Anesteloc max

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Anesteloc Max, 20 mg, enteric-coated tablets
pantoprazole
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
You must always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 weeks, or if you feel worse, consult your doctor.
• Do not take Anesteloc Max for longer than 4 weeks without consulting your doctor.

Table of contents:

1. What Anesteloc Max is and what it is 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 ANESTELOC MAX IS AND WHAT IT IS USED FOR

The active substance in Anesteloc Max is pantoprazole, which blocks the enzyme responsible for producing 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 refers to the backflow of stomach acid into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Anesteloc Max may relieve symptoms associated with reflux disease (such as heartburn, acid regurgitation) as early as on the first day of treatment; however, it is not a medicine intended for immediate relief of symptoms.
To achieve full symptom relief, it may be necessary to take the tablets for 2–3 consecutive days.
If there is no improvement after 2 weeks, or if you feel worse, consult your doctor.

2. IMPORTANT INFORMATION BEFORE USING ANESTELOC MAX

When not to use 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
  in the treatment of HIV infection). See "Anesteloc Max and other medicines".

Warnings and precautions

Before starting treatment with Anesteloc Max, consult your doctor:

• if the patient has been treated for heartburn or indigestion continuously for 4 weeks or longer;
• if the patient is over 55 years old and takes antacids daily without a prescription;
• if the patient is over 55 years old and has noticed any new concerning symptoms or a change in the nature of existing symptoms;
• if the patient has previously suffered from peptic ulcer disease or undergone stomach surgery;
• if the patient has liver problems or jaundice (yellowing of the skin and eyes);
• if the patient is under continuous medical care due to other serious conditions or diseases;
• if the patient is scheduled for endoscopic examination or urease test;
• if the patient has ever experienced a skin reaction after taking a medicine similar to Anesteloc Max that reduces gastric acid secretion;
• if the patient is scheduled for specific blood tests (chromogranin A levels);
• if the patient is taking HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection) together with pantoprazole, please consult your doctor for specific advice.

Do not take this medicine without consulting a doctor for longer than 4 weeks. If
symptoms of gastroesophageal reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks,
consult your doctor, who will decide whether long-term treatment is necessary.

Long-term use of Anesteloc Max may be associated with additional risks,
such as:

• reduced absorption of vitamin B12 and vitamin B12 deficiency in case of low vitamin B12 levels in the body. Contact your doctor if any of the following symptoms occur, which may indicate low vitamin B12 levels:
• extreme fatigue or lack of energy,
• numbness and tingling sensations,
• pain or redness of the tongue, mouth ulcers,
• muscle weakness,
• vision disturbances,
• memory problems, disorientation, depression;
• fractures of the hip, wrist, or spine, especially if the patient already has osteoporosis (reduced bone density) or is taking corticosteroids (which may increase the risk of osteoporosis);
• decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. If the medicine is used for longer than 4 weeks, consult your doctor. The doctor may decide that periodic monitoring of magnesium levels is necessary.

Contact your doctor immediately before or after taking this medicine if the patient
experiences any of the following symptoms, which may indicate other, more serious
conditions:

• unintentional weight loss (not related to diet or exercise);

• vomiting, especially recurrent;

• vomiting blood, which may look like dark coffee grounds;

• blood in the stool, black or tarry stools;

• difficulty swallowing or pain during swallowing;

• paleness and weakness (anemia);

• chest pain;

• abdominal pain;

• severe and/or persistent diarrhea, as use of this medicine is associated with a slightly increased risk of infectious diarrhea;
  if the patient develops a skin rash, especially in areas exposed to sunlight, inform the
  doctor as soon as possible, as discontinuation of Anesteloc Max may be necessary. Also report any other adverse reactions such as joint pain.

• 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. Discontinue pantoprazole and seek immediate medical advice if any symptoms of these serious skin reactions described in section 4 occur.

The doctor may decide that additional tests are necessary.
If the patient is scheduled for blood tests, they should inform the doctor about taking this
medicine.
The patient may notice improvement in reflux and heartburn symptoms as early as the first day
of treatment with Anesteloc Max. However, this is not a medicine intended for immediate relief
of symptoms.
It should not be used preventively.
If the patient has been suffering from recurrent heartburn or indigestion symptoms 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
lack of safety data in this age group.

Anesteloc Max and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Anesteloc Max may reduce the effectiveness of other medicines, especially those containing any of the following active substances:

• HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). Concomitant use of Anesteloc Max with HIV protease inhibitors is not recommended. See "When not to use Anesteloc Max";
• ketoconazole (used for fungal infections);
• warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood tests may be required;
• methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer). When methotrexate is used, the doctor may temporarily discontinue Anesteloc Max, as pantoprazole may increase methotrexate blood levels.

Do not take Anesteloc Max together with medicines that reduce stomach acid production,
such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole), or
H2-receptor antagonists (e.g., ranitidine, famotidine).
Anesteloc Max may be used when necessary with antacids (e.g., magaldrate,
alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).
Before starting Anesteloc Max, discuss with your doctor if the patient is scheduled for a specific urine test [for tetrahydrocannabinol (THC)].

Anesteloc Max with food and drink
Take tablets before meals, swallow whole with water.

Pregnancy, breastfeeding, and fertility
Do not use this medicine if the patient is pregnant or breastfeeding. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or visual disturbances, they should
not drive or operate machinery.

Anesteloc Max contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. HOW TO USE ANESTELOC MAX

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
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 discontinued after complete resolution of symptoms. Relief of reflux symptoms and heartburn may occur as early as one day after starting Anesteloc Max; however, bear in mind that this medicine is not intended for immediate symptom relief.
Consult your doctor if symptoms persist after 2 weeks of treatment with this medicine. Do not take Anesteloc Max for longer than 4 weeks without consulting your doctor.
Take tablets before a meal, at the same time each day. Swallow the tablets whole, with plenty of water. Do not chew or divide the tablets.
Taking more Anesteloc Max than recommended
Immediately inform your doctor or pharmacist if you have taken more than the recommended dose. If possible, bring the medicine and this leaflet with you.
If you forget to take Anesteloc Max
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time on the following day.
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 everybody will experience them.
You should immediately inform your doctor or contact the nearest hospital if any of the following serious adverse reactions occur. At the same time, you should stop taking this medicine, but bring the package leaflet and (or) the tablets with you.

• Severe allergic reactions (rare: may occur in no more than 1 in 1000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue and (or) throat, which may cause difficulty in swallowing or breathing, urticaria, severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): rash with swelling, blisters or peeling of the skin, sheet-like peeling of the skin, bleeding from the eyes, nose, mouth or genital areas, and rapid deterioration in general condition. Rash, especially in areas of skin exposed to sunlight. Joint pain or flu-like symptoms may also occur, along with fever, swollen glands (e.g. under the arms), and blood tests may show changes in certain white blood cells or liver enzymes. Reddish, non-elevated spots or round patches 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 serious reactions (frequency unknown): yellowing of the skin and whites of the eyes (due to severe liver damage) or fever, rash and kidney problems manifested by painful urination, pain in the lower back, which may lead to kidney failure.

Other adverse reactions include:

• Common (may occur in no more than 1 in 10 people): mild gastric polyps.
• Uncommon (may occur in no more than 1 in 100 people): headache, dizziness, diarrhoea, nausea, vomiting, flatulence and bloating, constipation, dry mouth; abdominal pain and discomfort, skin rash or urticaria, itching of the skin, weakness, fatigue or malaise, sleep disturbances; increased liver enzyme activity, fracture of the hip, wrist or spine.
• Rare (may occur in no more than 1 in 1000 people): disturbances or complete loss of taste sensation, visual disturbances such as blurred vision, joint pain, muscle pain, changes in body weight, elevated body temperature, limb swelling, depression, increased levels of bilirubin and lipids in the blood (detected in blood tests), breast enlargement in men, high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
• Very rare (may occur in no more than 1 in 10,000 people): disturbances in orientation, decreased platelet count, which may cause increased tendency to bleeding and development of petechiae on the skin (bruising); decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets (detected in blood tests).
• Frequency unknown (frequency cannot be estimated from available data): hallucinations; confusion (particularly in patients who have previously experienced such symptoms), decreased concentration of sodium, magnesium, calcium or potassium in the blood (see section 2); rash which may be accompanied by joint pain, sensation of tingling, pricking, numbness, burning or stinging, inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. HOW TO STORE ANESTELOC MAX MEDICINAL PRODUCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special precautions for storage of this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Anesteloc Max contains
The active substance is pantoprazole. One enteric-coated tablet contains 20 mg of pantoprazole
(in the form of pantoprazole sodium sesquihydrate).
Other components of the medicine are:
Tablet core:
anhydrous sodium carbonate (E170),
mannitol (E421),
crospovidone type A,
hydroxypropyl cellulose,
microcrystalline cellulose,
calcium stearate.
Coating:
Opadry 02H52369 Yellow [hypromellose, propylene glycol, povidone K30, titanium dioxide (E171),
yellow iron oxide (E172)].
Enteric coating:
methacrylic acid and 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-tinged, oval, biconvex, smooth tablets on both sides.
Anesteloc Max is available in aluminum/aluminum foil blisters packed in a cardboard box.
Pack sizes contain 7 or 14 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 (European Economic Area) Member States, the medicinal product is authorised under the following names:
Poland: Anesteloc Max

June 2025

The following lifestyle and dietary recommendations may also help alleviate symptoms of heartburn or gastric acid hyperacidity:

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