Pantoprazol Tova Pharmaceutical Europe

PATIENT INFORMATION LEAFLET

Enclosed leaflet: 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.

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 gut conditions related to acid.

Pantogen 40 mg is used to treat:

Adults and adolescents from 12 years:

• Reflux oesophagitis - inflammation of the oesophagus (the tube that connects the throat to the stomach), accompanied by acid reflux.

Adults:

• Infection with a bacterium called Helicobacter pyloriin patients with duodenal and gastric ulcers in combination with 2 antibiotics (eradication therapy). The goal is to eliminate 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

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to medicines containing other proton pump inhibitors.

Warnings and precautions

Before taking Pantogen 40 mg, discuss with your doctor or pharmacist:

• if you have severe liver disease. If you have ever had liver disease, tell your doctor. Your doctor will monitor your liver enzymes more closely, especially if you are taking Pantogen 40 mg for a long time. If your liver enzymes increase, treatment should be stopped,
• if you have a low level of vitamin B12 in your body or risk factors for low vitamin B12 levels and are taking Pantogen 40 mg for a long time. Like all acid-suppressing medicines, Pantogen 40 mg may lead to reduced absorption of vitamin B12,
• if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as Pantogen 40 mg, consult your doctor,
• if you have ever had a skin reaction after taking a medicine similar to pantoprazole, which reduces stomach acid,
• if you are going to have a blood test to check your chromogranin A level.

If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop taking Pantogen 40 mg. Also, mention any other side effects, such as joint pain.
Tell your doctor immediatelyif you experience any of the following symptoms:

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

Your doctor may decide to perform certain tests to rule out cancer, as Pantogen 40 mg also relieves the symptoms of cancer and may delay its diagnosis. If the symptoms persist despite treatment, further diagnostic tests will be considered.
If you are taking Pantogen 40 mg for a long time (more than a year), your doctor will probably recommend regular check-ups. At each medical visit, report any new or unusual symptoms and situations to your doctor.
Taking a proton pump inhibitor like pantoprazole for more 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 can increase the risk of osteoporosis).

Pantogen 40 mg and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about 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 monitoring 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 the level of methotrexate 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 baby, ask your doctor or pharmacist for advice 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 baby.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, 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 an intolerance to some sugars, contact your doctor before taking the medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "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 little water.
Unless your doctor has told you otherwise, the recommended dose is:
Adults and adolescents from 12 years:

In the treatment of reflux oesophagitis

The recommended dose is 1 tablet per day. Your doctor may increase the dose to 2 tablets per day.
The duration of treatment for reflux oesophagitis is usually 4 to 8 weeks. Your doctor will determine how long you should take the medicine.
Adults:
In the treatment of infection with the bacterium Helicobacter pyloriin 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. Take the first tablet of Pantogen 40 mg 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. The 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. The treatment of gastric ulcers usually lasts 4 to 8 weeks. The treatment of duodenal ulcers usually lasts 2 to 4 weeks.

In the 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.
Take both tablets 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 (20 mg pantoprazole tablets are available for this purpose).
• Children under 12 years. This medicine is not recommended for children under 12 years.

Taking a higher dose of Pantogen 40 mg than recommended

Contact 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 forgotten 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 department of your nearest hospital:

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 oedema/angioedema), severe dizziness with very fast heartbeat and sweating,
• reduced number of white and red blood cells and/or platelets, which may be seen in blood tests. You may also notice more frequent infections, bruising, or bleeding more often than normal.

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

• severe skin changes: blisters on 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 sensitivity 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 can 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 low 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 stomach polyps
• - Uncommon(may affect up to 1 in 100 people) Headache; dizziness; diarrhoea; nausea; vomiting; abdominal bloating and gas; constipation; dry mouth; abdominal pain and discomfort; rash, itching, skin eruptions; weakness, fatigue, or general malaise; sleep disorders, fractures of the hip, wrist, or spine.
• - Rare(may affect up to 1 in 1000 people) distortion or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs (peripheral oedema); 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 authorisation 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 authorisation 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Blister packs: Do not store above 30°C. Store in the original package.
Bottles: No special storage precautions.
Store in the original package..
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 (as 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 brownish-yellow and oval.
Packaging: plastic bottles and blister packs.
Pantogen 40 mg is available in packs of:
Packs of 7, 14, 15, 28, 30, 50, 56, 60, 100, and 250 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing authorisation 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 this medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorisation holder:

TOWA Pharmaceutical Europe, S.L.

Tel: +34 93 446 00 00

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