Asteloc

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

ASTELOC, 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, so you can read it again if you need to.
• 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS ASTELOC AND WHAT IS IT USED FOR

ASTELOC contains the active substance pantoprazole. ASTELOC is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and intestinal diseases associated with an excessive amount of hydrochloric acid.
ASTELOC is used in adults and adolescents aged 12 years and older for:

• Treating 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 (inflammation of the esophagus, accompanied by acid reflux) and prevention of its recurrence.

ASTELOC is used in adults:

• Preventing duodenal and (or) gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) in patients at risk who need to take NSAIDs continuously.

2. IMPORTANT INFORMATION BEFORE TAKING ASTELOC

When not to take ASTELOC

Warnings and precautions

Before starting to take ASTELOC, inform your doctor or pharmacist.

.
• taking a proton pump inhibitor, such as pantoprazole, especially for a period of more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should tell their doctor if they have osteoporosis or if they are taking corticosteroids (which can increase the risk of osteoporosis).
• about a planned specific blood test (chromogranin A levels).

Tell your doctor immediatelybefore or during treatment with ASTELOC if you experience any of the following symptoms, which may be signs of a more serious disease:

• unintentional weight loss;
• vomiting, especially if it recurs;
• bloody vomiting, which may look like coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing;
• pallor and weakness (anemia);
• chest pain;
• abdominal pain;
• blood in the stool;
• severe and/or persistent diarrhea, as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea.

The doctor may decide to perform tests to rule out an underlying malignant 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 ASTELOC for a longer period (more than 1 year), they will likely be under constant medical supervision. In this case, during each visit to the doctor, they should report any new and unexpected symptoms and the circumstances of their occurrence.

Children and adolescents

ASTELOC is not recommended for use in children, as its effect has not been studied in children under 12 years of age.

ASTELOC and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Since ASTELOC may affect the effectiveness of other medicines, inform 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 ASTELOC may inhibit the proper functioning of these and other medicines;
• warfarin and phenprocoumon, which affect blood density and prevent blood clots. 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 the use of ASTELOC, as pantoprazole may increase the level of methotrexate in the blood.
• fluvoxamine (used to treat depression and other mental disorders) - if the patient is taking fluvoxamine, the doctor may order a dose reduction.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

Experience with the use of ASTELOC in pregnant women is limited. It has been found that the active substance of the medicine passes into human milk.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine may be used in pregnant women or women who may be pregnant or are breastfeeding only if the doctor considers that the benefit of its use outweighs the potential risk to the unborn child or infant.

Driving and using machines

ASTELOC has no influence or negligible influence on the ability to drive vehicles and operate machinery.
Do not drive vehicles or operate machinery if you experience side effects such as dizziness or vision disturbances.

3. HOW TO TAKE ASTELOC

Take ASTELOC always as directed by your doctor. In case of doubt, consult your doctor or pharmacist.

Method of administration

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

Recommended dose

Adults and adolescents aged 12 years and older:

• -In the treatment of symptoms (e.g., heartburn, acid reflux, pain when swallowing) associated with gastroesophageal reflux diseaseThe usual dose is one tablet per day. This dose usually provides relief after 2-4 weeks of use - no later than within the next 4 weeks. The doctor will decide how long to take the medicine. Recurring symptoms can be controlled by taking one tablet per daywhen necessary.
• -In long-term treatment and prevention of recurrence of reflux esophagitisThe usual dose is one tablet per day. If symptoms of the disease return, the doctor may recommend doubling the dose. In this case, one tablet per day of ASTELOC can be used. After the symptoms have subsided, the dose can be reduced again to one tablet (20 mg) per day

Adults:

• - In the prevention of duodenal and (or) gastric ulcers in patients who must continuously take NSAIDsThe usual dose is one tablet per day.

Patients with liver function disorders

In case of severe liver disease, 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.

Taking a higher dose of ASTELOC than recommended

Consult a doctor or pharmacist. The symptoms of overdose are not known.

Missing a dose of ASTELOC

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

Stopping treatment with ASTELOC

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, ASTELOC can cause side effects, although not everybody gets them.

In case of any of the following side effects, stop taking the medicine and immediately inform your doctor or contact the nearest hospital where emergency services are provided:

• - severe allergic reactions (rare: less than 1 in 1000 people):swelling of the tongue and (or) throat, difficulty swallowing, hives (rash like after nettle sting), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with rapid heartbeat and profuse sweating;
• - severe skin reactions (frequency not known: frequency cannot be estimated from the available data):blistering of the skin and severe deterioration of the general condition, erosion (with slight bleeding) of the eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and hypersensitivity to light;
• - other severe reactions (frequency not known: frequency cannot be estimated from the available data):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(less than 1 in 10 people) mild gastric polyps
• - uncommon(less than 1 in 100 people) headache, dizziness, diarrhea, nausea, vomiting, feeling of fullness in the abdominal cavity and bloating with gas (gas), constipation, dryness in the mouth, abdominal pain and discomfort, skin rash, redness, skin eruptions, itching, weakness, fatigue, or general malaise, sleep disturbances, hip, wrist, or spine fractures.
• - rare(less than 1 in 1000 people) taste disorders or complete loss of taste, vision disturbances, such as blurred vision, hives, joint pain, muscle pain, weight changes, elevated body temperature, peripheral edema (peripheral edema), allergic reactions, depression, gynecomastia in men;
• - very rare(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 levels in the blood, decreased magnesium levels in the blood (see section 2), feeling of tingling, prickling, burning, or numbness, rash that may be accompanied by joint pain, and colitis that causes persistent watery diarrhea.

Side effects detected in blood tests:

• - uncommon(less than 1 in 100 people) increased liver enzyme activity;
• - rare(less than 1 in 1000 people) increased bilirubin levels, increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• - very rare(less than 1 in 10,000 people) decreased platelet count, which can cause more frequent bleeding and bruising; decreased white blood cell count, which can lead to more frequent infections; abnormal decrease in the number of red and white blood cells, as well as platelets.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.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 this medicine.

5. HOW TO STORE ASTELOC

Store the medicine out of sight and reach of children.
There are no special precautions for the storage of the medicinal product.
Do not use this medicine after the expiry date stated on the label and carton. 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 does ASTELOC contain

• The active substance of the medicine is pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• Each tablet contains 20 mg of pantoprazole.
• The other ingredients are: mannitol, anhydrous sodium carbonate, sodium carboxymethylcellulose (type A), methacrylic acid, and ethyl acrylate copolymer, calcium stearate. Coating: Opadry white OY-D-7233: hypromellose, titanium dioxide (E 171), talc, macrogol 400, sodium lauryl sulfate. Coating: Kollicoat MAE 30 DP yellow: methacrylic acid, and ethyl acrylate copolymer dispersion 30%, propylene glycol, yellow iron oxide (E 172), titanium dioxide (E 171), talc.

What does ASTELOC look like and what does the pack contain

Light yellow, elliptical, biconvex gastro-resistant tablet.
Pack sizes:
Blisters containing: 7, 14, 15, 20, 28, 30, 56, 60, 98, 100 tablets
HDPE bottle: 30, 100, 250 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

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

• 05 – 152 Czosnów

Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis ehf.
Reykjavíkurvegur 78
220 Hafnarfjörður
Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the EEA member states under the following names:

Poland: ASTELOC
Date of last revision of the leaflet:October 2019