MAALOX REFLUX 20 MG GASTRO-RESISTANT TABLETS 14 TABLETS IN OPA/ALU/PVC-AL BLISTER

Name
MAALOX REFLUX 20 mg gastro-resistant tablets
Pantoprazole


What it is and what it is used for
MAALOX REFLUX contains the active substance pantoprazole, which blocks the 'pump' that produces acid in the stomach. It therefore reduces the amount of acid in your stomach.
MAALOX REFLUX is used for the short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Reflux is the backflow of acid from the stomach into the esophagus (“food pipe”), which can become inflamed and painful. This can cause symptoms such as a painful burning sensation in the chest that travels up the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with MAALOX REFLUX , but this medicine is not designed to provide immediate relief.
You may need to take the tablets for 2-3 days in a row to improve 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 MAALOX REFLUX:
• if you are allergic to pantoprazole, peanuts, soya 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 REFLUX"


Warnings and precautions
Talk to your doctor or pharmacist before taking MAALOX REFLUX
• 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 of age and take non-prescription indigestion treatments on a daily basis.
• If you are over 55 years of age and have new or recently changed reflux symptoms.
• If you have previously had a gastric ulcer or stomach operations.
• If you regularly visit your doctor for serious health problems or conditions.
• If you need to undergo an endoscopy or a breath test called C-urea test.
• If you have had a skin reaction after treatment with a medicine similar to MAALOX REFLUX to reduce stomach acid.
• 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) at the same time as pantoprazole, ask your doctor for specific recommendations.
• Serious 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 syndrome may include blistering, peeling, or bleeding on any part of the skin (including the lips, eyes, mouth, nose, genitals, hands, or feet) with or without a rash. You may also have 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 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 reflux) persist for more than 2 weeks, talk to your doctor who will decide whether you need to take this medicine long-term.

Taking MAALOX REFLUX for prolonged periods could cause additional 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 have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• Reduction in magnesium levels in the blood (possible symptoms: tiredness, involuntary muscle contractions, disorientation, convulsions, dizziness, rapid heartbeat). Low magnesium levels can also lead to a reduction in potassium or calcium levels in the blood. Talk to your doctor if you are using this medicine for more than 4 weeks. Your doctor may decide to carry out blood tests from time to time 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, disorder:
• Unintentional weight loss (not related to a diet or exercise program).
• Vomiting, particularly if recurrent.
• Presence of blood in the vomit; in the vomit this may appear dark in color like coffee grounds.
• Presence of blood in the stool, which may appear black or tarry in color.
• Difficulty swallowing or pain when swallowing.
• Appears pale and feels weak (anemia).
• Chest pain.
• Stomach ache.
• Severe and/or persistent diarrhoea, as this medicine has been associated with a small increase in infectious diarrhoea.
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 experience relief from acid reflux and heartburn symptoms after just one day of treatment with MAALOX REFLUX, but this medicine is not designed to provide immediate relief. You should not take it as a preventative measure.

If you have been suffering from recurrent heartburn or indigestion symptoms for some time, remember to visit your doctor regularly.

If you develop a rash on your skin, especially in areas exposed to the sun, consult your doctor as soon as possible, as it may be necessary to stop treatment with MAALOX REFLUX. Remember to also mention other adverse effects such as joint pain.

Children and adolescents
MAALOX REFLUX should not be used by children and adolescents under 18 years of age due to the 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.
Tell your doctor immediately or contact your nearest hospital emergency department if you experience any of the following serious side effects . Stop taking this medicine immediately, but take this leaflet and/or your 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 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 syndrome may include blistering, peeling, or bleeding on any part of the skin (including the lips, eyes, mouth, nose, genitals, hands, or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills, or muscle aches.
• Signs and symptoms of DRESS may include flu-like symptoms and a widespread skin 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 painful urination and back pain with fever.

During treatment with the active substance of the product MAALOX REFLUX the following undesirable effects have been observed:

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; diarrhoea; feeling sick, vomiting; bloating and flatulence (flatulence); constipation; dry mouth; stomach ache and discomfort; skin rash or hives; itching; feeling weak, tired or generally unwell; trouble sleeping; 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 sense 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 (seen in blood tests), breast enlargement in men; high fever and severe decrease in circulating granulocytes (seen 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 you to bleed or bruise more often than normal; reduction in the number of white blood cells, which may lead to more frequent infections; at the same time an abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests).

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.