CHLORVESCENT potassium 14 mmol effervescent tablet tube (reformulation)

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

potassium chloride, Quantity: 595 mg; potassium bicarbonate, Quantity: 384 mg; potassium carbonate, Quantity: 152 mg

Disponible depuis:

Aspen Pharmacare Australia Pty Ltd

forme pharmaceutique:

Tablet, effervescent

Composition:

Excipient Ingredients: leucine; macrogol 6000; acesulfame potassium; citric acid; sorbitol; aspartame; Flavour

Mode d'administration:

Oral

Unités en paquet:

60 (30 x 2 tubes)

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

For the treatment and specific prevention of hypokalaemia.

Descriptif du produit:

Visual Identification: White or white to yellow, round and flat tablets.; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Registered

Date de l'autorisation:

1999-12-01

Notice patient

CHLORVESCENT
®
1
CHLORVESCENT
®
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Chlorvescent.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CHLORVESCENT IS
USED FOR
Chlorvescent tablets are used to
provide extra potassium for people
who have lost potassium from their
bodies because of illness or treatment
with certain medicines. It is also used
for people who do not have enough
potassium in their regular diet or
cannot replace the potassium they
have lost from their diet alone.
Potassium is essential for life and
health. Vegetables, potatoes and fruit
are good sources of dietary
potassium.
HOWEVER, AS TOO MUCH POTASSIUM
CAN BE HARMFUL, DO NOT CHANGE
YOUR DOSE WITHOUT FIRST CHECKING
WITH YOUR DOCTOR.
The dose of Chlorvescent may need
to be adjusted if your diet is rich in
natural sources of potassium.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CHLORVESCENT
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CHLORVESCENT:
•
IF YOU HAVE AN ALLERGY TO IT OR TO
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing, swelling of
the face, lips or tongue, skin rash,
itching or hives.
•
IF YOU HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
−
high potassium levels
−
kidney impairment
−
stomach ulcers
−
severe burns or other serious
injury
−
significant dehydration or heat
cramps
−
Addison's Disease - a disease
where the adrenal glands don't
work proper

Résumé des caractéristiques du produit

CHLORVESCENT – Full & Marketed Product Information Page 1 of 6
_ _
_AUSTRALIAN PI – CHLORVESCENT (POTASSIUM CHLORIDE, _
_POTASSIUM BICARBONATE & POTASSIUM CARBONATE) _
1.
NAME OF THE MEDICINE potassium chloride, potassium bicarbonate and potassium carbonate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
effervescent
tablet
contains
potassium
chloride,
potassium
bicarbonate
and
potassium carbonate, providing 14 mmol potassium (548 mg) and 8 mmol
chloride (283
mg) in the form of an acceptable drink.
Excipients
include
citric
acid,
sorbitol,
aspartame,
acesulfame
potassium,
leucin,
macrogol 6000 and blackcurrant flavour.
3.
PHARMACEUTICAL FORM
Flat, round, white or white to yellow tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment and specific prevention of hypokalaemia.
4.2 DOSE AND METHOD OF ADMINISTRATION
Adults and children 12 years and over: Dissolve 1 or 2 tablets in
one-half to one
glass of cold water (120 - 240mL) two to three times a day, or as
directed by your
doctor. Take with or immediately after food. Not for use in children
under 12 years of
age.
4.3
CONTRAINDICATIONS
Potassium supplements should not be used in any of the following
conditions:
•
hyperkalaemia;
•
chronic renal impairment;
•
potassium-sparing
diuretic
therapy
(such
as
triamterene,
spironolactone,
amiloride);
•
acute peptic ulcer or gastritis;
•
acute dehydration or heat cramps;
•
extensive tissue breakdown (such as burns or crush injuries);
•
adrenal insufficiency (such as Addison’s disease); or
•
if on therapy with any drugs that may cause hyperkalaemia (see
Interactions).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Potassium salts should be administered with caution to patients with
chronic renal disease,
liver cirrhosis, cardiac disease. Potassium salts should be given with
caution to patients in
whom passage through the gastro-intestinal tract may be delayed as in
pregnant patients or
in those receiving anti-muscarinic agents. Attention should be paid to
the concurrent use of
other d