Rabeprazole Krka 10mg Gastro-Resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rabeprazole sodium

Available from:

KRKA, d.d., Novo mesto

ATC code:

A02BC; A02BC04

INN (International Name):

Rabeprazole sodium

Dosage:

10 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; rabeprazole

Authorization status:

Marketed

Authorization date:

2013-08-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RABEPRAZOLE KRKA 10 MG GASTRO-RESISTANT TABLETS
RABEPRAZOLE KRKA 20 MG GASTRO-RESISTANT TABLETS
rabeprazole sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rabeprazole Krka is and what it is used for
2.
What you need to know before you take Rabeprazole Krka
3.
How to take Rabeprazole Krka
4.
Possible side effects
5.
How to store Rabeprazole Krka
6.
Contents of the pack and other information
1.
WHAT RABEPRAZOLE KRKA IS AND WHAT IT IS USED FOR
Rabeprazole Krka tablets contain rabeprazole. It belongs to a class of
medicines called proton pump
inhibitors. They act by reducing the amount of acid made by the
stomach.
Rabeprazole Krka tablets are used for:
-
Active duodenal ulcer or active benign gastric/stomach ulcer (peptic
ulcers).
-
Symptomatic erosive or ulcerative gastro-oesophageal reflux disease
(GORD) commonly
referred to as inflammation of the gullet caused by acid and
associated with heartburn, or for
long-term treatment of GORD (GORD maintenance).
-
The symptomatic treatment of moderate to very severe gastrooesophageal
reflux disease
(symptomatic GORD) also associated with heartburn.
-
Zollinger-Ellison syndrome, a rare condition in patients whose
stomachs make extremely high
amounts of acid.
-
In combination with two antibiotics (clarithromycin and amoxycillin)
Rabeprazole Krka tablets
are used for the eradication of
_H pylori_
infection in patients with peptic ulcer disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RABEPRAZOLE KRKA
DO NO

Summary of Product characteristics

Health Products Regulatory Authority
29 November 2022
CRN00D643
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rabeprazole Krka 10mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rabeprazole Krka 10 mg gastro-resistant tablets
Each gastro-resistant tablet contains 10 mg rabeprazole sodium,
equivalent to 9.42 mg rabeprazole.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
10 mg gastro-resistant tablets are orange-pink, biconvex, round
tablets with bevelled edges, tablet diameter approximately 5.7
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rabeprazole Krka tablets are indicated for the treatment of:
- Active duodenal ulcer
- Active benign gastric ulcer
- Symptomatic erosive or ulcerative gastro-oesophageal reflux disease
(GORD)
- Gastro-oesophageal reflux disease long-term management (GORD
maintenance)
- Symptomatic treatment of moderate to very severe gastro-oesophageal
reflux disease (symptomatic GORD)
- Zollinger-Ellison syndrome
- In combination with appropriate antibacterial therapeutic regimens
for the eradication of _Helicobacter pylori_ in patients with
peptic ulcer disease. See section 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults/elderly:
_Active duodenal ulcer and active benign gastric ulcer: _The
recommended oral dose for both active duodenal ulcer and active
benign gastric ulcer is 20 mg to be taken once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks.
However, a few patients may require an additional four weeks
of therapy to achieve healing. Most patients with active benign
gastric ulcer heal within six weeks. However again a few
patients may require an additional six weeks of therapy to achieve
healing.
_Erosive or ulcerative gastro-oesophageal reflux disease (GORD):_ The
recommended oral dose for this condition is 20 mg to be
taken once daily for four to eight weeks.
_Gastro-oesophageal reflux disease long-term management (GORD
maint