Package leaflet: Information for the patient

Panzol Pro, 20 mg, enteric-coated tablets
pantoprazole
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used in accordance with the instructions provided in this patient leaflet or as directed by a physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
Consult your pharmacist if you need advice or further information.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 weeks, or if symptoms worsen, consult your doctor.
Do not take Panzol Pro for longer than 4 weeks without consulting a doctor.

Leaflet contents:

What Panzol Pro is and what it is used for
Important information before taking Panzol Pro
How to take Panzol Pro
Possible side effects
How to store Panzol Pro
Contents of the package and other information

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

The active substance in Panzol Pro is pantoprazole, which inhibits the enzyme responsible for producing hydrochloric acid in the stomach. Thus, the medicine reduces the amount of acid in the stomach.
Panzol Pro is used for short-term treatment of symptoms of gastroesophageal reflux disease (GERD) (e.g. heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of stomach acid into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Panzol Pro may relieve symptoms associated with reflux disease (such as heartburn, acid regurgitation) as early as on the first day of treatment, but it is not intended for immediate relief of symptoms.
To achieve complete symptom resolution, it may be necessary to take the tablets for 2–3 consecutive days.
If there is no improvement after 2 weeks, or if symptoms worsen, consult your doctor.

2. Important information before using Panzol Pro

When not to use Panzol Pro

If the patient has a known allergy (hypersensitivity) to pantoprazole or any of the other ingredients of Panzol Pro (listed in section 6, "What Panzol Pro contains").
If the patient is taking HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). See Panzol Pro and other medicines.

Warnings and precautions
Before starting to take Panzol Pro, consult a doctor or pharmacist or nurse if:

the patient has been treated for heartburn or indigestion continuously for 4 or more weeks;
the patient is over 55 years old and takes over-the-counter medicines for indigestion daily;
the patient is over 55 years old and has noticed any new or worsening symptoms, or a change in the pattern of existing reflux disease symptoms;
the patient has a history of peptic ulcer disease or has undergone stomach surgery;
the patient has liver problems or jaundice (yellowing of the skin and eyes);
the patient is under continuous medical care for other serious conditions or diseases;
the patient is scheduled for an endoscopic examination or urease test;
the patient has ever experienced a skin reaction due to taking a medicine similar to Panzol Pro that reduces gastric acid secretion;
the patient is scheduled for a blood test to measure chromogranin A levels.
if the patient is taking HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the doctor should be consulted for specific advice. This medicine should not be used without medical consultation for longer than 4 weeks. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, the patient should consult a doctor, who will decide whether long-term treatment is necessary.

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. Contact a doctor if any of the following symptoms occur, which may indicate low vitamin B12 levels:
extreme fatigue or lack of energy
pins and needles sensation
sore or red tongue, mouth ulcers
muscle weakness
vision disturbances
memory problems, disorientation, depression.
fracture of the hip, wrist, or spine, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (e.g., if the patient is taking steroid medicines);
decreased magnesium levels in blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to decreased potassium and calcium levels in blood. If the medicine is used for longer than 4 weeks, consult a doctor. The doctor may recommend regular blood tests to monitor magnesium levels.

Immediately inform the doctor before or after using this medicine if the patient notices any of the following symptoms, which may indicate other, more serious conditions:

unintentional weight loss (not related to diet or exercise);
vomiting, especially recurrent;
vomiting blood, which may look like dark coffee grounds;
blood in stool, black or tarry stools;
difficulty swallowing or pain when swallowing;
paleness and weakness (anaemia);
chest pain;
abdominal pain;
severe and (or) persistent diarrhoea (because use of this medicine is associated with a small increased risk of infectious diarrhoea).
if the patient develops a skin rash, especially in sun-exposed areas, they should inform the doctor as soon as possible, as this may require discontinuation of Panzol Pro. Also report any other adverse reactions occurring, such as joint pain.
serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, which have been reported with pantoprazole treatment. Pantoprazole should be discontinued and medical advice sought immediately if any of the symptoms associated with these serious skin reactions described in section 4 occur.

The doctor may decide that additional tests are necessary.
If the patient is scheduled for a blood test, they should inform the doctor about taking this medicine.
Symptom relief from reflux and heartburn may occur as early as one day after starting Panzol Pro. However, this is not a medicine intended for immediate symptom relief. It should not be used preventively. If the patient has recurrent heartburn or indigestion symptoms over a period of time, regular medical monitoring is recommended.

Children and adolescents
Do not use in children and adolescents under 18 years of age due to lack of safety data in this age group.

Panzol Pro and other medicines
Tell the doctor or pharmacist about all other medicines currently taken or recently taken by the patient, because pantoprazole may reduce the effectiveness of other medicines, especially those containing any of the following active substances:

HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). Pantoprazole must not be used concomitantly with HIV protease inhibitors. See "When not to use Panzol Pro".
ketoconazole (used for fungal infections).
warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be required.
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer diseases). If methotrexate is used, the doctor may temporarily discontinue Panzol Pro, as pantoprazole may increase methotrexate blood levels.

Do not use pantoprazole together with other medicines that reduce stomach acid production, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2-antagonists (e.g., ranitidine, famotidine).
Pantoprazole may be used if necessary together with antacids that neutralize gastric hydrochloric acid (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).
Before starting pantoprazole, consult a doctor if a urine test for THC (tetrahydrocannabinol) is planned.

Pregnancy and breastfeeding
Do not use this medicine if the patient is pregnant or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive or operate machinery.

Panzol Pro contains
This medicine contains maltitol. If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Panzol Pro contains soya lecithin. Do not use this medicine if the patient is hypersensitive to peanuts or soya.

Panzol Pro contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Panzol Pro

This medicine should always be used exactly as described in this leaflet. If in doubt,
consult your doctor or pharmacist.
The recommended dose is 1 tablet per day. The daily dose of pantoprazole should not exceed
20 mg.
The medicine should be taken for at least 2-3 consecutive days. Pantoprazole treatment should be discontinued once symptoms have completely resolved. Improvement of reflux symptoms and heartburn may occur already after one day of taking Panzol Pro; however, it should be remembered that this medicine is not intended for immediate relief of symptoms.
Consult your doctor if symptoms do not improve after taking this medicine for a full period of 2 weeks.
Do not take Panzol Pro for longer than 4 weeks without consulting
your doctor.
Take tablets before a meal, at the same time each day. Swallow the tablets whole, with plenty of water. Do not chew or divide the tablets.
Taking more Panzol Pro than recommended
If a patient takes more than the recommended dose, consult a doctor or pharmacist.
If possible, bring the medicine and the 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 scheduled dose at the usual time the following day.
If you have any further doubts about using 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.
You should immediately contact your doctor or go to the nearest hospital if any of the following serious adverse reactions occur. At the same time, you should stop taking this medicine, but bring the package leaflet and (or) tablets with you.

Severe allergic reactions (rare: may occur in no more than 1 in 1,000 patients): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue and (or) throat, which may cause difficulty in swallowing or breathing, urticaria, severe dizziness with rapid heartbeat and excessive sweating.
Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): One or more of the following symptoms may be observed:
- Rash with swelling, blisters or peeling skin, sheet-like peeling of the skin, bleeding from the eyes, nose, mouth or genital organs, and rapid deterioration in general condition; rash especially in areas of skin more exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arm) may occur, and blood tests may show changes in certain white blood cells or liver enzymes.
- Reddish, flat, disc-shaped or round spots on the trunk, often with central blisters, peeling skin, and ulcers in the mouth, throat, nose, genital organs 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 syndrome or drug hypersensitivity syndrome).

Other serious reactions (frequency unknown): Yellowing of the skin and whites of the eyes (due to severe liver damage), fever, rash, and sometimes kidney enlargement manifesting as painful urination, pain in the lower back (serious kidney inflammation), which may lead to kidney failure.
Other adverse reactions include:

Common (may occur in up to 1 in 10 patients): Benign gastric polyps.
Uncommon (may occur in up to 1 in 100 patients): Headache; dizziness; diarrhoea; nausea, vomiting; flatulence and bloating with gas release; constipation; dryness of the mouth; abdominal pain and discomfort; skin rash or urticaria; itching of the skin; weakness, fatigue or malaise; sleep disturbances; increased liver enzyme activity in blood tests, fracture of the hip, wrist or spine.
Rare (may occur in up to 1 in 1,000 patients): Disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; swelling of the extremities; depression; increased levels of bilirubin and lipids in blood (detected in blood tests); breast enlargement in men; high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
Very rare (may occur in up to 1 in 10,000 patients): Disorientation; decreased platelet count, which may lead to increased tendency to bleed and development of skin petechiae (bruises); decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets (detected in blood tests).
Not known (frequency cannot be estimated from available data): Hallucinations; confusion (especially in patients who have previously experienced such symptoms); decreased levels of sodium, magnesium, calcium or potassium in blood (see section 2); rash possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, PL-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 responsible entity in Poland. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Panzol Pro

Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the specified month.
No special precautions regarding storage temperature are required.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Panzol Pro contains
The active substance is pantoprazole. Each enteric-coated 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, soy lecithin, yellow iron oxide (E172), sodium carbonate, copolymer of methacrylic acid and ethyl acrylate (1:1), sodium lauryl sulfate, polysorbate 80, triethyl citrate.
What Panzol Pro looks like and contents of the pack
Yellow, oval enteric-coated tablets.
Panzol Pro is available in blisters containing 7 or 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok.27
01-909 Warszawa
Poland
Manufacturers:
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias, Alto do Colaride
2735-213 Cacém
Portugal
Advance Pharma GmbH
Wallenroder Strasse 8-14
13435 Berlin
Germany
Delorbis Pharmaceuticals Ltd.
17 Athinon Street, Ergates Industrial Area, Ergates,
2643 Lefkosia
Cyprus
The following lifestyle recommendations and dietary changes may also help relieve heartburn or other symptoms related to stomach acid:

Avoid large meals.
Eat slowly.
Stop smoking.
Limit alcohol and caffeine intake.
Reduce body weight (in case of overweight).
Avoid tight clothing or belts.
Avoid eating meals less than three hours before lying down.
Sleep with the head elevated (in case of nocturnal symptoms).
Limit consumption of foods that commonly trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic or spicy foods, citrus fruits and fruit juices, tomatoes.