CONTROLOC 20 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PANTOPRAZOLE

Available from:

TAKEDA ISRAEL LTD

ATC code:

A02BC02

Pharmaceutical form:

TABLETS

Composition:

PANTOPRAZOLE 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TAKEDA GMBH, GERMANY

Therapeutic group:

PANTOPRAZOLE

Therapeutic area:

PANTOPRAZOLE

Therapeutic indications:

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.

Authorization date:

2014-10-31

Patient Information leaflet

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

Summary of Product characteristics

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