Panzol

Package Leaflet: Information for the Patient

Panzol, 20 mg, Gastro-Resistant Tablets

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Panzol and what is it used for

Panzol contains the active substance pantoprazole. Panzol is a selective “proton pump inhibitor” medicine, which reduces the amount of acid produced in the stomach. It is used for treating diseases of the stomach and intestines caused by acid production in the stomach.

Panzol is used in adults and adolescents aged 12 years and above for:

• Treating symptoms (e.g., heartburn, acid reflux, difficulty swallowing) associated with acid reflux disease.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus caused by acid reflux) and prevention of its recurrence.

Panzol is used in adults for:

• Preventing ulcers of the duodenum and (or) stomach caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who need to continuously take NSAIDs.

2. Before you take Panzol

When not to take Panzol

• If you are allergic to pantoprazole, soy lecithin, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before taking Panzol, tell your doctor or pharmacist:

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor may need to monitor your liver function more closely, especially if you are taking Panzol for a long time. If your liver function worsens, stop taking Panzol.
• If you are taking NSAIDs and Panzol at the same time, as this may increase the risk of side effects affecting the stomach or intestines. Your doctor will assess the increased risk based on your individual risk factors, such as age (65 years or older), history of stomach or duodenal ulcers, or bleeding from the stomach or intestines.
• If you have a vitamin B12 deficiency or risk factors for vitamin B12 deficiency, and you are taking pantoprazole long-term. Like all medicines that reduce acid production in the stomach, pantoprazole may lead to reduced absorption of vitamin B12. Tell your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:
• Extreme fatigue or lack of energy
• Numbness or tingling
• Sore or inflamed tongue, mouth ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression
• If you are taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), with pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor like Panzol, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis (reduced bone density) or are at risk of osteoporosis (e.g., if you are taking steroids).
• If you take pantoprazole for more than three months, it is possible that the level of magnesium in your blood may decrease. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to low potassium and calcium levels in the blood. Your doctor may order regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid, such as Panzol.
• If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking Panzol. Also, tell your doctor about any other side effects, such as joint pain.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with pantoprazole. Stop taking pantoprazole and contact your doctor immediately if you experience any of the symptoms associated with these severe skin reactions described in section 4.
• Your doctor will perform a blood test to measure chromogranin A levels.

Tell your doctor immediately before or during treatment with

the medicine, if you experience any of the following symptoms, which may be signs of a more serious condition:

• Unintentional weight loss;
• Recurring vomiting;
• Bloody vomiting, which may look like coffee grounds;
• Blood in the stool, black or tarry stools;
• Difficulty swallowing or pain when swallowing;
• Pale skin and weakness (anemia);
• Chest pain;
• Abdominal pain;
• Severe diarrhea and (or) persistent diarrhea, as Panzol may be associated with a small increased risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out an underlying malignant disease, as pantoprazole treatment may alleviate the symptoms of the disease and delay its diagnosis. If symptoms persist despite treatment, further investigations should be considered.

If you are taking Panzol for a long period (more than 1 year), you will likely be under regular medical supervision. In this case, inform your doctor about any new or unexpected symptoms and their onset during each visit.

Children and adolescents

Panzol is not recommended for use in children and adolescents below 12 years of age, as its use in this age group has not been studied.

Panzol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

• Ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Panzol may interfere with the proper functioning of these and other medicines;
• Warfarin and phenprocoumon, which affect blood clotting. Further tests may be necessary;
• HIV medicines, such as atazanavir;
• Methotrexate (used to treat autoimmune diseases or cancer) - if you are taking methotrexate, your doctor may temporarily stop Panzol, as pantoprazole may increase methotrexate levels in the blood;
• Fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may reduce the dose;
• Rifampicin (used to treat infections);
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

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

Pregnancy and breastfeeding

There is limited data on the use of pantoprazole in pregnant women. Pantoprazole has been detected in breast milk of nursing mothers.

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

The medicine may be used if your doctor considers that the benefit to the mother outweighs the potential risk to the unborn child or baby.

Driving and using machines

Panzol has no or negligible influence on the ability to drive and use machines. Patients who experience side effects such as dizziness and blurred vision should not drive or operate machines.

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

Panzol contains soy lecithin.Do not take this medicine if you are allergic to peanuts or soy.

Panzol contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Panzol

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration

Take the medicine 1 hour before a meal, without chewing or breaking the tablet. Swallow the tablet whole with water.

The recommended dose is:

For treating symptoms (e.g., heartburn, acid reflux, difficulty swallowing) associated with acid reflux disease.

The usual dose is one tablet per day. This dose usually provides relief within 2-4 weeks of treatment - at the latest within a further 4 weeks. Your doctor will decide how long you need to take the medicine. Recurring symptoms can be controlled by taking one tablet per day, as needed.

For long-term treatment and prevention of recurrence of reflux esophagitis.

The usual dose is one tablet per day. If symptoms of the disease return, your doctor may increase the dose to one tablet of Panzol 40 mgper day. Once symptoms have resolved, the dose can be reduced back to one tablet (20 mg) per day.

For preventing duodenal and (or) stomach ulcers in patients who need to continuously take NSAIDs.

The usual dose is one tablet per day.

Patients with liver problems

• In case of severe liver problems, do not take more than 1 tablet of 20 mg per day.
• Use in children and adolescents
• This medicine is not recommended for use in children and adolescents below 12 years of age.

If you take more Panzol than you should

Consult your doctor or pharmacist. Symptoms of overdose are not known.

If you forget to take Panzol

Do not take a double dose to make up for a forgotten dose. Take the next scheduled dose at the usual time.

If you stop taking Panzol

Do not stop taking the tablets without consulting your doctor or pharmacist first.

4. Possible side effects

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

If you experience any of the following side effects, contact your doctor or go to the nearest hospital with an emergency department:

• Severe allergic reactions (rare -occur in less than 1 in 1000 people ):swelling of the tongue and (or) throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known -frequency cannot be estimated from the available data ):you may notice one or more of the following symptoms - blistering of the skin and rapid worsening of the general condition; erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals, or increased sensitivity of the skin/skin rash, especially in areas of skin exposed to light/sun. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g., under the arm), and changes in some white blood cells or liver enzymes may also occur.
• Red, non-raised, targeted, or circular patches on the torso, often with central blisters, peeling skin, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Other severe reactions (frequency not known):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever; rash and kidney problems, which may lead to kidney failure.

Other side effects that may occur:

• Common(occur in less than 1 in 10 people): mild polyps in the stomach.
• Uncommon(occur in less than 1 in 100 people): headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the stomach and bloating with gas; constipation; dry mouth; abdominal pain and discomfort; skin rash, redness, skin eruptions; itching; weakness, fatigue, or general feeling of being unwell; sleep disturbances; fractures of the hip, wrist, or spine.
• Rare(occur in less than 1 in 1000 people): visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever, swelling of the limbs (peripheral edema); allergic reactions; depression, breast enlargement in men, taste disturbances.
• Very rare(occur in less than 1 in 10,000 people): disorientation.
• Frequency not known(frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients who have had these symptoms before); feeling of tingling, prickling, burning, or numbness; rash that may be associated with joint pain; inflammatory bowel disease, which may cause persistent watery diarrhea.

Side effects detected by blood tests:

• Uncommon(occur in less than 1 in 100 people): increased liver enzyme activity.
• Rare(occur in less than 1 in 1000 people): increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very rare(occur in less than 1 in 10,000 people): decreased platelet count, which may lead to increased bleeding and bruising; decreased white blood cell count, which may lead to increased risk of infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.
• Frequency not known(frequency cannot be estimated from the available data): decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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

You can also report side effects 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

Keep out of the sight and reach of children.

Do not use Panzol 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 of the medicinal product are necessary.

Medicines should 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 pack and other information

What Panzol contains

The active substance is pantoprazole.

Each gastro-resistant tablet contains 20 mg of pantoprazole in the form of pantoprazole sodium sesquihydrate.

The other ingredients are:

Core of the tablet:

Maltitol (E 965), crospovidone type B, sodium carmellose, sodium carbonate (E 500), calcium stearate.

Coating of the tablet:

Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172), sodium carbonate (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505).

What Panzol looks like and contents of the pack

Yellow, oval, gastro-resistant tablets.

Panzol is available in packs of 28 or 56 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 de Colaride, Agualva

2735-213 Cacêm

Portugal

Delorbis Pharmaceuticals Ltd.

17 Athinon Street, Ergates Industrial Area, Ergates,

2643 Lefkosia

Cyprus

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:

Pantoprazol 20 mg Auro maagsapresistente tabletten

United Kingdom:

Pantoprazole 20 mg gastro-resistant tablets

Date of last revision of the leaflet: 11.2024