GOPRAZOL 20 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Goprazol 20 mg, 20 mg, Gastro-Resistant Hard Capsules
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
3. What is Goprazol and what is it used for
4. Important information before taking Goprazol
   1. When not to take Goprazol
   2. Warnings and precautions
   3. Children
   4. Goprazol and other medications
   5. Goprazol with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Goprazol contains sucrose
   9. Goprazol contains sodium
5. How to take Goprazol
   1. Prevention of duodenal and gastric ulcers during NSAID use
   2. Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome)
   3. How to take this medication
   4. What to do if you have difficulty swallowing the capsules (in adults or children)
   5. What to do if you take more Goprazol than you should
   6. What to do if you miss a dose of Goprazol
   7. What to do if you stop taking Goprazol
6. Possible side effects
   1. If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Goprazol and contact a doctor immediately:
   2. Reporting side effects
7. How to store Goprazol
8. Contents of the pack and other information
   1. What Goprazol contains
   2. What Goprazol looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet: 09/2023

Package Leaflet: Information for the Patient

Goprazol 20 mg, 20 mg, Gastro-Resistant Hard Capsules

Omeprazole

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Goprazol and what is it used for

Goprazol contains the active substance omeprazole. It belongs to a group of medications called "proton pump inhibitors". Their action involves reducing the amount of acid secreted in the stomach.
Goprazol is used to treat the following diseases and disorders:
In adults:

• Gastroesophageal reflux disease (GERD). This condition involves stomach acid flowing back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers infected with bacteria called "Helicobacter pylori". In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). Goprazol can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid due to a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and ≥ 10 kg body weight

• Gastroesophageal reflux disease (GERD). This condition involves stomach acid flowing back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers infected with bacteria called "Helicobacter pylori". If a child has this condition, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Goprazol

When not to take Goprazol

In case of any doubts before starting to take Goprazol, consult a doctor or pharmacist.

Warnings and precautions

Consult a doctor or pharmacist before taking Goprazol.
Severe skin reactions, including Stevens-Johnson syndrome (ang. Stevens-Johnson syndrome), toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (ang. drug reaction with eosinophilia and systemic symptoms, DRESS), and acute generalized exanthematous pustulosis (ang. acute generalized exanthematous pustulosis, AGEP) have been reported with omeprazole. If symptoms of these severe skin reactions occur, stop taking omeprazole and seek medical help immediately.
Goprazol may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Goprazol, consult a doctor immediately:

• unexplained weight loss and difficulty swallowing,
• stomach pain or indigestion,
• vomiting blood or black tarry stools,
• severe or persistent diarrhea, as omeprazole is associated with a slight increase in the frequency of infectious diarrhea,
• severe liver problems,
• long-term use of proton pump inhibitors, such as Goprazol, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• inform your doctor about any planned specific blood test (chromogranin A levels).

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. Such symptoms should be reported to the attending physician.
In the case of long-term use of Goprazol (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During a visit to the doctor, report any new or unusual symptoms and circumstances.
If a rash appears on the skin, especially in areas exposed to the sun, inform the doctor as soon as possible, as it may be necessary to discontinue treatment with Goprazol. Remember to also tell the doctor about any other side effects, such as joint pain.

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. Do not give this medication to children under 1 year of age or <10 kg.< p>

Goprazol and other medications

Tell your doctor about all medications you are currently taking or have recently taken. This includes medications available without a prescription. This is important because Goprazol may affect the way some other medications work, and some other medications may affect the way Goprazol works.
Do not take Goprazol if you are taking a medication containing nelfinavir(used to treat HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazole, 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 Goprazol.
• Medications 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 Goprazol.
• 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).
• Erlotinib (used to treat cancer).
• Methotrexate (used to treat rheumatoid arthritis and certain types of cancer) - if you are receiving high doses of methotrexate, your doctor may decide to temporarily discontinue Goprazol

If your doctor has prescribed you antibiotics amoxicillin and clarithromycin and Goprazol to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medications you are taking.

Goprazol with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medication.
Omeprazole passes into breast milk, but it is unlikely to affect the baby when therapeutic doses are used. The doctor will decide whether the breastfeeding mother can take Goprazol at this time.

Driving and using machines

Goprazol does not affect the ability to drive or use tools and machines.
However, side effects such as dizziness and blurred vision (see section 4) may occur. If they do, do not drive or operate machinery.

Goprazol contains sucrose

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

Goprazol contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Goprazol

Always take Goprazol exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist again.
Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age.
The recommended dose is:
Adults:

• Treatment of GERD symptoms, such as heartburn and acid regurgitation:
• If the doctor has found that the esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. The doctor may recommend that you 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 is not damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers(duodenal ulcers):

• The usual dose is 20 mg once a day for 2 weeks. The doctor may recommend that you take the same dose for another 2 weeks if the ulcers have not healed within this time.
• 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(gastric ulcers):

• The usual dose is 20 mg once a day for 4 weeks. The doctor may recommend that you take the same dose for another 4 weeks if the ulcers have not healed within this time.
• 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 duodenal and gastric ulcers caused by NSAIDs(nonsteroidal anti-inflammatory drugs):

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

Prevention of duodenal and gastric ulcers during NSAID use

(nonsteroidal anti-inflammatory drugs):

• 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 Goprazol is 20 mg twice a day for one week.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

Treatment of excessive stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome)

• The recommended dose is 60 mg per day.

The doctor will adjust the dose according to individual patient needs and decide how long the treatment should last.
Use in children and adolescents:
Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• Children over 1 year of age and weighing more than 10 kg can take Goprazol. The dose for children depends on the child's weight. The doctor will recommend a dose suitable for the child.

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

• Children over 4 years of age can take Goprazol. The dose for children depends on the child's weight; the doctor will recommend a dose suitable for the child.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

How to take this medication

• It is recommended to take the capsules in the morning.
• The capsules can 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 enteric-coated pellets that prevent the medication from being broken down by stomach acid. It is essential that the pellets are not damaged.

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, 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 grapefruit), or applesauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes of preparation.
• To ensure that you have taken the entire dose, rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medication - do not chew or crush them.

What to do if you take more Goprazol than you should

If you have taken more Goprazol than you should, contact a doctor or pharmacist immediately.

What to do if you miss a dose of Goprazol

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose, but continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

What to do if you stop taking Goprazol

Do not stop taking Goprazol without consulting your doctor or pharmacist first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Goprazol can cause side effects, although not everybody gets them.

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Goprazol and contact a doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). (rare)
• Redness of the skin with blistering or peeling. Large blisters and bleeding in the mouth, eyes, lips, genitals, or anus may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis. (very rare)
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). (rare)
• A red, blistering, widespread rash with fever, which may develop into widespread skin peeling and blistering. Symptoms usually appear within the first few days of treatment (acute generalized exanthematous pustulosis). (rare)
• Jaundice (yellowing of the skin or eyes), dark urine, and tiredness, which can be signs of liver problems. (rare)

Side effects may occur with the following frequencies, which are defined as follows:
Other side effects include:
Common side effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Feeling of dizziness, tingling, or 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 (may affect up to 1 in 1,000 people)

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, easy bruising, or increased risk of infection.
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• A fungal infection, which can affect the intestines and is caused by fungi.
• 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 (may affect up to 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 disease.
• ERYthema multiforme.
• Muscle weakness.
• Breast enlargement in men.

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

• Colitis (leading to diarrhea).
• If you have taken Goprazol for more than three months, there is a possibility of reduced 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.
• Rash, sometimes also accompanied by joint pain.

In very rare cases, Goprazol 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 severe deterioration in general condition or fever with local infection symptoms, such as sore throat, mouth, or urinary problems, consult a 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 the doctor about the medication you are taking.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 medication.

5. How to store Goprazol

Keep out of the sight and reach of children.
Do not use Goprazol after the expiry date stated on the carton, bottle, label, or blister after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original package to protect from moisture.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Goprazol contains

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• Other ingredients are:
• Contents of the capsule:sucrose, pellets (containing cornstarch and sucrose), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion.
• Capsule shell:gelatin. The 20 mg capsules also contain the colorants quinoline yellow (E 104) and titanium dioxide (E 171).

What Goprazol looks like and contents of the pack

Hard gastro-resistant capsules.
Goprazol 20 mg are yellow, non-transparent capsules containing spherical, almost white to cream-white microgranules.
The capsules are available in blisters of 7, 14, 15, 28, 30, 35, 50, 56, 60, 90, 98, 100, 140, 280, and 500 capsules and HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 62, 90, 100, 110, and 500 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Manufacturer:
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
To obtain information on the names of the medication in the Member States of the European Economic Area, contact the marketing authorization holder:
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
tel.: 71 330 50 80

Date of last revision of the leaflet: 09/2023