NEXIUM CONTROL*7GAST TAB 20MG

Nexium Control 20 mg gastro-resistant tablets
Esomeprazole

What it is and what it is used for
Nexium Control contains the active ingredient esomeprazole. It belongs to a group of medicines called 'proton pump inhibitors'. These 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 esophagus (food pipe) which can become inflamed and painful. This can cause symptoms such as a painful sensation in the chest rising towards the throat (heartburn) and an acidic taste in the mouth (acid regurgitation).

Nexium Control is not designed to provide immediate relief. It may be necessary to take the tablets for 2-3 consecutive days before feeling better. Consult your doctor if you do not feel better or if you feel worse after 14 days.

What you need to know before taking the medicine
Do not take Nexium Control
- if you are allergic to esomeprazole or 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 or omeprazole);
- if you are taking a medicine containing nelfinavir (used to treat HIV infections);
- if you have ever had a severe skin rash or skin peeling, rash with blisters and/or mouth ulcers after taking Nexium Control or other related medicines.

You should not take this medicine if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Consult your doctor before taking Nexium Control if:
• you have previously had a stomach ulcer or undergone stomach surgery;
• you are on continuous treatment for 4 or more weeks for reflux or heartburn;
• you have jaundice (yellowing of the skin and eyes) or severe liver problems;
• you have severe kidney problems;
• you are over 55 years old and have new or recently changed reflux symptoms or need to take over-the-counter remedies for indigestion or heartburn daily;
• you have ever had a skin reaction after treatment with a medicine similar to Nexium Control that reduces stomach acidity. Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Nexium Control treatment.
Stop using Nexium Control and seek immediate medical advice if you notice any of the symptoms related to these severe skin reactions described in section 4;
• you need to undergo endoscopy or a urea breath test;
• you need to have a specific blood test (Chromogranin A).

Contact your doctor immediately before or after taking this medicine if you notice any of the following symptoms, which could be signs of another more serious illness.
• You are losing a lot of weight for no reason.
• You have difficulty or pain swallowing.
• You develop stomach pain or signs of indigestion such as nausea, feeling of fullness, bloating, especially after eating.
• You start vomiting food or blood, which may appear dark like coffee grounds in your vomit.
• Your stools are black (stools with blood spots).
• You have severe or persistent diarrhea; esomeprazole has been associated with a slight increase in the risk of infectious diarrhea.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop Nexium Control therapy. Remember to also report any other side effects such as joint pain.

Seek urgent medical advice if you experience chest pain accompanied by mental confusion, sweating, dizziness, or shoulder pain and shortness of breath. This could be a symptom of a serious heart problem.

If any of the above apply to you (or if you are in doubt), contact your doctor immediately.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.

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

If you notice any of the following serious side effects, stop taking Nexium Control and contact your doctor immediately:
• sudden wheezing, swelling of the lips, tongue and throat, rash, feeling faint or difficulty swallowing (severe allergic reaction, observed rarely);
• redness of the skin with blistering or peeling. Severe blistering and bleeding may also occur on the lips, eyes, mouth, nose and genitals. This may be 'Stevens-Johnson syndrome' or 'toxic epidermal necrolysis', observed very rarely;
• yellow skin, dark urine and fatigue which may be symptoms of liver problems, observed rarely;
• extensive skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.

Contact your doctor as soon as possible if you experience any of the following signs of infection:

This medicine affects white blood cells in very rare cases, 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 should 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 include:

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

Uncommon (may affect up to 1 in 100 people)
• Swelling of the feet and ankles;
• Disturbed sleep (insomnia), drowsiness;
• Dizziness, tingling sensation like pins and needles;
• Feeling of spinning (vertigo);
• Dry mouth;
• Increased liver enzymes shown in blood tests that check how the liver is working;
• Skin rash, hives (urticaria) and skin itching.

Rare (may affect up to 1 in 1,000 people)
• Blood problems such as a reduced number of white blood cells or platelets. This can cause weakness, bruising or an increased chance of getting infections;
• Low sodium levels in the blood. This can cause weakness, feeling sick (vomiting) and cramps;
• Feeling agitated, confused or depressed;
• Changes in taste;
• Vision problems such as blurred vision;
• Sudden wheezing or shortness of breath (bronchospasm);
• Inflammation inside the mouth;
• An infection called candidiasis that can affect the intestines and is caused by a fungus;
• Hair loss (alopecia);
• Rash on exposure to the sun;
• Joint pain (arthralgia) or muscle pain (myalgia);
• General feeling of being unwell and lack of strength;
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)
• Low number of red blood cells, white blood cells, and platelets (a condition called pancytopenia);
• Aggressiveness;
• Seeing, perceiving or hearing things that do not exist (hallucinations);
• Severe liver problems leading to liver failure and brain inflammation;
• Muscle weakness;
• Severe kidney problems;
• Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)
• Low magnesium levels in the blood. This can cause fatigue, feeling sick (vomiting), involuntary muscle contractions, tremors and changes in heart rhythm (arrhythmia). If you have very low magnesium levels, you may also experience low blood levels of calcium and/or potassium;
• Inflammation of the intestine (which can lead to diarrhea);
• Rash, possible joint pain.

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.