ZANTAC-RANITIDINE 150 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS RANITIDINE HYDROCHLORIDE EQUIVALENT TO 150 MG RANITIDINE

Authorization status:

Registered

Authorization date:

1995-05-12

Patient Information leaflet

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
14/05/2018
Type
A
ZANTAC
O
RAL
R
ANGE
Implementation
15/05/2018
Category
10(b)
T
ABLETS
/S
YRUP
150
mg
OR
300
mg
Reference
GDSv45 - v0005
CONFIDENTIAL
1.3.2
PATIENT INFORMATION LEAFLET (CLEAN)
Page 1 of 11
GDS-045
ZANTAC ORAL RANGE
1
PATIENT INFORMATION LEAFLET
2
3
4
SCHEDULING STATUS:
5
S3
6
7
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
8
ZANTAC TABLETS
9
ZANTAC 300 MG Tablets
10
ZANTAC EFFERVESCENT 150 Tablets
11
ZANTAC EFFERVESCENT 300 Tablets
12
ZANTAC SYRUP
13
Ranitidine 150 mg or 300 mg
14
15
Read all of this leaflet carefully before you start taking ZANTAC.
16

Keep this leaflet. You may need to read it again.
17

If you have further questions, please ask your doctor or your
pharmacist.
18

ZANTAC has been prescribed for you personally and you should not share
your
19
medicine with other people. It may harm them, even if their symptoms
are the same
20
as yours.
21
22
WHAT ZANTAC CONTAINS:
23
ZANTAC TABLETS: Each tablet contains the active substance, ranitidine
150 mg (as the
24
hydrochloride).
25
ZANTAC 300 MG: Each tablet contains the active substance, ranitidine
300 mg (as the
26
hydrochloride).
27
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
14/05/2018
Type
A
ZANTAC
O
RAL
R
ANGE
Implementation
15/05/2018
Category
10(b)
T
ABLETS
/S
YRUP
150
mg
OR
300
mg
Reference
GDSv45 - v0005
CONFIDENTIAL
1.3.2
PATIENT INFORMATION LEAFLET (CLEAN)
Page 2 of 11
GDS-045
The other ingredients include:
28
_Tablet core:_ Croscarmellose sodium (300 mg tablet only), magnesium
stearate and
29
microcrystalline cellulose.
30
_Film coat:_ Hydroxypropyl cellulose, hydroxypropyl methylcellulose
2910 and titanium
31
dioxide (E171).
32
Sugar-free.
33
34
ZANTAC EFFERVESCENT 150: Each effervescent tablet contains the active
substance,
35
ranitidine 150 mg (as the hydrochloride).
36
Contains sugar (sorbitol): 1,14 mg/tablet.
37
These tablets contain aspartame as a sweetening agent and
38
sodium benzoate.
39
ZANTAC 150 mg efferves

Summary of Product characteristics

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
14/05/2018
Type
A
ZANTAC
O
RAL
R
ANGE
Implementation
15/05/2018
Category
10(b)
T
ABLETS
/S
YRUP
150
mg
OR
300
mg
Reference
GDSv45 - v0005
CONFIDENTIAL
1.3
SOUTH AFRICAN LABELLING AND PACKAGING
1.3.1
SOUTH AFRICAN PACKAGE INSERT
1.3.1.1
PACKAGE INSERT (CLEAN)
Page 1 of 14
GDS-045
ZANTAC
1
TABLETS/DISPERSIBLE TABLETS/SYRUP
2
3
SCHEDULING STATUS:
4
S3
5
6
PROPRIETARY NAME AND DOSAGE FORM:
7
ZANTAC TABLETS
8
ZANTAC 300 MG Tablets
9
ZANTAC EFFERVESCENT 150 Tablets
10
ZANTAC EFFERVESCENT 300 Tablets
11
ZANTAC SYRUP
12
13
COMPOSITION:
14
ZANTAC TABLETS: Each tablet contains ranitidine 150 mg (as the
hydrochloride).
15
ZANTAC
300
MG
TABLETS:
Each
tablet
contains
ranitidine
300
mg
(as
the
16
hydrochloride).
17
The excipients include:
18
_Tablet core:_ Croscarmellose sodium (300 mg tablet only), magnesium
stearate and
19
microcrystalline cellulose.
20
_Film coat:_ Hydroxypropyl cellulose, hydroxypropyl methylcellulose
2910 and titanium
21
dioxide (E171).
22
Sugar-free.
23
24
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
14/05/2018
Type
A
ZANTAC
O
RAL
R
ANGE
Implementation
15/05/2018
Category
10(b)
T
ABLETS
/S
YRUP
150
mg
OR
300
mg
Reference
GDSv45 - v0005
CONFIDENTIAL
1.3
SOUTH AFRICAN LABELLING AND PACKAGING
1.3.1
SOUTH AFRICAN PACKAGE INSERT
1.3.1.1
PACKAGE INSERT (CLEAN)
Page 2 of 14
GDS-045
ZANTAC EFFERVESCENT 150 TABLETS: Each effervescent tablet contains
ranitidine 150 mg (as
25
the hydrochloride).
26
Contains sugar (sorbitol): 1,14 mg/tablet.
27
These tablets contain aspartame as a sweetening agent and sodium
benzoate.
28
ZANTAC EFFERVESCENT 300 TABLETS: Each effervescent tablet contains
ranitidine 300 mg (as
29
the hydrochloride).
30
Contains sugar (sorbitol): 1,71 mg/tablet.
31
These tablets contain aspartame as a sweetening agent and sodium
benzoate.
32
The other excipients include grapefruit flavour IFF 18 C222,
monosodium citrate anhydrous,
33
orange flavour IFF 6, povidone K30 and sodium bicarbonate.
34
35
ZANTAC SYRUP: