Pantopraz 40 mg

Leaflet attached to the packaging: information for the user

Pantopraz 40 mg

40 mg, gastro-resistant tablets
Pantoprazolum

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pantopraz 40 mg and what is it used for
• 2. Important information before taking Pantopraz 40 mg
• 3. How to take Pantopraz 40 mg
• 4. Possible side effects
• 5. How to store Pantopraz 40 mg
• 6. Contents of the packaging and other information

1. What is Pantopraz 40 mg and what is it used for

Pantopraz 40 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 hydrochloric acid secretion.

Pantopraz 40 mg is used to treat:

Adults and adolescents aged 12 years and older:

• Reflux esophagitis. This is an inflammatory condition of the esophagus (the tube that connects the throat to the stomach) in which acid from the stomach flows back into the esophagus.

Adults:

• Infections with the bacterium Helicobacter pyloriin patients with stomach and/or duodenal ulcers, in combination with 2 antibiotics (eradication therapy), in order to eliminate the bacteria and prevent recurrence of ulcers.
• Stomach and/or duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before taking Pantopraz 40 mg

When not to take Pantopraz 40 mg

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• if you have been diagnosed with an allergy to other proton pump inhibitors.

Warnings and precautions

Before taking Pantopraz 40 mg, you should discuss this with your doctor:

• if you have severe liver problems. You should inform your doctor if you have ever had liver problems. Your doctor may order more frequent monitoring of liver enzyme activity, especially if you are taking long-term treatment with Pantopraz 40 mg. If liver enzyme activity increases, the use of the medicine should be discontinued.
• if you need to take non-steroidal anti-inflammatory drugs (NSAIDs) regularly and also take Pantopraz 40 mg, due to the increased risk of stomach or intestinal complications. The increased risk will be assessed according to the risk factors for the individual patient, such as age (65 years or older), stomach or duodenal ulcers in the medical history, or stomach or intestinal bleeding.
• if you have a vitamin B12 deficiency or risk factors indicating a possible decrease in vitamin B12 levels, and you are being treated with pantoprazole long-term. Like all medicines that reduce hydrochloric acid secretion in the stomach, pantoprazole may lead to reduced absorption of vitamin B12.
• if you are taking a medicine containing atazanavir (used to treat HIV infection) at the same time as pantoprazole, you should ask your doctor for detailed advice.
• if you have ever had a skin reaction after taking a medicine similar to Pantopraz 40 mg, which reduces stomach acid secretion.
• if you are going to have a specific blood test (chromogranin A levels).
• if you are taking pantoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should tell your doctor immediately. Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. Your doctor may order regular blood tests to monitor your magnesium levels.

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantopraz 40 mg. You should also tell your doctor about any other side effects, such as joint pain.
If you experience any of the following symptoms, you should immediately inform your doctor:

• unintentional weight loss;
• recurring vomiting;
• difficulty swallowing;
• bloody vomiting;
• pallor and weakness (anemia);
• blood in the stool;
• severe and/or persistent diarrhea, as taking Pantopraz 40 mg is associated with a slight increase in the risk of infectious diarrhea.

Your 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 symptoms persist despite treatment, further tests should be considered.
If you are taking Pantopraz 40 mg for a long period (more than 1 year), you will probably be under constant medical supervision. In this case, you should report any new and unexpected symptoms and the circumstances of their occurrence during each visit to the doctor.
When taking proton pump inhibitors like Pantopraz 40 mg, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. You should inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis) - see also section 4.

Children

Pantopraz 40 mg should not be used 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 40 mg and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You should remember to inform your doctor about treatment with Pantopraz 40 mg if another medicine is prescribed during treatment.
Pantopraz 40 mg may affect the effectiveness of other medicines, so you should tell your doctor if you 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 40 mg may inhibit the proper action of these and other medicines,
• warfarin or phenprocoumon, which affect blood density. Further tests may be necessary.
• if you are taking atazanavir (used to treat HIV infection).

Pantopraz 40 mg with food and drink

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Experience with the use of the medicine in pregnant women is limited.
The active substance of the medicine has been found to pass 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

You should not drive vehicles or operate machinery if you experience side effects such as dizziness or vision disturbances.
Pantopraz 40 mg contains lactose(a sugar found in milk).
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Pantopraz 40 mg

This medicine should always be taken according to the doctor's instructions. If you are unsure, you should ask your doctor or pharmacist.

When and how to take Pantopraz 40 mg

Gastro-resistant tablets should be taken 1 hour before breakfast, whole, without chewing or crushing, with water.
In the case of combination therapy, the second tablet should be taken 1 hour before dinner.

Dosage

If your doctor has not prescribed a different dosage, the usual dose is:

In the treatment of reflux esophagitis

The usual dose is one tablet per day. Your doctor may recommend increasing the dose to 2 tablets per day. The treatment period for reflux esophagitis usually lasts 4 to 8 weeks.
Your doctor will decide how long you should take the medicine.
Adults:
In the treatment of Helicobacter pyloriinfection, in patients with duodenal and/or stomach ulcers, in combination with 2 antibiotics (eradication therapy)

One Pantopraz 40 mg tablet plus two antibiotic tablets [amoxicillin, clarithromycin, or metronidazole (or tinidazole)] twice a day.
The first Pantopraz 40 mg tablet should be taken 1 hour before breakfast, and the second Pantopraz 40 mg tablet 1 hour before dinner.
You should follow the instructions given by your doctor and read the patient information leaflets in the antibiotic packaging. The treatment usually lasts for one to two weeks.

In the treatment of stomach and/or duodenal ulcers

The usual dose is one tablet per day. After consulting your doctor, the dose can be doubled. Your doctor will decide how long you should take the medicine. The treatment period for stomach 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 hydrochloric acid secretion in the stomach

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 your doctor, depending on the amount of hydrochloric acid secreted in the stomach. If more than two tablets per day are prescribed, they should be taken twice a day.
If your doctor prescribes a daily dose greater than four tablets per day, they will inform you when to stop taking the medicine.

Special patient groups:

• In the case of kidney problems, moderate or severe liver damage you should nottake Pantopraz 40 mg for the eradication of Helicobacter pylori.
• In severe liver disease, you should not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).
• Children under 12 years of age. Tablets are not recommended for use in children under 12 years of age.

Taking a higher dose of Pantopraz 40 mg than recommended

Overdose symptoms are not known.
You should immediately consult your doctor or pharmacist if you have taken a higher dose of the medicine than recommended.

Missing a dose of Pantopraz 40 mg

If you miss a dose, you should start taking the medicine from the next planned dose.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Pantopraz 40 mg

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, you should immediately inform your doctor or contact the nearest hospital where emergency services are available:

Severe allergic reactions (rarely):

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 blisters on the skin and sudden deterioration of 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 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:

• Frequently(in 1 to 10 out of 100 treated patients): mild stomach 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, dry mouth, abdominal pain and discomfort; skin rash, redness, skin eruptions, itching; fractures of the hip, wrist, or spine; weakness, fatigue, or general malaise; sleep disturbances.
• 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; changes in body weight; elevated body temperature, high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.
• Very rarely(less frequently than in 1 out of 10,000 treated patients): orientation disorders.
• Frequency not known(cannot be estimated from available data): hallucinations, confusion (especially in patients who have experienced such symptoms before); decreased sodium levels in the blood; rash that may be accompanied by joint pain; feeling of tingling, prickling, numbness, burning, or itching. If you are taking Pantopraz 40 mg for more than three months, you may experience a decrease in blood magnesium levels, which can cause fatigue, muscle cramps, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should inform your doctor. Low magnesium levels in the blood can also lead to decreased potassium and calcium levels in the blood. Your doctor may decide to perform periodic tests to monitor your magnesium levels.

Side effects detected by blood tests:

• 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 frequently 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 cause more frequent infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, you can help provide more information on the safety of this medicine.

5. How to store Pantopraz 40 mg

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 40 mg contains

• The active substance of the medicine is 40 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 85F32029 Yellow coating: polyvinyl alcohol, partially hydrolyzed, macrogol 3350, titanium dioxide (E 171), talc, yellow iron oxide (E 172);
• enteric coating: methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.

What Pantopraz 40 mg looks like and what the packaging contains

Yellow, elongated tablets.
Available packaging:
A plastic container containing 14, 28, or 30 gastro-resistant tablets in a cardboard box.
Aluminum/Aluminum blisters containing 14, 28, 30, or 56 gastro-resistant 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