Pantoprazole towa pharmaceutical europe

Package leaflet: Information for the user

Pantogen 40 mg
40 mg, enteric-coated tablets
( Pantoprazole )
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Pantogen 40 mg is and what it is 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 package and other information

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

Pantoprazole is a selective "proton pump inhibitor," a medicine that reduces the amount of acid
produced in the stomach. It is used in the treatment of stomach and intestinal disorders related to stomach acid.
Pantogen 40 mg is used to treat:
Adults and adolescents from 12 years of age:

• Gastro-oesophageal reflux disease (GORD) – inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with regurgitation of stomach acid.

Adults:

• Infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and gastric ulcers, in combination with two antibiotics (eradication therapy). The aim is to eliminate the bacteria and thereby reduce the likelihood of ulcer recurrence.
• Gastric and duodenal ulcers
• Zollinger-Ellison syndrome and other conditions characterized by excessive acid production in the stomach.

1. Important information before using Pantogen 40 mg

When not to use Pantogen 40 mg

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

Warnings and precautions
Before starting treatment with Pantogen 40 mg, discuss this with your doctor or pharmacist:

• if the patient has severe liver disease. If there has ever been liver disease in the past, inform the doctor. The doctor will monitor liver enzymes more frequently, especially if Pantogen 40 mg is used for a prolonged period. If liver enzymes rise, treatment should be discontinued,
• if the patient has low vitamin B12 levels in the body or risk factors for vitamin B12 deficiency and is receiving Pantogen 40 mg for a long time. Like all acid-reducing medicines, Pantogen 40 mg may lead to reduced absorption of vitamin B12,
• if the patient is taking HIV protease inhibitors, such as atazanavir (used in the treatment of HIV infection), at the same time as Pantogen 40 mg, medical advice should be sought,
• if the patient has previously experienced a skin reaction after using a medicine similar to pantoprazole that reduces gastric acid secretion,
• if the patient is scheduled for a blood test to determine chromogranin A levels.

If the patient develops a skin rash, especially in areas exposed to sunlight,
the doctor should be informed as soon as possible, as treatment with Pantogen 40 mg may need to be discontinued.
Also report any other adverse effects occurring, such as joint pain.
Immediately inform the doctor if any of the following symptoms occur:

• unintentional weight loss,
• recurrent vomiting,
• difficulty swallowing,
• vomiting blood,
• paleness and weakness (anaemia),
• presence of blood in the stool,
• severe or persistent diarrhoea, as Pantogen 40 mg is associated with a slightly increased risk of infectious diarrhoea.

The doctor may decide to perform certain tests to rule out tumour disease, as Pantogen 40 mg also alleviates symptoms of tumours and may delay diagnosis. If symptoms persist despite treatment, further diagnostic tests will be considered.
If the patient takes Pantogen 40 mg for a long time (over one year), the doctor will likely recommend regular check-ups. During each doctor's visit, report any new or unusual symptoms or conditions.
Long-term use (more than one year) of a proton pump inhibitor such as pantoprazole may slightly increase the risk of fractures of the hip, wrist, and spine. Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).
Pantogen 40 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pantogen 40 mg may affect the effectiveness of other medicines, so inform the doctor if the patient is taking:

• medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), as Pantogen 40 mg may inhibit the proper action of these and other similar medicines,
• warfarin and phenprocoumon, which affect blood clotting or thinning. Additional monitoring tests may be required,
• 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 psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend reducing the dose,
• rifampicin (used to treat infections),
• St. John's wort ( Hypericum perforatum ) (used to treat mild depression).
  Pregnancy and breastfeeding
  If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Do not use this medicine if the patient is pregnant or breastfeeding unless the doctor considers
the benefits to the patient to outweigh the potential risk to the unborn child or infant.
Driving and operating machinery
If adverse effects such as dizziness or visual disturbances occur, do not drive or operate machinery.
Pantogen 40 mg contains lactose and sodium
Pantogen 40 mg contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Pantogen 40 mg

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
When and how to take Pantogen 40 mg
The tablets should be taken one hour before a meal. Do not chew or crush them. Swallow the tablets whole,
with a small amount of water.
Unless otherwise directed by your doctor, the recommended dose is:
Adults and adolescents from 12 years of age:
For treatment of reflux oesophagitis
The recommended dose is 1 tablet daily. Your doctor may recommend increasing the dose to 2 tablets daily.
Treatment for reflux oesophagitis usually lasts from 4 to 8 weeks. Your doctor will determine how long you should take the medicine.
Adults:
For treatment of infection with a bacterium called Helicobacter pylori in patients with duodenal and gastric ulcers, in combination with 2 antibiotics (eradication therapy).
1 tablet twice daily plus 2 antibiotics in tablet form (chosen from the following: amoxicillin, clarithromycin and metronidazole (or tinidazole)), which should be taken twice daily together with Pantogen 40 mg tablets. The first tablet of Pantogen 40 mg should be taken one hour before breakfast and the second tablet one 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.
For treatment of gastric and duodenal ulcers
The recommended dose is 1 tablet daily. After consultation with your doctor, this dose may be doubled. Your doctor will determine how long you should take the medicine. Treatment of gastric ulcers usually lasts from 4 to 8 weeks. Treatment of duodenal ulcers usually lasts from 2 to 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive gastric acid production
The recommended initial dose is 2 tablets daily.
Both tablets should be taken one hour before meals. Your doctor may later adjust the dose depending on the amount of acid produced in the stomach. If your doctor prescribes more than 2 tablets daily, the tablets should be taken twice daily.
If your doctor prescribes a daily dose exceeding 4 tablets, he or she will clearly advise when to stop taking the medicine.
Special patient groups:

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

Taking more than the recommended dose of Pantogen 40 mg
Consult your doctor or pharmacist. Symptoms of overdose are not known.
Missed 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 Pantogen 40 mg
Do not stop taking this medicine without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse symptoms occur, stop taking the medicine immediately and inform your doctor
or go to the emergency department of the nearest hospital:
Rare (may affect up to 1 in 1,000 patients)

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

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

• Severe skin reactions: development of blisters on the skin and rapid deterioration of general condition, erosions (with slight bleeding) of the eyes, nose, mouth/lips or genital organs (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), rash sometimes accompanied by joint pain and photosensitivity,
• Other severe disorders: yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice) or fever, rash, enlarged kidneys sometimes with painful urination and back pain (serious kidney inflammation which may lead to kidney failure)

If the patient takes pantoprazole for longer than three months, blood magnesium levels may decrease.
Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If the patient observes any of the above symptoms, the doctor should be informed immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor magnesium levels.
Other adverse reactions include:

• Common (may affect up to 1 in 10 patients): benign gastric polyps
• Uncommon (may affect up to 1 in 100 patients): Headache; dizziness; diarrhoea; nausea; vomiting; abdominal bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; rash, urticaria, skin eruptions; itching; weakness, feeling of exhaustion or general malaise; sleep disturbances, fractures of the hip, wrist or spine.
• Rare (may affect up to 1 in 1,000 patients): distortion or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; limb swelling (peripheral oedema); allergic reactions; depression; gynaecomastia in males
• Frequency not known (frequency cannot be estimated from the available data): hallucinations, confusion (particularly in patients with such symptoms in their history); paraesthesia.

Adverse reactions observed in blood tests:

• Uncommon (may affect up to 1 in 100 patients): Increased liver enzyme activity
• Rare (may affect up to 1 in 1,000 patients): Increased bilirubin concentration, increased blood lipid levels
• Frequency not known (frequency cannot be estimated from the available data): decreased sodium levels in blood

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine. Adverse reactions 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 stated on the pack after EXP. The expiry date refers to the last day of the stated month.
Blister packs: Do not store above 30°C. Store in the original packaging.
Bottles: No special requirements regarding storage temperature. 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 enteric-coated tablet contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• 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-ethyl acrylate copolymer, triethyl citrate, polyvinyl alcohol, polyethylene glycol 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 oblong in shape.
Packaging: plastic bottles and blister packs.
Pantogen 40 mg is available in the following pack sizes:
7, 14, 15, 28, 30, 50, 56, 60, 100 and 250 enteric-coated 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

For further information about this medicinal product and its trade names in the European Economic Area countries, please contact the representative of the marketing authorisation holder:
TOWA Pharmaceutical Europe, S.L.
Tel: +34 93 446 00 00