MAALOX REFLUSSO*14 tablets 20mg

MAALOX REFLUSSO 20 mg gastro-resistant tablets
Pantoprazole

What it is and what it is used for
MAALOX REFLUSSO contains the active ingredient pantoprazole, which blocks the 'pump' that produces acid in the stomach. Therefore, it reduces the amount of acid in your stomach.
MAALOX REFLUSSO is used for the short-term treatment of reflux symptoms (e.g., heartburn, acid regurgitation) in adults.
Reflux is the return of acid from the stomach into the esophagus ("food pipe"), which can become inflamed and cause pain. This can cause symptoms such as a painful burning sensation in the chest that rises towards the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
You might experience relief from symptoms related to acid reflux and heartburn after just one day of treatment with MAALOX REFLUSSO, but this medicine is not designed to provide immediate relief.
It may be necessary to take the tablets for 2-3 consecutive days to improve 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 the medicine
Do not take MAALOX REFLUSSO:
• if you are allergic to pantoprazole, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6);
• if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection), see Other medicines and MAALOX REFLUSSO

Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX REFLUSSO
• If you have liver problems or jaundice (yellowing of the skin or eyes).
• If you have been treated for heartburn or indigestion continuously for 4 or more weeks.
• If you are over 55 years old and take daily over-the-counter indigestion treatments.
• If you are over 55 years old and have new or recently changed reflux symptoms.
• If you have previously had a stomach ulcer or stomach surgery.
• If you regularly visit a doctor for serious health conditions or disorders.
• If you need to undergo an endoscopy or a breath test called the C-urea test.
• If you have had a skin reaction after treatment with a medicine similar to MAALOX REFLUSSO to reduce stomach acidity.
• If you need to undergo a specific blood test (Chromogranin A).
• If you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection) concomitantly with pantoprazole, consult your doctor for specific recommendations.
• Severe skin problems such as Stevens-Johnson syndrome (SJS), Lyell's syndrome, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with pantoprazole:

- Symptoms of SJS/Lyell's syndrome may include blistering, peeling, or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet) with or without a rash. You may also experience flu-like symptoms such as fever, chills, or muscle aches.
- Signs and symptoms of DRESS may include flu-like symptoms and a widespread rash accompanied by high body temperature and swollen lymph nodes. Abnormal blood test results may include increased levels of liver enzymes and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

If you develop severe skin reactions or any of the reactions listed above, stop treatment immediately and contact your doctor or a healthcare professional.
• If you experience chest pain.

Do not take this medicine 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 if long-term use of this medicine is necessary.

Taking MAALOX REFLUSSO for prolonged periods may cause additional risks such as:
• Reduced absorption of vitamin B12, and vitamin B12 deficiency if your body's vitamin B12 stores 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).
• Reduction of magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, accelerated heartbeat). Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Consult your doctor if you have been using this medicine for more than 4 weeks. Your doctor may decide to perform 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 disorder:
• Unintentional weight loss (not related to a diet or exercise program).
• Vomiting, especially if recurrent.
• Blood in vomit; in vomit, this may appear dark like coffee grounds.
• Blood in stools, which may appear black or tar-like.
• Difficulty swallowing or pain during swallowing.
• Appears pale and feels weak (anemia).
• Chest pain.
• Stomach ache.
• Severe and/or persistent diarrhea, because this medicine has been associated with a slight increase in infectious diarrhea.
Your doctor may decide that you need some tests.

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

You may get relief from acid reflux and heartburn symptoms after only one day of treatment with MAALOX REFLUSSO, but this medicine is not designed to provide immediate relief. You should not take it as a preventive measure.

If you have suffered from recurrent heartburn or indigestion symptoms for some time, remember to see your doctor regularly.

If you experience a skin rash, especially in areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with MAALOX REFLUSSO. Remember to also mention other negative effects such as joint pain.

Children and adolescents
MAALOX REFLUSSO should not be used by children and adolescents under 18 years of age due to lack of safety data in this younger age group.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult your doctor immediately or contact the nearest hospital emergency room if you experience any of the following serious side effects. Stop taking this medicine immediately, but carry 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 are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with a very fast heartbeat and heavy sweating.
• Severe skin reactions (frequency not known: frequency cannot be estimated from the available data):

• Symptoms of SJS/Lyell's syndrome may include blistering, peeling, or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet) with or without a rash. You may also experience flu-like symptoms such as fever, chills, or muscle aches.
• Signs and symptoms of DRESS may include flu-like symptoms and a widespread rash accompanied by high body temperature and swollen lymph nodes. Abnormal blood test results may include increased levels of liver enzymes and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

• Other serious side effects (frequency not known: frequency cannot be estimated from the available data):
yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain on urination and lower back pain with fever.

The following side effects have been observed during treatment with the active substance of MAALOX REFLUSSO:

Common (may affect up to 1 in 10 people)
• benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people)
• headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence; constipation; dry mouth; abdominal pain and discomfort; skin rash or hives; itching; feeling of weakness, exhaustion or general malaise; sleep disorders; increased liver enzymes in blood tests; fracture of the hip, wrist or spine.

Rare (may affect up to 1 in 1,000 people):
• altered or complete lack of taste; visual disturbances such as blurred vision; joint pain; muscle pain; weight changes; increased body temperature; swelling of the extremities; allergic reactions; depression; increased levels of bilirubin and fat in the blood (detected in blood tests), breast enlargement in men; high fever and severe decrease in circulating granulocytes (observed in blood tests).

Very rare (may affect up to 1 in 10,000 people):
• disorientation; reduction in the number of platelets in the blood, which may cause bleeding or bruising more frequently than normal; reduction in the number of white blood cells, which may lead to more frequent infections; concomitant abnormal reduction in the number of red and white blood cells, as well as platelets (observed in blood tests).

Frequency not known (frequency cannot be estimated from the available data):
• hallucinations, confusion (especially in patients with a medical history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood, tingling, prickling, stinging, burning or numbness sensation; inflammation of the large intestine, causing persistent watery diarrhea.
• chest pain, which may be a sign or a severe allergic reaction called Kounis syndrome.

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.