OMEPRAZOL 40 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Omeprazol Biofarm
3. 20 mg, enteric-coated hard capsules
4. Omeprazol Biofarm
5. 40 mg, enteric-coated hard capsules
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Omeprazol Biofarm and what is it used for
   1. Omeprazol Biofarm is used to treat the following diseases and disorders:
7. Important information before taking Omeprazol Biofarm
   1. When not to take Omeprazol Biofarm
   2. Warnings and precautions
   3. Children and adolescents
   4. Omeprazol Biofarm and other medicines
   5. Omeprazol Biofarm with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Omeprazol Biofarm contains sucrose and lactose
8. How to take Omeprazol Biofarm
   1. How to take Omeprazol Biofarm
   2. What to do if the patient has difficulty swallowing the capsules (in adults or children)
   3. What to do if the patient has taken more than the recommended dose of Omeprazol Biofarm
   4. What to do if the patient has missed a dose of Omeprazol Biofarm
   5. What to do if the patient wants to stop taking Omeprazol Biofarm
9. Possible side effects
   1. If the patient experiences any of the following rare but serious side effects, they should stop taking Omeprazol Biofarm and immediately consult their doctor:
   2. Common side effects (occurring in 1 to 10 out of 100 people):
   3. Uncommon side effects (occurring in 1 to 10 out of 1,000 people):
   4. Rare side effects (occurring in 1 to 10 out of 10,000 people):
   5. Very rare side effects (occurring less frequently than 1 in 10,000 people):
   6. Frequency not known (cannot be estimated from the available data):
   7. Reporting side effects
10. How to store Omeprazol Biofarm
11. Contents of the packaging and other information
    1. What Omeprazol Biofarm contains
    2. What Omeprazol Biofarm looks like and contents of the packaging
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Omeprazol Biofarm

20 mg, enteric-coated hard capsules

Omeprazol Biofarm

40 mg, enteric-coated hard capsules

Omeprazolum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same. If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Omeprazol Biofarm and what is it used for
• 2. Important information before taking Omeprazol Biofarm
• 3. How to take Omeprazol Biofarm
• 4. Possible side effects
• 5. How to store Omeprazol Biofarm
• 6. Contents of the packaging and other information

1. What is Omeprazol Biofarm and what is it used for

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

Omeprazol Biofarm 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 section 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 the healing of the ulcers.
• Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Omeprazol Biofarm can also be used to prevent the development of ulcers when taking NSAIDs.
• Zollinger-Ellison syndrome, in which the stomach produces an excessive amount of acid due to the presence of a tumor in the pancreas.

In children:

• Children over 1 year of age and weighing over 10 kg can take Omeprazol Biofarm. 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 Omeprazol Biofarm

When not to take Omeprazol Biofarm

In case of any doubts before taking Omeprazol Biofarm, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Omeprazol Biofarm, the patient should discuss it with their doctor or pharmacist.

Omeprazol Biofarm may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Omeprazol Biofarm, the patient should immediately consult a doctor:

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

Before starting to take Omeprazol Biofarm, the patient should consult a doctor:

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 Omeprazol Biofarm. The patient should also report any other side effects, such as joint pain.

In the case of long-term use of Omeprazol Biofarm (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 Omeprazol Biofarm, 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).

Children and adolescents

Detailed information on the use of Omeprazol Biofarm in children and adolescents is included in section 3, "How to take Omeprazol Biofarm".

Omeprazol Biofarm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. This is important because Omeprazol Biofarm may affect the way some other medicines work, and some other medicines may affect the way Omeprazol Biofarm works.

The patient should not take Omeprazol Biofarm if they are taking a medicine containing nelfinavir (used to treat HIV infection).

The patient should inform their doctor or pharmacist if they 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 the patient is taking phenytoin, the doctor will need to monitor their condition when starting or stopping Omeprazol Biofarm.
• 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 or stopping Omeprazol Biofarm.
• 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 the doctor has prescribed antibiotics such as amoxicillin and clarithromycin, as well as Omeprazol Biofarm, to treat ulcers caused by Helicobacter pylori infection, it is very important for the patient to inform their doctor about any other medicines they are taking.

Omeprazol Biofarm with food and drink

The capsules can be taken during a meal or 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 their doctor or pharmacist before taking this medicine. The doctor will decide whether the patient can take Omeprazol Biofarm at this time.

Driving and using machines

Omeprazol Biofarm does not affect the ability to drive or use machines.

However, it is possible to experience side effects such as dizziness or visual disturbances (see section 4 of this leaflet). If these occur, the patient should not drive or use machines.

Omeprazol Biofarm contains sucrose and lactose

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

3. How to take Omeprazol Biofarm

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

The doctor will inform the patient about the dose and duration of treatment, depending on their health condition and age.

Usual doses of Omeprazol Biofarm are given below.

Adults

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

• If the doctor has found that the patient's esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. The doctor may recommend that the patient take a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The usual dose after healing of the esophagus is 10 mg once a day.
• If the esophagus has not been 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. The doctor may recommend that the patient 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. The doctor may recommend that the patient 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. The 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 caused by Helicobacter pylori infection and prevention of their recurrence:

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

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

• The usual dose is 60 mg per day.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long the patient should take Omeprazol Biofarm.

Children and adolescents

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

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

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

How to take Omeprazol Biofarm

• The capsules should be taken in the morning.
• The capsules can be taken during a meal or on an empty stomach.
• The capsules should be swallowed whole, with half a glass of water. The capsules should not be chewed or crushed. 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 that the pellets are not damaged.

What to do if the patient has difficulty swallowing the capsules (in adults or children)

• If the patient has difficulty swallowing the capsules:
• The capsule can be opened and the contents can be swallowed directly, with a glass of water, or the contents can be mixed with a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or grapefruit), or apple sauce.
• The mixture should always be stirred just before drinking (the mixture will not be clear). The mixture should be drunk immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose of Omeprazol Biofarm, the glass should be rinsed with half a glass of water and the rinse should be drunk. The solid particles contain the medicine - they should not be chewed or crushed before swallowing.
• CARBONATED WATER OR MILK SHOULD NOT BE USED.

What to do if the patient has taken more than the recommended dose of Omeprazol Biofarm

If the patient has taken a larger dose of Omeprazol Biofarm than prescribed by the doctor, they should immediately consult their doctor or pharmacist.

What to do if the patient has missed a dose of Omeprazol Biofarm

If the patient has missed a dose due to forgetting, they should take the dose as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed dose.

What to do if the patient wants to stop taking Omeprazol Biofarm

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following rare but serious side effects, they should stop taking Omeprazol Biofarm and immediately consult their doctor:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. Large blisters and bleeding in the area of the lips, eyes, mouth, 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 disorders.

Other side effects include:

Common side effects (occurring in 1 to 10 out of 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 out of 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, urticaria, and itching
• general malaise and lack of energy

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

• blood disorders, such as a decrease in the number of white blood cells or platelets, which may 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 may lead to weakness, vomiting, and muscle cramps
• agitation, disorientation, or depression
• change in taste
• vision problems (e.g., blurred vision)
• sudden wheezing or shortness of breath (bronchospasm)
• dry mouth
• oral thrush
• fungal infections, which may affect the intestines and are caused by fungi
• liver disorders, including jaundice with yellowing of the skin, dark urine, and fatigue
• excessive hair loss (alopecia)
• skin rash during sun exposure
• joint pain (arthralgia) or muscle pain (myalgia)
• severe kidney disorders (interstitial nephritis)
• increased sweating

Very rare side effects (occurring less frequently 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 disorders 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 the patient has taken Omeprazol Biofarm for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat.

If the patient experiences any of these symptoms, they should immediately inform their doctor. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

In very rare cases, Omeprazol Biofarm 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 severe deterioration of general well-being or fever with signs of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, they should consult their doctor as soon as possible to rule out a 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.

The patient should not worry about the list of side effects mentioned above. It is possible that they will not experience any of them.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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

e-mail: [email protected]

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Omeprazol Biofarm

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

The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.

There are no special precautions for storing the medicine.

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

6. Contents of the packaging and other information

What Omeprazol Biofarm contains

• The active substance of the medicine is omeprazole (Omeprazolum). Omeprazol Biofarm, 20 mg: Each enteric-coated hard capsule contains 20 mg of omeprazole. Omeprazol Biofarm, 40 mg: Each enteric-coated hard capsule contains 40 mg of omeprazole.
• Other ingredients of the medicine are: capsule contents: sucrose, pellets; lactose anhydrous, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, hypromellose phthalate, diethyl phthalate.

Capsule shell:

Omeprazol Biofarm, 20 mg: gelatin, indigo carmine (E132), quinoline yellow (E104);

Omeprazol Biofarm, 40 mg: gelatin, indigo carmine (E132), erythrosine (E127).

What Omeprazol Biofarm looks like and contents of the packaging

Omeprazol Biofarm, 20 mg: hard capsules, green in color, containing light yellow pellets.

Omeprazol Biofarm, 40 mg: hard capsules, purple in color, containing light yellow pellets

The capsules are packaged in aluminum/PVC/aluminum/PA blisters, placed in a cardboard box.

The packaging contains 7, 14, 28, or 56 enteric-coated 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

[email protected]

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of last revision of the leaflet: