NEXIUM CONTROL 20 MG - GASTRO-RESISTANT TABLET - ORAL USE - BLISTER (ALU) - 14 TABLETS

Name
Nexium Control 20 mg gastro-resistant tablets
Esomeprazole


What is it and what is it for?
Nexium Control contains the active substance 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 (for example, heartburn and acid regurgitation).

Reflux is the backflow of stomach acid into the esophagus (food pipe), which can become inflamed and painful. This can cause symptoms such as a pain in the chest that rises to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Nexium Control is not designed to provide immediate relief. You may need to take the tablets for 2-3 consecutive days before you feel better. Talk to your doctor if you don't 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 peeling skin, 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 you are unsure, consult your doctor or pharmacist before taking this medicine.


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

Talk to your doctor immediately before taking or after taking this medicine if you notice any of the following symptoms, which could be signs of another, more serious illness.
• loses a lot of weight for no reason;
• has problems or pain when swallowing;
• stomach pain or signs of indigestion such as nausea, feeling of fullness, bloating appear especially after eating;
• begins vomiting food or blood, which may appear dark like coffee grounds in his vomit;
• the stool is black (stool with blood spots);
• have severe or persistent diarrhoea; esomeprazole has been associated with a small increased risk of infectious diarrhoea;
• If you notice a skin rash, especially in areas exposed to the sun, contact your doctor as soon as possible, as you may need to stop treatment with Nexium Control. Remember to also report any other side effects such as joint pain.

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

If any of the above applies to you (or if you have any doubts), 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, skin rash, feeling faint or difficulty swallowing (severe allergic reaction, seen rarely);
• redness of the skin with blisters or peeling. Severe blisters and bleeding may also occur in the lips, eyes, mouth, nose, and genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis, which are seen very rarely;
• yellow skin, dark urine and tiredness which may be symptoms of liver problems, seen rarely;
• extensive skin rash, high body temperature and swollen 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:

In very rare cases, this medicine affects white blood cells, leading to immunodeficiency. If you experience an infection with symptoms such as fever with severe deterioration in your general health, or fever with symptoms of a 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 to inform your doctor about the medicine you are taking.

Other side effects include:

Common (may affect up to 1 in 10 people)
• heachache;
• effects on the stomach or intestines: diarrhea, stomach pain, constipation, wind (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 itchy skin.

Rare (affects up to 1 in 1,000 people)
• blood problems such as a low number of white blood cells or platelets. This can cause weakness, bruising, or the possibility 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;
• taste alterations;
• vision problems such as blurred vision;
• sudden sensation of wheezing or shortness of breath (bronchospasm);
• inflammation inside the mouth;
• infection called "candidiasis" which can affect the intestine and is caused by a fungus;
• hair loss (alopecia);
• skin rash on sun exposure;
• joint pain (arthralgia) or muscle pain (myalgia);
• general feeling of malaise and lack of strength;
• increased sweating.

Very rare (affects up to 1 in 10,000 people)
• low number of red blood cells, white blood cells, and platelets (a condition called pancytopenia);
• aggression;
• seeing, perceiving or hearing things that are not there (hallucinations);
• serious liver problems leading to liver failure and inflammation of the brain;
• muscle weakness;
• severe kidney problems;
• breast enlargement in men.

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

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.