CONTROLOC TABLET 20 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE EQV PANTOPRAZOLE

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

A02BC02

Dosage:

20 mg

Pharmaceutical form:

ENTERIC COATED TABLET

Composition:

PANTOPRAZOLE SODIUM SESQUIHYDRATE EQV PANTOPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Takeda GmbH

Authorization status:

ACTIVE

Authorization date:

1999-10-07

Patient Information leaflet

INSTRUCTIONS FOR USE 
CONTROLOC® 20 MG 
Active ingredient: Pantoprazole sodium sesquihydrate 
Description 
Controloc: contains Pantoprazole, a proton pump inhibitors which inhibits the gastric H
+
K
+
 ATPase which 
is responsible for acid secretion in the parietal cells of the stomach. Pantoprazole is white to off‐white 
powder with a molecular weight of 432.4. Pantoprazole is freely soluble in water, very slightly soluble in 
phosphate buffer at pH 7.4, and practically insoluble in n‐hexane. Pantoprazole is a racemic mixture with 
a melting point of 138° C. 
The 
chemical 
name 
for 
Pantoprazole 
is 
sodium‐5‐(difluoromethoxy)‐2‐[[(3,4‐dimethoxy‐2‐
pyridinyl)methyl]  sulfinyl]‐1  H‐benzimidazole  sesquihydrate  and  is  represented  by  the  following 
chemical structure : 

Empirical chemical structure : C
16
H
14
F
2
N
3
NaO
4
Sx1.5H
2
O 
NAME AND STRENGTH OF ACTIVE INGREDIENT 

Active ingredient 
20mg pantoprazole (as pantoprazole sodium sesquihydrate 22.6 mg) 

Excipients 
Sodium carbonate; mannitol;  crospovidone; povidone K 90; calcium stearate; hypromellose; povidone K 
25;  propylene  glycol;  methacrylic  acid‐ethylacrylate‐copolymer  (1:1);  polysorbate  80;  sodium 
laurylsulphate; triethyl citrate; colours (E 171 and E 172); printing ink 

PHARMACOTHERAPEUTIC / INDICATION GROUP / ACTION MECHANISM 
Selective proton pump inhibitor, substituted benzimidazole 

PHARMACODYNAMIC PROPERTIES 
Pantoprazole  is  a  substituted  benzimidazole  which  inhibits  the  secretion  of  hydrochloric  acid  in  the 
stomach  by  specific  action  on  the proton  pumps  of  the  parietal cells.  Pantoprazole  is  converted  to  its 
active form in the acidic canaliculi of the parietal cells where it inhibits the H
+
, K
+

Summary of Product characteristics

INSTRUCTIONS FOR USE
1.
NAME OF THE MEDICINAL PRODUCT
CONTROLOC® 20 MG
CONTROLOC® 40 MG
CONTROLOC® I.V
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_CONTROLOC® 20 MG_
1 gastro-resistant (enteric coated) tablet contains 20 mg pantoprazole
(as pantoprazole sodium) for
oral use. Active ingredient: 20mg pantoprazole (as pantoprazole sodium
sesquihydrate 22.6 mg)
_CONTROLOC® 40 MG_
1 gastro-resistant (enteric coated) tablet contains 40 mg pantoprazole
(as pantoprazole sodium) for
oral use. Active ingredient: 40mg pantoprazole (as pantoprazole sodium
sesquihydrate 45.1 mg)
_CONTROLOC® I.V_
1 vial contains 40 mg pantoprazole (as pantoprazole sodium) as powder
for solution for injection.
Sodium: This medicinal product contains less than 1 mmol sodium (23
mg) per vial. Active
ingredient: 40mg pantoprazole (as pantoprazole sodium 42.3 mg)
3.
PHARMACEUTICAL FORM
_CONTROLOC® 20 MG_
Gastro-resistant tablets, yellow, oval, biconvex, “P20” in brown
printing ink
Packs with 7 and 14 gastro-resistant tablets
_CONTROLOC® 40 MG_
Gastro-resistant tablets, yellow, oval, biconvex, “P40” in brown
printing ink
Packs with 7and 14 gastro-resistant tablets
_CONTROLOC® I.V_
Powder for solution for injection
Packs of 1 vial with 42.3mg white to off-white powder
4.
CLINICAL PARTICULARS
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®