Panrazol

Package leaflet: Information for the patient

Panrazol, 40 mg, enteric-coated tablets
pantoprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Panrazol is and what it is used for
2. What you need to know 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 Panrazol is and what it is 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 disorders 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 inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with backflow of hydrochloric acid from the stomach.

Panrazol is used in adults for:

• Infection with a bacterium called Helicobacter pylori in patients with peptic ulcer of the stomach and duodenum, in combination with two antibiotics (eradication therapy). The aim of this 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 secretion of hydrochloric acid in the stomach.

2. Important information before using Panrazol

When not to use 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 this with your doctor, pharmacist, or nurse.

• If the patient has severe liver function disorders. The patient should inform the doctor if they currently have or have ever had liver problems in the past. The doctor will monitor liver enzyme activity more frequently, especially if the patient is receiving long-term treatment with Panrazol. If liver enzyme activity increases, treatment should be discontinued.
• If the patient has vitamin B12 deficiency or risk factors for low vitamin B12 levels and is receiving long-term pantoprazole treatment. As with all medicines that reduce gastric acid secretion, taking pantoprazole may lead to reduced absorption of vitamin B12. Contact your doctor if any of the following symptoms occur, which may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy
• numbness and tingling sensations
• sore or red tongue, mouth ulcers
• muscle weakness
• vision disturbances
• memory problems, disorientation, depression.
• If the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection), they should consult their doctor before using pantoprazole.
• Use of proton pump inhibitors such as pantoprazole, particularly when used for over one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (for example, if the patient is taking steroid medicines).
• If the patient takes pantoprazole for longer than three months, magnesium levels in the blood may decrease. Low magnesium levels may cause: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. The doctor may decide that regular blood magnesium tests are necessary.
• If the patient has ever had a skin reaction after treatment with a medicine that reduces gastric acid secretion, similar to Panrazol.
• If a specific blood test (chromogranin A level) is planned.

If a rash appears on the skin, especially in areas exposed to sunlight, inform the doctor immediately, as treatment with Panrazol may need to be discontinued. Also report any other symptoms of illness, such as joint pain.
Contact your doctor immediately before starting treatment if the patient notices any of the following symptoms, which may indicate another, more serious condition:

• unintentional weight loss
• vomiting, especially recurrent
• vomiting blood, which may look like dark coffee grounds
• blood in stool, black or tarry stools
• difficulty swallowing, pain during swallowing
• paleness or weakness (anaemia)
• chest pain
• abdominal pain
• severe and/or prolonged diarrhoea, because use of this medicine may slightly increase the risk of infectious diarrhoea
• severe skin reactions have been reported with the use of pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Discontinue pantoprazole and seek immediate medical advice if any symptoms associated with these serious skin reactions described in section 4 occur.

The doctor may decide to perform tests to rule out an underlying tumour, because treatment with pantoprazole may relieve symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Panrazol is taken for a long time (longer than 1 year), the doctor will likely recommend regular check-ups. In such cases, report any new or unexpected symptoms and their circumstances at each doctor's visit.

Children and adolescents
Panrazol is not recommended for use in children, as its effects have not been studied in children under 12 years of age.

Panrazol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including medicines available without a prescription.
Since Panrazol may affect the effectiveness of other medicines, inform your doctor if the patient is taking:

• Medicines such as: ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), because Panrazol may inhibit the proper action of these and other medicines.
• Warfarin or phenprocoumon, which affect blood clotting. This may require additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer conditions) – when taking methotrexate, the doctor may advise temporarily stopping Panrazol, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric 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).

Discuss with your doctor before starting Panrazol if a specific urine test (for tetrahydrocannabinol (THC)) is planned.

Pregnancy and breastfeeding
There are 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The patient should use this medicine only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.

Driving and using machines
Panrazol has no effect or a negligible effect on the ability to drive and operate machinery.
The patient should not drive or operate any machinery if they experience adverse effects such as dizziness or visual disturbances.

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

3. How to use Panrazol

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Instructions for use
Do not chew or crush the tablets; swallow them whole, one hour before a meal, with water.
The recommended dose is:
Adults and adolescents from 12 years of age:
Treatment of reflux esophagitis
The recommended dose is 1 tablet per day. Your doctor may increase the dose to 2 tablets per day.
Treatment for reflux esophagitis usually lasts from 4 to 8 weeks. Your doctor will decide how long you should take the medicine.
Adults:
Treatment of infection with the bacterium called Helicobacter pylori in patients with duodenal
and gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily plus tablets of two antibiotics selected from the following: amoxicillin,
clarithromycin, and metronidazole (or tinidazole); antibiotics should be taken twice daily together with pantoprazole tablets. The first pantoprazole tablet should be taken one hour before breakfast, and the second pantoprazole tablet one hour before dinner. Follow your doctor's instructions and read the package leaflets of the antibiotics.
The duration of treatment is usually one to two weeks.
Treatment of gastric and duodenal ulcers
The recommended dose is 1 tablet per day. After consultation with your doctor, the dose may be doubled. Your doctor will decide how long you should take the medicine. Treatment for gastric ulcer usually lasts from 4 to 8 weeks. Treatment for duodenal ulcer usually lasts from 2 to 4 weeks.
Long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive
production of hydrochloric acid in the stomach
The usual initial dose is 2 tablets per day. Both tablets should be taken one hour before breakfast. Your doctor may then adjust the dose depending on the amount of hydrochloric acid secreted in the stomach. If more than 2 tablets per day are prescribed, the medicine should be taken twice daily.
If your doctor prescribes a dose greater than 4 tablets per day, you will be given specific instructions on when to stop taking the medicine.
Patients with kidney function disorders
Panrazol should not be used for Helicobacter pylori eradication in patients with kidney problems.
Patients with liver function disorders
In severe liver disease, do not take more than one 20 mg pantoprazole tablet per day (tablets containing 20 mg pantoprazole are available for this purpose).
Panrazol should not be used for Helicobacter pylori eradication in patients with moderate or severe liver disease.
Use in children and adolescents
The tablets are not recommended for use in children under 12 years of age.
Taking more Panrazol than recommended
Inform your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Panrazol
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping Panrazol
Do not stop taking the tablets without first consulting your doctor, pharmacist, or nurse.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking these tablets immediately and inform your doctor
or contact the emergency department of your nearest hospital without delay:

• Severe allergic reactions (rare: may affect up to 1 in 1,000 patients): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash with stinging or burning sensation like nettle rash), breathing difficulties, angioedema of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): the patient may notice one or more of the following symptoms:
  • blistering of the skin and rapid deterioration in general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/genital organs, or rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
  • red, flat, target-shaped or circular lesions on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs, and eyes. These severe 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 severe reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, rash, and enlarged kidneys, sometimes associated with painful urination and back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

• Common (may affect up to 1 in 10 patients): benign gastric polyps.
• Uncommon (may affect up to 1 in 100 patients):

headache; dizziness; diarrhoea; nausea; vomiting; flatulence;
constipation; dryness of the mouth; pain and discomfort in the upper abdomen; skin rash, urticaria,
skin eruptions; itching; feeling of weakness, fatigue, and general malaise;
sleep disturbances; fractures of the hip, wrist, or spine.

• Rare (may affect up to 1 in 1,000 patients): 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; swelling of limbs (peripheral oedema); allergic reactions; depression; breast enlargement in males.
• Very rare (may affect up to 1 in 10,000 patients): disorientation.
• Frequency not known (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); tingling, itching, pricking, burning sensation or numbness; muscle cramps due to electrolyte disturbances (changes in salt levels in the body); inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified from blood tests:

• Uncommon (may affect up to 1 in 100 patients): increased liver enzyme activity.
• Rare (may affect up to 1 in 1,000 patients): increased bilirubin concentration; increased blood lipid levels; sudden decrease in granulocyte count in peripheral blood associated with high fever.
• Very rare (may affect up to 1 in 10,000 patients): decreased platelet count, which may lead to bleeding or bruising more easily than usual; decreased white blood cell count, which may lead to increased susceptibility to infections; concurrent abnormal decrease in red blood cells, white blood cells, and platelets, which may lead to fatigue, shortness of breath, and pallor.
• Frequency not known (frequency cannot be estimated from available data): decreased sodium, magnesium, calcium, or potassium levels in blood (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Panrazol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the stated month.
Blister pack: this medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Panrazol contains

• The active substance is pantoprazole. Each tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• Other components of the medicine are:
  Tablet core: mannitol, sodium carbonate, sodium carboxymethyl starch (type A), basic butyl methacrylate 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, 30% dispersion, propylene glycol, yellow iron oxide (E172), titanium dioxide (E171), talc.

What Panrazol looks like and contents of the pack
Panrazol 40 mg: dark yellow, enteric-coated, elliptical, biconvex tablets.
Pack sizes:
Blister packs: 14, 28, 56 enteric-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information about this medicine and its trade names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.