Controloc Control - pantoprazole

What is Controloc Control?

Controloc Control is a medicine that contains the active substance pantoprazole. It is available as yellow, oval gastro-resistant tablets (20 mg). "Gastro-resistant" means that the contents of the tablet pass through the stomach and remain intact until it reaches the intestine. This prevents the active ingredient from being destroyed by the acid in the stomach.
Controloc Control is similar to a 'reference medicine' already authorized in the European Union (EU) called Controloc.

What is Controloc Control used for?

Controloc Control is used for the short-term treatment of acid reflux symptoms in adults. Acid reflux is called acid reflux when acid produced in the stomach passes into the esophagus, causing heartburn and acid regurgitation (acid that flows back into the mouth).
The medicine can be obtained without a prescription.

How is Controloc Control used?

The recommended dose of Controloc Control is one tablet once a day until symptoms disappear. The patient may need to take the medicine for two to three days in a row before symptoms improve. In the absence of symptom improvement within two weeks of continued treatment, patients should consult their physician. 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. Controloc Control is not recommended for use in patients under the age of 18.

How does Controloc Control work?

The active substance in Controloc Control, pantoprazole, is a proton pump inhibitor. It acts
by blocking the "proton pumps", proteins found in specialized cells in the tissue lining the stomach that pump acid into the stomach. By blocking the pumps, pantoprazole reduces acid production, relieving acid reflux symptoms.
Medicines that contain pantoprazole have been available in the European Union (EU) since 1994. The reference medicine, Controloc, is available only with a prescription. It is used for long-term therapy and also to treat a wider variety of gastrointestinal diseases ( diseases affecting the gut) compared to Controloc Control.

How has Controloc Control been studied?

As pantoprazole has been used for many years, the applicant submitted data from the scientific literature. The applicant also presented information from two main studies looking at the effects of pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one heartburn episode 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 heartburn symptoms in the first two weeks of treatment.

What benefit has Controloc Control shown during the studies?

Pantoprazole was more effective than placebo and ranitidine in improving acid reflux symptoms. In the first study, 74% of 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 acid regurgitation symptoms. 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 Controloc Control?

The most common side effects with Controloc Control (seen in approximately 1 in 100 patients) are diarrhea and headache. For the full list of side effects reported with pantoprazole, yes
refer to the package leaflet.
Controloc Control must not be used in people who may be hypersensitive (allergic) to pantoprazole, soy or any of the other ingredients. The medicine must not be used together with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).

Why has Controloc 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 medicine as a prescription medicine. The Committee is also of the opinion that based on the experience of using pantoprazole, the availability of Controloc Control without medical supervision is desirable. The CHMP therefore decided that Controloc Control's benefits are greater than its risks for the Short-Term Treatment of Reflux Symptoms in Adults Without Prescription The Committee recommended that Controloc Control be given a marketing authorization.

Other information about Controloc Control:

On June 12, 2009, the European Commission granted Nycomed GmbH a "Marketing Authorization" for Controloc Control, valid throughout the European Union.
For the full version of Controloc Control EPAR, click here.

Last update of this summary: 03-2009.

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