BIOPRAZOL 40 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. BIOPRAZOL
3. 40 mg, gastro-resistant hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What Bioprazol is and what it is used for
   1. Bioprazol is used to treat the following diseases and disorders:
5. Important information before taking Bioprazol
   1. When not to take Bioprazol
   2. Warnings and precautions
   3. Children and adolescents
   4. Bioprazol and other medicines
   5. Bioprazol with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Bioprazol contains sucrose
   9. Bioprazol is considered sodium-free
6. How to take Bioprazol
   1. How to take Bioprazol
   2. What to do if you have difficulty swallowing the capsules (in adults or children)
   3. Taking a higher dose of Bioprazol than prescribed
   4. Missing a dose of Bioprazol
   5. Stopping Bioprazol treatment
7. Possible side effects
   1. If you experience any of the following rare but serious side effects, stop taking Bioprazol and contact your doctor immediately:
   2. Common side effects (occurring in 1 to 10 in 100 people):
   3. Uncommon side effects (occurring in 1 to 10 in 1,000 people):
   4. Rare side effects (occurring in 1 to 10 in 10,000 people):
   5. Very rare side effects (occurring in less than 1 in 10,000 people):
   6. Reporting side effects
8. How to store Bioprazol
9. Contents of the pack and other information
   1. What Bioprazol contains
   2. What Bioprazol looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: 20.03.2023

Leaflet accompanying the packaging: information for the user

BIOPRAZOL

40 mg, gastro-resistant hard capsules

Omeprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of 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 pack and other information

1. What Bioprazol is and what it is used for

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

Bioprazol is used to treat the following diseases and disorders:

In adults:

• Gastroesophageal reflux disease. In this disease, acidic stomach juice flows into the esophagus (the part of the digestive tract that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the initial part of the small intestine (duodenal ulcers) or in the stomach (gastric ulcers).
• Ulcers associated with Helicobacter pylori infection. In this case, the doctor may also prescribe antibiotics to cure the infection and facilitate ulcer healing.
• Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Bioprazol can also be used to prevent the development of ulcers when taking NSAIDs.
• Zollinger-Ellison syndrome, in which the stomach produces excessive amounts of acid due to the presence of a tumor in the pancreas.

In children:

• Children over 1 year of age and weighing 10 kg or more can take Bioprazol. The dose for children depends on the child's weight, and the appropriate dose will be recommended by the doctor.

2. Important information before taking Bioprazol

When not to take Bioprazol

In case of any doubts before taking Bioprazol, consult your doctor or pharmacist.

Warnings and precautions

Before starting to take Bioprazol, discuss it with your doctor or pharmacist:

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Bioprazol. The patient should also report any other side effects, such as joint pain.

Bioprazol may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Bioprazol, the patient should contact their doctor immediately:

• unexplained weight loss and difficulty swallowing,
• stomach pain or indigestion,
• vomiting blood or food,
• passing black stools (stool discolored by blood),
• severe or persistent diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea,
• severe liver problems.

In the case of long-term use of Bioprazol (longer than 1 year), the patient will likely remain under close and regular medical supervision. During the visit to the doctor, the patient should report any new or unusual symptoms and circumstances.

When taking proton pump inhibitors like Bioprazol, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. 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, 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

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

Bioprazol and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription. This is important because Bioprazol may affect the way some other medicines work, and some other medicines may affect the way Bioprazol works.

Do not take Bioprazol if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• ketokonazole, itraconazole, or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart rhythm disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy);
• phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Bioprazol.
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting or stopping Bioprazol.
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used in 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 your doctor has prescribed you antibiotics such as amoxicillin and clarithromycin, as well as Bioprazol, to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Bioprazol with food and drink

Capsules can be taken during meals or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Before starting to take Bioprazol, the patient should inform their doctor if they are pregnant or trying to become pregnant. The doctor will decide whether the patient can take Bioprazol during this time.

The doctor will decide whether a breastfeeding patient can take Bioprazol.

Driving and using machines

Bioprazol does not affect the ability to drive or use machines. However, possible side effects such as dizziness and blurred vision (see section 4 of this leaflet) may occur. If these symptoms occur, do not drive or operate machines.

Bioprazol contains sucrose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Bioprazol is considered sodium-free

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

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Your doctor will tell you how many capsules to take and for how long. This will depend on your health and age.

Usual doses of Bioprazol are given below.

Adults

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

• If your doctor has found that your esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may recommend that you take a dose of 40 mg for another 8 weeks if your esophagus has not yet healed.
• The usual dose after healing of the esophagus is 10 mg once a day.
• If your esophagus is not damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

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

Treatment of gastric ulcers:

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

Prevention of duodenal and gastric ulcers:

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

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

• The usual dose is 20 mg once a day for 4-8 weeks.

Prevention of duodenal and gastric ulcers during NSAID use:

• The usual dose is 20 mg once a day.

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

• The usual dose of Bioprazol is 20 mg twice a day for 1 week.
• Your doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

Treatment of Zollinger-Ellison syndrome (in which the stomach produces excessive amounts of acid due to the presence of a tumor in the pancreas):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and decide how long you need to take Bioprazol.

Children and adolescents

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

• Children over 1 year of age and weighing 10 kg or more can take Bioprazol. The dose for children depends on the child's weight, and the appropriate dose will be recommended by the doctor.

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

• Children over 4 years of age can take Bioprazol. The dose for children depends on the child's weight, and the appropriate dose will be recommended by the doctor.
• Your doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take Bioprazol

• It is recommended to take the capsules in the morning.
• Capsules can be taken during meals or 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 enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is essential not to damage the pellets.

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

• If you have difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or pineapple), or applesauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure that you have taken the entire dose of Bioprazol, rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them before swallowing.
• DO NOT USE carbonated water or milk.

Taking a higher dose of Bioprazol than prescribed

If you have taken a higher dose of Bioprazol than prescribed by your doctor, contact your doctor or pharmacist immediately.

Missing a dose of Bioprazol

If you miss a dose due to forgetting, take the dose 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 the missed dose.

Stopping Bioprazol treatment

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

4. Possible side effects

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

If you experience any of the following rare but serious side effects, stop taking Bioprazol and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Large blisters and bleeding in the mouth, eyes, lips, nose, and genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver problems.

Other side effects include:

Common side effects (occurring in 1 to 10 in 100 people):

• headache
• effects on the stomach or intestines: diarrhea, stomach pain, constipation, bloating with gas
• nausea or vomiting
• mild gastric polyps

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

• swelling of the feet and ankles
• sleep disturbances (insomnia)
• dizziness, tingling, and numbness, drowsiness
• feeling of spinning (vertigo)
• changes in liver function test results
• skin rash, hives, and itching
• general feeling of being unwell and lack of energy

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

• blood problems, such as a decrease in white blood cells or platelets, which can lead to weakness, bruising, or increased risk of infection
• allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, wheezing
• low sodium levels in the blood, which can lead to weakness, vomiting, and muscle cramps
• agitation, confusion, or depression
• change in taste
• vision problems (e.g., blurred vision)
• sudden shortness of breath or wheezing (bronchospasm)
• dry mouth
• inflammation of the mouth
• a fungal infection that can affect the intestines and is caused by fungi
• liver problems, including jaundice with yellowing of the skin, dark urine, and fatigue
• hair loss (alopecia)
• skin rash when exposed to sunlight
• joint pain (arthralgia) or muscle pain (myalgia)
• severe kidney problems (interstitial nephritis)
• increased sweating

Very rare side effects (occurring in 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 brain inflammation
• sudden development of a severe rash or blisters on the skin, or peeling of the skin. These symptoms 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 the available data):

• a rash that may be associated with joint pain.

If you have taken Bioprazol for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If you experience any of these symptoms, inform your doctor immediately.

Low magnesium levels can lead to low potassium or calcium levels in the blood. Your 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 a lack of immunity. If you experience an infection with symptoms such as fever with a serious deterioration in general health or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on blood test results. It is essential to inform your doctor that you are taking Bioprazol.

Do not worry about the list of side effects mentioned above. It is possible that you will not experience any of them.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Bioprazol

Keep this medicine out of the sight and reach of children.

Store in a temperature below 30°C.

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

Medicines should 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 contains

• The active substance of Bioprazol is omeprazole (omeprazolum). Each gastro-resistant hard capsule contains 40 mg of omeprazole.
• Other ingredients of the medicine are: capsule filling: sucrose, pellets (containing sucrose and cornstarch), methacrylic acid - ethyl acrylate copolymer (1:1), dispersion, 30% (containing methacrylic acid - ethyl acrylate copolymer, 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): iron oxide black (E172), shellac, potassium hydroxide.

What Bioprazol looks like and contents of the pack

Bioprazol is a non-transparent, hard gelatin capsule, white, filled with pellets.

The capsules are marked with the letters "OM" (cap) and the number "40" (body).

The capsules are packaged in blisters made of PVC-PVDC/Aluminum foil, along with the patient information leaflet, in a cardboard box.

Package sizes:

7, 10, 14, 20, 21, 28, 30, 50, 56, and 60 gastro-resistant hard 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

fax: +48 61 66 51 505

e-mail: [email protected]

Manufacturer

Towa Pharmaceutical Europe S.L.

C/ de Sant Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

Date of last revision of the leaflet: 20.03.2023