Polprazol

Package leaflet: Information for the user

Polprazol, 20 mg, hard enteric-coated 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Polprazol contains the active substance called omeprazole.
It belongs to a group of medicines known as "proton pump inhibitors". These medicines work
by reducing the amount of acid produced in the stomach.
Polprazol is used in the treatment of the following conditions:
In adults:

• Gastro-esophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or in the stomach (gastric ulcers).
• Ulcers infected with bacteria known as Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to eradicate the infection and allow ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Polprazol may also be used to prevent the development of ulcers during NSAID treatment.
• Excessive acid production due to a tumour in the pancreas (Zollinger-Ellison syndrome).

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

• Gastro-esophageal reflux disease (GERD). This condition occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn. In children, symptoms may include regurgitation of gastric contents into the mouth (spitting up/vomiting), vomiting, and poor weight gain.

Children aged above 4 years and adolescents

• Ulcers infected with bacteria known as Helicobacter pylori. If your child has this condition, the doctor may also prescribe antibiotics to treat the infection and allow ulcers to heal.

2. Important information before using Polprazol

When not to use Polprazol

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

Warnings and precautions
Before starting treatment with Polprazol, discuss this with your doctor or pharmacist.
Before taking the medicine, inform your doctor:

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

Polprazol may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Polprazol, contact your doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• passing black stools (stools discolored by blood);
• severe or persistent diarrhoea, as there is a small increased risk of infectious diarrhoea associated with omeprazole use;
• severe liver problems;
• if the patient has ever had a skin reaction due to taking a medicine similar to Polprazol that reduces gastric acid secretion.

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue Polprazol. Also report any other adverse effects such as joint pain.
If Polprazol is used long-term (longer than 1 year), the patient will likely require close and regular medical monitoring. During visits to the doctor, report any new or unusual symptoms and circumstances.
Taking proton pump inhibitors such as Polprazol, 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 corticosteroid medicines (which may increase the risk of osteoporosis).
Kidney inflammation may occur during treatment with omeprazole. Symptoms may include reduced urine volume or presence of blood in urine and/or allergic reactions such as fever, rash and joint stiffness. Patients should report such symptoms to their doctor.

Polprazol with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
This is important because Polprazol may affect how some other medicines work, and some other medicines may affect how Polprazol works.
Do not take Polprazol if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, itraconazole or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment);
• 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.
• 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.
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used after organ transplantation);
• erlotinib (used to treat cancers);
• methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient receives high doses of methotrexate, the doctor may recommend temporarily discontinuing 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 antibiotics amoxicillin and clarithromycin, together with Polprazol, to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

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 the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether she can take Polprazol during this time.
The doctor will decide whether a breastfeeding woman can take Polprazol.

Driving and using machines
Polprazol does not affect the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Polprazol contains sucrose and sodium
The medicine contains 80.02 mg of sucrose per capsule. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
The medicine contains 0.819 mg (0.036 mmol) of sodium, i.e. less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Polprazol

Polprazol should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will depend on your medical condition and age.

Recommended dose

Adults:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

• If your doctor has determined that your oesophagus has been slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. Your doctor may recommend taking 40 mg for an additional 8 weeks if the oesophagus has not yet healed.
• The usual dose after healing of the oesophagus is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

**Treatment of **(duodenal ulcers):

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

**Treatment of **(gastric ulcers):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for another 4 weeks if ulcers have not healed by then.
• If the ulcer has not completely healed, the dose may be increased to 40 mg once daily for 8 weeks.

**Prevention of recurrence 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 **(duodenal and gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs)):

• The usual dose is 20 mg once daily for 4–8 weeks.

**Prevention of recurrence of duodenal and gastric ulcers during treatment with **(NSAIDs (non-steroidal anti-inflammatory drugs)):

• The usual dose is 20 mg once daily.

**Treatment of **(ulcers caused by Helicobacter pylori infection) and prevention of their recurrence:

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

**Treatment of excessive gastric acid secretion caused by **(pancreatic tumour (Zollinger-Ellison syndrome)):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and determine how long the treatment should continue.

Use in children and adolescents:

Treatment of GERD symptoms, such as heartburn and acid regurgitation:

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

**Treatment of **(ulcers caused by Helicobacter pylori infection) and prevention of their recurrence:

• Children above 4 years of age may take Polprazol. The dose for children depends on body weight. The appropriate dose for each child will be determined 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 protect the medicine from being broken down by stomach acid. It is essential that the microgranules remain intact.

What to do if you have difficulty swallowing the capsules (in adults or children)

• If an adult or child has difficulty swallowing the capsules:
  • Open the capsule and swallow the contents directly with a glass of water, or mix the contents with a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, or pineapple juice), or apple puree.
  • 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 the patient receives the full dose, thoroughly rinse the glass with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

Taking more Polprazol than prescribed
If you take more Polprazol than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you miss a dose of 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any of the following rare but serious adverse effects, stop taking Polprazol immediately
and contact your doctor without delay:

• sudden wheezing, swelling of the lips, tongue or throat, or body, rash, fainting or difficulty swallowing (severe allergic reaction);
• redness of the skin with formation of blisters 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;
• yellowing of the skin, dark urine and fatigue, which may be symptoms of liver dysfunction.

Other adverse effects include:
Common adverse effects (occurring in fewer than 1 in 10 patients)

• headache;
• effects on stomach or intestines: abdominal pain, diarrhoea, constipation, gas (bloating);
• nausea or vomiting;
• benign gastric polyps.

Uncommon adverse effects (occurring in fewer than 1 in 100 patients)

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

Rare adverse effects (occurring in fewer than 1 in 1,000 patients)

• blood-related problems, such as reduced number of white blood cells or platelets; this may lead to weakness, easier bruising or increased risk of infection;
• allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing;
• low sodium levels in the blood; this may lead to weakness, vomiting and muscle cramps;
• feeling of agitation, confusion or depression;
• altered sense of taste;
• vision problems, such as blurred vision;
• sudden sensation of wheezing or breathlessness (bronchospasm);
• dryness of the mouth;
• inflammation of the mucous membrane of the mouth;
• fungal infection known as "thrush", which may affect the intestines and is caused by fungi;
• liver-related disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue;
• hair loss (alopecia);
• skin rash occurring during exposure to sunlight;
• joint pain (arthralgia) or muscle pain (myalgia);
• severe kidney problems (interstitial nephritis);
• increased sweating.

Very rare adverse effects (occurring in fewer than 1 in 10,000 patients)

• changes in blood count including agranulocytosis (absence of white blood cells);
• aggression;
• seeing, feeling or hearing things that are not real (hallucinations);
• severe liver disorders leading to liver failure and encephalopathy;
• sudden onset of severe rash or formation of blisters or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• muscle weakness;
• breast enlargement in males.

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

• inflammation of the large intestine (which may lead to diarrhoea);
• hypomagnesemia. If Polprazol has been taken for longer than three months, blood magnesium levels may decrease. 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. Very low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• rash occurring with joint pain.

In very rare cases, Polprazol 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 worsening of general condition, or fever with local signs of 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 about the medicine being taken in such a situation.
The patient should not be alarmed by the list of adverse effects listed above. It is possible that none of these effects will occur.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Polprazol

Blister packs: Store below 30 °C. Keep in the original packaging.
HDPE bottles: Store below 30 °C. Keep the bottle tightly closed.
Store in the original packaging.
Keep this 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 stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine Polprazol contains

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

What Polprazol looks like and contents of the pack
Blue-orange capsules marked with the letter “O” on the cap and “20” on the body,
containing white to off-white microgranules.
HDPE bottles or Aluminium/Aluminium blisters containing 7, 14 or 28 capsules,
packaged in a cardboard box.
Not all pack types and sizes may be marketed.

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

Manufacturer
Teva Pharma S.L.U.
Poligono Industrial Malpica
c/C no. 4, 50016 Zaragoza
Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Poland