CITROGRAN GRANULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Cipla Medpro (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

GRANULES

Composition:

EACH 4,0 g GRANULES CONTAINS CITRIC ACID 0,702 g SODIUM BICARBONATE 1,716 g SODIUM CITRATE 0,613 g TARTARIC ACID 0,858 g

Authorization status:

Registered

Authorization date:

2018-06-09

Patient Information leaflet

PATIENT INFORMATION LEAFLET FOR
CITROGRAN
SCHEDULING STATUS
CITROGRAN (EFFERVESCENT GRANULES)
EACH (4 G) CONTAINS:
SODIUM CITRATE 0,613 G
SODIUM BICARBONATE 1,716 G
CITRIC ACID ANHYDROUS 0,702 G
TARTARIC ACID 0,858 G
CONTAINS SUGAR (LIQUID GLUCOSE) 0,252 ML
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
CITROGRAN is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use CITROGRAN carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share CITROGRAN with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
5 days.
WHAT IS IN THIS LEAFLET
1.
What CITROGRAN is and what it is used for
2.
What you need to know before you take CITROGRAN
S0
3.
How to take CITROGRAN
4.
Possible side effects
5.
How to store CITROGRAN
6.
Contents of the pack and other information.
1. WHAT CITROGRAN IS AND WHAT IT IS USED FOR
CITROGRAN belongs to a group of medicines acting on the genito-urinary
system.
CITROGRAN is used to relieve gastric acidity as well as for its
urinary alkalinising properties.
CITROGRAN can be used to relieve symptoms of inflammation of the
bladder, including
prevention of crystals forming in the urine due to the use of
sulphonamides.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITROGRAN
Do not take CITROGRAN:
•
if you are hypersensitive (allergic) to sodium citrate, sodium
bicarbonate, citric
acid anhydrous and tartaric acid or any of the other ingredients of
CITROGRAN
(listed in SECTION 6).
•
if you have severe kidney problems. Please discuss this with your
doctor.
•
If you have metabolic disturbances with alkalosis (rise in the level
of alkali in
blood resulting in feeling of weakness or cramp, hypocalcaemia
(deficiency of
calcium in the bloodstream) or hypochlorhydria (an abnormally low
level of
hydrochloric acid in the stomach).
•
If yo

Summary of Product characteristics

PROFESSIONAL INFORMATION FOR
CITROGRAN
SCHEDULING STATUS
1. NAME OF THE MEDICINE
CITROGRAN (Effervescent granules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicine measures (4 g) contains:
Sodium citrate 0,613 g
Sodium bicarbonate 1,716 g
Citric acid anhydrous 0,702 g
Tartaric acid 0,858 g
Contains sugar (liquid glucose) 0,252 mL
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Effervescent granules.
White to straw coloured granules with a lemon odour and a sweet/ sour
slightly lemon taste.
After reconstitution with water a clear to straw coloured solution
with a slight lemon odour
is obtained.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
S0
CITROGRAN is indicated as a gastric antacid and urinary alkalinising
agent. As a urinary
alkaliniser, CITROGRAN can be used to alleviate symptoms associated
with inflammatory
conditions of the bladder. CITROGRAN can be used to prevent
crystalluria during
sulphonamide treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS:
One to two 5 mL medicine measures (4 to 8 g) in half a glass of cold
water, 3 to 4 times
daily,
taken
on
an
empty
stomach
and
followed
with
additional
water.
Drink
after
effervescence (see SECTION 4.8).
Long-term therapy: One 5 mL (4 g) medicine measure daily.
PAEDIATRIC POPULATION
CHILDREN (6 - 12 YEARS):
One 5 mL medicine measure (4 g) in half a glass of cold water, 2 or 3
times daily, taken on
an empty stomach and followed with additional water. Drink after
effervescence (see
SECTION 4.8).
METHOD OF ADMINISTRATION
Take on an empty stomach, followed with additional water. Drink after
effervescence.
4.3 CONTRAINDICATIONS
CITROGRAN is contraindicated in:
•
Patients with known hypersensitivity to sodium bicarbonate, citric
acid, sodium
citrate,
tartaric
acid
or
to
any
of
the
excipients
used
in
the
formulation
of
CITROGRAN (see SECTION 6.1).
•
In patients with severe renal disease and metabolic disturbances with
alkalosis,
hypocalcaemia or hypochlorhydria.
•
When co-administered with urinary tract ant