POLPRAZOL 40 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Polprazol PPH, 40 mg, gastro-resistant hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Polprazol PPH and what is it used for
   1. Polprazol PPH is used to treat the following diseases and disorders:
4. Important information before taking Polprazol PPH
   1. When not to take Polprazol PPH:
   2. Warnings and precautions
   3. Children
   4. Polprazol PPH and other medicines
   5. Polprazol PPH with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Polprazol PPH contains sucrose
   9. Polprazol PPH contains sodium
5. How to take Polprazol PPH
   1. How to take this medicine
   2. What to do if you have difficulty swallowing the capsules (in adults or children)
   3. Taking a higher dose of Polprazol PPH than recommended
   4. Missing a dose of Polprazol PPH
   5. Stopping treatment with Polprazol PPH
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 Polprazol PPH and contact your doctor immediately:
   2. Reporting side effects
7. How to store Polprazol PPH
8. Contents of the pack and other information
   1. What Polprazol PPH contains
   2. What Polprazol PPH looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Polprazol PPH, 40 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.
• 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 Polprazol PPH and what is it used for
• 2. Important information before taking Polprazol PPH
• 3. How to take Polprazol PPH
• 4. Possible side effects
• 5. How to store Polprazol PPH
• 6. Contents of the pack and other information

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

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

Polprazol PPH 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 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 drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Polprazol PPH 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 and adolescents:

• 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 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 infected with bacteria called "Helicobacter pylori". If the 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 PPH

When not to take Polprazol PPH:

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

Warnings and precautions

Before starting to take Polprazol PPH, discuss it with your doctor or pharmacist.

• Unintentional weight loss and difficulty swallowing;
• Stomach pain or indigestion;
• Vomiting blood or black tarry stools;
• Severe or persistent diarrhea, as the use of omeprazole is associated with a slight increase in the frequency of infectious diarrhea;
• Severe liver problems.
• Taking a proton pump inhibitor like Polprazol PPH, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. If the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis), they should inform their doctor.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.
• If a specific blood test (chromogranin A) is planned.

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 their doctor.

Children

Some children with chronic diseases may require long-term treatment, although this is not recommended. This medicine should not be given to children under 1 year of age or weighing less than 10 kg.

Polprazol PPH and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription. This is important because Polprazol PPH may affect the way some other medicines work, and some other medicines may affect the way Polprazol PPH works.

• Ketoconazole, itraconazole, posaconazole, 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 or stopping Polprazol PPH;
• 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 or stopping Polprazol PPH.
• 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 (a chemotherapy medicine used in high doses to treat cancer) - if the patient is receiving high doses of methotrexate, the doctor may advise temporary discontinuation of Polprazol PPH.

If the doctor has prescribed the patient antibiotics amoxicillin and clarithromycin, as well as Polprazol PPH to treat ulcers caused by Helicobacter pylori infection, it is very important for the patient to inform the doctor about all other medicines they are taking.

Polprazol PPH with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Polprazol PPH does not affect the ability to drive or use machines.

Polprazol PPH contains sucrose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Polprazol PPH contains sodium

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

3. How to take Polprazol PPH

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The 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 the doctor has found that the patient's esophagus is slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. The doctor may recommend that the patient 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:
• The usual dose is 20 mg once a day for 2 weeks. The doctor may recommend taking the same dose for another 2 weeks if the ulcers have not healed by then.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once a day for 4 weeks.
• Treatment of gastric ulcers:
• The usual dose is 20 mg once a day for 4 weeks. The doctor may recommend taking the same dose for another 4 weeks if the ulcers have not healed by then.
• If the ulcer does not heal 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:
• The usual dose is 20 mg once a day for 4-8 weeks.
• Prevention of duodenal and gastric ulcers during NSAID treatment:
• The usual dose is 20 mg once a day.
• Treatment of ulcers caused by Helicobacter pylori infection:
• The usual dose of Polprazol PPH 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 the individual needs of the patient 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 PPH. The dose for children depends on the child's weight, and the doctor will recommend the appropriate dose.
• Treatment of ulcers caused by Helicobacter pylori infection:
• Children over 4 years of age can take Polprazol PPH. The dose for children depends on the child's weight, and the doctor will recommend the appropriate dose.
• The doctor will also prescribe two antibiotics: amoxicillin and clarithromycin.

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 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 the patient has 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 pineapple), or apple sauce.
• 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 patient has 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.

Taking a higher dose of Polprazol PPH than recommended

If you have taken a higher dose of Polprazol PPH than prescribed by your doctor, contact your doctor or pharmacist immediately.

Missing a dose of Polprazol PPH

If you forget to take a dose, take it 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.

Stopping treatment with Polprazol PPH

Do not stop taking Polprazol PPH without consulting your doctor or pharmacist first.

4. Possible side effects

Like all medicines, this medicine 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 Polprazol PPH 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)
• Redness of the skin with blistering or peeling; possible blisters and bleeding in the eyes, mouth, and genitals. 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, peeling, widespread rash with thickening of 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 problems; (rare).

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 gastric polyps.

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

• Swelling of the feet and ankles;
• Sleep disorders (insomnia);
• Dizziness, tingling, or numbness;
• Dizziness;
• Changes in liver function tests;
• Skin rash, urticaria, and itching;
• General malaise 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 may lead to weakness, easy bruising, or an increased risk of infection.
• Low sodium levels in the blood, which may cause 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;
• Oral mucositis;
• Fungal infection, which can affect the intestines and is caused by fungi;
• 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(may affect up to 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 problems leading to liver failure and encephalopathy;
• Erythema multiforme;
• Muscle weakness;
• Breast enlargement in men.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• Enteritis (leading to diarrhea);
• If the patient takes Polprazol PPH for more than three months, it is possible to reduce the magnesium level in the blood. Low magnesium levels can cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, the patient should inform their doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. The doctor may order regular blood tests to monitor magnesium levels.
• Rash that may be accompanied by joint pain.

In very rare cases, Polprazol PPH may affect the number of white blood cells in the blood, leading to a lack of immunity. If the patient develops an infection with symptoms such as fever with severe deterioration of general well-being or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should consult their doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential for the patient to inform their doctor about the medicine they are taking.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor. 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 medicine.

5. How to store Polprazol PPH

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.

Do not store above 25°C. Store in the original packaging to protect from moisture.

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 PPH contains

• The active substance of the medicine is omeprazole. Each capsule contains 40 mg of omeprazole.
• Other ingredients of the medicine are:
• capsule filling: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, indigo carmine (E 132), and titanium dioxide (E 171).

What Polprazol PPH looks like and contents of the pack

Polprazol PPH, 40 mg are non-transparent, blue-white capsules containing spherical microgranules of almost white to cream-white color.

The capsules are available in blisters of 28 capsules.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

LABORATORIOS LICONSA, S.A., Av. Miralcampo, Nº 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain

Date of last revision of the leaflet:September 2023