Package leaflet: Information for the user

Eugastrol Reflux 20 mg gastro-resistant tablets

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

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks.
You must not take Eugastrol Reflux for longer than 4 weeks without first consulting a doctor.

Contents of this leaflet

What Eugastrol Reflux is and what it is used for
What you need to know before taking Eugastrol Reflux
How to take Eugastrol Reflux
Possible side effects
How to store Eugastrol Reflux
Contents of the pack and other information

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

Eugastrol reflux contains the active substance pantoprazole, which blocks the "pump" that produces acid in the stomach. As a result, it is able to reduce the amount of acid in the stomach.
Eugastrol reflux 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 stomach contents into the oesophagus (the "tube" through which food passes), causing inflammation and pain. This can lead to symptoms such as a burning sensation in the chest rising towards the throat (heartburn) and a sour or bitter taste in the mouth (acid regurgitation).
You may experience relief from symptoms of acid regurgitation and heartburn as early as one day after starting treatment with Eugastrol reflux; however, this medicine is not designed to provide immediate symptom relief. It may be necessary to take the tablets for 2–3 consecutive days before experiencing a positive effect on symptoms.
Consult your doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you should know before taking Eugastrol Reflux

Do not take Eugastrol Reflux:

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

Warnings and precautions
Talk to your doctor before taking Eugastrol Reflux:

If you have been treated for heartburn or indigestion continuously for 4 or more weeks
If you are over 55 years old and take over-the-counter medicines for indigestion daily
If you are over 55 years old and experience any new symptoms or changes in pre-existing reflux symptoms
If you have previously suffered from gastric 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 consult your doctor for serious health conditions
If you are scheduled for an endoscopy or a breath test called C-urea test
If you have ever had a skin reaction after treatment with a medicine similar to Eugastrol Reflux 20 mg gastro-resistant tablets that reduces stomach acid
If you need to undergo a specific blood test (Chromogranin A)
If you are taking HIV protease inhibitors such as atazanavir or nelfinavir (for treatment of HIV infection) together with pantoprazole, consult your doctor for specific advice.

Do not take this product for longer than 4 weeks without consulting your doctor. If reflux symptoms (heartburn or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will determine whether long-term use of this medicine is necessary.
Prolonged use of Eugastrol Reflux may lead to additional risks such as:

Reduced absorption of vitamin B12 and vitamin B12 deficiency, especially if your body's vitamin B12 reserves are already low
Fractures of the hip, wrist, or spine, particularly if you already have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis)
Decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle spasms, confusion, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. You should consult your doctor if you have been using this product for more than 4 weeks. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

Contact your doctor immediately, before or after taking this medicine, if you notice any of the
following symptoms, which could indicate a more serious underlying condition:

Unintentional weight loss (not related to diet or exercise program)
Vomiting, especially if repeated
Vomiting blood, which may appear as dark material resembling ground coffee in the vomit
Blood in the stool, which may appear black or tarry
Difficulty swallowing or pain when swallowing
Pale appearance 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 develop a skin rash, especially in sun-exposed areas, contact your doctor as soon as possible, as treatment with Eugastrol Reflux may need to be discontinued. Remember to also report any other side effects such as joint pain.

Your doctor may decide to carry out tests.
If you need to have a blood test, inform your doctor that you are taking this medicine.
You may experience relief from acid regurgitation and heartburn symptoms as early as one day after
starting treatment with Eugastrol Reflux, but this medicine is not formulated to provide immediate
symptom relief.
Do not take this medicine for preventive purposes.
If you experience repeated and prolonged symptoms of heartburn or indigestion, remember to
consult your doctor regularly.

Children and adolescents
Eugastrol Reflux must not be taken by children and adolescents under 18 years of age due to lack of safety data in this younger age group.

Other medicines and Eugastrol Reflux
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Eugastrol Reflux may interfere with the proper action of certain other medicines. Especially medicines containing any of the following active substances:

HIV protease inhibitors such as atazanavir or nelfinavir (used for treatment of HIV infection). You must not use Eugastrol Reflux if you are taking HIV protease inhibitors. See "Do not take Eugastrol Reflux"
ketoconazole (used to treat fungal infections)
warfarin and fenprocumone (used to thin the blood and prevent clot formation). You may need additional blood tests
methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Eugastrol Reflux, as pantoprazole may increase methotrexate levels in the blood.

Do not take Eugastrol Reflux with other medicines that reduce stomach acid production, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2-receptor antagonists (e.g., ranitidine, famotidine).
However, you may take Eugastrol Reflux with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations), if needed.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or breastfeeding. If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
If you experience side effects such as dizziness or visual disturbances, do not drive or operate machinery.

Eugastrol Reflux contains maltitol and sodium
Eugastrol Reflux contains maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Eugastrol reflux

Always take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day. Do not exceed the recommended dose of 20 mg of pantoprazole per day.
You should take this medicine for at least 2–3 consecutive days. Discontinue taking Eugastrol reflux if your symptoms have completely disappeared. You may experience relief from acid reflux or heartburn symptoms as early as one day after starting treatment with Eugastrol reflux, but this medicine is not formulated to provide immediate relief.
If you do not experience symptom relief after taking this medicine continuously for 2 weeks, consult your doctor.
Do not take Eugastrol reflux for more than 4 weeks without first consulting your doctor.
Take the tablet before a meal, at the same time each day. Swallow the tablet whole with some water. The tablet must not be chewed or crushed.
If you take more Eugastrol reflux than you should
Inform your doctor or pharmacist if you have taken more than the recommended dose. If possible, bring the medicine and this leaflet with you. Symptoms of overdose are not known.
If you forget to take Eugastrol reflux
Do not take a double dose to make up for the missed dose. Take the next dose at your usual time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately or go to the nearest emergency department if you experience any
of the following serious side effects. Stop taking the medicine immediately, but bring this leaflet
and/or the tablets with you.

Severe allergic reactions (rare: may affect up to 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms include swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, urticaria (hives), severe dizziness with rapid heartbeat and intense sweating.
Severe skin reactions (frequency not known: frequency cannot be estimated from the available data): skin rash with swelling, blistering or peeling of the skin, skin shedding, bleeding around the eyes, nose, mouth or genitals, rapid deterioration in general health, or appearance of a skin rash after exposure to sunlight.
Other serious reactions (frequency not known: frequency cannot be estimated from the available data): yellowing of the skin and whites of the eyes (due to severe liver damage), or kidney problems such as pain during urination and pain in the lower back accompanied by fever.

Other side effects include:

Common side effects (may affect up to 1 in 10 people): benign gastric polyps
Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling unwell, vomiting; bloating and flatulence (meteorism); constipation; dry mouth; stomach ache and discomfort; skin rash or urticaria; itching; feeling of weakness, exhaustion or general malaise; sleep disorders; increased levels of liver enzymes in blood tests; fracture of the hip, wrist or spine.
Rare side effects (may affect up to 1 in 1,000 people): altered or complete loss of taste sensation; 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 blood fat levels (detected in blood tests); breast enlargement in men, high fever and a marked 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 platelet count, which may lead to increased bleeding or bruising; reduced white blood cell count, which may result in more frequent infections; concomitant abnormal reduction in red blood cells, white blood cells, and platelets (detected in blood tests).
Frequency not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with previous history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood; decreased calcium levels in the blood (associated with decreased magnesium levels); decreased potassium levels in the blood; muscle spasms as a consequence of electrolyte disturbances; erythema; possible joint pain; sensations of tingling, prickling, pins and needles, burning or numbness; inflammation of the large intestine causing persistent watery diarrhoea.
Very rarely, soy lecithin may cause allergic reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at the following website:
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps 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 stated on the carton and blister pack. The
expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 Eugastrol Reflux contains
The active substance is: pantoprazole.
Each gastro-resistant tablet contains 20 mg of pantoprazole (as sesquihydrate sodium).
The excipients are:
Tablet core
Maltitol (E965), crospovidone type B, sodium carmellose, sodium carbonate (E500), calcium stearate.
Coating of the tablet
Polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, soybean lecithin, yellow iron oxide (E172), sodium carbonate (E500), methacrylic acid copolymer ethyl acrylate (1:1), polysorbate 80, sodium lauryl sulfate, triethyl citrate (E1505).

Description of the appearance of Eugastrol Reflux and contents of the pack
Eugastrol Reflux is presented as yellow, oval-shaped, gastro-resistant tablets, approximately 8.2 mm x 4.4 mm.
Eugastrol Reflux is available in blister packs containing 7 or 14 gastro-resistant tablets.
It is possible that not all pack sizes are marketed.

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

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany (RMS): Pantomol 20 mg magensaftresistente Tabletten
Belgium: Pantogastrix 20 mg, comprimés gastro-resistants
France: Pandrea 20 mg comprime gastro-resistant
Italy: Eugastrol reflusso 20 mg compresse gastroresistenti
Luxembourg: Pantogastrix 20 mg, comprimés gastro-resistants

The following lifestyle and dietary recommendations may help 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 tight belts.
Avoid eating at least three hours before going to bed.
Elevate the head of the bed (if symptoms occur during the night).
Reduce intake of foods that may cause heartburn, such as chocolate, peppermint, mint, fatty and fried foods, acidic foods, spicy foods, citrus fruits and fruit juices, tomatoes.