Pantopraz 20 mg

Leaflet attached to the packaging: information for the user

Pantopraz 20 mg

20 mg, enteric-coated tablets
Pantoprazolum

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pantopraz 20 mg and what is it used for
• 2. Important information before taking Pantopraz 20 mg
• 3. How to take Pantopraz 20 mg
• 4. Possible side effects
• 5. How to store Pantopraz 20 mg
• 6. Contents of the packaging and other information

1. What is Pantopraz 20 mg and what is it used for

Pantopraz 20 mg is a selective "proton pump inhibitor", a medicine that reduces the secretion of hydrochloric acid in the stomach. It is used to treat stomach and intestinal diseases associated with the secretion of hydrochloric acid.

Pantopraz 20 mg is used in:

Adults and adolescents aged 12 and over:

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

Adults:

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

2. Important information before taking Pantopraz 20 mg

When not to take Pantopraz 20 mg

Warnings and precautions

Before starting treatment with Pantopraz 20 mg, the patient should consult a doctor:

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 Pantopraz 20 mg. The patient should also tell their doctor about any other side effects, such as joint pain.
In case of the following symptoms, 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 Pantopraz 20 mg is associated with a slight increase in the risk of infectious diarrhea.

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.
If the patient takes Pantopraz 20 mg for a longer period (more than 1 year), they will likely be under constant medical supervision. In this case, the patient should report any new and unexpected symptoms and circumstances during each visit to the doctor.
When taking proton pump inhibitors like Pantopraz 20 mg, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis) - see also section 4.

Children

Pantopraz 20 mg is not recommended for use in children under 12 years of age due to the lack of sufficient data on the use of the medicine in this age group.

Pantopraz 20 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should remember to inform their doctor about treatment with Pantopraz 20 mg if another medicine is prescribed during treatment.
Pantopraz 20 mg may affect the efficacy of other medicines, so the patient should tell their doctor if they are taking:

• medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections), or erlotinib (used to treat certain types of cancer), as Pantopraz 20 mg may inhibit the proper functioning of these and other medicines,
• warfarin or phenprocoumon, which affect blood density. Further tests may be necessary.
• atazanavir (used to treat HIV infection).

Pantopraz 20 mg with food and drink

Enteric-coated tablets should be taken 1 hour before meals, whole, without chewing or crushing, with water.

Pregnancy, breastfeeding, and fertility

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.
Experience with the use of the medicine in pregnant women is limited.
It has been found that the active substance of the medicine passes into breast milk.
The medicine may be used in pregnant women or women who cannot rule out pregnancy, or breastfeeding women only if the doctor considers that the benefit of its use is greater for the mother than the potential risk to the unborn child or infant.

Driving and using machines

The patient should not drive vehicles or operate machines if they experience side effects such as dizziness or vision disturbances.
Pantopraz 20 mg contains lactose(a sugar found in milk).
If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Pantopraz 20 mg

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.

When and how to take Pantopraz 20 mg

Enteric-coated tablets should be taken 1 hour before meals, whole, without chewing or crushing, with water.

Dosage

If the doctor has not prescribed a different dosage, the usual dose is:
Adults and adolescents aged 12 and over:

In 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 to take the medicine. Recurring symptoms can be controlled by taking one tablet per daywhen necessary.

In the long-term treatment and prevention of recurrence of reflux esophagitis

The usual dose is one tablet per day. If the symptoms of the disease return, the doctor may prescribe a double dose. In this case, one tablet per day of Pantopraz 40 mg can be used. After the symptoms have subsided, the dose can be reduced again to onetablet (20 mg) per day.
Adults

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

The usual dose is one tablet per day.

Special patient groups:

• In the case of severe liver disease, the patient should not take more than one 20 mg tablet per day.
• Children under 12 years of age. Tablets are not recommended for use in children under 12 years of age.

Use of a higher than recommended dose of Pantopraz 20 mg

Symptoms of overdose are not known.
The patient should immediately consult their doctor or pharmacist in case of taking a higher dose of the medicine than recommended.

Missing a dose of Pantopraz 20 mg

In case of missing a dose, the patient should start taking the medicine from the next planned dose.
The patient should not take a double dose to make up for the missed dose.

Discontinuation of Pantopraz 20 mg

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of the following side effects, the patient should immediately inform their doctor or contact the nearest hospital where emergency services are provided:

Severe allergic reactions (rarely):

swelling of the tongue and (or) throat, difficulty swallowing, hives (rash like after nettle burn), difficulty breathing, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.

Severe skin reactions (frequency unknown):

formation of blisters on the skin and sudden deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema) and hypersensitivity to light.

Other severe reactions (frequency unknown):

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:

• Frequently(in 1 to 10 out of 100 treated patients) mild gastric polyps.
• Less frequently(in 1 to 10 out of 1,000 treated patients): headache, dizziness; diarrhea, nausea, vomiting, feeling of fullness in the abdominal cavity and bloating with gas (gas), constipation, dryness in the mouth, abdominal pain and discomfort; skin rash, redness, skin eruptions, itching; fractures of the hip, wrist, or spine; weakness, fatigue, or general malaise; sleep disorders.
• Rarely(in 1 to 10 out of 10,000 treated patients): disorders or complete loss of taste; vision disorders, such as blurred vision; hives; joint pain, muscle pain; weight changes; elevated body temperature, high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.
• Very rarely(less often than in 1 out of 10,000 treated patients): orientation disorders.
• Frequency unknown(cannot be determined based on available data): hallucinations, confusion (especially in patients who have had such symptoms before); decreased sodium levels in the blood; rash that may be accompanied by joint pain; feeling of tingling, prickling, burning, or numbness, colitis causing persistent watery diarrhea. If the patient takes Pantopraz 20 mg for more than three months, they may experience a decrease in blood magnesium levels, which can cause fatigue, tetany, confusion, seizures, dizziness, and cardiac arrhythmias. If the patient experiences any of these symptoms, they should inform their doctor. Low magnesium levels in the blood can also lead to decreased potassium and calcium levels in the blood. The doctor may decide to perform periodic tests to monitor the patient's blood magnesium levels.

Side effects detected by blood tests that may occur:

• Less frequently(in 1 to 10 out of 1,000 treated patients): increased liver enzyme activity.
• Rarely(in 1 to 10 out of 10,000 treated patients): increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells, which can cause more frequent infections.
• Very rarely(less often than in 1 out of 10,000 treated patients): decreased platelet count, which can cause more frequent bleeding and bruising; decreased white blood cell count, which can lead to more frequent infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Pantopraz 20 mg

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Store in the original packaging, at a temperature below 25°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 Pantopraz 20 mg contains

• The active substance of the medicine is 20 mg of pantoprazole in the form of pantoprazole sodium sesquihydrate.
• Other ingredients are:
• microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal silica anhydrous, magnesium stearate;
• Opadry II 85F32081 Yellow: partially hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, yellow iron oxide (E 172), chinolinic yellow lake (E 104);
• enteric coating: methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

What Pantopraz 20 mg looks like and what the packaging contains

Yellow, elongated tablets.
Available packaging:
A plastic container containing 14, 28, or 30 enteric-coated tablets in a cardboard box.
Aluminum/Aluminum blisters containing 14, 28, 30, or 56 enteric-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500

Manufacturer:

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona
Spain
Date of last revision of the leaflet:16.06.2020