Anesteloc Max

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Anesteloc Max, 20 mg, gastro-resistant tablets

pantoprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 2 weeks there is no improvement or the patient feels worse, the doctor should be consulted.
• The medicine Anesteloc Max should not be taken for more than 4 weeks without consulting a doctor.

Table of contents of the leaflet:

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

1. WHAT IS ANESTELOC MAX AND WHAT IS IT USED FOR

The active substance of Anesteloc Max is pantoprazole, which blocks the enzyme that produces stomach acid. This reduces the amount of acid in the stomach. Anesteloc Max is used for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid regurgitation) in adults. Reflux occurs when stomach acid flows back into the esophagus, which can cause inflammation of the esophagus and pain. Symptoms may also include painful burning in the chest that can reach the throat (heartburn), sour taste in the mouth (acid regurgitation). Anesteloc Max can relieve symptoms of reflux disease (such as heartburn, acid regurgitation) as early as the first day of treatment, but it is not a medicine intended for immediate relief of symptoms. To achieve complete relief of symptoms, it may be necessary to take tablets for 2-3 consecutive days. If after 2 weeks there is no improvement or the patient feels worse, the doctor should be consulted.

2. IMPORTANT INFORMATION BEFORE TAKING ANESTELOC MAX

When not to take Anesteloc Max

• if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). See "Anesteloc Max and other medicines".

in the treatment of HIV infection). See "Anesteloc Max and other medicines".

Warnings and precautions

Before starting treatment with Anesteloc Max, the doctor should be consulted:

• if the patient has been treated for heartburn or indigestion continuously for 4 or more weeks;
• if the patient is over 55 and has taken over-the-counter indigestion medicines every day for more than 3 years;
• if the patient is over 55 and has noticed any new or changed symptoms, such as difficulty swallowing, vomiting blood or black tarry stools;
• if the patient has had stomach ulcers or stomach surgery;
• if the patient has liver or jaundice (yellowing of the skin and eyes);
• if the patient is under regular medical supervision for other serious conditions or diseases;
• if the patient is going to have an endoscopy or urea breath test;
• if the patient has ever had a skin reaction after taking a medicine that reduces stomach acid;
• if the patient is going to have a specific blood test (chromogranin A level);
• if the patient is taking HIV protease inhibitors, such as atazanavir or nelfinavir (used to treat HIV infection), the doctor should be asked for specific advice.

The doctor may decide that additional tests are needed. If the patient is going to have a blood test, the doctor should be informed about taking this medicine. It is possible that the patient will notice relief from reflux symptoms and heartburn as early as the first day of taking Anesteloc Max, but this medicine is not intended for immediate relief of symptoms. It should not be used as a preventive measure. If the patient has been suffering from recurring heartburn or indigestion for some time, they should remain under regular medical supervision.

Children and adolescents

Anesteloc Max should not be used in children and adolescents under 18 years of age due to the lack of information on the safety of use in this age group.

Anesteloc Max and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Anesteloc Max may affect the effectiveness of other medicines, especially those containing the following active substances:

• HIV protease inhibitors, such as atazanavir, nelfinavir (used to treat HIV infection). Anesteloc Max should not be taken with HIV protease inhibitors. See "When not to take Anesteloc Max";
• ketokonazole (used to treat fungal infections);
• warfarin and phenprocoumon (which affect blood density and prevent blood clots). Additional blood tests may be necessary;
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If methotrexate is used, the doctor may temporarily stop the use of Anesteloc Max, as pantoprazole may increase the level of methotrexate in the blood.

Anesteloc Max should not be taken with medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole), or H2 receptor antagonists (e.g., ranitidine, famotidine). Anesteloc Max can be taken if necessary with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations). Before starting treatment with Anesteloc Max, the doctor should be consulted if the patient is going to have a specific urine test (for tetrahydrocannabinol (THC)).

Anesteloc Max with food and drink

Tablets should be taken before a meal, swallowed whole, and washed down with water.

Pregnancy, breastfeeding, and fertility

This medicine should not be taken if the patient is pregnant or breastfeeding. If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines

If the patient experiences side effects such as dizziness or vision disturbances, they should not drive vehicles or operate machinery.

Anesteloc Max contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. HOW TO TAKE ANESTELOC MAX

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted. The recommended dose is 1 tablet per day. The daily dose should not exceed 20 mg. The medicine should be taken for at least 2-3 consecutive days. Treatment with Anesteloc Max should be stopped after complete relief of symptoms. It is possible that relief from reflux and heartburn symptoms may be noticed as early as the first day of taking Anesteloc Max, but this medicine is not intended for immediate relief of symptoms. The doctor should be consulted if, after taking this medicine for 2 weeks, the symptoms do not improve. Anesteloc Max should not be taken for more than 4 weeks without consulting a doctor. Tablets should be taken before a meal, at the same time every day. Tablets should be swallowed whole, with plenty of water, and should not be chewed or divided.

Taking a higher dose of Anesteloc Max than recommended

The doctor or pharmacist should be informed immediately if a higher dose of Anesteloc Max than recommended has been taken. If possible, the medicine and leaflet should be taken along.

Missing a dose of Anesteloc Max

A double dose should not be taken to make up for a missed dose. The next planned dose should be taken the next day at the usual time. In case of any further doubts about taking the medicine, the doctor or pharmacist should be consulted.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Anesteloc Max can cause side effects, although not everybody gets them. The doctor should be informed immediatelyor the nearest hospital should be contacted if any of the following serious side effectsoccur. At the same time, the use of this medicine should be stopped, but the leaflet and/or tablets should be taken along.

• Severe allergic reactions(rare: may occur in less than 1 in 1000 people): allergic reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms are: swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions(frequency not known: frequency cannot be estimated from the available data): rash with swelling, blisters, or peeling of the skin, patchy skin peeling, bleeding from the eyes, nose, mouth, or genitals, and rapid deterioration of general condition. Rash, especially in areas of skin exposed to sunlight. It may also occur joint pain or flu-like symptoms, fever, swelling of glands (e.g., under the arms), and blood test results may show changes in some white blood cells or liver enzymes. Red, non-raised dots or circular spots on the torso, often with blisters in the center, peeling skin, mouth ulcers, throat, nose, genitals, and eyes. The occurrence 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Other severe reactions(frequency not known): yellowing of the skin and whites of the eyes (caused by severe liver damage) or fever, rash, and kidney problems manifested by painful urination, back pain, which can lead to kidney failure.

Other side effects include:

• Common(may occur in less than 1 in 10 people): mild gastric polyps.
• Uncommon(may occur in less than 1 in 100 people): headache, dizziness, diarrhea, nausea, vomiting, bloating and gas, constipation, dry mouth; abdominal pain and discomfort, skin rash or hives, itching, weakness, fatigue, or malaise, sleep disturbances; increased activity of liver enzymes, hip, wrist, or spine fractures.
• Rare(may occur in less than 1 in 1000 people): disturbances or complete loss of taste, vision disturbances, such as blurred vision, joint pain, muscle pain, changes in body weight, increased body temperature, swelling of limbs, depression, increased levels of bilirubin and lipids in the blood (found in blood tests), gynecomastia in men, high fever, and sudden decrease in the number of circulating granulocytes - white blood cells (found in blood tests).
• Very rare(may occur in less than 1 in 10,000 people): disorientation, decreased platelet count, which may cause increased tendency to bleeding and bruising; decreased white blood cell count, which may predispose to more frequent infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets (found in blood tests).
• Frequency not known(frequency cannot be estimated from the available data): hallucinations; confusion (especially in patients who have had such symptoms before), decreased levels of sodium, magnesium, calcium, or potassium in the blood (see section 2); rash that may be accompanied by joint pain, sensation of tingling, prickling, burning, or numbness, inflammatory bowel disease causing persistent watery diarrhea.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed, or the nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE ANESTELOC MAX

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storage of the medicinal product. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Max contains

The active substance is pantoprazole. One gastro-resistant tablet contains 20 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).

Other ingredients of the medicine are:

Core:
sodium carbonate anhydrous (E170),
mannitol (E421),
crosprovidone type A,
hydroxypropyl cellulose,
microcrystalline cellulose,
calcium stearate.
Coating:
Opadry 02H52369 Yellow [hypromellose, propylene glycol, povidone K30, titanium dioxide (E171),
iron oxide yellow (E172)].
Enteric coating:
methacrylic acid - ethyl acrylate copolymer (1:1),
triethyl citrate,
sodium lauryl sulfate,
titanium dioxide (E171),
talc.

What Anesteloc Max looks like and contents of the pack

White, oval, biconvex, smooth gastro-resistant tablets. Anesteloc Max is available in aluminum/aluminum blisters in a cardboard box. The pack contains 7 or 14 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów, Poland

Manufacturer

S.C. Terapia S.A.
Str. Fabricii Nr. 124
400632 Cluj-Napoca
Romania
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów, Poland

In the EEA countries (European Economic Area), the medicine is authorized under the following names:

Poland
Anesteloc Max

Date of leaflet approval:

June 2025
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The following lifestyle and dietary recommendations may also help alleviate symptoms of heartburn or excessive stomach acid.

• Avoid large meals.
• Eat slowly.
• Stop smoking.
• Reduce alcohol and caffeine consumption.
• Reduce body weight (in case of overweight).
• Avoid tight clothing or belts.
• Avoid eating later than three hours before bedtime.
• Use a higher pillow (if the patient has nighttime symptoms).
• Reduce consumption of foods that may cause heartburn, such as: chocolate, peppermint, mint, fatty and fried foods, acidic and spicy foods, citrus fruits and juices, tomatoes.