EUGASTROL 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Eugastrol reflusso 20 mg gastro-resistant tablets
   1. What is Eugastrol reflusso and what is it used for
   2. What you need to know before taking Eugastrol reflusso
   3. How to take Eugastrol reflusso
   4. Possible side effects
   5. How to store Eugastrol reflusso
   6. Package contents and other information

Eugastrol reflusso 20 mg gastro-resistant tablets

Pantoprazolo

Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 2 weeks.
• Do not take Eugastrol reflusso for more than 4 weeks without first consulting a doctor.

Contents of this leaflet

• 1. What Eugastrol reflusso is and what it is used for
• 2. What you need to know before you take Eugastrol reflusso
• 3. How to take Eugastrol reflusso
• 4. Possible side effects
• 5. How to store Eugastrol reflusso
• 6. Contents of the pack and other information

1. What is Eugastrol reflusso and what is it used for

Eugastrol reflusso contains the active ingredient pantoprazole, which blocks the “pump” that produces
acid in the stomach. Consequently, it is able to reduce the amount of acid present in the
stomach.
Eugastrol reflusso is used for the short-term treatment of symptoms of reflux disease
(for example heartburn, acid regurgitation) in adults.
Reflux involves the backflow of acidic contents from the stomach into the esophagus (the “channel” through
which food passes), causing inflammation and causing pain. Symptoms such as a burning sensation in the chest that rises towards the throat (heartburn) and a bitter taste in the mouth (acid regurgitation) may therefore
occur.
You may experience relief from symptoms of acid regurgitation and heartburn after just one day of
treatment with Eugastrol reflusso, but this medicine is not formulated to provide immediate
relief from symptoms. It may be necessary to take the tablets for 2-3 days
consecutively to feel a positive effect on the symptoms.
See your doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before taking Eugastrol reflusso

Do not take Eugastrol reflusso:

• if you are allergic to pantoprazole, soy, peanuts or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to medicines containing other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole)
• if you are taking an HIV protease inhibitor, such as atazanavir or nelfinavir (for the treatment of HIV infection). See “Other medicines and Eugastrol reflusso”.

Warnings and precautions
Talk to your doctor before taking Eugastrol reflusso.

• If you have been treated for heartburn or indigestion continuously for 4 or more weeks
• If you are over 55 years of age and take indigestion remedies daily without a prescription
• If you are over 55 years of age and experience any new symptoms or changes in pre-existing reflux symptoms
• If you have previously suffered from a stomach ulcer or have undergone stomach surgery
• If you have liver problems or jaundice (yellowing of the skin or whites of the eyes)
• If you regularly see your doctor for serious health problems or conditions
• If you are going to have an endoscopy or a breath test called a C-urea test
• If you have ever had a skin reaction after treatment with a medicine similar to Eugastrol reflusso 20 mg gastro-resistant tablets that reduces stomach acid
• If you are going to have a specific blood test (Chromogranin A).
• If you are taking HIV protease inhibitors such as atazanavir or nelfinavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice.

Do not take this product for more than 4 weeks without consulting your doctor. If symptoms of
reflux (heartburn or acid regurgitation) persist for more than 2 weeks, consult your
doctor, who will decide whether you need to take this medicine long-term.
If you take Eugastrol reflusso for longer periods, this could cause further risks, such as:

• Reduced absorption of vitamin B12 and vitamin B12 deficiency, if your body’s stores of vitamin B12 are already low.
• Fracture of the hip, wrist or spine, especially if you already suffer from osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis)
• Decreased levels of magnesium in the blood (potential symptoms: fatigue, involuntary muscle contractions, confusion, convulsions, dizziness, rapid heartbeat). Low levels of magnesium can also lead to a decrease in potassium or calcium levels in the blood. You should see your doctor if you have been using this product for more than 4 weeks. Your doctor may decide to have you undergo periodic blood tests to monitor magnesium levels.

Tell your doctor immediately, before or after taking this medicine, if you notice any of the
following symptoms, which could be a sign of a more serious illness:

• unintentional weight loss (not related to a diet or exercise program)
• vomiting, especially if repeated
• vomiting blood, which may appear as dark, coffee-ground-like material in the vomit
• blood in the stool, which may appear black or tarry
• difficulty swallowing or pain when swallowing
• paleness and feeling weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in infectious diarrhea
• if you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Eugastrol reflusso. Also remember to report any other undesirable effects such as joint pain.

The doctor may decide to have you undergo some tests.
If you are going to have a blood test, tell your doctor that you are taking this medicine.
You may experience relief from symptoms of acid regurgitation and heartburn already after one day of
treatment with Eugastrol reflusso, but this medicine is not formulated to provide
immediate symptom relief.
You should not take this medicine for preventative purposes.
If you repeatedly and for a long time experience symptoms of heartburn or indigestion, be
sure to see your doctor regularly.

Children and adolescents
Eugastrol reflusso should not be taken by children and adolescents under 18 years of age due to
a lack of safety information in this younger age group.

Other medicines and Eugastrol reflusso
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Eugastrol reflusso can prevent some other medicines from working
properly. Especially medicines containing one of the following active ingredients:

• HIV protease inhibitors such as atazanavir or nelfinavir (used for the treatment of HIV infection). You should not use Eugastrol reflusso if you are taking HIV protease inhibitors. See “Do not take Eugastrol reflusso”
• ketoconazole (used to treat fungal infections)
• warfarin and phenprocoumon (used to thin the blood and prevent blood clots). You may need to have further blood tests
• methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily stop therapy with Eugastrol reflusso as pantoprazole can increase methotrexate levels in the blood.

Do not take Eugastrol reflusso with other medicines that limit 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).
However, you can take Eugastrol reflusso with antacids (e.g. magaldrate, alginic acid, sodium
bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations), if necessary.

Pregnancy and breastfeeding
You should not take this medicine if you are pregnant or breastfeeding. If you are pregnant or
breastfeeding, suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
If you experience side effects such as dizziness or visual disturbances, you should not drive or
operate machinery.

Eugastrol reflusso contains maltitol and sodium
Eugastrol reflusso contains maltitol. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means
it is essentially “sodium-free”.

3. How to take Eugastrol reflusso

Always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet a day. Do not exceed the recommended dose of 20 mg of
pantoprazole per day.
You must take this medicine for at least 2-3 consecutive days. Stop taking Eugastrol reflusso if your symptoms have completely disappeared. You may experience relief from
symptoms of acid reflux or heartburn after just one day of treatment with Eugastrol
reflusso, but this medicine is not formulated to provide immediate relief.
If you do not experience relief from symptoms after taking this medicine continuously for 2
weeks, consult your doctor.
Do not take Eugastrol reflusso for more than 4 weeks without consulting your doctor first.
Take the tablet before a meal, at the same time each day. You must swallow the tablet
whole, with a little water. The tablet must not be chewed or crushed.

If you take more Eugastrol reflusso than you should
Inform your doctor or pharmacist if you have taken more than the recommended dose. If possible, bring with

If you forget to take Eugastrol reflusso
Do not take a double dose to make up for a missed dose. Take the next
dose at the usual time.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Inform your doctor immediately or contact the emergency room of the nearest hospital if you experience
any of the following serious side effects. Stop taking the medicine immediately, but

• Serious allergic reactions (rare: may affect up to 1 in 1,000 people):hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are as follows: swelling of the face, lips, mouth, tongue and/or throat, which can cause difficulty swallowing or breathing, urticaria, severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated based onavailable data):skin rash with swelling, formation of blisters or detachment of the skin, scaling of the skin and bleeding in the area around the eyes, nose, mouth or genitals and rapid deterioration of general health, or onset of rash after exposure to sunlight.
• Other serious reactions (frequency not known:frequency cannot be estimated based onavailable data):yellowing of the skin and whites of the eyes (due to severe liver damage), or kidney problems such as pain during urination and lower back pain with fever.

Other side effects include:

• Common side effects (may affect up to 1 in 10 people):benign polyps in the stomach
• Uncommon side effects (may affect up to 1 in 100 people):headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence; constipation; dry mouth; stomach pain and discomfort; skin rash or urticaria; itching; feeling weak, exhausted or generally unwell; sleep disturbances; increased levels of liver enzymes in blood tests; hip, wrist or spine fracture.
• Rare side effects (may affect up to 1 in 1,000 people):alteration or complete loss of taste; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; increased body temperature; swelling of the extremities; allergic reactions; depression; increased bilirubin and fat levels in the blood (visible from blood tests); enlargement of the breasts in men, high fever and a sharp decrease in circulating granular white blood cells (detected in blood tests).
• Very rare side effects (may affect up to 1 in 10,000 people):disorientation; reduced number of platelets, which can cause increased ease of bleeding or bruising; reduced number of white blood cells, which can lead to a more frequent occurrence of infections; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as platelets (detected in blood tests).
• Frequency not known (frequency cannot be estimated based on available data) :hallucinations, confusion (especially in patients with a previous history of these symptoms);; decreased level of sodium in the blood; decreased level of magnesium in the blood; decreased level of calcium in the blood (associated with decreased level of magnesium); decreased level of potassium in the blood; muscle spasm as a result of electrolyte disorders, erythema, possible joint pain; sensation of tingling, prickling,

pinpricks, burning or numbness, inflammation of the colon,
causing persistent watery diarrhea.
Very rarely, soy lecithin can cause allergic reactions.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. Side effects can also be reported
directly through the national reporting system at:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the
safety of this medicine.

5. How to store Eugastrol reflusso

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister. The
expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What the medicine containsEugastrol reflusso
The active ingredient is: pantoprazole.
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
The excipients are:

Tablet core
Maltitol (E965), crospovidone type B, sodium carboxymethylcellulose, sodium carbonate (E500), calcium stearate.

Tablet coating
Polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, soybean lecithin, iron
oxide yellow (E172), sodium carbonate (E500), methacrylic acid-ethyl acrylate copolymer (1:1),
polysorbate 80, sodium lauryl sulfate, triethyl citrate (E1505).

Description of the appearance of Eugastrol reflusso and package contents
Eugastrol reflusso presents as yellow, oval-shaped, gastro-resistant tablets,
approximately 8.2 mm x 4.4 mm.
Eugastrol reflusso is available in blister packs of 7 or 14 gastro-resistant tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ratiopharm GmbH Graf-Arco Strasse 3, 89079 – Ulm (Germany).

Manufacturer
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Germany (RMS): Pantomol 20 mg magensaftresistente Tabletten
Belgium: Pantogastrix 20 mg, gastro-resistant tablets
France: Pandrea 20 mg gastro-resistant tablets
Italy: Eugastrol reflusso 20 mg gastro-resistant tablets
Luxembourg: Pantogastrix 20 mg, comprimés gastro-resistants
The following lifestyle and dietary recommendations may
help to relieve symptoms related to heartburn or acid regurgitation.

• Avoid large meals.
• Eat slowly.
• Stop smoking.
• Reduce alcohol and caffeine consumption.
• Reduce body weight (if overweight).
• Avoid wearing tight clothing or belts.
• Avoid eating at least three hours before bedtime.
• Raise the head of the bed (if symptoms occur at night).
• Reduce consumption of foods that may cause heartburn, such as chocolate, peppermint, spearmint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and juices, tomatoes.