Panrazol

Package leaflet: Information for the patient

Panrazol, 20 mg, enteric-coated tablets
pantoprazole
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet

1. What Panrazol is and what it is 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 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 related
to excessive production of hydrochloric acid in the stomach.
Panrazol is used in adults and adolescents aged 12 years and older for:

• Symptoms (i.e., heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease (GERD), caused by reflux (backflow) of acid from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid reflux from the stomach) and prevention of its recurrence.

Panrazol is used in adults for:

• Prevention of gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

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 impairment. 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 needs to take NSAIDs continuously and is also taking Panrazol due to an increased risk of gastrointestinal complications. Any increased risk will be assessed according to individual patient risk factors such as: age (65 years or older), history of gastric or esophageal ulceration, or gastrointestinal bleeding.
• If the patient has vitamin B12 deficiency or risk factors for reduced vitamin B12 levels and is receiving long-term pantoprazole therapy. As with all medicines that reduce gastric acid secretion, pantoprazole use may lead to decreased absorption of vitamin B12. Contact 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 sensations
• pain or redness of the 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 more than 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 monitoring of blood magnesium levels is necessary.
• If the patient has ever had a skin reaction after treatment with a medicine that reduces gastric acid secretion, similar to Panrazol.
• Regarding a planned specific blood test (chromogranin A levels).

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. Any other symptoms of illness, such as joint pain, should also be reported.
The patient should immediately inform their doctor before starting or during treatment if any of the following symptoms occur, as they 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 or pain during swallowing
• paleness or weakness (anaemia)
• chest pain
• abdominal pain
• severe and/or persistent diarrhoea, as 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. The patient should stop taking pantoprazole and seek immediate medical advice if any symptoms related to these severe skin reactions described in section 4 occur.

The doctor may decide to perform tests to rule out an underlying tumour, as treatment with pantoprazole may relieve symptoms of tumour-related 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, the patient should report any new or unexpected symptoms and their circumstances at every 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
Since Panrazol may affect the effectiveness of other medicines, inform the 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 or thinning. This may require further monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (a medicine used to treat rheumatoid arthritis, psoriasis, and cancer conditions) – when methotrexate is used, the doctor may recommend temporarily discontinuing 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).

Before starting Panrazol, discuss with the doctor if the patient is scheduled for a specific urine test (for the presence of tetrahydrocannabinol (THC)).

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, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The patient should use this medicine only if the doctor considers the benefit of its use to outweigh the potential risk to the unborn child or infant.

Driving and operating machinery
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 exactly as directed by your 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.
Recommended dosage:
Adults and adolescents from the age of 12:
Treatment of symptoms associated with gastroesophageal reflux disease (i.e. heartburn, acid regurgitation, pain when swallowing)
The recommended dose is 1 tablet per day. This dose usually provides relief within 2–4 weeks—
at the latest after an additional 4 weeks. Your doctor will decide how long you should continue treatment.
Recurrent symptoms may be managed by taking 1 tablet per day as needed.
Long-term treatment and prevention of relapse of reflux esophagitis
The recommended dose is 1 tablet per day. If symptoms return, your doctor may double the dose,
and in such case, Panrazol 40 mg enteric-coated tablets may be used, 1 tablet per day. After healing, the dose may be reduced again to 1 tablet (20 mg) per day.
Adult patients:
Prevention of gastric and duodenal ulcers in patients who must continuously take NSAIDs
The recommended dose is 1 tablet per day.
Patients with impaired liver function
In cases of severe liver disease, do not take more than one 20 mg tablet per day.
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 or pharmacist.
If you have any further doubts regarding the use of 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.
If any of the following adverse reactions occur, stop taking these tablets immediately and contact your doctor or go to 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, hives (rash resembling nettle rash), breathing difficulties, allergic facial swelling (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown: frequency cannot be determined 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, mouth/oral cavity or genital organs, or rash, particularly on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, and 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, round or target-shaped spots on the trunk, often with blisters in the centre, 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 body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other severe reactions (frequency unknown: frequency cannot be determined from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash and kidney enlargement, 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 unknown (frequency cannot be determined from available data):

hallucinations, confusion (especially in patients who have previously experienced such symptoms);
sensation of tingling, itching, pricking, burning 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 levels; 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 unknown (frequency cannot be determined from available data): decreased sodium levels in blood; magnesium, calcium or potassium in blood (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of 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 marketing authorisation holder.
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 special storage conditions.
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 Panrazol contains

• The active substance is pantoprazole. Each tablet contains 20 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 20 mg: elliptical, biconvex, light yellow enteric-coated 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

Manufacturers
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, Poland, tel. (22) 345 93 00.