Panzol

Leaflet attached to the packaging: patient information

Panzol, 40 mg, gastro-resistant tablets

Pantoprazole
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Panzol and what is it used for
• 2. Important information before taking 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 that reduces the amount of acid produced in the stomach. It is used to treat stomach and gut conditions related to acid production.

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

• Treatment of reflux oesophagitis. This is a condition in which the oesophagus (the tube that carries food from the mouth to the stomach) becomes inflamed due to the backflow of acid from the stomach.

Panzol is used in adults for:

• Infection with a bacterium called Helicobacter pyloriin patients with duodenal and/or stomach ulcers, in combination with two antibiotics (eradication therapy), to get rid of the bacteria and prevent recurrence of ulcers.
• Stomach and/or duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions related to excessive acid production.

2. Important information before taking Panzol

When not to take Panzol

• if you are allergic to pantoprazole, soya 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, you should tell your doctor or pharmacist if:

• you have severe liver problems. You should tell your doctor if you have ever had liver problems. Your doctor may need to monitor your liver function more closely when you are taking Panzol, especially if you are taking it for a long time. If your liver function is severely impaired, your doctor may need to reduce the dose or stop treatment with Panzol.
• you have a vitamin B12 deficiency or have risk factors for a vitamin B12 deficiency, and you are taking pantoprazole for a long time. Like all medicines that reduce acid production in the stomach, pantoprazole may lead to reduced absorption of vitamin B12. You should tell your doctor if you get any of the following symptoms, which could be signs of a vitamin B12 deficiency: feeling very tired or weak, numbness or tingling in the hands and feet, sore or inflamed tongue, mouth ulcers, weakness, blurred vision, problems with memory, confusion, or depression.
• you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection).
• taking a proton pump inhibitor like Panzol, especially over a period of more than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• 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 can include fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or a rapid heartbeat. If you experience any of these symptoms, you should tell your doctor immediately. Low magnesium can also lead to a reduction in the level of potassium and calcium in the blood. Your doctor may decide to monitor the level of magnesium in your blood regularly.
• if you have ever had a skin reaction with a medicine that reduces stomach acid.
• if you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor immediately, as you may need to stop taking Panzol. You should also tell your doctor about any other side effects, such as joint pain.
• serious 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. If you experience any of the following symptoms, you should stop taking pantoprazole and contact your doctor immediately: blistering of the skin, severe skin rash, or severe inflammation of the skin, mouth, eyes, or genital area.
• a blood test to measure the level of chromogranin A (a protein) may be performed.

Tell your doctor before or during treatment with Panzol if you notice any of the following:

symptomsthat may be signs of a more serious condition:

• unintentional weight loss;
• vomiting blood or black tarry stools;
• difficulty swallowing or pain when swallowing;
• anaemia (paleness and weakness);
• chest pain;
• severe stomach pain;
• severe diarrhoea or persistent diarrhoea, as taking Panzol may slightly increase the risk of infectious diarrhoea.

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

Children and adolescents

Panzol is not recommended for use in children and adolescents under 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, or have recently taken, and about any medicines you plan to take.

• ketokonazol, itrakonazol, and pozakonazol (used to treat fungal infections) or erlotynib (used to treat certain types of cancer), as Panzol may interfere with the effects of these and other medicines;
• warfarin and fenprocoumon (which affect blood clotting);
• HIV medicines such as atazanavir;
• methotrexate (used to treat autoimmune diseases or cancer);
• fluvoxamine (used to treat depression and other mental health conditions);
• rifampicin (used to treat infections);
• St John's Wort (used to treat mild depression).

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

Pregnancy and breastfeeding

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

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.

Panzol can be used during pregnancy if your doctor considers that the benefits to the mother outweigh the potential risks to the unborn child or baby.

Driving and using machines

Panzol has no or negligible influence on the ability to drive and use machines. However, if you experience side effects such as dizziness or blurred vision, you should not drive or operate machinery.

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 medicinal product.

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

Panzol contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium 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. Check with your doctor or pharmacist if you are not sure.

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 the treatment of reflux oesophagitis.

The usual dose is one tablet per day. Your doctor may increase the dose to 2 tablets per day. The duration of treatment for reflux oesophagitis is usually 4 to 8 weeks. Your doctor will decide how long you need to take the medicine.

For the treatment of infection with a bacterium called Helicobacter pylori, in patients with duodenal and/or stomach ulcers, in combination with two antibiotics (eradication therapy).

One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin, or metronidazole (or tinidazole) taken twice daily with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. Follow the instructions given by your doctor and read the patient information leaflet that comes with the antibiotic packaging. The treatment usually lasts for 1 to 2 weeks.

For the treatment of stomach and/or duodenal ulcers.

The usual dose is one tablet per day. After consulting your doctor, the dose can be doubled. Your doctor will decide how long you need to take the medicine. The duration of treatment for stomach ulcers is usually 4 to 8 weeks. The duration of treatment for duodenal ulcers is usually 2 to 4 weeks.

For long-term treatment of Zollinger-Ellison syndrome and other conditions related to excessive acid production.

The recommended initial dose is usually 2 tablets per day. Take both tablets 1 hour before a meal. Later, the dose may be adjusted by your doctor, depending on the amount of acid produced in the stomach. If your doctor prescribes more than 2 tablets per day, take them twice daily.

Patients with kidney problems

In the case of kidney disease, do not take Panzol for the eradication of Helicobacter pylori.

Patients with liver problems

In severe liver disease, do not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose). In moderate or severe liver disease, do not take Panzol for the eradication of Helicobacter pylori.

Use in children and adolescents

Tablets are not recommended for use in children under 12 years of age.

Take more Panzol than you should

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

Miss a dose of Panzol

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

Stop taking Panzol

Do not stop taking the tablets without consulting your doctor or pharmacist first. If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 immediately:

• 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 oedema / 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 deterioration of the general condition, erosions (with minor bleeding) of the eyes, nose, mouth/ lips, or genitals, or increased sensitivity of the skin/skin rash, especially in areas of skin exposed to sunlight. 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 spots or patches, sometimes with blisters, on the skin, often accompanied by a high fever, and sometimes with changes in blood tests, including a decrease in the number of white blood cells (a type of blood cell that fights infection) and an increase in the number of eosinophils (a type of white blood cell that can cause allergic reactions) (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread skin rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Other severe reactions (frequency not known):yellowing of the skin and eyes (severe liver 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 stomach polyps.
• Uncommon(occur in less than 1 in 100 people) headache; dizziness; diarrhoea; nausea, vomiting; feeling of bloating and gas in the stomach and intestines; constipation; dry mouth; stomach pain and discomfort; skin rash, redness, and 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) changes in taste or loss of taste; changes in vision, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever, swollen limbs (peripheral oedema); allergic reactions; depression, breast enlargement in men.
• Very rare(occur in less than 1 in 10,000 people) disorientation.
• Frequency not known(cannot be estimated from the available data) hallucinations, confusion (especially in patients who have had these symptoms before); feeling of tingling, pricking, or burning, or numbness; skin rash that may be accompanied by joint pain; inflammation of the colon, which can cause persistent watery diarrhoea.

Side effects detected by blood tests:

• Uncommon(occur in less than 1 in 100 people) increased liver enzymes.
• Rare(occur in less than 1 in 1000 people) increased bilirubin; increased fat levels in the blood; increased body temperature, with a sudden decrease in the number of 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 infection; simultaneous decrease in red, white blood cells, and platelets.
• Frequency not known(cannot be estimated from the available data) decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the website https://smz.ezdrowie.gov.pl or to the marketing authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Panzol

Keep this medicine out of the sight and reach of children.

Do not use Panzol after the expiry date stated on the carton and blister after "EXP:".

There are no special precautions for storage.

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 40 mg of pantoprazole (as 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, soya 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 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warszawa
Polska

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 authorised in the Member States of the European Economic Area under the following names:

Netherlands:
Pantoprazol 40 mg Auro maagsapresistente tabletten
United Kingdom:
Pantoprazole 40 mg gastro-resistant tablets

Date of last revision of the leaflet: 11.2024