Pantoprazole Mercapharm

Leaflet accompanying the packaging: patient information

Pantoprazole Mercapharm, 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, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 secretion. It is used to treat stomach and intestinal diseases associated with acid secretion.

Pantoprazole Mercapharm tablets are used to treat:

Adults and adolescents aged 12 and over:

• Reflux esophagitis. This is an inflammatory condition of the esophagus (the tube that connects the throat to the stomach), accompanied by acid reflux.

Adults:

• Infection with the bacterium Helicobacter pyloriin patients with gastric and/or duodenal ulcers, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent recurrence of ulcers.
• Gastric and/or duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion.

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, the patient should discuss it with their doctor, pharmacist, or nurse:

• if they have severe liver function disorders. The patient should inform their doctor if they 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 planned. If liver enzyme activity increases, the use of the medicine should be discontinued.
• if the patient has a vitamin B12 deficiency or risk factors for a decrease in vitamin B12 levels, and is being treated long-term with pantoprazole. Like all medicines that reduce gastric acid secretion, pantoprazole may lead to decreased absorption of vitamin B12.
• 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 40 mg, which reduces stomach acid secretion.
• if the patient takes Pantoprazole Mercapharm 40 mg for more than three months, it is possible that their 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 inform their doctor immediately. 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 inform their doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazole Mercapharm 40 mg. The patient should also inform their doctor about any other side effects, such as joint pain. If the patient experiences any of the following symptoms, they 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 disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered. Taking proton pump inhibitors, such as Pantoprazole Mercapharm 40 mg, especially for a period longer than one 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). If the patient takes Pantoprazole Mercapharm for a long period (more than 1 year), they will likely be under constant medical supervision. In such cases, the patient should report any new and unexpected symptoms and circumstances to their doctor during each visit.

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 if 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 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 operating machinery

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 40 mg after consulting their doctor. This medicinal product contains 2.68 mg of sodium per dose. This should be taken into account in patients on a low-sodium diet.

3. How to take Pantoprazole Mercapharm

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient 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 prescribed a different dosage, the usual recommended dose is:

In the treatment of reflux esophagitis

The usual dose is one tablet per day. The doctor may recommend increasing the dose to 2 tablets per day. The treatment period for reflux esophagitis usually lasts 4 to 8 weeks. The doctor will decide how long the patient should take the medicine. Adults:

In the treatment of infection with the bacterium Helicobacter pylori, in patients with duodenal and/or gastric ulcers, in combination with two antibiotics (eradication therapy).

One tablet twice a day, plus two tablets of antibiotics: amoxicillin, clarithromycin, or metronidazole (or tinidazole) taken twice a day with a pantoprazole tablet. The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet 1 hour before dinner. The patient should follow the instructions given by their doctor and read the patient information leaflets in the antibiotic packaging. The treatment usually lasts for one to two weeks.

In the treatment of gastric and/or duodenal ulcers.

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

In long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid secretion.

The recommended initial dose is usually two tablets per day. Both tablets should be taken 1 hour before a meal. Later, the dosage may be adjusted by the doctor, depending on the amount of acid secreted in the stomach. If the doctor prescribes more than two tablets per day, they should be taken twice a day. If the doctor prescribes a daily dose greater than four tablets per day, they will inform the patient when to stop taking the medicine. Special patient groups:

• In case of kidney disease, moderate or severe liver damage, the patient should nottake Pantoprazole Mercapharm for the eradication of Helicobacter pylori.
• In severe liver disease, the patient should not take more than one 20 mg pantoprazole tablet per day (for this purpose, 20 mg pantoprazole tablets are available). The use of tablets is not recommended in 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 not known.

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 the use of 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 the use of 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 as follows:

very common (more than 1 in 10 patients treated)

common (between 1 and 10 in 100 patients treated)

uncommon (between 1 and 10 in 1,000 patients treated)

rare (between 1 and 10 in 10,000 patients treated)

very rare (less than 1 in 10,000 patients treated)

frequency not known (cannot be estimated from the available data)

In case of any of the following side effects, the patient 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 swelling of the face (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known):formation of skin blisters and severe deterioration of general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals (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 during urination and pain in the lower back (severe kidney inflammation).

Other side effects that may occur:

• Common(between 1 and 10 in 100 patients treated) mild gastric polyps.
• Uncommon(between 1 and 10 in 1,000 patients treated) 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; fractures of the hip, wrist, or spine (in cases where lansoprazole is used in high doses and for a long period).
• Rare(between 1 and 10 in 10,000 patients treated) vision disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; 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 patients treated) 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, pricking, burning, or numbness; colitis (inflammatory condition of the colon) causing persistent watery diarrhea.

Side effects detected by blood tests:

• Uncommon(between 1 and 10 in 1,000 patients treated) increased liver enzyme activity.
• Rare(between 1 and 10 in 10,000 patients treated) increased bilirubin levels; increased fat levels in the blood; significant decrease in white blood cell count (agranulocytosis), which may lead to increased frequency of infections.
• Very rare(less than 1 in 10,000 patients treated) 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 associated with joint pain.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, it is possible to gather more information 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 expiry date). The expiry date refers to the last day of the month. 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 40 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). 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 40 mg has the form of a prolonged-release tablet with a yellowish color. Pantoprazole Mercapharm 40 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:

Date of approval of the leaflet: