Probitor 20mg Capsules

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

OMEPRAZOLE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

OMEPRAZOLE

Unit dalam pakej:

14 Capsules

Dikeluarkan oleh:

Sandoz Grup Saglik Urunleri Ilaclari San. Ve Tic. A.S.

Risalah maklumat

PROBITOR
 CAPSULES
Omeprazole (20mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
WHAT IS IN THIS LEAFLET:
1.
What Probitor Capsules is used
for
2.
How Probitor Capsules works
3.
Before you use Probitor Capsules
4.
How to use Probitor Capsules
5.
While you are using Probitor
Capsules
6.
Side effects
7.
Storage and disposal of Probitor
Capsules
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PROBITOR CAPSULES IS USED FOR
Probitor Capsules is used to treat the
following conditions:
•
Ulcers in the upper part of the
intestine (duodenal ulcer) or
stomach (gastric ulcer).
•
Ulcers which are infected with
bacteria called ‘
_Helicobacter _
_pylori_
’. If you have this condition,
your doctor may also prescribed
antibiotics to treat the infection
and allow the ulcer to heal.
•
Ulcers caused by medicines called
NSAIDs (Non-Steroidal Anti-
Inflammatory Drugs).
•
Reflux oesophagitis. This is where
acid from the stomach escapes into
the gullet (the tube which connects
your throat to your stomach)
causing pain, inflammation and
heartburn.
•
Too much acid in the stomach
caused by a growth in the pancreas
(Zollinger-Ellison syndrome).
•
Prevention in people with in
increased risk of NSAIDs
associated ulcer, gastroduodenal
erosions or indigestion symptoms.
HOW PROBITOR CAPSULES WORKS
Probitor Capsules contains the active
substance omeprazole. It belongs to a
group of medicine called ‘proton pump
inhibitors’. They work by reducing the
amount of acid that your stomach
produces.
BEFORE YOU USE PROBITOR CAPSULES
-
_When you must not use it _
DO NOT TAKE PROBITOR CAPSULES_ _
•
if you are allergic (hypersensitive)
to omeprazole or any of the other
ingredients of Probitor.
_ _
•
if you are allergic to medicines
containing other proton pump
inhibitors (e.g. pantoprazole,
lansoprazole, rabeprazole,
esomeprazole).
_ _
•
If you are taking a medicine
containing nelfinavir (for HIV
infection).
_ _
If you are not sure, talk to your
doctor or pharmacist before

Ciri produk

PROBITOR
® 20 MG CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
Probitor 20 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant capsule contains 20 mg omeprazole.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule.
White cap, white body containing almost white to light brown pellets.
Not interchangeable with tablet form.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of duodenal and benign gastric ulcers including those
complicating NSAID therapy.
•
Treatment of NSAIDs associated peptic and gastro-duodenal erosions.
•
Prophylactic treatment in patients with an increased risk of NSAIDs
associated peptic ulcer, gastro-
duodenal erosions or dyspeptic symptoms.
•
_Helicobacter pylori_ associated peptic ulcer disease.
•
Reflux oesophagitis.
•
Zollinger-Ellison syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For duodenal and benign gastric ulcers, the usual dose is 20 mg
omeprazole once daily. Symptom resolution
is rapid. The majority of patients with duodenal ulcer are healed
after 4 weeks. In severe cases, the dose may
be increased to 40 mg omeprazole once daily and healing is usually
achieved within 4 weeks. The majority of
patients with duodenal ulcer are healed after 8 weeks.
Long-term therapy for patients with a history of recurrent duodenal
ulcer is recommended at a dose of 20 mg
omeprazole once daily, up to one year.
NSAID associated gastric ulcers, duodenal ulcers or gastro-duodenal
erosions in patients with or without
continued NSAID treatment, the recommended dose of omeprazole is 20 mg
once daily. Symptom resolution
is rapid and in most patients, healing occurs within 4 weeks. For
those patients who may not be fully healed
after the initial course, healing usually occurs during a further 4
weeks treatment period.
For the prevention of NSAID associated gastric ulcers, duodenal
ulcers, gastro-duodenal erosion and
dyspeptic symptoms the recommended dosage of omeprazole is 20 mg once
daily.
Treatment of