TUMS SMOOTHIES EX BERRY FUSION

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
17-08-2016
Ciri produk Ciri produk (SPC)
15-10-2020
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
15-10-2020

Bahan aktif:

CALCIUM CARBONATE

Boleh didapati daripada:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

Kod ATC:

A12AA04

Borang farmaseutikal:

CHEWABLE TABLETS

Komposisi:

CALCIUM CARBONATE 750 MG

Laluan pentadbiran:

PER OS

Jenis preskripsi:

Not required

Dikeluarkan oleh:

GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC, USA

Kumpulan terapeutik:

CALCIUM CARBONATE

Kawasan terapeutik:

CALCIUM CARBONATE

Tanda-tanda terapeutik:

For relief from heartburn and acidity

Tarikh kebenaran:

2020-06-30

Risalah maklumat

                                PATIENT LEAFLET IN
ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed
without a physician's
prescription
TUMS
™
SMOOTHIES
EX BERRY FUSION
Chewable tablets
Each
tablet
contains
Calcium Carbonate 750 mg
(elemental calcium 300 mg)
Acid-neutralizing capacity
per tablet: 15 mEq.
List
of
the
additional
ingredients
detailed
in
section 6.
READ THE ENTIRE LEAFLET
CAREFULLY BEFORE USING
THE MEDICINE. This leaflet
contains concise information
about the medicine. If you
have any other questions,
refer to the physician or the
pharmacist.
1. WHAT IS THE MEDICINE
INTENDED FOR?
Relief of heartburn (pyrosis)
and sour stomach.
THERAPEUTIC
GROUP:
antacids.
2. BEFORE
USING
THE
MEDICINE
DO NOT USE THE MEDICINE:
• If
you
are
sensitive
(allergic) to the Calcium
Carbonate or to any of
the additional ingredients
contained in the medicine
(listed in section 6)
• In patients with
hypercalcaemia,
hypercalciuria
• In patients on a low-
phosphate diet
• In patients with problems
with parathyroid glands
function
• In patients with kidney
problems (e.g. kidney
stones)
• In patients with Zollinger-
Ellison Syndrome
• In patients taking Digoxin
for heart diseases.
DO NOT TAKE THIS MEDICINE
WITHOUT
CONSULTING
A
PHYSICIAN BEFORE STARTING
THE TREATMENT:
• In children under the age of
12
• If you are suffering from
diabetes
(the
medicine
contains sugar).
IF YOU ARE TAKING OR HAVE
RECENTLY
TAKEN
OTHER
M E D I C I N E S
I N C L U D I N G
NON-PRESCRIPTION MEDICINES
AND
FOOD
SUPPLEMENTS,
TELL THE PHYSICIAN OR THE
PHARMACIST. Especially if you
are taking:
T h i a z i d e
d i u r e t i c s ,
bisphosphonates for treatment
of bone loss, tetracyclines and
ciprofloxacin (antibiotics).
It is recommended to wait
2-3 hours between taking this
medicine and taking other oral
medicines.
PREGNANCY
AND
BREAST-
FEEDING
Consult the physician or the
pharmacist before using this
medicine. See section 3 for the
'usual dosage'.
IMPORTANT INFORMATION ABOUT
SOME INGREDIENTS OF THE
MEDICINE
• The
medicine
contai
                                
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Ciri produk

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TUMS SMOOTHIES EX BERRY FUSION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Carbonate 750 mg per tablet.
3
PHARMACEUTICAL FORM
Chewable Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of heartburn.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual dosage for adults and children over the age of 12 is
generally:
chew 2 to 4 tablets when symptoms occur, or as recommended by the
physician. Maximal daily dose is 10 tablets.
For pregnant, maximal daily dose is 6 tablets in 24 hours. Do not use
the
maximum dose for more than two weeks except under the advice and
supervision of your physician. Do not use the medicine if the symptoms
persist for more than two weeks, unless recommended by the physician.
Do
not exceed the recommended dose.
If you accidentally took a higher dosage, or if a child has
accidentally
swallowed the medicine, refer immediately to a physician or proceed to
a
hospital emergency room and bring the package of the medicine with
you.
Symptoms of overdose may include: anorexia, thirst, nausea, vomiting,
constipation, abdominal pains, muscle weakness, tiredness, mental
disturbances, excessive thirst, excessive urination, bone pain, renal
calcification, nephrolithiasis and, in severe cases, heart rate
disturbances.
Extreme overdose of calcium may cause coma and death.
If you forgot to take this medicine at the designated time, do not
take a double
dose. Take the next dose at the usual time and consult a physician
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Contraindicated in patients with hypercalcaemia, hypercalciuria, or on
a low-
phosphate diet. Or those receiving cardiac glycosides or with impaired
renal
function.
Contraindicated in patient with thyroid dysfunction, Zollinger-Ellison
syndrome.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use of higher than recommended doses may result in
hypercalcaemia and milk alkali syndr
                                
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