Rabeprazole 20mg gastro-resistant tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Rabeprazole sodium

Pieejams no:

Torrent Pharma (UK) Ltd

ATĶ kods:

A02BC04

SNN (starptautisko nepatentēto nosaukumu):

Rabeprazole sodium

Deva:

20mg

Zāļu forma:

Gastro-resistant tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 01030500; GTIN: 5060623370435

Lietošanas instrukcija

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GTIN 13
(Belgium & Slovenia):
[e-mail]
RABEPRAZOLE ALL STRENGTHS GASTRO-RESISTANT TABLETS PIL - UK
Black
BBBA7466
C Fox
03/02/2020
05/02/2020
CF
190x600
10 pt
Teva Bulgaria
Dupnitsa
04/02/2020
04/02/2020
2
Version 6
12.12.2019
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
RABEPRAZOLE 10MG AND 20MG
GASTRO-RESISTANT TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BBBA7466
_Continued over page_
_Continued top of next column_
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,
pharmacist or nurse.
•
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
•
The full name of the product is Rabeprazole 10mg
and 20mg Gastro-resistant Tablets but within the
leaflet it will be referred to as Rabeprazole tablets.
WHAT IS IN THIS LEAFLET:
1
WHAT RABEPRAZOLE TABLETS ARE AND WHAT
THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RABEPRAZOLE TABLETS
3
HOW TO TAKE RABEPRAZOLE TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RABEPRAZOLE TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT RABEPRAZOLE TABLETS ARE AND WHAT
THEY ARE USED FOR
Rabeprazole tablets belong to a g

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rabeprazole 20mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rabeprazole 20mg gastro-resistant tablet contains rabeprazole sodium
20mg
corresponding to 18.85mg rabeprazole.
Excipients with known effect:
Sodium laurilsulfate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet.
20 mg: Yellow, coated, elliptical, biconvex tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rabeprazole 20mg Gastro-resistant 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
Maintenance)_:
For long-term management, a maintenance dose of Rabeprazole 20 mg or
10 mg once
daily can