Prazol

Package leaflet: Information for the patient

Prazol, 20 mg, capsules
Omeprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Prazol is and what it is used for
Prazol contains the active substance called omeprazole. It belongs to a group of medicines known as
proton pump inhibitors. Omeprazole reduces the secretion of hydrochloric acid in the stomach, thereby
decreasing the irritating effect of acidic gastric contents on the oesophagus and gastric mucosa.
The onset of action occurs shortly after administration.
Prazol is used in the treatment of the following conditions:
In adults:

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

In children and adolescents:
Children above 1 year of age and weighing ≥ 10 kg

• treatment of gastro-oesophageal reflux disease in children,
• symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease.

Children above 4 years of age and adolescents

• treatment of Helicobacter pylori-induced duodenal ulcers and prevention of their recurrence.

2. Important information before taking Prazol

When not to take Prazol

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6),
• if you have had an allergic reaction to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if you are taking nelfinavir (a medicine used in the treatment of HIV infection).

Do not take Prazol if any of the above apply to you.
If you have any doubts, consult your doctor or pharmacist before starting treatment with Prazol.
Warnings and precautions
Before starting treatment with Prazol, discuss it with your doctor.
Severe skin reactions have been reported during treatment with Prazol, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalised exanthematous pustulosis (AGEP).
If you notice any symptoms related to these severe skin reactions described in section 4, stop taking Prazol immediately and seek medical help without delay.
Prazol may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Prazol, inform your doctor immediately:

• significant, unexpected weight loss and difficulty swallowing, stomach pain or indigestion, recurrent vomiting, vomiting blood, black tarry stools,
• severe or persistent diarrhoea, as omeprazole use is associated with a slight increase in the risk of infectious diarrhoea,
• severe liver problems,
• if you have previously had a skin reaction to a medicine similar to Prazol that reduces gastric acid secretion,
• if you are scheduled for a specific blood test (chromogranin A level).

If Prazol is used long-term (longer than 1 year), you will likely require close and regular medical monitoring. During visits to your doctor, report any new or unusual symptoms or circumstances.
If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor as soon as possible, as discontinuation of Prazol may be necessary. Also report any other adverse effects, such as joint pain.
Taking proton pump inhibitors such as Prazol, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. 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 any medical tests, inform your doctor that you are taking Prazol, as it may affect test results.
During treatment with Prazol, interstitial nephritis (kidney inflammation) may occur. Symptoms may include reduced urine volume or blood in the urine and/or allergic-type reactions such as fever, rash, and joint stiffness. You should report such symptoms to your doctor.
This medicine may affect how your body absorbs vitamin B_, particularly if taken for a prolonged period. Contact your doctor if you notice any of the following symptoms, which may indicate low vitamin B_ levels:

• extreme tiredness or lack of energy,
• tingling and numbness,
• sore 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 this is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.
Prazol with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Prazol if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Treatment with Prazol should be discussed with your doctor or pharmacist 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 or sleep aid, or used in epilepsy treatment),
• antifungal and antifungal agents (e.g. ketoconazole, itraconazole, posaconazole, voriconazole),
• tacrolimus (a medicine used in organ transplantation),
• digoxin (a medicine used in heart failure treatment),
• methotrexate (a medicine used in cancer treatment). If you are taking high doses of methotrexate, your doctor may temporarily discontinue Prazol.
• erlotinib (used in cancer treatment),
• atazanavir (a medicine used in HIV infection treatment),
• saquinavir (used in HIV infection treatment),
• clopidogrel (used to prevent blood clots),
• cilostazol (used to treat symptoms of pain in the lower limbs while walking),
• rifampicin (used in tuberculosis treatment),
• St John's wort (Hypericum perforatum) (used in the treatment of mild depression).

If your doctor has prescribed amoxicillin and clarithromycin antibiotics along with Prazol for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about all 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, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Omeprazole passes into breast milk, but its effect on the infant is unlikely when used at therapeutic doses. Whether a breastfeeding woman can take Prazol will be decided by the doctor.
Driving and operating machinery
Prazol does not affect the ability to drive or operate tools and machinery.
However, possible adverse effects such as dizziness and visual disturbances (see section 4 of this leaflet) may occur. If such effects occur, do not drive or operate machinery.
Prazol contains sucrose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is considered "sodium-free".

3. How to use Prazol

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose

Use in adults

Treatment of duodenal ulcers

• The usual dose of Prazol is 20 mg once daily for 2 weeks.
• In patients in whom ulcer healing has not occurred within this time, your doctor may recommend continuing the same dose for another 2 weeks.
• If the ulcer has not completely healed, your doctor may recommend treatment with Prazol 40 mg once daily for 4 weeks.

Prevention of recurrence of duodenal ulcers

• The usual dose of Prazol is 10 mg to 20 mg once daily. Your doctor may increase the dose up to 40 mg daily.

Treatment of gastric ulcers

• The usual dose of Prazol is 20 mg once daily for 4 weeks.
• In patients in whom ulcer healing has not occurred within this time, your doctor may recommend continuing the same dose for another 4 weeks.
• If the ulcer has not completely healed, your doctor may recommend treatment with Prazol 40 mg once daily for 8 weeks.

Prevention of recurrence of gastric ulcers

• The usual dose of Prazol is 20 mg once daily. Your doctor may increase the dose up to 40 mg daily.

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

• The usual dose of Prazol is 20 mg twice daily for one week.
• Your doctor will also prescribe two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

Treatment of reflux esophagitis

• The usual dose of Prazol is 20 mg once daily for 4 weeks.
• In patients in whom healing of the esophagus has not occurred, your doctor may recommend continuing the same dose for another 4 weeks.
• If the esophagus has still not healed, your doctor may recommend treatment with Prazol 40 mg once daily for 8 weeks.
• The usual maintenance dose of Prazol after healing of the esophagus is 10 mg once daily.

Treatment of excessive gastric acid secretion due to pancreatic tumor (Zollinger-Ellison syndrome)

• Your doctor will adjust the dose of Prazol according to individual patient needs and determine how long treatment should continue.
• The usual dose of Prazol is 60 mg daily.
• When doses greater than 80 mg daily are required, Prazol should be administered in two divided doses.

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

• The usual dose of Prazol is 20 mg once daily for 4 weeks.
• In patients in whom complete healing has not occurred within this time, your doctor may recommend continuing the same dose for another 4 weeks.

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

• The usual dose of Prazol is 20 mg once daily.

Use in children and adolescents

Treatment of reflux esophagitis

• Children over 1 year of age and weighing more than 10 kg may take Prazol.
• The dose for children depends on body weight. The appropriate dose will be determined by the doctor.

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

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

Special patient groups

Patients with impaired kidney function
Dose adjustment is not necessary in patients with impaired kidney function.

Patients with impaired liver function
In patients with impaired liver function, a daily dose of 10–20 mg may be sufficient.

Elderly patients
Dose adjustment is not necessary 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. Do not chew or crush it before swallowing.

Instructions for patients with swallowing difficulties and for children able to drink or swallow semi-solid food

• Open the capsule and swallow the contents directly with half a glass of water, or pour the capsule contents into a glass containing about 10 ml of fruit juice or another acidic liquid, and mix thoroughly (the mixture will not be clear).
• Drink the mixture immediately after preparation or within 30 minutes.
• To ensure the full dose has been taken, add half the volume of the original glass with water, mix thoroughly, and drink.

Use of a higher than recommended dose of Prazol

If you take more than the recommended dose and experience any concerning symptoms, seek immediate medical advice from your doctor or pharmacist.

Missed dose of Prazol

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

Stopping treatment with Prazol

Do not stop taking Prazol without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following rare (occurring in more than 1 in 10,000 people and less than 1 in 1,000 people) or very rare (occurring in less than 1 in 10,000 people), but serious adverse reactions, stop taking Prazol and contact your doctor immediately:

• sudden wheezing, swelling of the lips, tongue or throat, or body, rash, fainting or difficulty swallowing (severe allergic reaction) (rare),
• skin redness with blistering or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare),
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare),
• red, scaly, widespread rash with nodules 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 symptoms of liver function disorders (rare).

The following adverse reactions have been observed during treatment with the medicine:
Common adverse reactions (occur in up to 1 in 10 people):

• headache,
• diarrhoea,
• constipation,
• abdominal pain,
• nausea, vomiting,
• bloating,
• mild gastric polyps.

Uncommon adverse reactions (occur in up to 1 in 100 people):

• swelling of feet and ankles,
• changes in liver function test results,
• sleep disturbance (insomnia),
• skin rash, nodular rash (urticaria), itching,
• general malaise and lack of energy,
• dizziness, tingling or pricking sensation, drowsiness,
• sensation of spinning (vertigo).

Rare adverse reactions (occur in up to 1 in 1,000 people):

• sudden wheezing or shortness of breath (bronchospasm),
• inflammation of the mucous membrane of the mouth, dryness in the mouth,
• fungal infection known as "thrush", which may affect the intestines,
• hair loss (alopecia),
• skin rash upon exposure to sunlight,
• feeling of restlessness, confusion, depression,
• altered sense of taste,
• vision problems such as blurred vision,
• serious kidney problems (interstitial nephritis),
• increased sweating,
• muscle pain (myalgia) or joint pain (arthralgia),
• blood problems such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising or increased risk of infection,
• low sodium levels in the blood. This may lead to weakness, vomiting and muscle cramps.

Very rare adverse reactions (occur in less than 1 in 10,000 people):

• blood count abnormalities including agranulocytosis (lack of white blood cells),
• aggression,
• seeing, feeling or hearing things that are not real (hallucinations),
• severe liver function disorders leading to liver failure and encephalopathy,
• erythema multiforme,
• muscle weakness,
• gynaecomastia (enlargement of breast tissue in males).

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

• inflammation of the intestine (causing diarrhoea),
• if Prazol has been taken for longer than three months, there may be a decrease in magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels,
• rash which may be accompanied by joint pain.

In very rare cases, Prazol may affect the number of white blood cells in the blood, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by severe deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis), based on blood test results. It is important that the patient informs the doctor or pharmacist about the medicine being taken in such a situation.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Prazol

Keep this medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Prazol contains
The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
Excipients:
Capsule contents: sugar pellets (sucrose, corn starch), sodium starch glycolate, sodium lauryl sulfate,
hypromellose, talc, povidone (K-30), disodium phosphate dodecahydrate, 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 pack
The Prazol capsule consists of an orange body printed with "20" and a blue cap printed with "O".
The pack contains 7, 14, 28 or 56 capsules in a polyethylene container with a polypropylene closure and a drying agent, packed in a cardboard box.
The pack contains 7, 14, 28 or 56 capsules in aluminum/aluminum foil blisters, packed in a cardboard box. Each blister contains 7 capsules.

Marketing Authorisation 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