Polprazol

Leaflet accompanying the packaging: information for the user

Polprazol, 20 mg, gastro-resistant hard capsules

Omeprazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Polprazol and what is it used for

Polprazol contains the active substance omeprazole.
It belongs to a group of medicines called "proton pump inhibitors". Their action consists in reducing the amount of acid produced in the stomach.

Polprazol is used to treat the following diseases and disorders:

In adults:

• Gastroesophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus, causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers caused by 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 non-steroidal anti-inflammatory drugs (NSAIDs). Polprazol can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive acid production in the stomach due to a tumor in the pancreas (Zollinger-Ellison syndrome).

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

• Gastroesophageal reflux disease (GERD). This is when stomach acid flows back into the esophagus, causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include reflux of stomach contents into the mouth (regurgitation), vomiting, and poor weight gain.

Children over 4 years of age and adolescents

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

2. Important information before taking Polprazol

When not to take Polprazol

Warnings and precautions

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

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

Polprazol may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Polprazol, you should contact your 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;

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Polprazol. You should also tell your doctor about any other side effects, such as joint pain.
In the case of long-term use of Polprazol (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During the visit to the doctor, you should report any new and unusual symptoms and circumstances.
When taking proton pump inhibitors like Polprazol, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. You should inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
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. Such symptoms should be reported to the attending physician.

Polprazol 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 may affect the way some other medicines work, and some other medicines may affect the way Polprazol works.
Do not take Polprazol 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 you are taking phenytoin, your doctor will need to monitor your condition when starting or stopping Polprazol.
• medicines 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 Polprazol.
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used in organ transplantation);
• erlotinib (used to treat cancer);
• methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if you are receiving high doses of methotrexate, your doctor may recommend temporary discontinuation of Polprazol;
• 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 your doctor has prescribed you antibiotics amoxicillin and clarithromycin, as well as Polprazol, to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Polprazol with food and drink

It is recommended to take the capsules (preferably in the morning), 30-60 minutes before the first meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Polprazol during this time.
Your doctor will decide whether you can take Polprazol while breastfeeding.

Driving and using machines

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

• In the event of their occurrence, do not drive vehicles or operate machinery.

Polprazol contains sugar and sodium

The medicine contains 80.02 mg of sucrose in one capsule. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains 0.819 mg (0.036 mmol) of sodium, i.e. less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Polprazol

Polprazol should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Your doctor will tell you how many capsules to take and for how long. This will depend on your health and age.
Recommended dose
Adults:

• Treatment of GERD symptoms, such as heartburn and acid reflux:
• If your doctor has found that your esophagus has been slightly damaged, the usual dose is 20 mg once daily for 4-8 weeks. Your doctor may recommend that you take a dose of 40 mg for another 8 weeks if your esophagus has not yet healed.
• The usual dose after healing of the esophagus is 10 mg once daily.
• If your esophagus has not been damaged, the usual dose is 10 mg once daily.

Treatment of duodenal ulcers(duodenal ulcers):

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

Treatment of gastric ulcers(gastric ulcers):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the ulcers have not healed by then.
• If the ulcer has not healed 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. Your 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 treatment:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The usual dose of Polprazol is 20 mg twice daily for one week.
• Your doctor will also prescribe you two antibiotics: amoxicillin and clarithromycin.

Treatment of excessive acid production in the stomach due to a tumor in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg daily.
• Your doctor will adjust the dose according to individual needs and decide how long the treatment should last.

Use in children and adolescents:
Treatment of GERD symptoms, such as heartburn and acid reflux:

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

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

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

How to take this medicine

• It is recommended to take the capsules (preferably in the morning), 30-60 minutes before the first meal.
• 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 stomach acid. It is important not to damage the microgranules.

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, 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 you have taken the entire dose, 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.

What to do if you take more Polprazol than you should

If you have taken more Polprazol than prescribed by your doctor, contact your doctor or pharmacist immediately.

What to do if you forget to take Polprazol

If you forget to take a dose, take it as soon as you remember. However, 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.

4. Possible side effects

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

If you notice any of the following rare but serious side effects, stop taking Polprazol and contact your 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 can be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Other side effects include:
Common side effects(less than 1 in 10 people)

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

Uncommon side effects(less than 1 in 100 people)

• swelling of the feet and ankles;
• sleep disorders (insomnia);
• dizziness, tingling, or numbness;
• vertigo (dizziness);
• changes in liver function tests;
• skin rash, urticaria, and itching;
• general malaise and lack of energy.

Rare side effects(less than 1 in 1000 people)

• blood problems, such as a decrease in white blood cells or platelets. This can lead to weakness, easy bruising, or an 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.
• agitation;
• change in taste;
• vision problems, such as blurred vision;
• sudden shortness of breath or wheezing (bronchospasm);
• dry mouth;
• inflammation of the mouth;
• a fungal infection that can affect the intestines and is caused by fungi;
• liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue;
• hair loss (alopecia);
• skin rash in areas exposed to sunlight;
• joint pain (arthralgia) or muscle pain (myalgia);
• severe kidney problems (interstitial nephritis);
• increased sweating.

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

• changes in blood cell count, 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 inflammation;
• sudden onset of severe rash or blistering of the skin, or peeling of the skin. 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)

• inflammation of the colon (leading to diarrhea);
• hypomagnesemia. If you have taken Polprazol for more than three months, there is a possibility of decreased 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, you should inform your doctor immediately. Very low magnesium levels can lead to decreased 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, Polprazol 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, you should 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 with information about the medicine you are taking.
You should not be concerned about the list of side effects mentioned above. It is possible that you will not experience any of them.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polprazol

Blister packs: Store in a temperature below 30°C. Store in the original packaging.
HDPE bottles: Store in a temperature below 30°C. Store the bottle tightly closed. Store in the original packaging.
Keep the 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.
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 pack and other information

What Polprazol contains

• The active substance of Polprazol is omeprazole. Each capsule contains 20 mg of omeprazole.
• The other ingredients of the medicine are: capsule filling: cornstarch and sucrose; sodium carboxymethyl starch (type A); sodium lauryl sulfate; Povidone K30; disodium phosphate dodecahydrate; hypromellose (6 cP); methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%; triethyl citrate; sodium hydroxide; titanium dioxide; talc; capsule cap ingredients: erythrosine (E 127); indigo carmine (E 132); titanium dioxide (E 171); purified water; gelatin; capsule body ingredients: quinoline yellow (E 104); erythrosine (E 127); titanium dioxide (E 171); purified water; gelatin; ink ingredients: shellac; anhydrous ethanol; isopropyl alcohol; propylene glycol; n-butyl alcohol; Povidone; sodium hydroxide; titanium dioxide (E 171).

What Polprazol looks like and contents of the pack

The capsules are blue-orange in color, with the inscription "O" on the cap and "20" on the body, containing white to light beige microgranules.
HDPE bottles or aluminum/aluminum blisters containing 7, 14, or 28 capsules, in a cardboard box.
Not all pack sizes and types may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
phone: +48 22 364 61 01

Manufacturer

Teva Pharma S.L.U.
Poligono Industrial Malpica
c/C no. 4, 50016 Zaragoza
Spain
Polpharma S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca Street 2
39-460 Nowa Dęba
Poland

Date of last revision of the leaflet: