Ulcesep Capsules 20mg

País: Malta

Língua: inglês

Origem: Malta Medicines Authority

Ingredientes ativos:

OMEPRAZOLE

Disponível em:

Especialidades Farmaceuticas Centrium SA Laboratories CENTRUM S.A., C/ Sagitario, 14 03006 Alicante, Spain

Código ATC:

A02BC01

DCI (Denominação Comum Internacional):

OMEPRAZOLE 20 mg

Forma farmacêutica:

HARD CAPSULE

Composição:

OMEPRAZOLE 20 mg

Tipo de prescrição:

POM

Área terapêutica:

DRUGS FOR ACID RELATED DISORDERS

Status de autorização:

Authorised

Data de autorização:

2007-12-21

Folheto informativo - Bula

ULCESEP 
OMEPRAZOLE 
COMPOSITION 
Each capsule contains: 
Omeprazole  (D.C.I.)
.......................................................... 20 mg. 
Inactive ingredients: Saccharose Phtalate hydroxypropyl 
methylcellulose, CornStarch, Hydroxypropyl methyl cellulose, 
Lactose, Hydroxypropyl cellulose, Crystallised disodium 
phosphate, Lauryl sodium sulphate, Diethyl Phtalate. Covering: 
Hard gelatine, colorants (C.I. 73015, C.I. 47005, C.I. 77891). 
HOW SUPPLIED 
Capsules of hard gelatin containing micropellets of omeprazole 
with enteric coating. 
Packages of 28 capsules in aluminum blisters. 
PROPERTIES 
ULCESEP® acts by inhibition the acid (proton) pump in the 
gastric parietal cell reducing the secretion of gastric acid.
Acts 
rapidly and produces a reversible control of the
acid secretion of 
the stomach. 
HOLDER AND MANUFACTURER 
LABORATORIOS CENTRUM, S.A. (A.S.A.C. Pharma) 
Sagitario, 14 - 03006 ALICANTE (Spain) 
INDICATIONS 
- Duodenal ulcer and benign gastric ulcer (including those 
provoked by NSAIs) 
-Treatment and prevention of Gastroesophageal reflux disease, 
severe symptoms of no inflammatory disease due to reflux and 
light symptoms which do not respond to traditional treatment. 
-Zollinger-Ellison Syndrome 
- Gastric and
duodenal ulcer; treatment of ulcer with Helicobacter 
ULCESEP 
OMEPRAZOL 
COMPOSICION: 
CADA CÁPSULA CONTIENE: 
Omeprazol
(D.C.I.) .............................................................
20 mg. 
Excipientes: Sacarosa, ftalato de hidroxipropil metil celulosa, 
almidón de maíz, hidroxipropil metil celulosa, lactosa, 
hidroxipropilcelulosa,
fosfato disódico cristalizado, lauril sulfato 
sódico, ftalato de dietilo. Cubierta: Gelatina
dura, colorantes (C.I. 
73015, C.I. 47005, C.I. 77891). 
FORMA FARMACÉUTICA Y CONTENIDO DEL 
ENVASE: 
Cápsulas de gelatina dura conteniendo microgránulos de 
omeprazol con recubrimient

Características técnicas

 
Page 1 of 10 

ULCESEP CAPSULES  20MG 

1. NAME OF THE MEDICINAL PRODUCT 
  Ulcesep Capsules 20mg.  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains omeprazole 20 mg.  
For excipients, see 6.1.  

3. PHARMACEUTICAL FORM 

Hard gelatin capsules.  
Ulcesep Capsules 20mg: hard gelatin capsules containing omeprazole
20mg as 
enteric coated granules.  

4. CLINICAL PARTICULARS 

  4.1 THERAPEUTIC INDICATIONS  

Treatment of oesophageal reflux disease. In reflux oesophagitis the
majority of 
patients are healed after 4 weeks. Symptom relief is rapid.  
Treatment of duodenal and benign gastric ulcers including those
complicating 
NSAID therapy.  
Relief of associated dyspeptic symptoms.  
_Helicobacter pylori_ eradication: Omeprazole should be used in
combination with 
antibiotics for eradication of _Helicobacter pylori_ (_Hp_) in
peptic ulcer disease.  
Prophylaxis of acid aspiration.  
Zollinger-Ellison syndrome.  
Relief of reflux-like symptoms (e.g. heartburn) and/or ulcer-like
symptoms (e.g. 
epigastric pain) associated with acid-related dyspepsia.  
Treatment and prophylaxis of NSAID-associated benign gastric ulcers,
duodenal 
ulcers and gastroduodenal erosions in patients with a previous
history of 
gastroduodenal lesions who require continued NSAID treatment.  

  4.2 POSOLOGY AND METHOD OF ADMINISTRATION  

ADULTS 
OESOPHAGEAL REFLUX DISEASE INCLUDING REFLUX OESOPHAGITIS  
The usual dosage is 20 mg Ulcesep once daily. The majority of patients
are healed 
after 4 weeks. For those patients not fully healed after the initial
course, healing 
usually occurs during a further 4-8 weeks treatment.  
Ulcesep has also been used in a dose of 20 mg twice daily in
patients with reflux 
oesophagitis refractory to other therapy. Healing usually occurred
within 8 weeks. 
Patients can be continued at a dosage of 20 mg once daily.  

Page 2 of 10 
ACID REFLUX DISEASE 
For long-term man