Anesteloc 40 mg

Package leaflet: Information for the patient

Anesteloc 40 mg, 40 mg, enteric-coated tablets
Pantoprazole
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Anesteloc 40 mg is a selective "proton pump inhibitor," a medicine that reduces
gastric acid secretion. It is used in the treatment of stomach and intestinal disorders related
to hydrochloric acid secretion.
Anesteloc 40 mg is used to treat:
Adults and adolescents aged 12 years and older:

• Gastroesophageal reflux disease (GERD). This is inflammation of the esophagus (the tube connecting the throat to the stomach), associated with backflow of stomach acid.

Adults:

• Helicobacter pylori infection in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent ulcer recurrence.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion.

2. Important information before using Anesteloc 40 mg

When not to use Anesteloc 40 mg

• If the patient is allergic to pantoprazole, soy lecithin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has had an allergic reaction to medicines containing other proton pump inhibitors.

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

• If the patient has severe liver function impairment. Inform the doctor if there has ever been any liver disorder. The doctor may recommend more frequent monitoring of liver enzyme activity, especially during long-term treatment with Anesteloc 40 mg. If liver enzyme activity increases, treatment should be discontinued.
• If the patient has vitamin B__ deficiency or risk factors indicating possible reduced vitamin B__ levels and is undergoing long-term treatment with pantoprazole. As with all drugs that reduce (inhibit) gastric hydrochloric acid secretion, pantoprazole may lead to reduced absorption of vitamin B__. Contact your doctor if any of the following symptoms occur, which may indicate low vitamin B__ levels:
  • unusually severe fatigue or lack of energy,
  • numbness or tingling sensations,
  • pain or redness of the tongue, mouth ulcers,
  • muscle weakness,
  • vision disturbances,
  • memory problems, disorientation, depression.
• If the patient is taking HIV protease inhibitors such as atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, they should seek detailed advice from their doctor.
• If the patient has ever experienced a skin reaction due to taking a medicine similar to Anesteloc 40 mg that reduces gastric acid secretion.
• Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. Treatment with pantoprazole should be discontinued and immediate medical advice sought if any symptoms related to these serious skin reactions described in section 4 occur.
• If the patient has been taking pantoprazole for more than three months, magnesium levels in the blood may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

Before taking this medicine, inform your doctor about a planned specific blood test
(measurement of chromogranin A levels).
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Anesteloc 40 mg may be necessary. Also report any other adverse effects occurring, such as joint pain.
If any of the following symptoms occur, contact the doctor immediately:

• unintentional weight loss,
• recurrent vomiting,
• difficulty swallowing or pain when swallowing,
• vomiting blood, which may look like dark coffee grounds,
• paleness and weakness (anaemia),
• blood in stools, black or tarry stools,
• chest pain,
• abdominal pain,
• severe and/or persistent diarrhoea, as use of Anesteloc 40 mg is associated with a slightly increased risk of infectious diarrhoea.

The doctor may decide that tests are necessary to rule out an underlying tumour disease, as treatment with pantoprazole may relieve symptoms of tumour disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Anesteloc 40 mg is taken for a prolonged period (over 1 year), the patient will likely remain under continuous medical supervision. In such cases, report any new or unexpected symptoms and circumstances of their occurrence during each doctor visit.
Taking proton pump inhibitors such as Anesteloc 40 mg, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform the doctor if osteoporosis (reduced bone density) has been diagnosed or if corticosteroid medicines (which may increase the risk of osteoporosis) are being taken.

Anesteloc 40 mg and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Anesteloc 40 mg may affect the effectiveness of other medicines, so inform your doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), because pantoprazole may inhibit the proper action of these and other medicines.
• Warfarin, phenprocoumon, which affect blood clotting. Further testing may be required.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancerous diseases); when methotrexate is used, the doctor may temporarily discontinue Anesteloc, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used to treat depression and other psychiatric disorders); if fluvoxamine is taken, the doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's wort (Hypericum perforatum) (used to treat mild depression).

Before starting pantoprazole, discuss this with your doctor if a specific urine test [for tetrahydrocannabinol (THC)] is to be performed.

Anesteloc 40 mg with food and drink
Take the medicine 1 hour before a meal, without chewing or dividing the tablet. Swallow whole with water.

Pregnancy, breastfeeding, and fertility
Experience with use in pregnant women is limited. It has been shown that the active substance passes into breast milk.
This medicine may be used in pregnant women, women who may be pregnant, or women who are breastfeeding only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Anesteloc 40 mg has no effect or negligible effect on the ability to drive motor vehicles or operate mechanical equipment.
Do not drive motor vehicles or operate machinery if the patient experiences adverse effects such as dizziness or vision disturbances.

Anesteloc 40 mg contains soy lecithin.
Do not use this medicine if allergic to peanuts or soy.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., the medicine is considered "sodium-free."

3. How to use Anesteloc 40 mg

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose
If your doctor has not advised otherwise, the usual dose is:
Adults and adolescents aged 12 years and older:
For 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:
For the treatment of infection with the bacterium called Helicobacter pylori , in patients with duodenal
and/or gastric ulcers, in combination with two antibiotics (eradication therapy)
One tablet twice daily plus two antibiotic tablets: amoxicillin, clarithromycin, or
metronidazole (or tinidazole), each taken twice daily together with a pantoprazole tablet.
The first pantoprazole tablet should be taken 1 hour before breakfast, and the second
pantoprazole tablet 1 hour before dinner. Follow your doctor's instructions and
read the package leaflets provided with the antibiotic packages. Treatment usually lasts
from one to two weeks.
For the treatment of gastric and/or duodenal ulcers
The usual dose is one tablet per day. After consultation with your doctor, the dose may be
doubled. Your doctor will decide how long you should take the medicine. The treatment period
for gastric ulcers usually lasts from 4 to 8 weeks. The treatment period for duodenal ulcers
usually lasts from 2 to 4 weeks.
For long-term treatment of Zollinger-Ellison syndrome and other conditions
associated with excessive hydrochloric acid secretion
The usual initial dose is two tablets per day.
Both tablets should be taken 1 hour before a meal. The dosage may later be adjusted by
your doctor, depending on the amount of hydrochloric acid secreted in the stomach.
If a daily dose greater than two tablets is prescribed, they should be taken in two divided doses.
If your doctor prescribes a daily dose exceeding four tablets, you will be specifically informed
when to stop taking the medicine.
Patients with impaired kidney function
In case of kidney disease, do not take Anesteloc 40 mg for the eradication of
Helicobacter pylori.
Patients with impaired liver function
In severe liver disease, do not take more than one 20 mg pantoprazole tablet per day
(for this purpose, tablets containing 20 mg pantoprazole are available).
Do not take Controloc 40 for the eradication of Helicobacter pylori in moderate or severe
liver disease.
Use in children and adolescents
The tablets are not recommended for use in children under 12 years of age.
Taking more than the recommended dose of Anesteloc 40 mg
Consult a doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Anesteloc 40 mg
Do not take a double dose to make up for a missed dose. Take the next scheduled dose
at the usual time.
Stopping Anesteloc 40 mg
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The occurrence of adverse reactions is defined according to the following frequency categories:

• very common (affects more than 1 in 10 people)
• common (affects up to 1 in 10 people)
• uncommon (affects up to 1 in 100 people)
• rare (affects up to 1 in 1,000 people)
• very rare (affects up to 1 in 10,000 people)
• frequency not known (cannot be estimated from the available data)

If any of the following adverse reactions occur,
seek immediate medical attention by contacting your doctor or visiting the nearest hospital with an emergency department:

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing,
  urticaria (rash similar to nettle rash), difficulty breathing, angioedema (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known): blistering of the skin and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, oral cavity/mouth, or genital organs, or rash, particularly in sun-exposed skin areas. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes. Red, non-elevated spots or circular lesions on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs, and eyes. Such severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• 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 kidney enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions occurring:

• Common (affects up to 1 in 10 people): benign gastric polyps.
• Uncommon (affects up to 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with passing wind (flatulence); constipation; dry mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, fatigue, or general malaise; sleep disturbances, fractures of the hip, wrist, or spine.
• Rare (affects up to 1 in 1,000 people): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of limbs (peripheral oedema); allergic reactions; depression, gynaecomastia (enlargement of breasts in males).
• Very rare (affects up to 1 in 10,000 people): disturbances in orientation.
• Frequency not known (cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); decreased sodium levels in blood, rash associated with joint pain, sensations of tingling, pricking, numbness, burning, or paraesthesia; colitis causing persistent watery diarrhoea.

If Anesteloc 40 mg has been taken for longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms are observed, inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

Adverse reactions identified through blood tests occurring:

• Uncommon (affects up to 1 in 100 people): increased liver enzyme activity.
• Rare (affects up to 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating granulocytes—white blood cells—associated with high fever.
• Very rare (affects up to 1 in 10,000 people): decreased platelet count, which may lead to increased bleeding and bruising; decreased white blood cell count, which may increase susceptibility to infections; concurrent, abnormal reduction in red blood cells, white blood cells, and platelets.
• Frequency not known (cannot be estimated from the available data): decreased levels of sodium, magnesium, calcium, or potassium in blood (see section 2).

If any adverse reaction worsens or if any adverse reaction not listed in this leaflet occurs, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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.

5. How to store Anesteloc 40 mg

Keep the medicine out of sight and reach of children.
Store below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Anesteloc 40 mg contains

• The active substance is pantoprazole. Each tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• Other ingredients are:
  Core: mannitol, crospovidone, hydroxypropylcellulose, sodium lauryl sulfate, colloidal anhydrous silica, talc, magnesium stearate.
  Coating: Opadry AMB light yellow 80W220017, which contains: polyvinyl alcohol, titanium dioxide (E171), talc, yellow iron oxide (E172), quinoline yellow, aluminium lake (E104), soy lecithin, xanthan gum.
  Enteric coating: methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, glyceryl monostearate, triethyl citrate.

What Anesteloc 40 mg looks like and contents of the pack
Anesteloc 40 mg is a light yellow, round, biconvex tablet coated with a shiny, transparent film.
The pack contains 14, 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05 – 152 Czosnów
tel. 22 732 77 00

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05 – 152 Czosnów