What is Nexium Control - esomeprazole and what is it used for?
Nexium Control is a medicine that contains the active substance esomeprazole . It is indicated in adults for the short-term treatment of reflux symptoms (also called acid reflux), such as heartburn and acid regurgitation. Nexium Control is similar to a 'reference medicine' already authorized in the European Union (EU) containing the same active substance called Nexium. The reference medicine can only be obtained with a prescription, while Nexium Control is indicated for short-term treatments that do not require a prescription.
How is Nexium Control - esomeprazole used?
Nexium Control can be obtained without a prescription. It is available in gastroresistant tablets (20 mg) (the contents pass through the stomach without being assimilated and reaches the intestine intact). The recommended dose is one tablet a day to be taken until symptoms improve, for a maximum period of 2 weeks. If symptoms persist after 2 weeks, the patient should consult a doctor. For more information, see the package leaflet.
How does Nexium Control - esomeprazole work?
The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor. It works by blocking the "proton pumps", ie the proteins present in specialized cells of the gastric lining membrane, which pump acid into the stomach. By inhibiting proton pumps, esomeprazole reduces acid production, thereby alleviating the symptoms of acid reflux.
What benefit has Nexium Control - esomeprazole shown during the studies?
Nexium Control was compared with a placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms, including heartburn. Patients were treated for 4 weeks. The main measure of effectiveness in both studies was the percentage of patients who reported no heartburn symptoms at the end of the study. In the first study, the symptoms of heartburn disappeared in about 34% of patients who took the 20 mg dose of Nexium Control (41 out of 121) compared to 14% of patients who received placebo (17 of 124 ). In the second study, the symptoms of heartburn had disappeared in about 42% of patients who had been treated with Nexium Control (47 out of 113) compared to 12% of patients who had been treated with placebo (14 out of 118). In both studies the total disappearance of symptoms had been reached within the first 2 weeks in most patients, while subjects in whom the symptoms had not completely disappeared after 2 weeks showed no benefit from continued treatment.
What is the risk associated with Nexium Control - esomeprazole?
The most common side effects with Nexium Control (which may affect up to 1 in 10 people) are headache, abdominal pain, diarrhea and nausea. For the full list of all side effects reported with Nexium Control, see the package leaflet. Nexium Control should not be used in combination with another medicine called nelfinavir (used to treat HIV infection). For the full list of limitations, see the package leaflet.
Why has Nexium Control - esomeprazole been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the effects of the medicine had already been established, since esomeprazole-based medicines have been authorized in EU Member States since 2000, and that the short-term benefits had already been demonstrated in studies where the Most symptoms reported by patients had disappeared within 2 weeks. The committee concluded that patients can safely take the medicine for up to 2 weeks.
What measures are being taken to ensure the safe and effective use of Nexium Control - esomeprazole?
A risk management plan has been developed to ensure that Nexium Control is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nexium Control, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Nexium Control - esomeprazole
On 26 August 2013, the European Commission issued a marketing authorization for Nexium Control, valid throughout the European Union. The full EPAR for Nexium Control can be found on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Nexium Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08/2013.
