EUGASTROL REFLUX "20 MG GASTRO-RESISTANT TABLETS" 14 TABLETS IN AL/AL BLISTER"

Name
Eugastrol reflux 20 mg gastro-resistant tablets
Pantoprazole
Equivalent medicine


What is it and what is it for?
Eugastrol Reflux contains the active ingredient pantoprazole, which blocks the "pump" that produces stomach acid. Consequently, it can reduce the amount of acid present in the stomach.

Eugastrol Reflux is used for the short-term treatment of symptoms of reflux disease (e.g. heartburn, acid regurgitation) in adults.
Reflux involves the reflux of acid from the stomach into the esophagus (the "tube" through which food passes), causing inflammation and pain. Symptoms may then appear, such as a burning sensation in the chest that rises to the throat (heartburn) and a bitter taste in the mouth (acid regurgitation).

You may experience relief from acid reflux and heartburn symptoms after just one day of treatment with Eugastrol Reflux, but this medicine is not designed to provide immediate relief. You may need to take the tablets for 2-3 consecutive days to experience a positive effect on your symptoms.

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


What you need to know before taking the medicine
Do not take Eugastrol reflux:
- if you are allergic to pantoprazole, soya, 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 reflux".


Warnings and precautions
Talk to your doctor or pharmacist 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 of age and take non-prescription medications for indigestion on a daily basis.
- If you are over 55 years of age and have any new or changes in existing reflux symptoms.
- If you have previously suffered from gastric ulcers 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 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 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 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 reflux symptoms (heartburn or acid reflux) persist for more than 2 weeks, consult your doctor, who will decide whether long-term use of this medicine is necessary.

If you take Eugastrol reflux for longer periods, this could cause additional risks, such as:
- reduced vitamin B12 absorption and vitamin B12 deficiency, if your body's vitamin B12 stores are already low. Contact 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 stinging;
- red and sore tongue, mouth ulcers;
- muscle weakness;
- vision disorders;
- memory problems, confusion, depression;
- fracture of the hip, wrist or spine, especially if you already have osteoporosis (low bone density) or if your doctor has told you that you are at risk of getting osteoporosis (for example if you are taking steroids);
- Decreased magnesium levels in the blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels can also lead to decreased 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 order periodic blood tests to monitor your 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 another, more serious illness:
- unintentional weight loss (not related to a diet or exercise program);
- vomiting, especially if repeated;
- vomiting blood, which may manifest itself with the presence of dark contents similar to ground coffee in the vomit;
- presence of blood in the stool, which may appear black or dark like tar;
- difficulty swallowing or pain when swallowing;
- pale appearance and feeling weak (anemia);
- chest pain;
- stomach pain;
- severe and/or persistent diarrhoea, as this medicine has been associated with a small increase in infectious diarrhoea;
- If you notice a skin rash, especially in areas exposed to the sun, contact your doctor as soon as possible, as you may need to stop treatment with Eugastrol Reflux. 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. Stop using pantoprazole and contact your doctor immediately if you notice any symptoms of these serious skin reactions, as described in section 4.

Your doctor may decide to have you undergo some tests.

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

You may experience relief from the symptoms of acid reflux and heartburn after just one day of treatment with Eugastrol reflux, but this medicine is not designed to provide immediate relief from symptoms.
You should not take this medicine as a preventative measure.

If you experience heartburn or indigestion symptoms repeatedly and over a long period of time, remember to see your doctor regularly.

Children and adolescents
Eugastrol reflux 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.

Tell your doctor immediately or contact the nearest hospital emergency department 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 (frequency 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 swallowing or breathing, hives, severe dizziness with a very rapid heartbeat, 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;
- a rash with swelling, blistering, or peeling skin, peeling skin, and bleeding around the eyes, nose, mouth, or genitals, and a rapid deterioration in general health, or the appearance of a rash, especially on sun-exposed areas of the skin. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g., under the armpits), and blood tests may show changes in certain white blood cells or liver enzymes;
- flat, circular, or target-shaped reddish spots on the trunk, often with central blisters, peeling skin, and ulcers on the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
- widespread skin rash, high fever and swollen 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 painful urination and lower back pain (severe inflammation of the kidneys), which may 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; diarrhea; feeling sick, vomiting; bloating and flatulence (flatulence); constipation; dry mouth; stomach ache and feeling unwell; rash or hives; itching; feeling weak, exhausted, or generally unwell; trouble sleeping; increased levels of liver enzymes in blood tests; fracture of the hip, wrist, or spine.

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

- Very rare side effects (may affect up to 1 in 10,000 people)
disorientation; a reduction in the number of platelets, which may cause you to bleed or bruise more easily; a reduction in the number of white blood cells, which may lead to more frequent infections; a coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (detected in blood tests).

- Frequency not known (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, possibly joint pain; sensation of tingling, prickling, pins and needles, burning sensation, or numbness; inflammation of the large intestine, causing persistent watery diarrhea.

Very rarely, soy lecithin can cause allergic reactions.

Reporting of side effects
If you experience 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.