Panzol Pro

Package Leaflet: Information for the Patient

Panzol Pro, 20 mg, Gastro-Resistant Tablets

Pantoprazole

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

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the package leaflet. See section 4.
• If after 2 weeks there is no improvement, or if you feel worse, you should consult a doctor.
• Do not take Panzol Pro for more than 4 weeks without consulting a doctor.

Table of Contents of the Package Leaflet:

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

1. What is Panzol Pro and what is it used for

The active substance of Panzol Pro is pantoprazole, which blocks an enzyme that produces stomach acid. In this way, the medicine reduces the amount of acid in the stomach.

Panzol Pro is used for short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn, acid regurgitation) in adults.

Reflux occurs when stomach acid flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Symptoms may also include painful burning in the chest that can extend to the throat (heartburn), sour taste in the mouth (acid regurgitation).

Panzol Pro can relieve symptoms of reflux disease (such as heartburn, acid regurgitation) as early as the first day of treatment, but it is not a medicine intended for immediate relief of symptoms.

In order to achieve complete relief of symptoms, it may be necessary to take tablets for 2-3 consecutive days.

If after 2 weeks there is no improvement, or if you feel worse, you should consult a doctor.

2. Important information before taking Panzol Pro

When not to take Panzol Pro

• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Panzol Pro (listed in section 6).
• If you are taking HIV protease inhibitors, such as atazanavir, nelfinavir (for HIV infection treatment). See Panzol Pro and other medicines.

Warnings and precautions

Before taking Panzol Pro, consult your doctor or pharmacist if:

• you have been treated for heartburn or indigestion continuously for 4 or more weeks;
• you are over 55 years old and take over-the-counter indigestion medicines every day;
• you are over 55 years old and have noticed any new or changed symptoms of reflux disease;
• you have had stomach ulcers or stomach surgery;
• you have liver or jaundice (yellowing of the skin and eyes) problems;
• you are under regular medical supervision for other serious conditions or diseases;
• you are going to have an endoscopy or urea breath test;
• you have ever had a skin reaction after taking a medicine that reduces stomach acid;
• you are going to have a blood test to check chromogranin A levels.
• if you are taking HIV protease inhibitors, such as atazanavir, nelfinavir (for HIV infection treatment) at the same time as pantoprazole, ask your doctor for specific advice. Do not take this medicine without consulting your doctor for more than 4 weeks. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will decide whether you need to take the medicine for a longer period.

Long-term use of Panzol Pro may be associated with additional risks, such as:

• reduced absorption of vitamin B12 and vitamin B12 deficiency in case of low vitamin B12 levels in the body. Consult your doctor if you experience any of the following symptoms that may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy
• feeling of pins and needles
• painful or inflamed tongue, mouth ulcers
• muscle weakness
• vision problems
• memory problems, disorientation, depression.
• hip, wrist, or spine fractures, especially if you already have osteoporosis (reduced bone density) or if your doctor has informed you that you are at risk of osteoporosis (e.g., if you are taking steroid medicines);
• reduced magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to reduced potassium and calcium levels in the blood. If you take this medicine for more than 4 weeks, consult your doctor. Your doctor may order regular blood tests to monitor magnesium levels.

Tell your doctor immediatelybefore or after taking this medicine if you notice any of the following symptoms, which may be signs of other, more serious diseases:

• unintentional weight loss (not related to diet or exercise);
• vomiting, especially repeated;
• bloody vomiting, which may look like dark coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pale skin and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea (as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea).
• serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, which have been reported in association with pantoprazole treatment. Stop taking pantoprazole and contact your doctor immediately if you experience any of the symptoms associated with these serious skin reactions described in section 4.

Your doctor may decide to perform additional tests.

If you are going to have a blood test, inform your doctor that you are taking this medicine. You may experience relief of reflux and heartburn symptoms as early as the first day of taking Panzol Pro. However, this medicine is not intended for immediate relief of symptoms. Do not take it as a preventive measure. If you have had recurring heartburn or indigestion for some time, you should remain under regular medical supervision.

Children and Adolescents

Do not take this medicine in children and adolescents under 18 years of age due to lack of data on the safety of this medicine in this age group.

Panzol Pro and Other Medicines

Tell your doctor or pharmacist about all other medicines you are taking, or have recently taken, as pantoprazole may affect the efficacy of other medicines, especially those containing the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used in HIV infection treatment). Do not take pantoprazole at the same time as HIV protease inhibitors. See "When not to take Panzol Pro".
• Ketoconazole (used in fungal infections).
• Warfarin and phenprocoumon (affecting blood density and preventing blood clots). Additional blood tests may be necessary.
• Methotrexate (used in rheumatoid arthritis, psoriasis, and cancer treatment). If you are taking methotrexate, your doctor may temporarily stop taking Panzol Pro, as pantoprazole may increase methotrexate levels in the blood.

Do not take pantoprazole with medicines that reduce stomach acid, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).

Pantoprazole can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.

Before taking pantoprazole, consult your doctor if you are planning a urine test for tetrahydrocannabinol (THC).

Pregnancy and Breastfeeding

Do not take this medicine if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

If you experience side effects such as dizziness or blurred vision, do not drive or operate machinery.

Panzol Pro Contains

The medicine contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Panzol Pro contains soya lecithin. Do not take this medicine if you are hypersensitive to peanuts or soya.

Panzol Pro Contains Sodium

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

3. How to Take Panzol Pro

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist.

The recommended dose is one tablet per day. Do not take more than 20 mg of pantoprazole per day.

Take the medicine for at least 2-3 consecutive days. Stop taking pantoprazole when symptoms completely disappear. You may experience relief of reflux and heartburn symptoms as early as the first day of taking Panzol Pro, but remember that this medicine is not intended for immediate relief of symptoms.

Consult your doctor if, after taking this medicine for 2 weeks, symptoms do not disappear.

Do not take Panzol Pro for more than 4 weeks without consulting a doctor.

Take the tablets before meals, once a day, at the same time. Swallow the tablets whole with plenty of water, do not chew or divide them.

Taking a Higher Dose of Panzol Pro than Recommended

Consult your doctor or pharmacist if you have taken more than the recommended dose of the medicine.

If possible, take the medicine and package leaflet with you.

Missing a Dose of Panzol Pro

Do not take a double dose to make up for a missed dose. Take the next planned dose the next day at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Tell your doctor immediatelyor contact your nearest hospital if you experience any of the following serious side effects. Also, stop taking this medicine, but take the package leaflet and/or tablets with you.

• Severe allergic reactions (rare: may affect up to 1 in 1000 people):Allergic reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data):You may notice 1 or more symptoms
• rash with swelling, blisters, or peeling of the skin, flaking skin, bleeding from the eyes, nose, mouth, or genitals, and rapid worsening of the general condition, rash, especially in areas of the skin more exposed to the sun. Joint pain or flu-like symptoms, fever, swelling of lymph nodes (e.g., under the arm) and blood tests may show changes in some white blood cells or liver enzymes.
• red, flat, target-like, or circular patches on the trunk, often with central blisters, peeling of the skin, mouth ulcers, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Other serious reactions (frequency not known):Yellowing of the skin and whites of the eyes (caused by severe liver damage), fever, rash, and sometimes enlarged kidneys, which may cause painful urination, back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects include:

• Common (may affect up to 1 in 10 people):Mild stomach polyps.
• Uncommon (may affect up to 1 in 100 people):Headache; dizziness; diarrhea; nausea, vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash or hives; itching; weakness, fatigue, or malaise; sleep disturbances; increased liver enzyme activity in blood tests, hip, wrist, or spine fractures.
• Rare (may affect up to 1 in 1000 people):Disturbances or complete loss of taste; vision disturbances, such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of limbs; depression; elevated bilirubin and lipid levels in the blood (detected in blood tests); breast enlargement in men; high fever and sudden decrease in the number of circulating granulocytes - white blood cells (detected in blood tests).

kończyn; depresja; zwiększone stężenie bilirubiny i lipidów we krwi (stwierdzane w badaniach krwi); powiększenie piersi u mężczyzn; wysoka gorączka i nagłe zmniejszenie ilości krążących granulocytów - białych krwinek (stwierdzane w badaniach krwi).

• Bardzo rzadko(mogą wystąpić u nie więcej niż 1 na 10 000 pacjentów):Zaburzenia orientacji; zmniejszenie liczby płytek krwi, co może powodować zwiększoną tendencję do krwawień i tworzenia się wybroczyn na skórze („siniaków”); zmniejszenie liczby białych krwinek, co może sprzyjać częstszym zakażeniom; współistniejące, nieprawidłowe zmniejszenie liczby czerwonych i białych krwinek, jak również płytek krwi (stwierdzane w badaniach krwi).
• Nieznana(częstość nie może być określona na podstawie dostępnych danych):Omamy; splątanie (szczególnie u pacjentów, u których występowały takie objawy); zmniejszenie stężenia sodu, magnezu, wapnia lub potasu we krwi (patrz punkt 2); wysypka mogąca przebiegać z bólem stawów, zapalenie jelita grubego powodujące uporczywą wodnistą biegunkę.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the package leaflet. 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, PL-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 in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Panzol Pro

Keep out of the sight and reach of children.

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

No special precautions for storage temperature are necessary.

Store in the original package.

Medicines should 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 Panzol Pro Contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are:

Tablet core:

Maltitol (E965), crospovidone type B, sodium carmellose, sodium carbonate, calcium stearate.

Tablet coating:

Polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, soya lecithin, yellow iron oxide (E172), sodium carbonate, methacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate.

What Panzol Pro Looks Like and Contents of the Pack

Yellow, oval, gastro-resistant tablets.

Panzol Pro is available in blisters of 7 or 14 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27

01-909 Warsaw

Poland

Manufacturer:

Sofarimex – Indústria Química e Farmacêutica, S.A.

Av. das Indústrias, Alto do Colaride

2735-213 Cacêm

Portugal

Advance Pharma GmbH

Wallenroder Strasse 8-14

13435 Berlin

Germany

Delorbis Pharmaceuticals Ltd.

17 Athinon Street, Ergates Industrial Area, Ergates,

2643 Lefkosia

Cyprus

Date of Last Revision of the Package Leaflet: 10.2024

The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms:

• Avoid large meals.
• Eat slowly.
• Stop smoking.
• Limit alcohol and caffeine consumption.
• Lose weight (if overweight).
• Avoid tight clothing or belts.
• Avoid eating meals later than 3 hours before bedtime.
• Sleep with your head elevated (if you experience nighttime symptoms).
• Limit consumption of foods that usually cause heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic, spicy, citrus fruits and juices, tomatoes.