Panrazol

Leaflet accompanying the packaging: patient information

Panrazol, 40 mg, gastro-resistant tablets

pantoprazole

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Panrazol and what is it used for

Panrazol contains the active substance pantoprazole.
Panrazol is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the patient's stomach. The medicine is used in stomach and intestinal diseases associated with excessive production of hydrochloric acid in the stomach.

Panrazol is used in adults and adolescents aged 12 years and older for the treatment of:

• Gastroesophageal reflux disease. This is a condition in which the esophagus (the tube connecting the throat to the stomach) becomes inflamed due to the backflow of hydrochloric acid from the stomach.

Panrazol is used in adults for:

• Infection with a bacterium called Helicobacter pyloriin patients with duodenal and gastric ulcers in combination with two antibiotics (eradication therapy). The goal of such treatment is to eliminate the bacteria and reduce the risk of ulcer recurrence.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive production of hydrochloric acid in the stomach.

2. Important information before taking Panrazol

When not to take Panrazol

• If the patient is allergic to pantoprazole 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.

Warnings and precautions

Before starting treatment with Panrazol, discuss it with your doctor, pharmacist, or nurse.

• If the patient has severe liver function disorders. The patient should inform the doctor about any current or past liver problems. The doctor will monitor liver enzyme activity more frequently, especially if the patient is taking Panrazol for long-term treatment. If liver enzyme activity increases, treatment should be discontinued.
• If the patient has a vitamin B12 deficiency or risk factors for reduced vitamin B12 levels and is being treated with pantoprazole for a long time. Like all medicines that reduce acid production in the stomach, taking pantoprazole may lead to reduced absorption of vitamin B12. The patient should contact the doctor if they notice any of the following symptoms, which may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy
• numbness or tingling
• pain or redness of the tongue, oral ulcers
• muscle weakness
• vision disturbances
• memory problems, disorientation, depression.
• If the patient is taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), they should consult their doctor for advice.
• Taking proton pump inhibitors like pantoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should tell their doctor if they have osteoporosis (reduced bone density) or if the doctor has informed them that they are at risk of osteoporosis (e.g., if they are taking steroid medications).
• If the patient takes pantoprazole for more than three months, it is possible that their blood magnesium level may decrease. Low magnesium levels can cause: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. The doctor may decide that regular magnesium level checks are necessary.
• If the patient has ever had a skin reaction after treatment with a medicine that reduces stomach acid production, similar to Panrazol.
• If a specific urine test (for the presence of tetrahydrocannabinol (THC)) is planned.

If a rash appears on the skin, especially in areas exposed to sunlight, the patient should immediately inform their doctor, as it may be necessary to discontinue treatment with Panrazol. The patient should also report any other symptoms of the disease, such as joint pain.
The patient should immediately inform their doctorbefore starting treatment with Panrazol if they notice any of the following symptoms, which may be a sign of a more serious disease:

• unintentional weight loss
• vomiting, especially recurring
• bloody vomiting, which may look like coffee grounds
• blood in the stool, black or tarry stools
• difficulty swallowing, pain when swallowing
• pallor or weakness (anemia)
• chest pain
• abdominal pain
• severe and/or prolonged diarrhea, as taking this medicine may slightly increase the risk of infectious diarrhea
• severe skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. The patient should discontinue taking pantoprazole and seek medical advice immediately if they notice any symptoms related to these severe skin reactions described in section 4.

The doctor may decide to perform tests to rule out a malignant disease, as treatment with pantoprazole may alleviate the symptoms of the disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.
In the case of long-term treatment with Panrazol (more than 1 year), the doctor will likely recommend regular check-ups. The patient should report all new and unexpected symptoms and their circumstances at each doctor's visit.

Children and adolescents

Panrazol is not recommended for use in children, as its effect has not been studied in children under 12 years of age.

Panrazol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Because Panrazol may affect the efficacy of other medicines, the patient should inform their doctor if they are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Panrazol may inhibit the proper functioning of these and other medicines.
• Warfarin or phenprocoumon, which affect blood clotting or thinning. This may require further monitoring.
• HIV medications such as atazanavir.
• Methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer) - if the patient is taking methotrexate, the doctor may recommend temporarily discontinuing Panrazol, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if the patient is taking fluvoxamine, the doctor may recommend reducing the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before starting treatment with Panrazol, the patient should discuss it with their doctor if they are to undergo a specific urine test (for the presence of tetrahydrocannabinol (THC)).

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women.
It has been reported that the active substance passes into human milk.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The patient should only take this medicine if the doctor considers that the benefit of taking it is greater than the potential risk to the unborn child or infant.

Driving and using machines

Panrazol has no or negligible influence on the ability to drive and use machines.
The patient should not drive or operate any machines if they experience side effects such as dizziness or vision disturbances.

Panrazol contains sodium

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

3. How to take Panrazol

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor or pharmacist.

Method of administration

The tablets should not be chewed or crushed; they should be swallowed whole, one hour before a meal, with water.
The recommended dose is:

Treatment of gastroesophageal reflux disease

The recommended dose is one tablet per day. The doctor may increase the dose to two tablets per day.
The treatment period for gastroesophageal reflux disease usually lasts from 4 to 8 weeks.
The doctor will decide how long the patient should take the medicine.
Adults and adolescents aged 12 years and older:

Treatment of Helicobacter pylori infection in patients with duodenal and gastric ulcers in combination with two antibiotics (eradication therapy)

One tablet twice a day plus tablets of two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole (or tinidazole); the antibiotics should be taken twice a day with a pantoprazole tablet. The first pantoprazole tablet should be taken one hour before breakfast, and the second pantoprazole tablet one hour before dinner. The patient should follow the doctor's instructions and read the antibiotic leaflets.
The treatment duration is usually one to two weeks.

Treatment of gastric and duodenal ulcers

The recommended dose is one tablet per day. After consulting the doctor, the dose may be doubled. The doctor will decide how long the patient should take the medicine. The treatment period for gastric ulcers usually lasts from 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts from 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive production of hydrochloric acid in the stomach

The usual initial dose is two tablets per day. Both tablets should be taken one hour before breakfast. Then, the doctor may adjust the dose of the medicine, depending on the amount of hydrochloric acid produced in the stomach. If the doctor prescribes more than two tablets per day, the medicine should be taken twice a day.
If the doctor prescribes a dose greater than four tablets per day, they will provide detailed instructions on when to stop taking the medicine.

Patients with renal impairment

In the case of kidney problems, the patient should not take Panrazol for the eradication of Helicobacter pylori.

Patients with hepatic impairment

In severe liver disease, the patient should 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, the patient should not take Panrazol for the eradication of Helicobacter pylori.

Use in children and adolescents

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

Overdose of Panrazol

The patient should inform their doctor or pharmacist. The symptoms of overdose are not known.

Missed dose of Panrazol

The patient should not take a double dose to make up for a missed dose.
The patient should take the next scheduled dose at the usual time.

Discontinuation of Panrazol

The patient should not stop taking the tablets without consulting their doctor or pharmacist first.
If the patient has any further questions about taking the medicine, they should ask their doctor or pharmacist or nurse.

4. Possible side effects

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

If the patient experiences any of the following side effects, they should stop taking the tablets and immediately inform their doctor or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare:may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), breathing difficulties, allergic swelling of the face (Quincke's edema/anaphylactic shock), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known:frequency cannot be estimated from the available data): the patient may notice one or more of the following symptoms
• blisters on the skin and rapid deterioration of the general condition, erosion (with minor bleeding) of the eyes, nose, mouth/ lips, or genitals, or rash, especially on skin areas exposed to sunlight. It may also be accompanied by joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in some white blood cells or liver enzymes in blood tests.
• red, non-raised, patchy, or circular spots on the torso, often with blisters in the center, peeling skin, oral ulcers, throat, nose, genitals, and eyes. These severe skin rashes may 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:frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and kidney enlargement, sometimes accompanied by painful urination and back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• Common(may affect up to 1 in 10 people) mild gastric polyps.
• Uncommon(may affect up to 1 in 100 people)

headache; dizziness; diarrhea; nausea; vomiting; bloating with gas;
constipation; dry mouth; abdominal pain and discomfort; skin rash, pruritus, erythema;
itching; feeling weak, tired, and unwell; sleep disturbances; fractures of the hip, wrist, or spine.

• Rare(may affect up to 1 in 1,000 people) disturbances or complete loss of taste; visual disturbances, such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; peripheral edema; allergic reactions; depression; gynecomastia in men.
• Very rare(may affect up to 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 such symptoms before); feeling of tingling, itching, prickling, burning, or numbness; muscle spasms caused by electrolyte disturbances (changes in salt levels in the body), colitis causing persistent watery diarrhea.

Side effects identified in blood tests:

• Uncommon(may affect up to 1 in 100 people) increased liver enzyme activity.
• Rare(may affect up to 1 in 1,000 people) increased bilirubin levels; increased fat levels in the blood; sudden decrease in granulocyte count in peripheral blood, associated with high fever.
• Very rare(may affect up to 1 in 10,000 people) decreased platelet count, which can cause bleeding or bruising more easily than usual; decreased white blood cell count, which can lead to more frequent infections; concurrent abnormal decrease in red and white blood cell and platelet counts, which can lead to fatigue, shortness of breath, and pallor.
• 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Panrazol

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
Blister: this medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Panrazol contains

• The active substance of the medicine is pantoprazole. Each tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients of the medicine are: Core: mannitol, sodium carbonate, sodium carboxymethylcellulose (type A), methacrylic acid-butyl acrylate copolymer (Eudragit E PO), calcium stearate. Coating: hypromellose 3 cP, titanium dioxide (E171), talc, macrogol 400, sodium lauryl sulfate. Enteric coating: methacrylic acid-ethyl acrylate copolymer dispersion 30%, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc.

What Panrazol looks like and contents of the pack

Panrazol 40 mg: elliptical, biconvex, dark yellow gastro-resistant tablets.
Pack sizes:
Blisters: 14, 28, 56 gastro-resistant tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
To obtain more detailed information on this medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:December 2023.