Regulatory Information
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INJECTION
**4.2. Posology and method of administration** _**Controloc® 20 mg**_ Controloc 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with water.  _**Controloc® 40 mg**_ Controloc 40 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with water.  _**Controloc® i.v**_ The intravenous administration of Controloc i.v. is recommended only if oral application is not appropriate.  **Special Patient Populations** _**Pediatric patients:**_ The experience in children is limited. Pantoprazole 20mg and 40mg tablet is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group. Pantoprazole 40mg powder for solution for injection is not recommended for use in patients below 18 years of age. _**Impaired hepatic function:**_ A daily dose of Pantoprazole 20mg should not be exceeded in patients with severe liver impairment (See section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In addition, pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin) for eradication of _H. pylori_ in patients with moderate to severe hepatic dysfunction since currently no data are available on the efficacy and safety of pantoprazole in combination treatment of these patients (See section 4.3). _**Impaired renal function:**_ No dose adjustment is necessary in those with impaired renal function. In addition, pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin) for eradication of _H. pylori_ in patients with impaired renal function, since currently no data are available on the efficacy and safety of pantoprazole in combination treatment for these patients. _**Elderly patients:**_ Generally, no dose adjustment is necessary in elderly patients. However, the daily dose of 40mg should not be exceeded in treatment of gastric or duodenal ulcer.
INTRAVENOUS
Medical Information
**4.1. Therapeutic indications** _**Controloc® 20 mg**_ - Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). - 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 NSAID treatment. _**Controloc® 40 mg**_ - In combination with two appropriate antibiotics (see Dosage) for the eradication of H.pylori in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. - Duodenal ulcer - Gastric ulcer - Moderate and severe reflux oesophagitis _**Controloc® i.v**_ Short term use for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: - Duodenal ulcer - Gastric ulcer - Moderate and severe reflux esophagitis
**4.3 Contraindications** Controloc should generally not be used in cases of known hypersensitivity to one of the other constituents of Controloc 20 mg, Controloc 40mg tablet and Controloc i.v. or of the combination partners. Controloc 40mg tablet must not be used in combination treatment for eradication of _H.pylori_ in patients with moderate to severe liver or kidney function disturbances since currently no clinical data are available on the efficacy and safety of Controloc 40mg in combination treatment of these patients.
A02BC02
pantoprazole
Manufacturer Information
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Takeda GmBH
Hikma Farmaceutica (Portugal), S.A.
Patheon Italia S.P.A.
Wasserburger Arzneimittelwerk GmbH
Active Ingredients
Documents
Package Inserts
Controloc PI.pdf
Approved: September 19, 2022