EUGASTROL REFLUSSO*7TAB 20MG

Eugastrol reflusso 20 mg gastro-resistant tablets
Pantoprazole
Equivalent medicinal product

What it is and what it is 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 reflux disease symptoms (e.g. heartburn, acid regurgitation) in adults. Reflux involves the backflow of acidic contents from the stomach into the oesophagus (the tube through which food passes), causing inflammation and pain. Symptoms may include a burning sensation in the chest that rises towards the throat (heartburn) and a bitter taste in the mouth (acid regurgitation).

You may experience relief from acid regurgitation and heartburn symptoms after just one day of treatment with Eugastrol reflusso, but this medicine is not formulated to provide immediate symptom relief. It may be necessary to take the tablets for 2-3 consecutive days to feel a positive effect on symptoms.

Consult your doctor if you do not feel better or if you feel worse after 2 weeks.

What you need to know before taking this medicine
Do not take Eugastrol reflusso:
- if you are allergic to pantoprazole, soy, peanuts, or any of the excipients 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
Consult your doctor or pharmacist 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 over-the-counter medicines daily for indigestion
- 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 gastric ulcer or have undergone stomach surgery
- If you suffer from liver problems or jaundice (yellowing of the skin or whites of the eyes)
- If you regularly consult your doctor for serious ailments or health conditions
- If you need to undergo 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 acidity
- If you need to undergo a specific blood test (Chromogranin A)
- If you are taking HIV protease inhibitors such as atazanavir or nelfinavir (for the treatment of HIV infection) concomitantly with pantoprazole, ask your doctor for specific advice.

Do not take this product for more 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 decide on the need for you to take this medicine long-term.

If Eugastrol reflusso is taken for longer periods, this could cause additional risks, such as:
- reduced vitamin B12 absorption and vitamin B12 deficiency, if your body's vitamin B12 reserves are already reduced. Consult your doctor if you notice any of the following symptoms, which may indicate low vitamin B12 levels:
     - extreme tiredness or lack of energy
     - tingling or prickling
     - red and sore tongue, mouth ulcers
     - muscle weakness
     - vision problems
     - memory problems, confusion, depression
- fracture of the hip, wrist or spine, especially if you already have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (for example, if you are taking steroids).
- decreased blood magnesium levels (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, accelerated heart rate). Low magnesium levels can also lead to a reduction in blood potassium or calcium levels. You should consult 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.

Inform your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another more serious disease:
- involuntary weight loss (unrelated to a diet or exercise program)
- vomiting, especially if repeated
- vomiting blood, which may appear as dark contents similar to coffee grounds in the vomit
- blood in the stools, which may appear black or dark like tar
- difficulty swallowing or pain on swallowing
- pale appearance and feeling of weakness (anemia)
- chest pain
- stomach pain
- severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in infectious diarrhoea
- if you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Eugastrol reflusso. Remember to also report any other side effects such as joint pain
- serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and erythema multiforme have been reported in association with pantoprazole treatment. Discontinue use of pantoprazole and consult your doctor immediately if you notice any of the symptoms related to these serious skin reactions, described in section 4.

Your doctor may decide to perform some tests.

If you need to undergo a blood test, inform your doctor that you are taking this medicine.

You may experience relief from acid regurgitation and heartburn symptoms after just 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 preventive purposes.

If you repeatedly experience symptoms of heartburn or indigestion for a long time, remember to consult 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.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody 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 take this leaflet and/or the tablets with you.
- Serious allergic reactions (rare frequency: may affect up to 1 in 1000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty swallowing or breathing, hives, severe dizziness with very fast heart rate and intense sweating.
- Serious skin reactions (frequency not known: frequency cannot be estimated from the available data): you may notice one or more of the following symptoms
- rash with swelling, blistering or peeling of the skin, desquamation of the skin and bleeding in the area around the eyes, nose, mouth or genitals and rapid deterioration of general health, or appearance of a rash particularly in areas of the skin exposed to the sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g. under the armpits) and blood tests may show changes in some white blood cells or liver enzymes.
- non-raised, reddish, circular or target-shaped spots on the trunk, often with blisters in the central part, peeling of the skin, ulcers on the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

- 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 fever, rash and enlarged kidneys, sometimes with pain during urination and lower back pain (severe kidney inflammation), which can lead to kidney failure.

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; diarrhoea; feeling unwell, vomiting; bloating and flatulence (wind); constipation; dry mouth; stomach ache and discomfort; skin rash or hives; itching; feeling of weakness, exhaustion or general malaise; sleep disturbances; increased liver enzyme levels in blood tests; hip, wrist or spinal fracture.

- Rare side effects (may affect up to 1 in 1000 people)
altered or complete loss of taste; vision 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 (visible in blood tests); breast enlargement in men, high fever and a sharp drop in circulating granular white blood cells (detected in blood tests).

- Very rare side effects (may affect up to 1 in 10000 people)
disorientation; reduction in the number of platelets, which may cause easier bleeding or bruising; reduction in the number of white blood cells, which may lead to a more frequent onset of infections; co-existing abnormal reduction in the number of red and white blood cells, as well as platelets (detected in blood tests).

- Not known frequency (frequency cannot be estimated from the available data)
hallucinations, confusion (especially in patients with a previous experience of these symptoms); decreased sodium, magnesium, calcium or potassium levels (see section 2); muscle spasms due to electrolyte disturbances (changes in salt levels in the body); rash, possible joint pain; tingling, prickling, pins and needles sensation, burning sensation or numbness, inflammation of the large intestine, causing persistent watery diarrhoea.

Very rarely soy lecithin can cause allergic reactions.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.