OMEPRAZOL 20 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Omeprazol Biofarm
3. 20 mg, gastro-resistant hard capsules
4. Omeprazol Biofarm
5. 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
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 there are difficulties in swallowing the capsules (in adults or children)
   3. Taking a higher dose of Omeprazol Biofarm than recommended
   4. Missing a dose of Omeprazol Biofarm
   5. Stopping Omeprazol Biofarm treatment
9. Possible side effects
   1. If any of the following rare but serious side effects occur, stop taking Omeprazol Biofarm and contact a 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 less frequently than 1 in 10,000 people):
   6. Frequency not known (cannot be estimated from 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 pack
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet

Leaflet accompanying the packaging: information for the user

Omeprazol Biofarm

20 mg, gastro-resistant hard capsules

Omeprazol Biofarm

40 mg, gastro-resistant hard capsules

Omeprazolum

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. 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 those 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 stomach acid produced in the stomach.

Omeprazol Biofarm is used to treat the following diseases and disorders:

In adults:

• Gastroesophageal reflux disease. In this disease, stomach acid flows back into the esophagus (the part of the digestive tract that connects the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the duodenum (duodenal ulcers) or 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). Omeprazol Biofarm may also be used to prevent the development of ulcers during NSAID therapy.
• Zollinger-Ellison syndrome, in which the stomach produces excessive amounts of stomach acid due to the presence of a tumor in the pancreas.

In children:

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

Children over 4 years of age

• Children over 4 years of age may 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.

2. Important information before taking Omeprazol Biofarm

When not to take Omeprazol Biofarm

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

Warnings and precautions

Before starting Omeprazol Biofarm, discuss it with a doctor or pharmacist.

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

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

Before starting Omeprazol Biofarm, consult a doctor:

If a skin rash occurs, especially in areas exposed to sunlight, tell a doctor as soon as possible, as it may be necessary to stop taking Omeprazol Biofarm. 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 doctor's visit, report any new or unusual symptoms and circumstances.

Taking proton pump inhibitors like Omeprazol Biofarm, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform the doctor if osteoporosis has been diagnosed or if corticosteroids are being taken (which may increase the risk of osteoporosis).

Children and adolescents

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

Omeprazol Biofarm and other medicines

Tell the doctor or pharmacist about all medicines being taken, including those purchased without a prescription. This is important because Omeprazol Biofarm may affect the action of some other medicines, and some other medicines may affect the action of Omeprazol Biofarm.

Do not take Omeprazol Biofarm if taking a medicine containing nelfinavir (used to treat HIV infection).

Inform the doctor or pharmacist if 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 taking phenytoin, the doctor will need to monitor the patient's 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 the doctor about any other medicines being taken.

Omeprazol Biofarm with food and drink

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or plans to have a baby, they should consult a 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, side effects such as dizziness and blurred vision (see section 4 of this leaflet) may occur. If these occur, do not drive or operate machinery.

Omeprazol Biofarm contains sucrose and lactose

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

3. How to take Omeprazol Biofarm

Take this medicine always as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

The doctor will inform the patient about the dose and duration of treatment, depending on the patient's health 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 daily for 4-8 weeks. The doctor may recommend taking a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.
• The usual dose after esophageal healing is 10 mg once daily.
• If the esophagus is not damaged, the usual dose is 10 mg once daily.

Treatment of duodenal ulcers:

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

Treatment of gastric ulcers:

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

Prevention of duodenal and gastric ulcers:

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

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

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

Prevention of duodenal and gastric ulcers during NSAID therapy:

• The usual dose is 20 mg once daily.

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

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

Treatment of Zollinger-Ellison syndrome:

• The usual dose is 60 mg daily.
• The doctor will adjust the dose according to individual patient needs and decide how long Omeprazol Biofarm should be taken.

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 may 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 associated with Helicobacter pylori infection and prevention of their recurrence:

• Children over 4 years of age may 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

• 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 there are difficulties in swallowing the capsules (in adults or children)

• If the patient has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, washing it down with a glass of water, 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). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose of Omeprazol Biofarm, 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 Omeprazol Biofarm than recommended

In case of taking a higher dose of Omeprazol Biofarm than prescribed by the doctor, contact the doctor or pharmacist immediately.

Missing a dose of Omeprazol Biofarm

In case of missing a dose due to forgetfulness, take the dose as soon as remembered. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Omeprazol Biofarm treatment

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If any of the following rare but serious side effects occur, stop taking Omeprazol Biofarm and contact a 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 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 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, urticaria, and itching
• general feeling of being unwell and lack of energy

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

• blood disorders, such as decreased white blood cell or platelet count, 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, confusion, or depression
• change in taste
• vision problems (e.g., blurred vision)
• sudden shortness of breath or wheezing (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 encephalopathy
• 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 available data):

Rash that may be associated with joint pain.

If Omeprazol Biofarm has been taken 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, confusion, convulsions, dizziness, and rapid heartbeat.

If any of these symptoms are observed, inform a doctor immediately. 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 white blood cell count in the blood, leading to impaired immunity. If the patient develops an infection with symptoms such as fever with severe deterioration of general well-being or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, consult a doctor as soon as possible to rule out agranulocytosis based on blood test results.

It is essential for the patient to inform the doctor about the medication being taken.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a 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.

Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Omeprazol Biofarm

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

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

There are no special precautions for storing this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask a 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 is omeprazole (Omeprazolum). Omeprazol Biofarm, 20 mg: Each gastro-resistant hard capsule contains 20 mg of omeprazole. Omeprazol Biofarm, 40 mg: Each gastro-resistant hard capsule contains 40 mg of omeprazole.
• Other ingredients are: capsule contents: sucrose, pellets; lactose anhydrous, hypromellose, hydroxypropyl cellulose, 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 pack

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 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

[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