Anesteloc

Package leaflet: Information for the patient

Anesteloc, 20 mg, enteric-coated tablets
Pantoprazolum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Anesteloc is and what it is used for
2. What you need to know 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 Anesteloc is and what it is used for

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

• Treatment of symptoms (e.g., heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease (GERD) caused by backflow of acid from the stomach;
• Long-term treatment of reflux esophagitis (inflammation of the esophagus due to backflow of gastric acid) and prevention of its recurrence.

Adults:

• Prevention of duodenal and/or gastric ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who require continuous NSAID therapy.

2. Information before using Anesteloc

When not to use Anesteloc

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

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

• In case of severe liver function impairment. Inform your doctor if you have ever had liver problems. Your doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Anesteloc is required. If liver enzyme levels increase, treatment should be discontinued.
• If the patient must continuously take non-steroidal anti-inflammatory drugs (NSAIDs) and is also taking Anesteloc, due to an increased risk of gastrointestinal complications. This increased risk will be assessed based on individual patient risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If the patient has vitamin B__ deficiency or risk factors indicating possible reduced vitamin B__ levels, particularly during long-term pantoprazole treatment. Like all drugs that reduce (inhibit) gastric 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:
• extreme fatigue or lack of energy,
• numbness and tingling,
• pain or redness of the tongue, mouth ulcers,
• muscle weakness,
• vision disturbances,
• memory problems, disorientation, depression.
• If the patient is taking protease inhibitors for HIV, such as atazanavir (used in the treatment of HIV infection), together 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 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 stopped immediately and medical advice sought without delay if any symptoms of these serious skin reactions described in section 4 occur.
• If the patient takes pantoprazole for longer than three months, magnesium levels in the blood may decrease. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

Before taking the medicine, inform your doctor about a planned specific blood test
(chromogranin A levels).
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as discontinuation of Anesteloc may be necessary. Also report any other adverse reactions occurring, such as joint pain.
If any of the following symptoms occur, contact your 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 (anemia);
• blood in the stool, black or tarry stools;
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea, as treatment with Anesteloc is associated with a slight increased risk of infectious diarrhea.

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

Anesteloc and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Anesteloc 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 Anesteloc may impair the proper action of these and other drugs.
• Warfarin and 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 cancer); when methotrexate is used, your 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, 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 with your doctor if a specific urine test [for tetrahydrocannabinol (THC)] is planned.

Anesteloc 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 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 have a child, she should consult her doctor or pharmacist before using this medicine.

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

Anesteloc contains soy lecithin.
Do not use this medicine if the patient is hypersensitive to peanuts or soy.
The medicine contains less than 1 mmol of sodium (23 mg) per 1 tablet, meaning the medicine is considered "sodium-free".

3. How to use Anesteloc

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your 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 treatment of symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated
with gastroesophageal reflux disease
The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks of treatment—
at the latest within the following 4 weeks. Recurrent symptoms may be managed by taking one tablet per day as needed.
For long-term treatment and prevention of relapses of reflux esophagitis
The usual dose is one tablet per day. If symptoms recur, your doctor may recommend doubling the dose.
In this case, one tablet of Anesteloc 40 mg per day may be used. After symptoms resolve, the dose may be reduced again to one tablet ( 20 mg ) per day.
Adults:
For prevention of gastric and/or duodenal ulcers in patients who must continuously take NSAIDs
The usual dose is one tablet per day.
Patients with impaired liver function
In case of severe impairment of liver function, no more than one 20 mg tablet per day should be taken.
Use in children and adolescents
The tablets are not recommended for use in children under 12 years of age.
Taking more Anesteloc than recommended
Consult your doctor or pharmacist. Symptoms of overdose are not known.
Missing a dose of Anesteloc
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping Anesteloc
Do not stop taking the tablets without first consulting your doctor or pharmacist.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The occurrence of adverse reactions is defined based on their frequency as follows:

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

If any of the following adverse reactions occur, you must immediately inform your doctor or contact the nearest hospital providing emergency care:

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle burn), breathing difficulties, allergic facial swelling (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known): formation of skin blisters and sudden deterioration in general condition, erosion (with slight bleeding) of the eyes, nose, oral cavity/mouth or genital organs, or rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, gland swelling (e.g. under the arms) may also occur, 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. The appearance of such a 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 their 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 (occur in up to 1 out of 10 people): benign gastric polyps.
• Uncommon (occur in up to 1 out of 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, redness, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances, fractures of the hip, wrist or spine.
• Rare (occur in up to 1 out of 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; breast enlargement in men.
• Very rare (occur in up to 1 out of 10,000 people): disturbances in orientation.
• Frequency not known (frequency cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); decreased sodium concentration in blood, rash possibly accompanied by joint pain, tingling, pricking, numbness, burning or stinging sensations, inflammation of the large intestine causing persistent watery diarrhoea.

If Anesteloc has been taken for longer than three months, there is a possibility of decreased magnesium levels in blood. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, disorientation, seizures, dizziness, rapid heartbeat. If any of the above symptoms are observed, you must immediately inform your doctor. Low magnesium levels may lead to decreased potassium or calcium levels in blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
Adverse reactions identified by blood tests occurring:

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

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Anesteloc

Keep this 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Anesteloc contains

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

What Anesteloc looks like and contents of the pack
Anesteloc is yellow, round, biconvex tablets coated with a shiny, transparent film coating.
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