GASTROSCHOUM REFLUX*14CAPS

GastroSchoum Reflusso 20 mg hard capsules
Omeprazole

What it is and what it is used for
Schoum gastroprotect contains the active ingredient omeprazole. It belongs to a group of medicines called proton pump inhibitors. These medicines work by reducing the amount of acid produced by the stomach.

This medicine is used in adults for the short-term treatment of reflux symptoms (e.g., heartburn and acid regurgitation).

Reflux is the return of acid from the stomach into the food pipe (esophagus), which can become inflamed and painful. 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 may need to take the capsules for 2-3 consecutive days before feeling better.

What you need to know before taking the medicine
Do not take GastroSchoum Reflusso:
- if you are allergic to omeprazole, or to 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., pantoprazole, lansoprazole, rabeprazole, esomeprazole);
- if you are taking a medicine containing nelfinavir (used for HIV infections).

You should not take GastroSchoum Reflusso if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Do not take GastroSchoum Reflusso for more than 14 days without consulting your doctor. If you do not feel relief, or if your symptoms worsen, consult your doctor.
Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment with GastroSchoum Reflusso. Stop using GastroSchoum Reflusso and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Kidney inflammation may occur during omeprazole treatment. Signs and symptoms may include decreased urine volume or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. Inform your doctor if you experience any of these symptoms.

This medicine may mask symptoms of other diseases. Therefore, if you have any of the following conditions before taking GastroSchoum Reflusso or if they occur while you are taking it, talk to your doctor immediately if:
• you lose a lot of weight for no reason and have difficulty swallowing;
• you experience stomach pain or indigestion;
• you start vomiting food or blood;
• you pass black stools (blood-stained stools);
• you experience severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea;
• you have had a stomach ulcer in the past or have undergone stomach surgery;
• you have been receiving continuous treatment for reflux or heartburn for 4 or more weeks;
• you suffer continuously from indigestion or heartburn for 4 or more weeks;
• you have jaundice or severe liver problems;
• you are over 55 years old and have new or recently changed reflux symptoms;
• you have ever had a skin reaction after treatment with a medicine similar to Schoum gastroprotect that reduces stomach acidity;
• you need to undergo a specific blood test (chromogranin A).

Patients should not take omeprazole as a preventive medicine.

If you notice a rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Schoum gastroprotect. Remember to also report any other side effects such as joint pain.

Children and adolescents
The use of GastroSchoum Reflusso is not recommended in children and adolescents under 18 years of age due to insufficient safety and efficacy data.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking GastroSchoum Reflusso and contact your doctor immediately:
• sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction). (rare);
• reddening of the skin with blisters or peeling. Severe blistering and bleeding of the lips, eyes, mouth, nose, and genitals may also occur. These manifestations could be signs of Stevens-Johnson Syndrome or toxic epidermal necrolysis. (very rare);
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare);
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare);
• yellow skin, dark urine, and fatigue that may be symptoms of liver problems. (rare)

GastroSchoum Reflusso can in very rare cases affect white blood cells leading to immunodeficiency. If you develop an infection with symptoms such as fever with severe deterioration of general health or fever with symptoms of local infection such as pain in the neck, throat, or mouth or difficulty urinating, you must consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by performing a blood test. In this case, it is important that you inform your doctor about the medicine you are taking.

Other side effects:

Common (may affect up to 1 in 10 people)
• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas in the intestines (flatulence).
• Feeling unwell (nausea) or being sick (vomiting).
• Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)
• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling sensation like pins and needles, feeling sleepy.
• Feeling dizzy (vertigo).
• Changes in blood tests that assess how the liver works.
• Skin rash, rash with hives (urticaria) and skin itching.
• Generally feeling not very well and with little strength.

Rare (may affect up to 1 in 1,000 people)
• Blood problems such as reduction of white cells or platelets. This can cause weakness, bruising, or an increased likelihood of getting infections more easily.
• Low sodium levels in the blood. This can cause weakness, feeling sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Altered taste.
• Vision problems such as blurred vision.
• Suddenly feeling breathless or short of breath (bronchospasm).• Dry mouth.
• Inflammation of the inside of the mouth.
• An infection called thrush that can involve the intestines and is caused by a fungus.
• Hair loss (alopecia).
• Rash during exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)
• Changes in blood count including agranulocytosis (lack of white blood cells).
• Aggressive behavior.
• Seeing, feeling or hearing things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Erythema multiforme.
• Muscle weakness.
• Gynecomastia in men.

Frequency not known (frequency cannot be estimated from the available data):
• Inflammation of the intestine (which can lead to diarrhea).
• Hypomagnesemia (magnesium deficiency in the blood).
• Rash, possible joint pain.

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.