RAPACID CAPSULES

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Adcock Ingram Limited

Annus:

See ingredients

Ravimvorm:

CAPSULES

Koostis:

EACH CAPSULE CONTAINS OMEPRAZOLE 10,0 mg

Volitamisolek:

Registered

Loa andmise kuupäev:

2008-09-12

Infovoldik

ADCOCK INGRAM LIMITED
RAPACID, capsules
Contains 10 mg omeprazole per capsule_ _
PROPOSED PATIENT INFORMATION LEAFLET
Date of submission: 15 January 2021
1.3.2 Rapacid clean proposed PIL
Page 1 of 7
1.3.2 CLEAN PROPOSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
RAPACID capsule
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RAPACID:
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
RAPACID has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
1.
WHAT RAPACID CONTAINS
The active substance is omeprazole.
RAPACID contains 10 mg omeprazole.
The other ingredients are disodium phosphate anhydrous, gelatine,
hypromellose, macrogol 6000,
maize starch, mannitol, methacrylic acid-ethyl acrylate copolymer,
polysorbate 80, quinoline yellow,
sodium lauryl sulphate, sucrose, talc, titanium dioxide.
Contains sugar (54,5 mg sucrose) and sugar alcohol (3,955 mg
mannitol).
2.
WHAT RAPACID IS USED FOR
RAPACID is indicated for the temporary, short-term relief of heartburn
and hyperacidity (excessive
acid).
3.
BEFORE YOU TAKE RAPACID
DO NOT TAKE RAPACID:
•
If you are hypersensitive (allergic) to omeprazole or any of the other
ingredients of
RAPACID (see WHAT RAPACID CONTAINS).
ADCOCK INGRAM LIMITED
RAPACID, capsules
Contains 10 mg omeprazole per capsule_ _
PROPOSED PATIENT INFORMATION LEAFLET
Date of submission: 15 January 2021
1.3.2 Rapacid clean proposed PIL
Page 2 of 7
•
If you are pregnant or breastfeeding; safety has not been established.
TAKE SPECIAL CARE WITH RAPACID:
•
RAPACID may hide symptoms of other diseases. If you experience any of
the following
symptoms while taking RAPACID contact your doctor immediately:

Stomach pain or indigestion.

Losing weight for no reason.

Difficulty in swallowing.

Vomiting (being sick) of blood.

Black stools (bl

Toote omadused

ADCOCK INGRAM LIMITED
RAPACID, capsules
Contains 10 mg omeprazole per capsule_ _
PROPOSED PROFESSIONAL INFORMATION
Date of submission: 15 January 2021
1.3.1.1 Rapacid clean proposed PI
Page 1 of 8
1.3.1.1 CLEAN PROPOSED PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S2
PROPRIETARY NAME AND DOSAGE FORM
RAPACID capsule
COMPOSITION
Each capsule contains 10 mg omeprazole.
EXCIPIENTS:
Disodium phosphate anhydrous, gelatine, hypromellose, macrogol 6000,
maize starch, mannitol,
methacrylic acid-ethyl acrylate copolymer, polysorbate 80, quinoline
yellow, sodium lauryl sulphate,
sucrose, talc, titanium dioxide.
Contains sugar (54,5 mg sucrose) and sugar alcohol (3,955 mg
mannitol).
PHARMACOLOGICAL CLASSIFICATION
A 11.4.3 Medicines acting on the gastrointestinal tract – other
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Omeprazole is an inhibitor of the gastric proton pump (H+,K+-ATPase).
It inhibits both basal and
stimulated gastric acid secretion by parietal cells, whether induced
by acetylcholine, gastrin or histamine.
Omeprazole has no effect on acetylcholine, histamine or gastrin
receptors.
PHARMACOKINETIC PROPERTIES
Orally administered omeprazole is well absorbed but to a variable
extent. Absorption of omeprazole
takes place in the small intestine and is usually completed within
three to six hours. Bioavailability
depends on the dose and gastric pH, and may reach 70 % with repeated
administration. Food has no
influence on the bioavailability of omeprazole. Omeprazole is more
than 95 % bound to plasma proteins.
Clearance from the circulation is by hepatic metabolism with a plasma
half-life of 30 to 90 minutes.
ADCOCK INGRAM LIMITED
RAPACID, capsules
Contains 10 mg omeprazole per capsule_ _
PROPOSED PROFESSIONAL INFORMATION
Date of submission: 15 January 2021
1.3.1.1 Rapacid clean proposed PI
Page 2 of 8
Hepatic metabolism occurs primarily via the cytochrome P450 (CYP)
isoform (CYP2C19). The inactive
metabolites are excreted mainly in the urine (80 %) whilst the
remaining 20 % are excreted via the
faeces. The avera