Anesteloc 40 mg

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: patient information

Anesteloc 40 mg, 40 mg, gastro-resistant tablets

Pantoprazole

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Anesteloc 40 mg is a selective "proton pump inhibitor", a medicine that reduces acid production in the stomach. It is used to treat stomach and intestinal diseases associated with acid production.

Anesteloc 40 mg is used to treat:

• Reflux esophagitis. This is an inflammatory condition of the esophagus (the tube that connects the throat to the stomach), accompanied by acid reflux from the stomach.

Adults and adolescents aged 12 and over:

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

2. Important information before taking Anesteloc 40 mg

When not to take 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 been diagnosed with an allergy to medicines containing other proton pump inhibitors.

Warnings and precautions

Before starting treatment with Anesteloc 40 mg, the patient should discuss it with their doctor or pharmacist.

• If there are severe liver function disorders. The patient should inform their doctor if they have ever had liver function disorders. The doctor may order more frequent monitoring of liver enzyme activity, especially if long-term treatment with Anesteloc 40 mg is planned. If liver enzyme activity increases, the use of the medicine should be discontinued.
• If the patient has a vitamin B12 deficiency or risk factors for vitamin B12 deficiency, and is being treated long-term with pantoprazole. Like all medicines that reduce gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B12. The patient should contact their doctor if they notice any of the following symptoms, which may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy,
• numbness or tingling,
• pain or redness of the tongue, mouth ulcers,
• muscle weakness,
• vision problems,
• memory problems, disorientation, depression.
• If the patient is taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), they should ask their doctor for detailed advice.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid production.
• Severe skin reactions have been reported with pantoprazole, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. The patient should stop taking pantoprazole and seek medical attention immediately if they notice any symptoms of these severe skin reactions described in section 4.
• -If the patient takes pantoprazole for more than three months, it is possible that the magnesium level in the blood may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If the patient experiences any of these symptoms, they should inform their doctor immediately. Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. The doctor may order regular blood tests to monitor magnesium levels.

Before taking the medicine, the patient should tell their doctor about any planned specific urine test (chromogranin A level).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue treatment with Anesteloc 40 mg. The patient should also inform their doctor about any other side effects, such as joint pain.
The patient should immediately inform their doctor if they experience any of the following symptoms:

• unintentional weight loss,
• recurring vomiting,
• difficulty swallowing or pain when swallowing,
• bloody vomiting, which may look like coffee grounds,
• pallor and weakness (anemia),
• blood in the stool, black or tarry stools,
• chest pain,
• abdominal pain,
• severe and/or persistent diarrhea, as treatment with Anesteloc 40 mg is associated with a slight increase in the risk of infectious diarrhea.

The doctor may decide to perform tests to rule out a malignant underlying disease, as treatment with pantoprazole may alleviate the symptoms of the malignant disease and delay its diagnosis. If the symptoms persist despite treatment, further tests should be considered.
If the patient takes Anesteloc 40 mg for a long period (more than 1 year), they will likely be under regular medical supervision. In this case, the patient should report any new or unexpected symptoms and their circumstances to their doctor during each visit.
Taking proton pump inhibitors like Anesteloc 40 mg, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have been diagnosed with osteoporosis (reduced bone density) or are taking corticosteroids (which may increase the risk of osteoporosis).

Anesteloc 40 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Anesteloc 40 mg may affect the action of other medicines, so the patient should tell their doctor if they are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may inhibit the proper action of these and other medicines.
• Warfarin, phenprocoumon, which affect blood density. Further tests may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer); if methotrexate is used, the doctor may temporarily discontinue treatment with Anesteloc, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental illnesses); if fluvoxamine is used, the doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Before starting treatment with pantoprazole, the patient should discuss it with their doctor if they are to undergo a specific urine test (for tetrahydrocannabinol (THC)).

Anesteloc 40 mg with food and drink

The medicine should be taken 1 hour before a meal, without chewing or breaking the tablet. The tablet should be swallowed whole, with water.

Pregnancy, breastfeeding, and fertility

Experience with the use of Anesteloc 40 mg in pregnant women is limited. The active substance of the medicine has been shown to pass into breast milk.
The medicine may be used in pregnant women or women who may become pregnant or are breastfeeding only if the doctor considers that the benefits of treatment outweigh the potential risks to the unborn child or infant.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Anesteloc 40 mg has no or negligible influence on the ability to drive and use machines.
The patient should not drive or operate machinery if they experience side effects such as dizziness or vision disturbances.

Anesteloc 40 mg contains soy lecithin

The medicine should not be used in patients with hypersensitivity to peanuts or soy.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Anesteloc 40 mg

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose
If the 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. The doctor may recommend increasing the dose to 2 tablets per day. The treatment period for reflux esophagitis usually lasts 4 to 8 weeks.
The doctor will decide how long the treatment should last.
Adults:
In the treatment of Helicobacter pylori infection, in patients with duodenal and/or gastric ulcers, in combination with 2 antibiotics (eradication therapy)

One tablet twice a day plus 2 antibiotic tablets: amoxicillin, clarithromycin, or metronidazole (or tinidazole) taken twice a day with a pantoprazole tablet.
The first pantoprazole tablet should be taken 1 hour before breakfast, and the second pantoprazole tablet 1 hour before dinner. The patient should follow the doctor's instructions and read the patient information leaflets in the antibiotic packaging. The treatment usually lasts for 1 to 2 weeks.

In the treatment of gastric and/or duodenal ulcers

The usual dose is one tablet per day. After consulting the doctor, the dose may be doubled. The doctor will decide how long the treatment should last. The treatment period for gastric 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 acid production

The recommended initial dose is usually 2 tablets per day.
Both tablets should be taken 1 hour before a meal. Later, the dosage may be adjusted by the doctor, depending on the amount of acid produced in the stomach. If the doctor prescribes more than 2 tablets per day, they should be taken twice a day.
If the doctor prescribes a daily dose greater than 4 tablets per day, they will provide detailed instructions on when to stop taking the medicine.

Patients with renal impairment

Anesteloc 40 mg should not be takenfor the eradication of Helicobacter pyloriin patients with renal impairment.

Patients with hepatic impairment

In severe liver disease, the patient should not take more than one 20 mg pantoprazole tablet per day (for this purpose, 20 mg pantoprazole tablets are available).
In moderate or severe liver disease, the patient should not take Anesteloc 40 mg for the eradication of Helicobacter pylori.

Use in children and adolescents

Tablets are not recommended for use in children under 12 years of age.

Taking a higher dose of Anesteloc 40 mg than recommended

The patient should consult their doctor or pharmacist. Symptoms of overdose are not known.

Missing a dose of Anesteloc 40 mg

The patient should not take a double dose to make up for a missed dose. The next planned dose should be taken at the usual time.

Stopping treatment with Anesteloc 40 mg

The patient should not stop taking the tablets without consulting their doctor or pharmacist first.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Anesteloc 40 mg can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:

• very common (occurring in more than 1 in 10 people)
• common (occurring in less than 1 in 10 people but more than 1 in 100 people)
• uncommon (occurring in less than 1 in 100 people but more than 1 in 1000 people)
• rare (occurring in less than 1 in 1000 people but more than 1 in 10,000 people)
• very rare (occurring in less than 1 in 10,000 people)
• frequency not known (cannot be estimated from the available data)

If the patient experiences any of the following side effects, they should immediately inform their doctor or contact the nearest hospital where emergency services are available:

• Severe allergic reactions (rare):swelling of the tongue and/or throat, difficulty swallowing,

hives (like nettle rash), 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):blistering of the skin and rapid deterioration of general condition, ulcers (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals, or rash, especially on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., in the armpits), and changes in blood test results may also occur. Red, non-raised spots or circular patches on the torso, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genitals, and eyes. The appearance of such a severe rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Widespread rash, high fever, and swollen lymph nodes (DRESS 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, which may lead to kidney failure.

Other side effects that may occur:

• Common(occurring in less than 1 in 10 people) mild gastric polyps.
• Uncommon(occurring in less than 1 in 100 people) 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; weakness, fatigue, or general malaise; sleep disturbances, fractures of the hip, wrist, or spine.
• Rare(occurring in less than 1 in 1000 people) disturbances or complete loss of taste; vision disturbances, 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 rare(occurring in less than 1 in 10,000 people) disorientation.
• Frequency not known(cannot be estimated from the available data) hallucinations, confusion (especially in patients who have experienced such symptoms before); decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2); rash that may be accompanied by joint pain, sensation of tingling, pricking, burning, or numbness; inflammatory bowel disease, which may cause persistent watery diarrhea.

If any of the side effects worsen or if the patient experiences any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Anesteloc 40 mg

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Anesteloc 40 mg contains

• The active substance of the medicine is pantoprazole. Each tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other ingredients are: Core: mannitol, crospovidone, hydroxypropyl cellulose, sodium lauryl sulfate, colloidal silicon dioxide, talc, magnesium stearate. Coating Opadry AMB light yellow 80W220017 consisting of: polyvinyl alcohol, titanium dioxide (E171), talc, yellow iron oxide (E172), quinoline yellow, aluminum lake (E104), soy lecithin, xanthan gum. Enteric coating consisting of: methacrylic acid and 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 with a glossy, transparent coating.
The pack contains 14, 28, or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A

• 05 – 152 Czosnów phone: 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A

• 05 – 152 Czosnów

Date of last revision of the leaflet: