Prazol

Leaflet accompanying the packaging: patient information

Prazol, 20 mg, 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.
• In case of any doubts, consult a 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 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 Prazol and what is it used for
• 2. Important information before taking Prazol
• 3. How to take Prazol
• 4. Possible side effects
• 5. How to store Prazol
• 6. Package contents and other information

1. What is Prazol and what is it used for

Prazol contains the active substance omeprazole. It belongs to a group of medicines called proton pump inhibitors. Omeprazole reduces the amount of acid produced by the stomach, which reduces the irritating effect of acidic stomach contents on the esophagus and stomach lining.
The onset of action of the medicine is observed after a short time from administration.
Prazol is used to treat the following diseases and disorders:
In adults:

• treatment of duodenal ulcers,
• prevention of duodenal ulcer recurrences,
• treatment of gastric ulcers,
• prevention of gastric ulcer recurrences,
• treatment of peptic ulcer disease caused by Helicobacter pylori bacterial infection,
• treatment of reflux esophagitis,
• Zollinger-Ellison syndrome,
• treatment of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs),
• prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk of their occurrence.

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

• treatment of reflux esophagitis in children,
• symptomatic treatment of heartburn and acid regurgitation in reflux esophagitis.

Children over 4 years of age and adolescents

• treatment of duodenal ulcers caused by Helicobacter pylori infection and prevention of their recurrences.

2. Important information before taking Prazol

When not to take Prazol

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed with an allergy to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if the patient is taking nelfinavir (a medicine used to treat HIV infection).

Do not take Prazol if any of the above points apply to the patient.
In case of any doubts before starting to take Prazol, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Prazol, discuss it with your doctor.
During treatment with Prazol, serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP).
If any symptoms of these serious skin reactions occur, as described in section 4, stop taking Prazol and seek medical help immediately.
Prazol may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Prazol, inform your doctor immediately:

• if the patient experiences: significant, unexpected weight loss and difficulty swallowing, stomach pain or nausea, recurrent vomiting, vomiting with blood, black stools,
• if the patient experiences severe or persistent diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea,
• if the patient experiences severe liver disorders,
• if the patient has ever had a skin reaction after taking a medicine that reduces stomach acid,
• if the patient is scheduled for a specific blood test (chromogranin A levels).

In case of long-term use of Prazol (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During visits to the doctor, report any new or unusual symptoms and circumstances.
If a skin rash occurs, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue Prazol. Also, report any other side effects, such as joint pain.
When taking proton pump inhibitors like Prazol, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. Inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
If you are planning to have any tests, inform your doctor that you are taking Prazol, as it may affect the results.
During treatment with Prazol, 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. Report such symptoms to your doctor.
This medicine may affect how the body absorbs vitamin B12, especially if it needs to be taken for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:

• extreme fatigue or lack of energy,
• tingling and numbness,
• painful or red tongue, mouth ulcers,
• muscle weakness,
• vision disturbances,
• memory problems, confusion, depression.

Children

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

Prazol and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Prazol if you are taking a medicine containing nelfinavir(used to treat HIV infection).
Consult your doctor or pharmacist before taking Prazol if you are taking any of the following medicines:

• warfarin (an anticoagulant) or other vitamin K antagonists. Your doctor will need to monitor your condition when starting or stopping Prazol.
• phenytoin (an antiepileptic medicine). If you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Prazol.
• diazepam (a sedative and hypnotic medicine, or used to treat epilepsy),
• antifungal and antiprotozoal medicines (e.g., ketoconazole, itraconazole, posaconazole, voriconazole),
• tacrolimus (a medicine used during organ transplantation),
• digoxin (a medicine used to treat heart failure),
• methotrexate (a medicine used to treat cancer). If you are taking high doses of methotrexate, your doctor may temporarily discontinue Prazol.
• erlotinib (used to treat cancer),
• atazanavir (a medicine used to treat HIV infection),
• saquinavir (used to treat HIV infection),
• clopidogrel (a medicine used to prevent blood clots),
• cilostazol (a medicine used to treat symptoms of intermittent claudication),
• rifampicin (used to treat tuberculosis),
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

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

Prazol with food and drink

It is recommended to take the medicine in the morning, before breakfast, with water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Omeprazole passes into breast milk, but its effect on the baby is unlikely when the medicine is used at therapeutic doses. Whether a breastfeeding woman can take Prazol will be decided by the doctor.

Driving and using machines

Prazol 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 they do, do not drive or operate machinery.
Prazol contains sucrose.
If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is essentially "sodium-free".

3. How to take Prazol

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Recommended dose

Adults

Treatment of duodenal ulcers

• The usual dose of Prazol is 20 mg once a day for 2 weeks.
• In patients who have not healed after this time, the doctor may recommend taking the same dose for another 2 weeks.
• If the ulcer has not healed completely, the doctor may recommend taking Prazol at a dose of 40 mg once a day for 4 weeks.

Prevention of duodenal ulcer recurrences

• The usual dose of Prazol is 10 mg to 20 mg once a day. The doctor may increase the dose to 40 mg per day.

Treatment of gastric ulcers

• The usual dose of Prazol is 20 mg once a day for 4 weeks.
• In patients who have not healed after this time, the doctor may recommend taking the same dose for another 4 weeks.
• If the ulcer has not healed completely, the doctor may recommend taking Prazol at a dose of 40 mg once a day for 8 weeks.

Prevention of gastric ulcer recurrences

• The usual dose of Prazol is 20 mg once a day. The doctor may increase the dose to 40 mg per day.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrences

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

Treatment of reflux esophagitis

• The usual dose of Prazol is 20 mg once a day for 4 weeks.
• In patients who have not healed after this time, the doctor may recommend taking the same dose for another 4 weeks.
• If the esophagus is not yet healed, the doctor may recommend taking Prazol at a dose of 40 mg once a day for 8 weeks.
• The usual dose of Prazol after healing of the esophagus is 10 mg once a day.

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

• The doctor will adjust the dose of Prazol according to the individual needs of the patient and decide how long the treatment should last.
• The usual dose of Prazol is 60 mg per day.
• If doses greater than 80 mg per day are used, Prazol should be taken in 2 divided doses.

Treatment of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs)

• The usual dose of Prazol is 20 mg once a day for 4 weeks.
• In patients who have not healed after this time, the doctor may recommend taking the same dose for another 4 weeks.

Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk of their occurrence

• The usual dose of Prazol is 20 mg once a day.

Children and adolescents

Treatment of reflux esophagitis

• Children over 1 year of age and with a body weight of over 10 kg can take Prazol.
• The dose for children depends on the child's body weight. The appropriate dose for the child will be recommended by the doctor.

Treatment of duodenal ulcers caused by Helicobacter pylori infection and prevention of their recurrences

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

Special patient groups

Patients with renal impairment
There is no need to adjust the dose in patients with renal impairment.
Patients with hepatic impairment
In patients with hepatic impairment, a daily dose of 10-20 mg may be sufficient.
Elderly patients
There is no need to adjust the dose in elderly patients.

Method of administration

It is recommended to take the medicine in the morning, before breakfast, with water.
The capsule should be swallowed whole, without chewing or crushing before swallowing.
Procedure for patients with swallowing difficulties and children who can drink or swallow semi-solid food

• Open the capsule and swallow the contents directly, washing it down with half a glass of water, or pour the contents of the capsule into a glass containing about 10 ml of fruit juice or other acidic liquid, and mix well (the mixture will not be clear).
• Drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the entire dose is taken, add half of the volume of the glass used to prepare the mixture, mix well, and drink.

Overdose of Prazol

In case of overdose, if disturbing symptoms occur, seek medical help immediately.

Missed dose of Prazol

If a dose is missed due to forgetfulness, take the dose as soon as you remember.
If it is time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Prazol treatment

Do not stop taking Prazol without consulting your doctor or pharmacist first.
In case of any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

In case of any of the following rare (affecting more than 1 in 10,000 people and less than 1 in 1,000 people) or very rare (affecting less than 1 in 10,000 people) but serious side effects, stop taking Prazol and

contact your doctor immediately:

• sudden wheezing, swelling of the lips, tongue, and 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 area of the lips, eyes, mouth, nose, and genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) (rare),
• red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rare).
• yellowing of the skin, dark urine, and fatigue, which may be signs of liver disorders (rare).

During treatment with Prazol, the following have been observed:
Common side effects (occurring in no more than 1 in 10 people):

• headaches,
• diarrhea,
• constipation,
• abdominal pain,
• nausea, vomiting,
• bloating,
• mild gastric polyps.

Uncommon side effects (occurring in no more than 1 in 100 people):

• swelling of the feet and ankles,
• changes in liver function test results,
• sleep disturbances (insomnia),
• skin rash, papular rash (hives), itching,
• general malaise and lack of energy,
• dizziness, tingling, and numbness,
• dizziness (vertigo).

Rare side effects (occurring in no more than 1 in 1,000 people):

• sudden breathing difficulties or shortness of breath (bronchospasm),
• inflammation of the mucous membrane of the mouth, dry mouth,
• infection known as "thrush", which can affect the intestines and is caused by fungi,
• hair loss (alopecia),
• skin rash during sun exposure,
• agitation, confusion, depression,
• change in taste,
• vision problems, such as blurred vision,
• severe kidney problems (interstitial nephritis),
• increased sweating,
• muscle pain (myalgia) or joint pain (arthralgia),
• blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, easy bruising, or an increased risk of infection.
• low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.

Very rare side effects (occurring in less than 1 in 10,000 people):

• changes in blood morphology, 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,
• erythema multiforme,
• muscle weakness,
• gynecomastia (enlargement of breast tissue in men).

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

• inflammation of the intestines (causing diarrhea),
• if you have taken Prazol 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 notice 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 that may be associated with joint pain.

In very rare cases, Prazol 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 condition 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 possible lack of white blood cells (agranulocytosis) based on blood test results. It is important for you to provide your doctor or pharmacist with information about the medicine you are taking.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. 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:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Prazol

Keep the medicine out of the sight and reach of children.
Store in the original packaging, at a temperature below 30 °C.
Do not use this medicine after the expiry date stated on the carton after "Expiry date". 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Prazol contains

The active substance of Prazol is omeprazole. Each capsule contains 20 mg of omeprazole.
The other ingredients are:
Contents of the capsule :sugar spheres (sucrose, cornstarch), sodium starch glycolate, sodium lauryl sulfate, hypromellose, talc, povidone (K-30), disodium phosphate, sodium hydroxide, methacrylic acid and ethyl acrylate copolymer 1:1, triethyl citrate, titanium dioxide (E 171).
Composition of the gelatin capsule :gelatin, titanium dioxide (E 171), indigo carmine (E 132), quinoline yellow (E 104), erythrosine (E 127), ink (shellac, propylene glycol, polyvinylpyrrolidone, sodium hydroxide, titanium dioxide (E 171), anhydrous ethanol, isopropyl alcohol, n-butyl alcohol).

What Prazol looks like and contents of the package

Prazol capsules consist of an orange body with the imprint "20" and a blue cap with the imprint "O".
The package contains 7, 14, 28, or 56 capsules in a polyethylene container with a polypropylene cap and a desiccant in a cardboard box.
The package contains 7, 14, 28, or 56 capsules in aluminum/aluminum blisters in a cardboard box. 1 blister contains 7 capsules.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel.: + 48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: