PANTOPRAZOLE 20 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Pantoprazole Mercapharm, 20 mg
3. Gastro-resistant tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Pantoprazole Mercapharm and what is it used for
   1. Pantoprazole Mercapharm is used in:
5. Important information before taking Pantoprazole Mercapharm
   1. When not to take Pantoprazole Mercapharm
   2. Warnings and precautions:
   3. Pantoprazole Mercapharm and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Pantoprazole Mercapharm contains lactose and sodium
6. How to take Pantoprazole Mercapharm
   1. For the treatment of symptoms (e.g., heartburn, acid reflux, difficulty swallowing) associated with gastroesophageal reflux disease
   2. For long-term treatment and prevention of reflux esophagitis recurrence
   3. For the prevention of duodenal and (or) gastric ulcers in patients who must continuously take NSAIDs
   4. Special patient groups:
   5. Taking a higher dose of Pantoprazole Mercapharm than recommended
   6. Missing a dose of Pantoprazole Mercapharm
   7. Stopping treatment with Pantoprazole Mercapharm
7. Possible side effects
   1. If the patient experiences any of the following side effects, they should immediately inform their doctor or contact the nearest hospital where emergency services are available:
   2. Other side effects that may occur:
   3. Side effects detected by blood tests:
   4. Reporting side effects
8. How to store Pantoprazole Mercapharm
9. Contents of the packaging and other information
   1. What Pantoprazole Mercapharm contains
   2. What Pantoprazole Mercapharm looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Approval date of the leaflet:

Leaflet accompanying the packaging: patient information

Pantoprazole Mercapharm, 20 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Pantoprazole Mercapharm and what is it used for

Pantoprazole Mercapharm is a selective "proton pump inhibitor", a medicine that reduces stomach acid production. It is used to treat stomach and intestinal diseases associated with acid production.

Pantoprazole Mercapharm is used in:

Adults and adolescents aged 12 and over:

• Treating symptoms (e.g., heartburn, acid reflux, difficulty swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid reflux) and prevention of its recurrence.

Adults:

• Preventing duodenal and (or) gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who must take NSAIDs continuously.

2. Important information before taking Pantoprazole Mercapharm

When not to take Pantoprazole Mercapharm

• If the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If the patient has been diagnosed with an allergy to medicines containing other proton pump inhibitors.

Warnings and precautions:

Before starting to take pantoprazole, discuss it with your doctor, pharmacist, or nurse:

• If there are severe liver function disorders. Inform your doctor if you have ever had liver function disorders. The doctor may order more frequent monitoring of liver enzyme activity, especially if long-term treatment with Pantoprazole Mercapharm is used. If liver enzyme activity increases, the use of the medicine should be discontinued.
• If the patient must continuously take NSAIDs and also take Pantoprazole Mercapharm, due to the increased risk of stomach or intestinal complications. The increased risk will be assessed according to the patient's risk factors, such as age (65 or older), stomach or duodenal ulcers in the medical history, or stomach or intestinal bleeding.
• If the patient has a vitamin B12 deficiency or risk factors indicating a possible decrease in vitamin B12 levels, and the patient is being treated long-term with pantoprazole. Like all medicines that reduce gastric acid production, pantoprazole may lead to decreased vitamin B12 absorption.
• If the patient is taking a medicine containing atazanavir (used to treat HIV infection) at the same time as pantoprazole, they should ask their doctor for detailed advice.
• If the patient has ever had a skin reaction after taking a medicine similar to Pantoprazole Mercapharm 20 mg, which reduces stomach acid production.
• If the patient takes Pantoprazole Mercapharm 20 mg for more than three months, it is possible that the patient's blood magnesium levels may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should immediately tell their doctor. Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. The doctor may order regular blood tests to monitor magnesium levels.

If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazole Mercapharm 20 mg. They should also tell their doctor about any other side effects, such as joint pain. If the following symptoms occur, the patient should immediately inform their doctor:

• Unintentional weight loss
• Recurring vomiting
• Difficulty swallowing
• Bloody vomiting
• Pallor and weakness (anemia)
• Blood in the stool
• Severe and (or) persistent diarrhea, as the use of Pantoprazole Mercapharm is associated with a slight increase in the risk of infectious diarrhea.

Before taking the medicine, the patient should inform their doctor:

• About a planned specific blood test (chromogranin A levels).

The doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may alleviate the symptoms of the malignant disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered. Taking proton pump inhibitors, such as Pantoprazole Mercapharm, 20 mg, especially when they are used for more than a year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis). When taking Pantoprazole Mercapharm for a long period (more than 1 year), the patient will likely be under constant medical supervision. In this case, the patient should report any new and unexpected symptoms and their circumstances during each visit to the doctor.

Pantoprazole Mercapharm and other medicines

Pantoprazole Mercapharm may affect the effectiveness of other medicines, so the patient should tell 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 Pantoprazole Mercapharm may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood density. Further tests may be necessary.
• Atazanavir (used to treat HIV infection).
• Methotrexate (used in high doses as an anticancer medicine for chemotherapy) - the doctor may decide to temporarily discontinue pantoprazole when the patient is taking high doses of methotrexate.

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

Experience with the use of Pantoprazole Mercapharm in pregnant women is limited. It has been found that the active substance of the medicine passes into breast 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.

Driving and using machines

The patient should not drive vehicles or operate machinery if they experience side effects such as dizziness or vision disturbances.

Pantoprazole Mercapharm contains lactose and sodium

The medicine contains lactose. If the patient has been diagnosed with intolerance to certain sugars, they should only take Pantoprazole Mercapharm 20 mg after consulting their doctor. This medicinal product contains 1.34 mg of sodium per dose. This should be taken into account for patients on a low-sodium diet.

3. How to take Pantoprazole Mercapharm

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The medicine should be taken 1 hour before a meal, without chewing or breaking the tablet. The patient should swallow the tablet whole, with water. If the doctor has not recommended a different dosage, the usual recommended dose is:

For the treatment of symptoms (e.g., heartburn, acid reflux, difficulty swallowing) associated with gastroesophageal reflux disease

The usual dose is one tablet per day. This dose usually provides relief after 2-4 weeks of treatment - no later than within the next 4 weeks. The doctor will decide how long the patient should take the medicine. Recurring symptoms can be controlled by taking one tablet per day as needed.

For long-term treatment and prevention of reflux esophagitis recurrence

The usual dose is one tablet per day. If the symptoms of the disease return, the doctor may recommend doubling the dose. In this case, one tablet per day of Pantoprazole Mercapharm 40 mg can be used. After the symptoms have subsided, the dose can be reduced again to one tablet (20 mg) per day.

For the prevention of duodenal and (or) gastric ulcers in patients who must continuously take NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• In the case of severe liver function disorders, the patient should not take more than one 20 mg tablet per day. The use of Pantoprazole Mercapharm is not recommended for children under 12 years of age.

Taking a higher dose of Pantoprazole Mercapharm than recommended

The patient should consult their doctor or pharmacist. The symptoms of overdose are unknown.

Missing a dose of Pantoprazole Mercapharm

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

Stopping treatment with Pantoprazole Mercapharm

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

4. Possible side effects

Like all medicines, Pantoprazole Mercapharm can cause side effects, although not everybody gets them. The frequency of side effects is defined based on the following categories:

• Very common (more than 1 in 10 treated patients)
• Common (between 1 in 10 and 1 in 100 treated patients)
• Uncommon (between 1 in 100 and 1 in 1,000 treated patients)
• Rare (between 1 in 1,000 and 1 in 10,000 treated patients)
• Very rare (less than 1 in 10,000 treated patients)
• Frequency not known (cannot be estimated from the available data)

If the patient experiences any of the following side effects, they should immediately inform their doctor or contact the nearest hospital where emergency services are available:

• Severe allergic reactions (rare):swelling of the tongue and (or) throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic edema (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known):blistering of the skin and rapid deterioration of the general condition; erosion (with slight bleeding) of the eyes, nose, mouth, or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and photosensitivity.
• Other severe reactions (frequency not known):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever; rash and kidney problems manifested by their enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation).

Other side effects that may occur:

• Common(between 1 in 10 and 1 in 100 treated patients) mild gastric polyps.
• Uncommon(between 1 in 100 and 1 in 1,000 treated patients) headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with gas (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, redness, skin eruptions; itching; weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, or spine fractures (in cases where lansoprazole is used in high doses and for a long period).
• Rare(between 1 in 1,000 and 1 in 10,000 treated patients) visual disturbances, such as blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs (peripheral edema); allergic reactions; depression, breast enlargement in men; disturbances or complete loss of taste.
• Very rare(less than 1 in 10,000 treated patients) disorientation.
• Frequency not known(cannot be estimated from the available data) hallucinations, confusion (especially in patients who have experienced such symptoms before); decreased sodium levels in the blood; muscle cramps; sensation of tingling, prickling, burning, or numbness; colitis (inflammable bowel disease) causing persistent watery diarrhea.

Side effects detected by blood tests:

• Uncommon(between 1 in 100 and 1 in 1,000 treated patients) increased liver enzyme activity
• Rare(between 1 in 1,000 and 1 in 10,000 treated patients) increased bilirubin levels; increased fat levels in the blood; significantly decreased white blood cell count (agranulocytosis), which may lead to an increased frequency of infections.
• Very rare(less than 1 in 10,000 treated patients) decreased platelet count, which may cause more frequent bleeding and bruising; decreased white blood cell count (leukopenia), which may lead to more frequent infections; concurrent abnormal reduction of red and white blood cell count (pancytopenia).
• Frequency not known(cannot be estimated from the available data) rash that may be accompanied by joint pain.

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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Pantoprazole Mercapharm

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 or bottle (after the expiration date). The expiry date refers to the last day of the given month. Tablet packaging: Shelf life after opening: 90 days. Storage conditions: Tablet packaging: Do not store above 25°C. Blister: Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazole Mercapharm contains

• The active substance of the medicine is pantoprazole. Each tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• Other ingredients of the medicine are:

Tablet core: Microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. Colored coating: Polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), aluminum lake of quinoline yellow (E104). Enteric coating: Methacrylic acid - ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triethyl citrate (E1505), talc (E553b).

What Pantoprazole Mercapharm looks like and what the packaging contains

Pantoprazole Mercapharm 20 mg has the form of a prolonged-release tablet with a yellow to ochre color. Pantoprazole Mercapharm 20 mg is available in: Tablet packaging (HDPE bottles with HDPE or PP caps with a desiccant) containing 7, 14, 28, 30, 50, or 90 gastro-resistant tablets. Blisters (aluminum/aluminum blisters) containing 7, 14, 28, 30, 56, 90, or 98 gastro-resistant tablets.

Marketing authorization holder and manufacturer

TOWA Pharmaceutical Europe, S.L., C/ de Sant Martí, 75-97, 08107 Martorelles (Barcelona), Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Approval date of the leaflet: