SEDIPANTO "20 MG GASTRO-RESISTANT TABLETS" 14 TABLETS IN OPA/AL/PVC-AL BLISTER"

Name
Sedipanto 20 mg gastro-resistant tablets
Pantoprazole


What is it and what is it for?
Sedipanto contains the active ingredient pantoprazole, which blocks the "pump" that produces stomach acid. This reduces the amount of stomach acid.

Sedipanto is used for the short-term treatment of reflux symptoms (e.g., heartburn, acid regurgitation) in adults.
Reflux is the backflow of stomach acid into the esophagus, which can become inflamed and cause pain. This can cause symptoms such as a burning pain in the chest that travels up 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 Sedipanto, but this medicine is not designed to provide immediate relief. You may need to take the tablets for 2-3 consecutive days to relieve 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 Sedipanto
- if you are allergic to pantoprazole 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 Sedipanto".


Warnings and precautions
Talk to your doctor or pharmacist before taking Sedipanto.
Talk to your doctor first:
- if you have been treated for heartburn or indigestion continuously for 4 weeks or more;
- if you are over 55 years of age and are taking indigestion medicines without a prescription on a daily basis;
- if you are over 55 years of age with new or recently changed reflux symptoms;
- if you have previously had a gastric ulcer or stomach surgery;
- if you have liver problems or jaundice (yellowing of the skin or eyes);
- if you regularly visit your doctor for serious ailments or conditions;
- if you are due to have an endoscopy or a breath test called a C-urea test - if you have ever had an allergic reaction after treatment with a medicine similar to Sedipanto 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; nelfinavir (for the treatment of HIV infection) at the same time as pantoprazole, ask your doctor for specific advice.

Do not take this medicine for longer than 4 weeks without consulting your doctor.
If symptoms of gastric reflux (heartburn or gastric regurgitation) persist for more than 2 weeks, tell your doctor who will decide whether long-term use of this medicine is necessary.

If you take Sedipanto for a long time, this may lead to additional risks, such as:
Reduced absorption of vitamin B12, and vitamin B12 deficiency if you already have low vitamin B12 levels. Talk to 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 wrist, hip or spine, especially if you already have osteoporosis (low bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g. if you are taking steroids);
- decreased magnesium levels in the blood (potential symptoms: tiredness, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Low magnesium levels can also lead to decreased potassium and calcium levels in the blood. You should tell your doctor if you have been taking this medicine for more than 4 weeks. Your doctor may decide to perform regular 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 condition:
- unintentional weight loss (not related to a diet or exercise program);
- vomiting, especially if recurrent;
- presence of blood in the vomit; this may appear dark in color like coffee grounds;
- presence of blood in the stool, which may be black or tar-colored;
- difficulty swallowing or pain when swallowing;
- if he is pale and feels 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 have a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop treatment with Sedipanto. Remember to also mention 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 that you need to do some tests.

If you need to have blood tests, 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 Sedipanto, but this medicine is not intended to provide immediate relief. It should not be taken as a preventative measure.

If you suffer from recurring heartburn or indigestion for some time, remember to visit your doctor regularly.

Children and adolescents
Sedipanto should not be used in children and adolescents under 18 years of age due to the lack of safety information in this 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 this medicine immediately, but take this leaflet and/or the tablets with you.
- Serious 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 swallowing or breathing, hives, severe dizziness with a very rapid heartbeat, and profuse sweating.
- Severe 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, skin loss and bleeding around the eyes, nose, mouth, or genitals, and rapid deterioration of general health, or a rash when exposed to the sun. You may also have joint pain or flu-like symptoms, fever, swollen glands (e.g., under the armpit), 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 ): yellowing of the skin and 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; diarrhoea; feeling sick; vomiting; bloating and flatulence (wind); constipation; dry mouth; stomach ache and discomfort; rash or hives; itching; feeling weak, tired and generally unwell; trouble sleeping; increased liver enzymes in blood tests; fracture of the wrist, hip and spine;
- Rare side effects (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; high body temperature; swelling of the extremities; depression; increased bilirubin and blood fat levels (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; reduction in the number of platelets in the blood, which may cause bleeding or bruising more than normal; reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests);
- Frequency not known : hallucinations, confusion (particularly in patients who have had these symptoms in the past); reduced level of sodium, magnesium, calcium, or potassium in the blood (see section 2); rash, possible joint pain; sensation of tingling, tingling, pins and needles, burning sensation, or numbness; inflammation of the large intestine causing persistent watery diarrhoea.

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.