Polprazol Max

Leaflet accompanying the packaging: patient information

Polprazol Max, 20 mg, gastro-resistant hard capsules

Omeprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet

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

1. What is Polprazol Max and what is it used for

Polprazol Max contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of hydrochloric acid produced in the stomach.
Polprazol Max is used in adults for the short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn and acid regurgitation).
Reflux occurs when stomach acid flows back into the esophagus, which can cause inflammation and pain.
This can cause symptoms such as a burning sensation in the chest rising to the throat (heartburn) and a sour taste in the mouth (due to acid regurgitation).
To achieve relief from symptoms, it may be necessary to take capsules for 2-3 consecutive days.

2. Important information before taking Polprazol Max

When not to take Polprazol Max

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

Warnings and precautions

Before starting to take Polprazol Max, discuss it with your doctor or pharmacist.
Before taking the medicine, tell your doctor:

• about a specific blood test planned (chromogranin A level).

Do not take Polprazol Max for more than 14 days without consulting a doctor.
In case of no improvement and in case of worsening symptoms, consult a doctor.
Polprazol Max may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Polprazol Max, consult a doctor immediately:

• unexplained weight loss and difficulty swallowing
• stomach pain or indigestion
• vomiting with food or blood
• passing black stools (stool discolored with blood)
• severe or persistent diarrhea, as omeprazole is associated with a slight increase in the frequency of infectious diarrhea
• previous stomach ulcer or gastrointestinal surgery
• continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks
• persistent indigestion or heartburn for 4 or more weeks
• jaundice or severe liver disease
• age over 55 and new symptoms or changes in existing symptoms recently
• if the patient has ever had a skin reaction after taking a medicine similar to Polprazol Max that reduces stomach acid production.

If a skin rash appears, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Polprazol Max. Also, tell your doctor about any other side effects, such as joint pain.
Patient should not take omeprazole as a preventive measure.
During treatment with 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. The patient should report such symptoms to the attending physician.

Polprazol Max and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
This is important because Polprazol Max may affect the way some other medicines work, and some other medicines may affect the action of Polprazol Max.
Do not take Polprazol Max if you are taking a medicine containing nelfinavir(used to treat HIV infection).
Tell your doctor or pharmacist if you 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 the patient's condition when starting and stopping Polprazol Max.
• 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 and stopping Polprazol Max.
• rifampicin (used to treat tuberculosis)
• atazanavir (used to treat HIV infection)
• tacrolimus (used in organ transplantation)
• erlotinib (used to treat cancer)
• methotrexate (a chemotherapeutic agent used to treat cancer). If the patient is receiving high doses of methotrexate, the doctor may recommend temporary discontinuation of Polprazol Max.
• 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).

Polprazol Max with food and drink

Polprazol Max can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
The doctor will decide whether you can take Polprazol Max at this time.
Whether a breastfeeding woman can take Polprazol Max will be decided by the doctor.

Driving and using machines

Polprazol Max does not affect the ability to drive or use machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they occur, do not drive or operate machinery.

Polprazol Max contains sugar, sodium, and erythrosine

Each capsule contains 80.02 mg of sugar. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
Each capsule contains 0.819 mg (0.036 mmol) of sodium, less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".
Polprazol Max contains erythrosine (E 127) - may cause allergic reactions.

3. How to take Polprazol Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose is: one capsule (20 mg) once a day for 14 days. If symptoms do not improve after this time, consult a doctor.
To achieve relief from symptoms, it may be necessary to take capsules for 2-3 consecutive days.

How to take this medicine

• 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 microgranules that prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the microgranules. These microgranules contain the active substance omeprazole and are protected from degradation in the stomach to allow absorption from the intestine. The microgranules release the active substance in the intestine, where it is absorbed and then acts.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly, with a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, pineapple), 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.
• To ensure that the entire dose of the medicine is taken, 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.

Taking a higher dose of Polprazol Max than recommended

In case of taking a higher dose of Polprazol Max than prescribed by the doctor, consult a doctor or pharmacist immediately.

Missing a dose of Polprazol Max

In case of missing a dose due to forgetting, take the dose as soon as you remember. 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.

4. Possible side effects

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

In case of noticing any of the following rare but serious side effects, stop taking Polprazol Max and consult 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. It is also possible to develop large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver function disorders.

Side effects may occur with a frequency that is defined below.

Other side effects include:

Common side effects (less than 1 in 10 patients)

• headache
• effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating)
• nausea or vomiting
• mild stomach polyps.

Uncommon side effects (less than 1 in 100 patients)

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

Rare side effects (less than 1 in 1,000 patients)

• blood problems, such as decreased white blood cell or platelet count. This can lead to weakness, easier bruising, or increased risk of infection.
• allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing
• low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• feeling of agitation, confusion, or depression
• change in taste
• vision problems, such as blurred vision
• sudden feeling of shortness of breath or wheezing (bronchospasm)
• dry mouth
• inflammation of the oral mucosa
• infection known as "thrush", which can affect the intestines and is caused by fungi
• inflammation of the large intestine (leading to diarrhea)
• liver disorders, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue
• hair loss (alopecia)
• skin rash during sun exposure
• joint pain (arthralgia) or muscle pain (myalgia)
• severe kidney problems (interstitial nephritis)
• increased sweating.

Very rare side effects (less than 1 in 10,000 patients)

• 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
• sudden onset of severe rash or blistering of the skin or peeling. This can 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 (frequency cannot be estimated from the available data)

• hypomagnesemia. Taking Polprazol Max for more than three months may lead to a decrease in magnesium levels in the blood. Magnesium deficiency can cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.
• rash that may be accompanied by joint pain.

In very rare cases, Polprazol Max may affect the number of white blood cells in the blood, leading to a decrease in immunity. If you experience an infection with symptoms such as fever with severe deterioration of general well-being or fever with symptoms of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, consult a 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 the patient to inform the doctor about the medicine being taken.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor. 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
Phone: +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 Polprazol Max

Keep the medicine out of the sight and reach of children.
Bottles: Do not store above 30°C. Store the bottle tightly closed, to protect from moisture. Store in the original packaging.
Blister packs: Do not store above 30°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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. Contents of the packaging and other information

What Polprazol Max contains

• The active substance of the medicine is omeprazole. Each capsule contains microgranules of 20 mg of omeprazole.
• The other ingredients are: sugar, pellets (containing sugar and corn starch); povidone K30; sodium lauryl sulfate; sodium carboxymethyl starch (type A); disodium phosphate dodecahydrate; hypromellose 6 cP; triethyl citrate; methacrylic acid and ethyl acrylate copolymer (1:1); sodium hydroxide; titanium dioxide (E 171); talc. The composition of the capsule cap: erythrosine (E 127); indigo carmine (E132); titanium dioxide (E 171); purified water; gelatin. The composition of the capsule body: quinoline yellow (E 104); erythrosine (E 127); titanium dioxide (E 171); purified water; gelatin.

The composition of the ink: shellac; propylene glycol; polyvinylpyrrolidone; sodium hydroxide; titanium dioxide (E 171).

What Polprazol Max looks like and what the packaging contains

Polprazol Max is blue (cap) - orange (body) capsules marked with the symbol "O" on the cap and "20" on the body, containing white-beige microgranules.
The packaging contains 5, 7, or 14 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01
Manufacturer
Teva Pharma S.L.U.
Poligono Industrial Malpica
Calle C, Number 4
50016 Zaragoza
Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Poland
Date of last revision of the leaflet:May 2023