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). "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.

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. 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 Controloc Control used?

The recommended dose of Controloc 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 Controloc Control is not recommended for 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

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.

Medicines that contain pantoprazole have been available in the European Union (EU) since 1994. The reference medicine, Controloc, 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 Controloc Control.

How has Controloc 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 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 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 Controloc Control?

The most common side effects with Controloc 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.

Controloc 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 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 drug 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 appropriate. 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 a prescription. The committee recommended issuing marketing authorization for Controloc Control.