Polprazol max

Patient Information Leaflet

Polprazol Max, 20 mg, enteric-coated capsules, hard
Omeprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if the patient feels worse, consult a doctor.

Table of contents

1. What Polprazol Max is and what it is 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 pack and other information

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

Polprazol Max contains an active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of hydrochloric acid produced in the stomach.
Polprazol Max is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (e.g. heartburn and regurgitation of acidic stomach contents – acid reflux).
Reflux occurs when stomach acid flows back into the oesophagus, which may lead to inflammation and associated pain. This may result in symptoms such as a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (due to regurgitation of acidic contents).
To achieve symptom relief, it may be necessary to take the capsules for 2–3 consecutive days.

2. Information before using Polprazol Max

When not to use Polprazol Max

• 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 Max, discuss this with your doctor or pharmacist.
Before taking this medicine, inform your doctor:

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

Do not take Polprazol Max for longer than 14 days without consulting a doctor.
If symptoms do not improve or worsen, seek medical advice promptly.
Polprazol Max may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Polprazol Max, contact your 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 use of omeprazole is associated with a slightly increased risk of infectious diarrhoea
• history of gastric ulcer or previous gastrointestinal surgery
• ongoing symptomatic treatment for indigestion or heartburn for 4 or more weeks
• persistent indigestion or heartburn lasting 4 or more weeks
• presence of jaundice or severe liver disease
• age over 55 years and new onset of symptoms or recent change in existing symptoms
• if the patient has ever had a skin reaction due to treatment with a medicine similar to Polprazol Max that reduces stomach 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 discontinuation of Polprazol Max may be necessary. The patient should also report any other adverse effects such as joint pain.
Patients should not take omeprazole preventively.
During treatment with omeprazole, kidney inflammation 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. The patient should report such symptoms to their doctor.

Polprazol Max and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is important because Polprazol Max may affect the action of certain other medicines, 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 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 conditions)
• diazepam (used to treat anxiety, reduce muscle tension, or 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 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 or stopping Polprazol Max.
• rifampicin (used to treat tuberculosis)
• atazanavir (used to treat HIV infection)
• tacrolimus (used in organ transplantation)
• erlotinib (used in cancer treatment)
• methotrexate (a chemotherapeutic agent used in cancer treatment). If the patient is receiving high doses of methotrexate, the doctor may recommend temporarily discontinuing 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 food or on an empty stomach.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The doctor will decide whether the patient may take Polprazol Max during pregnancy.
The decision whether a breastfeeding woman may take Polprazol Max will be made by the doctor.

Driving and using machines
Polprazol Max 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, the patient should not drive or operate machinery.

Polprazol Max contains sucrose, sodium and erythrosine
Each capsule contains 80.02 mg of sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Each capsule contains 0.819 mg (0.036 mmol) of sodium, less than 1 mmol of sodium (23 mg) per dose, meaning 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is: one capsule (20 mg) once daily for 14 days. If symptoms do not improve after this time, consult your doctor.
To achieve symptom relief, it may be necessary to continue taking the capsules for 2-3 additional days.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules may be taken with food or on an empty stomach.
• 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 designed to protect the medicine from being broken down by stomach acid. It is essential that the microgranules remain intact. These microgranules contain the active substance omeprazole and are specially coated to prevent breakdown in the stomach, allowing absorption from the intestine. The microgranules release the active substance in the intestine, where it is absorbed and then exerts its effect.

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 mix the contents into a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, pineapple juice), or apple puree.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure the full dose is taken, rinse the glass thoroughly with half a glass of water and drink this liquid as well. The solid particles contain the medicine—do not chew or crush them.

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

If you forget to take Polprazol Max
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 forgotten dose.

4. Possible adverse reactions

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

• Sudden wheezing, swelling of the lips, tongue or throat, 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.

Adverse reactions may occur with frequencies defined below.
Other adverse reactions include:
Common adverse reactions (affecting less than 1 in 10 people)

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

Uncommon adverse reactions (affecting less than 1 in 100 people)

• swelling of feet and ankles
• sleep disturbance (insomnia)
• dizziness, tingling and pricking sensations, drowsiness
• sensation of spinning (vertigo)
• changes in liver function test results
• skin rash, nodular rash (urticaria) and skin itching
• general malaise and lack of energy.

Rare adverse reactions (affecting less than 1 in 1,000 people)

• blood-related problems, such as reduced numbers of white blood cells or platelets. This may lead to weakness, easier bruising or increased likelihood of infection.
• allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing
• low blood sodium levels. This may lead to weakness, vomiting and muscle cramps.
• feeling of agitation, confusion or depression
• altered taste sensation
• vision problems, such as blurred vision
• sudden wheezing or shortness of breath (bronchospasm)
• dry mouth
• inflammation of the mucous membrane of the mouth
• a fungal infection known as "thrush", which may affect the intestines
• inflammation of the large intestine (leading to diarrhoea)
• 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 reactions (affecting less than 1 in 10,000 people)

• changes in blood cell counts including agranulocytosis (lack 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 blistering 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 men.

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

• hypomagnesemia. Taking Polprazol Max for longer than three months may lead to decreased magnesium levels in the blood. Magnesium deficiency 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 reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• rash possibly associated with joint pain.

In very rare cases, Polprazol Max may affect the number of white blood cells in the blood, leading to reduced immunity. If a patient develops an infection with symptoms such as fever accompanied by a significant worsening of general condition, or fever with symptoms of local 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 white blood cell deficiency (agranulocytosis) based on blood test results. It is important that, in such a situation, the patient informs the doctor about the medicine being taken.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform 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
Phone: +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 provide more information on the safety of this medicine.

5. How to store Polprazol Max

Keep this medicine out of sight and reach of children.
Bottles: Do not store above 30°C. Keep 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation 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. This will help protect the environment.

6. Contents of the pack and other information

What Polprazol Max contains

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

Ink composition: shellac; propylene glycol; polyvinylpyrrolidone; sodium hydroxide; titanium dioxide (E 171).

What Polprazol Max looks like and contents of the pack

Polprazol Max is a capsule with a blue cap and orange body, marked with the symbol “O” on the cap and “20” on the body, containing white to beige granules.

The pack contains 5, 7 or 14 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturer
Teva Pharma S.L.U.
Poligono Industrial Malpica
Calle C, Numbero 4
50016 Zaragoza
Spain

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Poland