Asteloc

PACKAGE LEAFLET: INFORMATION FOR THE USER

ASTELOC, 40 mg, gastro-resistant tablets
Pantoprazole

Read the package 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 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 gut conditions related to excessive acid production, such as gastroesophageal reflux disease.

ASTELOC is used in adults and adolescents aged 12 years and older for:

• Gastroesophageal reflux disease. This is a condition in which the acid in the stomach flows back up into the gullet (the tube that connects the mouth to the stomach), causing pain and discomfort.

ASTELOC is used in adults for:

• Infection with the bacterium Helicobacter pylori in patients with stomach and duodenal ulcers, in combination with two antibiotics (eradication therapy) to eliminate the bacteria and reduce the risk of ulcer recurrence.
• Stomach and duodenal ulcers;
• Zollinger-Ellison syndrome and other conditions related to excessive acid production in the stomach.

2. IMPORTANT INFORMATION BEFORE TAKING ASTELOC

When not to take ASTELOC

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to medicines that reduce acid production in the stomach (proton pump inhibitors).

Warnings and precautions

Before taking ASTELOC, inform your doctor or pharmacist.

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor may need to monitor your liver function more closely, especially if you are taking ASTELOC for a long time. If your liver function is impaired, treatment should be discontinued.
• Patients with reduced vitamin B12 reserves or risk factors for vitamin B12 deficiency, if pantoprazole treatment is long-term. Like all medicines that reduce acid production in the stomach, pantoprazole may lead to reduced vitamin B12 absorption.
• If you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection), ask your doctor for specific advice.
• Taking a proton pump inhibitor like pantoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures.
• Tell your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you take pantoprazole for more than three months, it is possible that the level of magnesium in your blood may decrease. Symptoms of low magnesium levels can include fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to low potassium and calcium levels in the blood. Your doctor may need to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces acid production in the stomach.
• If you get a rash on your skin, especially in areas exposed to sunlight, inform your doctor as soon as possible, as you may need to stop taking ASTELOC 40. Also, inform your doctor about any other side effects, such as joint pain.
• About a specific blood test (chromogranin A levels).

Inform your doctor immediatelybefore or during treatment with ASTELOC, if you experience any of the following symptoms, which may be signs of a more serious condition: - unintentional weight loss,

• vomiting, especially if it is repeated,
• blood in your vomit, which may look like coffee grounds,
• blood in your stools, black or tar-like stools
• difficulty swallowing or pain when swallowing;
• pale skin and weakness (anemia),
• chest pain,
• stomach pain,
• severe and/or persistent diarrhea, as the use of this medicine is associated with a small increased risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out an underlying malignant condition, as pantoprazole treatment may alleviate the symptoms of the disease and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered. If you are taking ASTELOC for a long period (more than 1 year), you will likely be under regular medical supervision. In this case, inform your doctor about any new or unexpected symptoms and their circumstances during each visit.

Children and adolescents

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

ASTELOC and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Since ASTELOC may affect the efficacy 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. Additional 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 temporarily stop ASTELOC treatment, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may need to reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazole in pregnant women. It has been found that the medicine passes into breast milk in women who are breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The medicine may be used in pregnant women or women who are breastfeeding, or who may become pregnant or are breastfeeding, only if the doctor considers that the benefit of the treatment outweighs the potential risk to the unborn child or baby.

Driving and using machines

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

3. HOW TO TAKE ASTELOC

Always take ASTELOC exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Method of administrationTake the medicine 1 hour before a meal, do not chew or crush the tablets, swallow them whole with water.

Recommended dose:

Adults and adolescents aged 12 years and older:

Treatment of gastroesophageal reflux disease

The usual dose is one tablet per day. Your doctor may increase the dose to 2 tablets per day. The treatment duration for gastroesophageal reflux disease is usually 4 to 8 weeks. Your doctor will tell you how long to take the medicine. Adults: Treatment of Helicobacter pylori infection in patients with duodenal and stomach ulcers in combination with two antibiotics (eradication therapy)

Jedna tabletka dwa razy na dobę wraz z dwoma tabletkami antybiotyków: amoksycyliny, klarytromycyny, metronidazolu (lub tynidazolu), każdy antybiotyk należy przyjmować dwa razy na dobę z tabletką pantoprazolu. Pierwszą tabletkę pantoprazolu należy przyjmować 1 godzinę przed śniadaniem, a drugą - 1 godzinę przed kolacją. Należy przestrzegać wskazówek lekarza i zapoznać się z treścią ulotek załączonych do opakowań antybiotyków. Leczenie trwa zazwyczaj od jednego do dwóch tygodni.

Treatment of stomach and duodenal ulcers

The usual dose is one tablet per day. After consulting your doctor, the dose can be doubled. Your doctor will tell you how long to take the medicine. The treatment duration for stomach ulcers is usually 4 to 8 weeks. The treatment duration for duodenal ulcers is usually 2 to 4 weeks.

Long-term treatment of Zollinger-Ellison syndrome and other conditions related to excessive acid production in the stomach

The usual initial dose is two tablets per day. Both tablets should be taken 1 hour before a meal. Later, your doctor may change the dose of the medicine, depending on the amount of acid produced in the stomach. If your doctor prescribes more than two tablets per day, the medicine should be taken in two divided doses. If your doctor prescribes a daily dose greater than four tablets per day, he will inform you exactly when to stop taking the medicine. Patients with kidney problems- In case of kidney problems, do not take ASTELOC for the eradication of Helicobacter pylori.

Patients with liver problems

• In severe liver disease, do not take more than one 20 mg pantoprazole tablet per day (20 mg pantoprazole tablets are available for this purpose).

In moderate or severe liver disease, do not take ASTELOC 40 for the eradication of Helicobacter pylori.

Use in children and adolescents

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

Take more than the recommended dose of ASTELOC

Ask your doctor or pharmacist. The symptoms of overdose are not known.

Miss a dose of ASTELOC

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

Stop taking ASTELOC

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

If you experience any of the following side effects, stop taking the medicine and inform your doctor or go to the nearest hospital immediately:

• - severe allergic reactions (rare: less than 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very fast heartbeat and excessive sweating;
• - severe skin reactions (frequency not known: frequency cannot be estimated from the available data):blistering of the skin and severe deterioration of general health, ulcers (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, polymorphic erythema) and increased sensitivity to light;
• - other severe conditions (frequency not known: frequency cannot be estimated from the available data):yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlarged kidneys with pain when urinating and pain in the lower back (severe kidney inflammation).

Other side effects:

• common(less than 1 in 10 people) Mild stomach polyps.
• - uncommon(less than 1 in 100 people): Headache, dizziness, diarrhea, nausea, vomiting, bloating and gas, constipation, dry mouth, stomach pain and discomfort, skin rash, itching, fatigue, weakness, or general feeling of being unwell, sleep disorders, fractures of the hip, wrist, or spine.
• - rare(less than 1 in 1000 people): Disturbances or complete loss of taste; visual disturbances, such as blurred vision, hives, joint pain, muscle pain, weight change, increased body temperature, swelling of the limbs (peripheral edema), allergic reactions, depression, breast enlargement 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 had 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, inflammatory bowel disease (causing persistent watery diarrhea).

Side effects identified 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 may manifest as more frequent than usual bleeding or bruising; decreased white blood cell count, which may lead to more frequent infections, concurrent abnormal decrease in red and white blood cell and platelet counts.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ASTELOC

Keep the medicine out of the sight and reach of children. There are no special storage instructions for 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 no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ASTELOC contains

• The active substance is pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• Each tablet contains 40 mg of pantoprazole.
• The other ingredients are: mannitol, sodium carbonate anhydrous, sodium carboxymethylcellulose (type A), methacrylic acid and ethyl acrylate copolymer, calcium stearate.

Coating :Opadry white OY-D-7233:
hypromellose 3 cP,
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 ASTELOC looks like and contents of the pack

Dark yellow, elliptical, biconvex gastro-resistant tablet. Pack sizes: Blister packs 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 hf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the Member States of the EEA under the following names:

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