Active ingredients

• 22.56 mg pantoprazole sodium 1.5-water

Excipients

• Hyprolose
• Hypromellose
• Triethyl citrate
• Iron(III) oxide hydrate, black
• Crospovidone
• Methacrylic acid-ethyl acrylate copolymer (1:1)
• Iron(III) oxide
• Calcium stearate (vegetable)
• Mannitol
• Sodium carbonate

• The medicine contains the active ingredient pantoprazole, which blocks a type of pump that produces stomach acid. This reduces the amount of acid in the stomach.
• It is used for the short-term treatment of reflux symptoms (e.g., heartburn, acid reflux) in adults. Reflux is the backflow of stomach acid into the esophagus, which can become painfully inflamed. This can cause symptoms such as a painful burning sensation in the chest area that spreads to the throat (heartburn) and a sour taste in the mouth (acid reflux).
• Your symptoms of reflux and heartburn may be relieved after just one day of treatment, but this medicine may not provide immediate relief. You may need to take the tablets for 2-3 consecutive days to relieve symptoms.
• If you do not feel better or if you feel worse after 2 weeks, consult your doctor.

• The medicine must not be taken:
  • if you are allergic to pantoprazole or any of the other ingredients of this medicine.
  • if you are allergic to medicines containing other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole).
  • if you are taking HIV protease inhibitors such as atazanavir or nelfinavir (used to treat HIV infection). See "Interactions" section.

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.
• The recommended dose is one tablet daily. Do not exceed the recommended daily dose of 20 mg pantoprazole.
• Take this medicine for at least 2-3 consecutive days. Stop taking the medicine when you are completely free of symptoms. Your symptoms of acid reflux and heartburn may be relieved after just one day of treatment, but this medicine may not provide immediate relief.

• Duration of application
  • If you do not notice any improvement in your symptoms after 2 weeks of continuous use of this medicine, consult your doctor.
  • Do not take this medicine for more than 4 weeks without consulting your doctor.

• If you have taken more than you should
  • Inform your doctor or pharmacist if you have taken more than the recommended dose. If possible, take the medicine and the package leaflet with you.

• If you forget to take it
  • Do not take a double dose to make up for a forgotten dose. Simply take your usual dose at the next scheduled time.

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• If you experience any of the following serious side effects, tell your doctor immediately or go to the emergency department of your nearest hospital. Do not take any more tablets and take the package leaflet and/or the tablets with you.
  • Severe hypersensitivity reactions (frequency rare: may affect up to 1 in 1,000 people):
    • Hypersensitivity reactions, known as anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms include swelling of the face, lips, mouth, tongue, and/or throat, possibly leading to difficulty swallowing or breathing, hives (urticaria), severe dizziness with a rapid heartbeat, and heavy sweating.
  • Severe skin reactions (frequency not known: frequency cannot be estimated from the available data):
    • You may notice one or more of the following reactions: a rash with swelling, blistering, or flaking of the skin; skin erosion and easy bleeding around the eyes, nose, mouth, or genitals; and rapid deterioration of your general condition or rash, especially on areas of skin exposed to the sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.
  • Other severe reactions (frequency not known: frequency cannot be estimated from the available data):
    • 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 kidney inflammation), which may lead to kidney failure.
• Other side effects include:
  • Common side effects (may affect up to 1 in 10 people):
    • Benign gastric polyps.
  • Uncommon side effects (may affect up to 1 in 100 people):
    • Headache, dizziness, diarrhea, nausea, vomiting, flatulence, constipation, dry mouth, upper abdominal pain and discomfort, rash or hives, itching, feeling faint, tired or generally unwell, difficulty sleeping, increased liver enzymes in blood test, hip, wrist or spine fractures.
  • Rare side effects (may affect up to 1 in 1,000 people):
    • Disturbance or complete absence of taste perception, visual disturbances such as blurred vision, joint pain, muscle pain, weight fluctuations, increased body temperature, swelling of the limbs, depression, increased levels of bilirubin and fat in the blood (detectable in blood tests), enlargement of the male breast, high fever and a severe decrease in circulating granular white blood cells (seen in blood tests).
  • Very rare side effects (may affect up to 1 in 10,000 people):
    • Disorientation, decrease in the number of platelets in the blood, possibly causing more bleeding and bruising, decrease in the number of white blood cells, possibly causing more frequent infections, simultaneous abnormal decrease in the number of red and white blood cells and also platelets (seen in blood tests).
  • Frequency not known (frequency cannot be estimated from the available data):
    • Hallucinations, confusion (particularly in patients with a history of these symptoms); sensation of tingling, prickling, pins and needles, burning or numbness; decrease in sodium, magnesium, calcium or potassium levels in the blood, muscle cramps due to electrolyte imbalance; rash, possibly associated with joint pain; inflammation of the colon causing persistent watery diarrhea.
• If you experience any side effects, contact your doctor or pharmacist. This includes any possible side effects not listed.