Pantoprazole

Patient Information Leaflet

Panzol, 20 mg, enteric-coated tablets
Pantoprazole
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people. 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 inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Panzol is and what it is used for
2. What you need to know 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 Panzol is and what it is used for

Panzol contains the active substance pantoprazole. Panzol is a selective "proton pump inhibitor," a medicine that reduces the production of stomach acid. It is used to treat stomach and intestinal disorders related to the secretion of hydrochloric acid in the stomach.

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

• Treatment of symptoms (e.g., heartburn, acid regurgitation, pain on swallowing) associated with gastroesophageal reflux disease (GERD) caused by acid reflux from the stomach;
• Long-term treatment of reflux esophagitis (inflammation of the oesophagus associated with reflux of hydrochloric acid from the stomach) and prevention of its recurrence.

Panzol is used in adults for:

• Prevention of duodenal and/or gastric 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 the medicine Panzol

When not to use Panzol

• if the patient has a known hypersensitivity to pantoprazole, soybean lecithin, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a known hypersensitivity to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Panzol, consult a doctor or pharmacist.

• If the patient has severe liver function impairment. Inform the doctor if there has ever been any liver disorder. The doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Panzol is required. If liver enzyme activity increases, treatment should be discontinued.
• If the patient is required to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously while also taking Panzol, due to an increased risk of gastrointestinal complications. This increased risk will be assessed according to patient-specific risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If the patient has vitamin B__ deficiency or risk factors indicating possible reduced vitamin B__ levels, and is being treated long-term with pantoprazole. Like all drugs that reduce (inhibit) gastric hydrochloric acid secretion, pantoprazole may lead to reduced absorption of vitamin B__. Contact the doctor if any of the following symptoms occur, which may indicate low vitamin B12 levels:
• Extreme fatigue or lack of energy
• Tingling and burning sensations
• Sore or red tongue, oral ulcers
• Muscle weakness
• Blurred vision
• Memory problems, confusion, depression
• If the patient is taking protease inhibitors for HIV, such as atazanavir (used in the treatment of HIV infection), together with pantoprazole, the patient should seek detailed advice from the doctor.
• Taking a proton pump inhibitor such as Panzol, particularly for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis (reduced bone density) or risk factors for osteoporosis (e.g. if taking steroids).
• If the patient takes pantoprazole for more than three months, magnesium levels in the blood may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• If the patient has ever experienced a skin reaction due to taking a medicine similar to Panzol that reduces gastric acid secretion.
• If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Panzol may be necessary. Also report any other adverse reactions such as joint pain.
• Serious skin reactions have been reported with pantoprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Discontinue pantoprazole and contact the doctor immediately if any symptoms associated with these serious skin reactions described in section 4 occur.
• The patient will undergo a blood test to measure chromogranin A levels.

Immediately inform the doctor before starting or during treatment with Panzol if any of the following symptoms occur, as they may indicate a more serious underlying condition:

• Unintentional weight loss;
• Recurrent vomiting;
• Vomiting blood, which may look like dark coffee grounds;
• Blood in stool, black or tarry stools;
• Difficulty swallowing or pain when swallowing;
• Pallor and weakness (anaemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhoea, as use of Panzol is associated with a slight increase in the risk of infectious diarrhoea.

The doctor may decide that further investigations are necessary to exclude 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 Panzol is taken for a prolonged period (over 1 year), the patient will likely be under continuous medical supervision. In such cases, any new or unexpected symptoms and their circumstances should be reported during every visit to the doctor.

Children and adolescents
Panzol is not recommended for use in children and adolescents under 12 years of age, as its efficacy and safety have not been established in this age group.

Panzol with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Panzol may affect the effectiveness of other medicines, so inform the doctor if the patient is taking:

• ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used to treat certain types of cancer), as Panzol may inhibit the proper action of these and other drugs;
• warfarin and phenprocoumon, which affect blood clotting. Further testing may be required;
• medicines used to treat HIV infection, such as atazanavir;
• methotrexate (used to treat autoimmune diseases or cancer) – when methotrexate is used, the doctor may temporarily discontinue Panzol, as pantoprazole may increase methotrexate levels in the blood;
• fluvoxamine (used to treat depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend a dose reduction;
• rifampicin (used to treat infections);
• St John's wort (Hypericum perforatum) (used to treat mild depression).

Before starting pantoprazole, consult the doctor if a urine test for THC (tetrahydrocannabinol) is planned.

Pregnancy and breastfeeding
There is insufficient data on the use of pantoprazole in pregnant women. It has been shown that the drug passes into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor determines that the benefit to the mother outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Panzol has no effect or has a negligible effect on the ability to drive and operate machinery. Patients experiencing adverse effects such as dizziness or visual disturbances should not drive or operate machinery.

Panzol contains maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Panzol contains soybean lecithin. This medicine should not be used in case of hypersensitivity to peanuts or soy.

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

3. How to take Panzol

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Method of administration
Take the medicine one hour before a meal. Do not chew or divide the tablet. Swallow the tablet whole with water.

Recommended dose:

Adults and adolescents aged 12 years and above:

For treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastro-oesophageal reflux disease.
The usual dose is one tablet daily. This dose usually provides relief within 2–4 weeks of treatment – at the latest within the following 4 weeks. Your doctor will decide how long you should take the medicine. Recurring symptoms may be managed by taking one tablet daily as needed.

For long-term treatment and prevention of relapse of reflux oesophagitis.
The usual dose is one tablet daily. If symptoms return, your doctor may recommend doubling the dose. In this case, one tablet of Panzol 40 mg may be taken daily. After symptoms have resolved, the dose may be reduced again to one tablet (20 mg) daily.

Adults:

For prevention of gastric and/or duodenal ulcers in patients who must continuously take NSAIDs.
The usual dose is one tablet daily.

Patients with impaired liver function

• In case of severe liver problems, do not take more than one 20 mg tablet daily.

Use in children and adolescents

• This medicine is not recommended for use in children and adolescents under 12 years of age.

Taking more Panzol than recommended
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 the missed dose. Take the next scheduled dose at the usual time.

Stopping Panzol treatment
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any doubts about how to use 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, you should
immediately inform your doctor or contact the nearest hospital providing emergency care:

• Severe allergic reactions (rare - occurring in less than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle burns), breathing difficulties, angioedema of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown - frequency cannot be estimated from available data): one or more of the following symptoms may be observed – blistering of the skin and sudden worsening of general condition; erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity, or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to light/sunlight. Joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arm) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• Reddish, flat, target-like or round spots on the trunk, often with central blisters, peeling of the skin, ulceration of the mouth, throat, nose, genital organs, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other severe reactions (frequency unknown): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever; rash and kidney problems manifested by kidney enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions occurring:

• Common (affecting less than 1 in 10 people): mild gastric polyps.
• Uncommon (affecting less than 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with passing wind (flatulence); constipation; dry mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances; fractures of the hip, wrist or spine.
• Rare (affecting less than 1 in 1,000 people): 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 men, taste disturbances.
• Very rare (affecting less than 1 in 10,000 treated people): disorientation.
• Frequency unknown (cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); sensations of tingling, pricking, burning or numbness; rash possibly associated with joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions detected by blood tests occurring:

• Uncommon (occurring in 1 to 10 out of 1,000 treated people): increased liver enzyme activity.
• Rare (occurring in 1 to 10 out of 10,000 treated people): increased bilirubin levels; increased blood lipid levels; associated with high fever, sudden decrease in circulating granulocytes - white blood cells.
• Very rare (occurring 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 increase susceptibility to infections; concurrent abnormal decrease in red blood cells, white blood cells, and platelets.
• Frequency unknown (cannot be estimated from available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, you should 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, PL-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 in Poland. By
reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Panzol

Keep the medicine out of sight and reach of children.
Do not use the medicine Panzol after the expiry date stated on the cardboard box and
blister after "Expiry date:" ("EXP:"). The expiry date refers to the last day of the specified month.
No special storage precautions are required for this medicinal product.
Medicines must 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 packaging and other information

What Panzol contains
The active substance is pantoprazole.
Each enteric-coated tablet contains 20 mg of pantoprazole in the form of pantoprazole sodium
sesquihydrate.
Other ingredients are:
Tablet core:
Maltitol (E 965), crospovidone type B, sodium carmellose, sodium carbonate (E 500), calcium stearate.
Tablet coating:
Polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), macrogol 3350, soy lecithin,
yellow iron oxide (E 172), sodium carbonate (E 500), copolymer (1:1) of methacrylic acid and ethyl acrylate, triethyl citrate (E 1505).

What Panzol looks like and contents of the pack
Yellow, oval enteric-coated tablets.
Panzol is available in packs containing 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok.27
01-909 Warszawa
Poland

Manufacturers:
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 European Economic Area countries under the following names:
Netherlands: Pantoprazol 20 mg Auro maagsapresistente tabletten
United Kingdom: Pantoprazole 20 mg gastro-resistant tablets