What is Pantecta Control?
Pantecta Control is a medicine that contains the active substance pantoprazole. It is available as yellow, oval gastro-resistant tablets (20 mg). "Gastroresistant" means that the contents of the tablet cross the stomach and remain intact until it reaches the intestine. This prevents the active ingredient from being destroyed by the acid present in the stomach.
Pantecta Control is similar to a "reference medicine" already authorized in the European Union (EU) called Pantecta.
What is Pantecta Control used for?
Pantecta Control is used for the short-term treatment of acid reflux symptoms in adults. There is talk of acid reflux when the acid produced in the stomach passes into the esophagus, causing heartburn and acid regurgitation (acid that rises in the mouth).
The medicine can be obtained without a prescription.
How is Pantecta Control used?
The recommended dose of Pantecta Control is one tablet once a day until the symptoms disappear. The patient may need to take the medicine for two or three days in a row before the symptoms improve. In the absence of an improvement in symptoms within two weeks of continued treatment, patients should consult their doctor. Patients should not take the medicine for longer than four weeks without consulting their doctor.
The tablets should be swallowed whole with liquid before meals and should not be chewed or crushed. The use of Pantecta Control is not recommended for patients under the age of 18.
How does Pantecta Control work?
The active substance in Pantecta Control, pantoprazole, is a proton pump inhibitor. It works by blocking "proton pumps", proteins found in specialized cells in the stomach lining that pump acid into the stomach. By blocking the pumps, pantoprazole reduces acid production, relieving acid reflux symptoms.
Pantoprazole-containing medicines have been available in the European Union (EU) since 1994. The reference medicine, Pantecta, is only available with a prescription. It is used for long-term therapies and also to treat a wider variety of gastrointestinal diseases (diseases that affect the intestine) than Pantecta Control.
How has Pantecta Control been studied?
As pantoprazole has been used for many years, the applicant presented data from the scientific literature. The applicant also presented information from two main studies that observed the effects of pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one episode of heartburn in the three days before the studies began . The first study compared pantoprazole with placebo (a dummy treatment) in 219 adults and the second compared it with ranitidine (another medicine used to treat acid reflux symptoms) in 344 adults. The main measure of effectiveness was the number of patients with symptoms of heartburn in the first two weeks of treatment.
What benefit has Pantecta Control shown during the studies?
Pantoprazole was more effective than placebo and ranitidine in improving acid reflux symptoms. In the first study, 74% of the patients taking pantoprazole (80 out of 108) and 43% of those taking placebo (48 out of 111) had no heartburn after two weeks. Pantoprazole was also more effective than placebo in reducing symptoms from acid regurgitation. In the second study, 70% of the patients taking pantoprazole (121 out of 172) and 59% of those taking ranitidine (102 out of 172) had no heartburn after two weeks of treatment.
What is the risk associated with Pantecta Control?
The most common side effects with Pantecta Control (seen in about 1 patient in 100) are diarrhea and headache. For the full list of side effects reported with pantoprazole, yes
refers to the package leaflet.
Pantecta Control should not be used in people who may be hypersensitive (allergic) to pantoprazole, soy or any of the other ingredients. The medicine should not be used together with atazanavir (a medicine used to treat human immunodeficiency virus infection [HIV]).
Why has Pantecta Control been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that pantoprazole 20 mg was effective in the short-term treatment of reflux symptoms and that there is a long safety experience with the drug as a prescription medicine. The committee is also of the opinion that, based on the experience of using pantoprazole, the availability of Pantecta Control without medical supervision is appropriate. The CHMP therefore decided that Pantecta Control's benefits are greater than its risks for the short-term treatment of reflux symptoms in adults without a prescription. The committee recommended the granting of the marketing authorization for Pantecta Control.
More information on Pantecta Control:
On 12 June 2009, the European Commission issued a marketing authorization for Pantecta Control to Nycomed GmbH, valid throughout the European Union.
For the full EPAR of Pantecta Control, click here.
Last update of this summary: 03-2009.
