Polprazol pph

Package leaflet: Information for the patient

Polprazol PPH, 40 mg, hard enteric-coated capsules
omeprazolum
Please read this leaflet carefully before using the medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, 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.

Table of contents

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

Polprazol PPH contains the active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.

Polprazol PPH is used to treat the following conditions:

In adults:

• Gastro-esophageal reflux disease (GERD). This 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 called 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 PPH may also be used to prevent the development of ulcers during NSAID treatment.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).

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

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

Children aged over 4 years and adolescents

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

2. Important information before using Polprazol PPH

When not to use Polprazol PPH:

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an allergic reaction 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).

If there are any doubts, consult a doctor or pharmacist before starting to take Polprazol PPH.
Warnings and precautions
Before starting treatment with Polprazol PPH, discuss it with your doctor or pharmacist.
Severe skin reactions have been reported during treatment with omeprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP).
Treatment with Polprazol PPH must be discontinued and immediate medical help sought if any symptoms of these severe skin reactions described in section 4 occur.
Polprazol PPH may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Polprazol PPH, contact a doctor immediately:

• unexplained weight loss and difficulty swallowing;

• stomach pain or indigestion;

• vomiting of food or blood;

• passing black stools (blood-stained faeces);

• severe or persistent diarrhoea, as a slight increase in the frequency of infectious diarrhoea has been associated with the use of omeprazole;

• severe liver disorders.

• The use of a proton pump inhibitor such as Polprazol PPH, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. If the patient suffers from osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis), this should be reported to the doctor.

• If the patient has ever had a skin reaction to a medicine similar to Polprazol PPH that reduces gastric acid secretion.

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

During treatment with omeprazole, interstitial nephritis (inflammation of the kidneys) may occur. Symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.
If Polprazol PPH 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 or circumstances.
Taking proton pump inhibitors such as Polprazol PPH, particularly for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Inform the doctor if osteoporosis has been diagnosed or if corticosteroid medicines (which may increase the risk of osteoporosis) are being taken.
If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Polprazol PPH may be necessary. Also report any other adverse effects such as joint pain.

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 with body weight <10 kg.

Polprazol PPH and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use. This includes medicines available without a prescription. This is important because Polprazol PPH may affect the way some other medicines work, and some other medicines may affect how Polprazol PPH works.
Do not take Polprazol PPH 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, posaconazole, or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or in the treatment of 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 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 and 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 cancers);
• methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient is receiving high-dose methotrexate, the doctor may recommend temporarily discontinuing Polprazol PPH.

If the doctor has prescribed the antibiotics amoxicillin and clarithromycin, as well as Polprazol PPH, for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

Polprazol PPH with food and drink
See section 3.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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 Polprazol PPH will be decided by the doctor.

Driving and using machines
Polprazol PPH has no influence on the ability to drive or use tools and machines.
However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Polprazol PPH contains sucrose
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Polprazol PPH contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Polprazol PPH

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The doctor will inform the patient how many capsules to take and for how long. This will
depend on the patient's health condition and age.

Recommended dosage:
Adults:

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

• If the doctor has determined that the patient's oesophagus has been slightly damaged, the usual dose is 20 mg once daily for 4–8 weeks. The doctor may recommend taking 40 mg once daily 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. The doctor may recommend continuing the same dose for another 2 weeks if the 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. The doctor may recommend continuing the same dose for another 4 weeks if the 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. The 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 bacterial infection) Helicobacter pylori and prevention of their recurrence:

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

**Treatment of excessive gastric acid secretion caused by **(pancreatic hyperplasia) (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 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 PPH. The dose for children depends on the child's body weight. The appropriate dose for a given child will be determined by the doctor.

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

• Children above 4 years of age may take Polprazol PPH. The dose for children depends on the child's body weight. The appropriate dose for a given child will be determined by the doctor.
• The doctor will also prescribe two antibiotics for the child: amoxicillin and clarithromycin.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules may 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 protect the medicine from being broken down by stomach acid. It is essential that the microgranules remain intact.

What to do if there is 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 with 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, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

Taking more than the recommended dose of Polprazol PPH
If more Polprazol PPH has been taken than prescribed, contact your doctor or pharmacist immediately.

If a dose of Polprazol PPH is missed
If a dose is missed due to forgetfulness, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Polprazol PPH
Do not stop taking Polprazol PPH 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 (may occur in fewer than 1 in 1,000 people) or very rare (may occur in fewer than 1 in 10,000 people), but serious adverse reactions, 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 blister formation 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 subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis); (rare)
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver disorders; (rare)

Other adverse reactions include:
Common adverse reactions (may occur in fewer than 1 in 10 people)

• Headache;
• Effects on stomach or intestines: diarrhoea, stomach pain, constipation, gas (bloating);
• Nausea or vomiting;
• Benign gastric polyps.

Uncommon adverse reactions (may occur in fewer than 1 in 100 people)

• Swelling of feet and ankles;
• Sleep disturbance (insomnia);
• Dizziness, tingling or prickling sensation, drowsiness;
• Sensation of spinning (dizziness);
• Changes in liver function test results;
• Skin rash, nodular rash (urticaria) and skin itching;
• General malaise and lack of energy.

Rare adverse reactions (may occur in fewer than 1 in 1,000 people)

• 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, which may cause weakness, vomiting and muscle cramps;
• Feeling of restlessness, confusion or depression;
• Change in taste sensation;
• Vision problems, such as blurred vision;
• Sudden sensation of wheezing or shortness of breath (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;
• Hair loss (alopecia);
• Skin rash during exposure to sunlight;
• Joint pain (arthralgia) or muscle pain (myalgia);
• Severe kidney problems (interstitial nephritis);
• Increased sweating.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 people)

• Changes in blood morphology 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;
• Erythema multiforme;
• Muscle weakness;
• Breast enlargement in men.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• Inflammation of the intestines (leading to diarrhoea);
• If the patient takes Polprazol PPH for longer than three months, blood magnesium levels may decrease. Low magnesium levels may result in symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash possibly accompanied by joint pain.

In very rare cases, Polprazol PPH may affect the number of white blood cells in the blood, resulting in immunodeficiency. If the 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, consult a doctor 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.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor. 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 this medicine.

5. How to store the medicine Polprazol PPH

Keep the 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 the specified month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
Do not store above 25 °C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Polprazol PPH contains

• The active substance is omeprazole. Each capsule contains 40 mg of omeprazole.
• The other ingredients are:
  • Capsule filling: sucrose, pellets (containing maize starch 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), dispersion 30%.
  • 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 opaque, blue and white capsules containing nearly white to creamy-white spherical microgranules.
The capsules are available in blister packs of 28 capsules.
Marketing Authorisation 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