Anesteloc

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Anesteloc, 20 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.
• 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, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Anesteloc and what is it used for

Anesteloc is a selective "proton pump inhibitor" that reduces stomach acid secretion. It is used to treat stomach and intestinal diseases related to acid secretion.

Anesteloc is used in:

Adults and adolescents aged 12 and over:

• Treatment of symptoms (e.g. heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach;
• Long-term treatment of reflux esophagitis (inflammatory disease of the esophagus, accompanied by acid reflux) and prevention of its recurrence.

Adults:

• Prevention of duodenal and (or) gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who must constantly take NSAIDs.

2. Important information before taking Anesteloc

When not to take Anesteloc

• If you are allergic to pantoprazole, soy, or any of the other ingredients of this medicine (listed in section 6).
• If you have been diagnosed with an allergy to proton pump inhibitors.

Warnings and precautions

Before starting Anesteloc, discuss it with your doctor or pharmacist.

• If you have severe liver function disorders. You should inform your doctor if you have ever had liver function disorders. Your doctor may order more frequent monitoring of liver enzyme activity, especially if you are taking long-term treatment with Anesteloc. If liver enzyme activity increases, the use of the medicine should be discontinued.
• If you must constantly take NSAIDs and take Anesteloc at the same time, due to the increased risk of complications from the stomach or intestines. The increased risk will be assessed according to the risk factors for the individual patient, such as age (65 or older), stomach or duodenal ulcers in the medical history, or stomach or intestinal bleeding.
• If you have a vitamin B12 deficiency or risk factors indicating a possible decrease in vitamin B12 levels, and you are being treated with pantoprazole long-term. Like all medicines that reduce gastric acid secretion, pantoprazole may lead to reduced vitamin B12 absorption. You should contact your doctor if you notice any of the following symptoms that 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 you are taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), you should ask your doctor for detailed advice.
• If you have ever had a skin reaction after taking a medicine that reduces stomach acid secretion, similar to Anesteloc.
• 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. You should stop taking pantoprazole and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.
• If you have been taking pantoprazole for more than three months, it is possible that your blood magnesium levels may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should inform your doctor immediately. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.

Before taking the medicine, inform your doctor about any planned specific urine test (for tetrahydrocannabinol (THC)).
If you experience a skin rash, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to discontinue Anesteloc. You should also inform your doctor about any other side effects, such as joint pain.
In case of the following symptoms, you should immediately inform your doctor:

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

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

Anesteloc and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Anesteloc may affect the efficacy of other medicines, so you should 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 Anesteloc may inhibit the proper functioning of these and other medicines.
• Warfarin and 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 you are taking methotrexate, your doctor may periodically discontinue Anesteloc, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental illnesses); 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).

Before starting pantoprazole, discuss it with your doctor if you are to undergo a specific urine test (for tetrahydrocannabinol (THC)).

Anesteloc with food and drink

Take the medicine 1 hour before a meal, without chewing or breaking the tablet. Swallow whole with water.

Pregnancy, breastfeeding, and fertility

Experience with the use of Anesteloc 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 cannot rule out pregnancy or breastfeeding women only if the doctor considers that the benefit of its use outweighs the potential risk to the unborn child or infant.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Anesteloc contains soy lecithin.

Do not take this medicine if you are hypersensitive to peanuts or soy.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Anesteloc

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
If your doctor has not prescribed a different dosage, the usual dose is:

In the treatment of symptoms (e.g. heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux disease

The usual dose is one tablet per day. This dose usually provides relief after 2-4 weeks of treatment - no later than within the next 4 weeks. Recurring symptoms can be controlled by taking one tablet per daywhen necessary.

In the long-term treatment and prevention of recurrence of reflux esophagitis

The usual dose is one tablet per day. If symptoms of the disease return, your doctor may recommend doubling the dose. In this case, you can take one tablet per day of Anesteloc 40 mg. After the symptoms have subsided, you can reduce the dose to onetablet (20 mg) per day.
Adults:

In the prevention of duodenal and (or) gastric ulcers in patients who must constantly take NSAIDs

The usual dose is one tablet per day.

Patients with liver function disorders

In case of severe liver function disorders, do not take more than one 20 mg tablet per day.

Use in children and adolescents

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

Overdose of Anesteloc

Consult your doctor or pharmacist. Symptoms of overdose are not known.

Missed dose of Anesteloc

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

Stopping Anesteloc treatment

Do not stop taking the tablets 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.
The frequency of side effects is defined based on the following categories:

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

If you experience any of the following side effects, you should immediately inform your doctor or contact the nearest hospital where emergency services are provided:

• Severe allergic reactions (rare):swelling of the tongue and (or) throat, difficulty swallowing, hives (urticaria), 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 sudden worsening of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/ lips, or genitals, or rash, especially on sun-exposed skin areas. It may also be accompanied by joint pain or flu-like symptoms, fever, swelling of the glands (e.g. under the arms), and blood test results may show changes in some white blood cells or liver enzymes. Red, unraised spots or round patches on the torso, often with blisters in the center, peeling skin, mouth ulcers, throat, nose, genitals, and eyes. The onset of such a severe skin 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, manifested by their enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which can 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 1,000 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; peripheral edema (peripheral edema); allergic reactions; depression; gynecomastia in men.
• Very rare(occurring in less than 1 in 10,000 people) disorientation.
• Frequency not known(frequency 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, colitis that causes persistent watery diarrhea.

If any of the side effects gets worse, or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 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

Keep the medicine out of the 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. Ask your 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 contains

• The active substance of the medicine is pantoprazole. Each tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• The other ingredients are: Core: mannitol, crospovidone, hydroxypropyl cellulose, sodium lauryl sulfate, colloidal anhydrous silica, talc, magnesium stearate. Coating Opadry AMB yellow 80W32009 with the composition: polyvinyl alcohol, titanium dioxide (E171), talc, yellow iron oxide (E172), quinoline yellow, aluminum lake (E104), soy lecithin, xanthan gum. Enteric coating with the composition: methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, polysorbate 80, glyceryl monostearate, triethyl citrate.

What Anesteloc looks like and contents of the pack

Anesteloc is a 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 tel. 22 732 77 00

Manufacturer

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

• 05 – 152 Czosnów

Date of last revision of the leaflet: