potassium hydroxide.

What Bioprazol looks like and contents of the pack
Bioprazol is an opaque, white, gelatinous, hard enteric capsule filled with pellets.
The capsules are marked with the letters "OM" (on the cap) and the number "40" (on the body).
The enteric capsules are packed in blisters made of PVC-PVDC/Aluminium, placed together with the patient leaflet in a cardboard box.
Pack sizes:
7, 10, 14, 20, 21, 28, 30, 50, 56 and 60 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
fax: +48 61 66 51 505
email address: [email protected]

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