Pantoprazol Tova Pharmaceutical Europe

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Pantogen 40 mg

40 mg, gastro-resistant tablets
(Pantoprazolum)

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.
• If you have any further questions, 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Pantoprazole is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and intestinal diseases related to stomach acid.

Pantogen 40 mg is used to treat:

Adults and adolescents from 12 years:

• Reflux esophagitis - esophagitis (the tube connecting the throat to the stomach), accompanied by acid reflux.

Adults:

• Infection with the bacterium called Helicobacter pyloriin patients with duodenal and gastric ulcers in combination with 2 antibiotics (eradication therapy). The goal is to get rid of the bacteria and thus reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers
• Zollinger-Ellison syndrome and other conditions with excessive acid production in the stomach.

1. Important information before taking Pantogen 40 mg

When not to take Pantogen 40 mg

Warnings and precautions

Before starting treatment with Pantogen 40 mg, discuss it with your doctor or pharmacist:

If a rash appears on the skin, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantogen 40 mg. Also, mention any other side effects that occur, such as joint pain.
Tell your doctor immediatelyif you experience any of the following symptoms:

• unintentional weight loss,
• recurring vomiting,
• difficulty swallowing
• vomiting blood
• pallor and weakness (anemia)
• blood in the stool,
• severe or prolonged diarrhea, as Pantogen 40 mg is associated with a slight increase in the incidence of infectious diarrhea.

Your doctor may decide to perform certain tests to rule out cancer, as Pantogen 40 mg also relieves symptoms of cancer and may delay its diagnosis. If symptoms persist despite treatment, further diagnostic tests will be considered.
If you take Pantogen 40 mg for a long time (over a year), your doctor will likely recommend regular check-ups. At each doctor's visit, report any new and unusual symptoms and situations to your doctor.
Taking a proton pump inhibitor like pantoprazole for a period longer than one year may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Pantogen 40 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Pantogen 40 mg may affect the effectiveness of other medicines, so tell your doctor if you are taking:

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantogen 40 mg may inhibit the proper functioning of these and other similar medicines,
• warfarin and phenprocoumon, which affect blood clotting or thinning. Additional control tests may be necessary,
• medicines used to treat HIV infection, such as atazanavir (see section 2 "Warnings and precautions"),
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), as pantoprazole may increase methotrexate levels in the body,
• Fluvoxamine (used to treat depression and other mental disorders - if you are taking fluvoxamine, your doctor may reduce the dose,
• Rifampicin (used to treat infections),
• St. John's Wort ( Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant or breastfeeding, unless your doctor considers that the benefits to you are greater than the potential risk to the unborn child or infant.

Driving and using machines

If you experience side effects such as dizziness or vision disturbances, do not drive or operate machinery.

Pantogen 40 mg contains lactose and sodium

Pantogen 40 mg contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is considered "sodium-free".

3. How to take Pantogen 40 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

When and how to take Pantogen 40 mg

Take the tablets 1 hour before a meal. Do not chew or crush them. Swallow the tablets whole with a small amount of water.
Unless your doctor has told you otherwise, the recommended dose is:
Adults and adolescents from 12 years:

In the treatment of reflux esophagitis

The recommended dose is 1 tablet per day. Your doctor may recommend increasing the dose to 2 tablets per day.
The duration of treatment for reflux esophagitis is usually 4 to 8 weeks. Your doctor will determine how long you should take the medicine.
Adults:

In the treatment of Helicobacter pylori infection in patients with duodenal and gastric ulcers, in combination with 2 antibiotics (eradication therapy)

1 tablet twice a day plus 2 antibiotics in tablets (from the following: amoxicillin, clarithromycin, and metronidazole (or tinidazole)), which should be taken twice a day with a tablet of Pantogen 40 mg. The first tablet of Pantogen 40 mg should be taken 1 hour before breakfast, and the second tablet 1 hour before the evening meal. Follow your doctor's instructions and read the package leaflets of the antibiotics used. Treatment usually lasts 1 to 2 weeks.

In the treatment of gastric and duodenal ulcers

The recommended dose is 1 tablet per day. After consulting your doctor, this dose can be doubled. Your doctor will determine how long you should take the medicine. Treatment of gastric ulcers usually lasts 4 to 8 weeks. Treatment of duodenal ulcers usually lasts 2 to 4 weeks.

In long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive acid production in the stomach

The initial recommended dose is 2 tablets per day.
Both tablets should be taken 1 hour before a meal. Your doctor may later adjust the dose depending on the amount of acid produced in the stomach. If your doctor recommends more than 2 tablets per day, take them twice a day.
If your doctor recommends a daily dose greater than 4 tablets, he will tell you exactly when to stop taking the medicine.

Special patient groups:

• If you have kidney or moderate to severe liver disease, you should not take Pantogen 40 mg for the eradication of Helicobacter pylori.
• If you have severe liver disease, you should not take more than 1 tablet of Pantogen 20 mg per day (for this purpose, tablets containing 20 mg of pantoprazole are available).
• Children under 12 years. This medicine is not recommended for children under 12 years.

Taking a higher dose of Pantogen 40 mg than recommended

Consult your doctor or pharmacist. The symptoms of overdose are not known

Missing a dose of Pantogen 40 mg

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time

Stopping treatment with Pantogen 40 mg

Do not stop taking the medicine without consulting your doctor or pharmacist first
If you have any further questions about the use of this medicine, 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, stop taking the medicine and tell your doctor or go to the emergency room immediately:

Rare(may affect up to 1 in 1000 people)

• severe allergic reactions:swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and sweating,
• reduced number of white and red blood cells and/or platelets, which may be visible in blood tests. You may also notice more frequent infections, bruising, or bleeding more often than usual.

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

• severe skin changes: blistering of the skin and rapid deterioration of the general condition, ulcers (with minor bleeding) of the eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), rash, sometimes with accompanying joint pain and hypersensitivity to light,
• other severe disorders:yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, kidney enlargement sometimes with painful urination and back pain (severe kidney inflammation, which can lead to kidney failure)

If you take pantoprazole for more than three months, it is possible that your blood magnesium level may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and rapid heartbeat. If you notice any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
Other side effects are:

• Common(may affect up to 1 in 10 people) mild gastric polyps
• - Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhea; nausea; vomiting; abdominal bloating and gas; constipation; dry mouth; abdominal pain and discomfort; rash, itching, skin eruptions; weakness, feeling of tiredness or general malaise; sleep disturbances, hip, wrist, or spine fractures.
• - Rare(may affect up to 1 in 1000 people) distortion or complete loss of taste; vision disturbances, such as blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; peripheral edema; allergic reactions; depression; breast enlargement in men
• - Frequency not known(frequency cannot be estimated from the available data) hallucinations, confusion (especially in patients with a history of these symptoms); tingling.

Side effects detected in blood tests:

• Uncommon(may affect up to 1 in 100 people) Elevated liver enzyme activity
• - Rare(may affect up to 1 in 1000 people) Elevated bilirubin levels, elevated fat levels in the blood
• - Frequency not known(frequency cannot be estimated from the available data) decreased sodium levels in the blood

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, 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 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, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Pantogen 40 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
Blister packs: Do not store the medicine at temperatures above 30°C. Store in the original packaging.
Bottles: There are no special storage instructions. Store in the original packaging..
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pantogen 40 mg contains

• The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate. The coating contains sodium lauryl sulfate, polysorbate 80, methacrylic acid, and ethyl acrylate copolymer, triethyl citrate, polyvinyl alcohol, macrogol 3350, titanium dioxide, talc, and yellow iron oxide (see section 2 "Pantogen 40 mg contains lactose and sodium")..

What Pantogen 40 mg looks like and contents of the pack

The tablets are pale yellow to yellow-brown and oval.
Packaging: plastic bottles and blister packs.
Pantogen 40 mg is available in packs of the following sizes:
Packs of 7, 14, 15, 28, 30, 50, 56, 60, 100, and 250 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer:

TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97, 08107
Martorelles (Barcelona), Spain
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder:

TOWA Pharmaceutical Europe, S.L.

Tel: +34 93 446 00 00

Date of last revision of the leaflet: 24/05/2022