Страна: Израиль
Язык: английский
Источник: Ministry of Health
PANTOPRAZOLE
TAKEDA ISRAEL LTD
A02BC02
TABLETS
PANTOPRAZOLE 40 MG
PER OS
Required
TAKEDA GMBH, GERMANY
PANTOPRAZOLE
PANTOPRAZOLE
Short term treatment of acute duodenal ulcer. Acute gastric ulcer.Moderate and severe reflux oesophagitis.Eradication of the Helicobacter pylori in combination with clarithromycin and amoxycillin or clarithromycin and metronidazole/tinidazole or amoxycillin and metronidazole/tinidazole in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.Zollinger-Ellison-Syndrome.
2022-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only CONTROLOC ® 20 MG TABLETS CONTROLOC ® 40 MG TABLETS Each tablet of Controloc 20 mg contains 20 mg pantoprazole . Each tablet of Controloc 40 mg contains 40 mg pantoprazole . Inactive ingredients and allergens: see section 2 "Before using this medicine" and section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? Controloc inhibits the secretion of acid from cells in the stomach wall and helps reduce gastric acidity. CONTROLOC 20 MG: This medicine is intended for treating reflux oesophagitis that is associated with symptoms such as heartburn, acid regurgitation, pain on swallowing. This medicine is intended for long-term treatment and preventing reflux oesophagitis from recurring. To prevent duodenal and stomach ulcers that are a result of using non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAIDs treatment. CONTROLOC 40 MG: This medicine is intended for short-term treatment of acute duodenal and gastric ulcers and moderate to severe reflux oesophagitis. To eradicate bacteria called Helicobacter pylori (present in the digestive system) in combination with clarithromycin and amoxycillin or clarithromycin and metronidazole/tinidazole or amoxycillin and metronidazole/tinidazole in cases of duodenal and gastric ulcers caused by this microorganism, with the objective of reducing the recurrence of these ulcers. To treat Zollinger-Ellison Syndrome. THERAPEUTIC GROUP: proton pump inhibitors (PPIs). 2. BEFORE USING THIS ME Прочитать полный документ
PRESCRIBING INFORMATION CONTROLOC ® 20 mg CONTROLOC ® 40 mg Tablets 1. NAME OF THE MEDICINAL PRODUCT Controloc ® 20 mg Controloc ® 40 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Controloc 20 mg - Each gastro-resistant tablet contains 22.57 mg pantoprazole sodium sesquihydrate (equivalent to 20 mg of pantoprazole) Controloc 40 mg - Each gastro-resistant tablet contains 45.1 mg pantoprazole sodium sesquihydrate (equivalent to 40 mg of pantoprazole). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet. Controloc 20 mg : Yellow, oval biconvex film-coated tablet imprinted with “P20” in brown ink on one side. Controloc 40 mg: Yellow, oval, biconvex film-coated tablet imprinted with "P40" in brown ink on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Controloc 20 mg: For the treatment of reflux oesophagitis and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). For long-term management and prevention of relapse in reflux oesophagitis. Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAIDs treatment (see section 4.4). Controloc 40 mg: Short term treatment of acute duodenal ulcer. Acute gastric ulcer. Moderate and severe reflux oesophagitis. Eradication of the _Helicobacter pylori_ in combination with clarithromycin and amoxycillin or clarithromycin and metronidazole/tinidazole or amoxycillin and metronidazole/tinidazole in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. Zollinger-Ellison-Syndrome. 4.2 Posology and method of administration Posology Controloc 20 mg: _ _ _Adults and adolescents 12 years of age and above _ Reflux oesophagitis and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). The recommended oral dose is one Controloc 20 mg tablet per day. Symptom relief is generally accomplish Прочитать полный документ