BURNLOC CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS LANSOPRAZOLE 15,0 mg

Authorization status:

Registered

Authorization date:

2006-07-07

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
PROPREITARY NAME AND DOSAGE FORM:
BURNLOC (CAPSULES)
Lansoprazole 15 mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
BURNLOC is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless you still need to use BURNLOC carefully to get the best
results from it.

Keep this leaflet. You may need to read it again.

Do not share BURNLOC with any other person.

Ask your pharmacist if you need more information or advice.

You must see a doctor if your symptoms worsen or do not improve after
(14 days)
days
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
BURNLOC is available without a doctor’s prescription, for you to
treat a mild illness. Nevertheless you still need to use BURNLOC
carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.
You must see a doctor if your symptoms worsen or do not improve
after 14 days.
S2
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1.
WHAT BURNLOC CONTAINS:
The active substance is lansoprazole 15 mg
Contains sugar: Sucrose [101 mg] 0.1 g
The other ingredients are gelatine, hypromellose, macrogol 6 000,
mannitol, maize starch,
N-methylglucamine, polysorbate 80, purified water, quinolone yellow,
sodium laurilsulfate,
talc, titanium dioxide.
2.
WHAT BURNLOC IS USED FOR:
BURNLOC contains the active substance lansoprazole.
Lansoprazole belongs to a group of medicines called proton pump
inhibitors.
BURNLOC is used to treat conditions in which there is too much acid in
the stomach.
BURNLOC is used for the short-term symptomatic relief of heartburn and
acid indigestion
at a maximum daily dose of 15 mg for a maximum period of 14 days.
3.
BEFORE YOU USE BURNLOC: DO NOT TAKE BURNLOC:

If you are hypersensitive (allergic) to lansoprazole or any of the
other ingredients
in BURNLOC.

If you are breastfeeding or pregnant.
�

Summary of Product characteristics

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PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S2
PROPRIETARY NAME AND DOSAGE FORM:
BURNLOC (CAPSULE)
COMPOSITION:
Each capsule contains 15 mg Lansoprazole
Contains sugar: Sucrose 0.1 g
Each BURNLOC capsule contains the following excipients: gelatine,
hypromellose, macrogol 6 000,
mannitol, maize starch, N-methylglucamine, polysorbate 80, purified
water, quinolone yellow, sodium
laurilsulfate, talc, titanium dioxide.
CATEGORY AND CLASS:
A 11.4.3 Medicines acting on the gastrointestinal tract
PHARMACOLOGICAL ACTION:
Lansoprazole is an inhibitor of the gastric H
+
K
+
- ATPase (proton pump). Lansoprazole inhibits gastric
acid secretion in a dose related manner irrespective of the source of
stimulation. Gastric secretory
functions recover gradually following discontinuation of the medicine.
Lansoprazole has no effect on
histamine, gastrin or cholinergic receptors.
PHARMACOKINETICS:
Following
oral
administration,
lansoprazole
is
well
absorbed
with
a
resultant
bioavailability
of
approximately 78 %. The bioavailability is decreased if lansoprazole
is taken with food. Peak serum
concentrations are achieved approximately 1 to 2 hours following
ingestion. Lansoprazole is highly protein
bound (97 %).
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Lansoprazole is extensively metabolised via the hepatic cytochrome
P450 system to the inactive,
sulphated metabolites – sulphone, sulphide and
5-hydroxyllansoprazole. The half life for lansoprazole is
1,4 to 1,5 hours.
The main route of elimination is via the bile with 15 to 30 % of
lansoprazole being excreted via the kidneys
as the hydroxylated metabolite.
INDICATIONS:

BURNLOC is indicated in the short-term symptomatic relief of heartburn
and hyperacidity at a
maximum daily dose of 15 mg for a maximum period of 14 days.
CONTRAINDICATIONS:

Hypersensitivity to lansoprazole or to any of the ingredients.

Pregnancy and lactation.

Liver impairment.
WARNINGS AND SPECIAL PRECAUTIONS:
Safety and efficacy in children has not been established.
Treatment with BURNLOC ma