Phosphate Sandoz effervescent tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Sodium dihydrogen phosphate anhydrous

Διαθέσιμο από:

Alturix Ltd

INN (Διεθνής Όνομα):

Sodium dihydrogen phosphate anhydrous

Δοσολογία:

1.936gram

Φαρμακοτεχνική μορφή:

Effervescent tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 09050201; GTIN: 5036376224639

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHOSPHATE SANDOZ
EFFERVESCENT TABLETS
Sodium acid phosphate
The name of your medicine is Phosphate Sandoz Effervescent Tablets and
will
be referred to as Phosphate Sandoz throughout the rest of this
leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor
or pharmacist has told you.
„ Keep this leaflet. You may need to read it again.
„ Ask your pharmacist if you need more information or advice.
„ If you get any side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Phosphate Sandoz is and what it is used for
2. What you need to know before you take Phosphate Sandoz
3. How to take Phosphate Sandoz
4. Possible side effects
5. How to store Phosphate Sandoz
6. Contents of the pack and other information
1. WHAT PHOSPHATE SANDOZ IS AND WHAT IT IS USED FOR
Phosphate Sandoz contains the active substance sodium acid phosphate.
Phosphate Sandoz is used for the treatment of high blood calcium
caused by
conditions such as:
„ overactive parathyroid glands (hyperparathyroidism)
„ a cancer of the blood (multiple myelomatosis) and in other cancers.
Phosphate Sandoz is also used for the treatment of low blood phosphate
caused
by a bone disease that does not respond to treatment with vitamin D
(vitamin D
resistant rickets) and a bone softening condition (vitamin D resistant
hypophosphataemic osteomalacia).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PHOSPHATE SANDOZ
DO NOT TAKE PHOSPHATE SANDOZ
„ if you are allergic to sodium acid phosphate or any of the other
ingredients
of Phosphate Sandoz (listed in Section 6). An allergic reaction may
include
rash, itching, difficulty breathing or swelling of the face, lips,
throat or tongue.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Phosphate Sandoz.
If yo

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PHOSPHATE SANDOZ
®
Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet_ _contains 1.936g of sodium acid phosphate
anhydrous.
Excipients with known effect:
Each tablet contains:
•
123mg potassium
•
469mg sodium
•
136mg sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent Tablet
White, round, effervescent tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercalcaemia associated with such conditions as hyperparathyroidism,
multiple
myelomatosis and malignancy.
Hypophosphataemia associated with vitamin D resistant rickets and
vitamin D
resistant hypophosphataemic osteomalacia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage should be adjusted to suit the requirements of individual
patients. Excessive
dosage has been reported to produce hypocalcaemia in isolated cases.
Particular care
should therefore be taken to ensure appropriate dosage in the elderly.
Adults, adolescents and children 5 years and over
Hypercalcaemia: Up to 6 tablets daily (adjustment being made according
to
requirements).
Vitamin D resistant hypophosphateaemic osteomalacia: 4-6 tablets
daily.
Children under 5 years
Hypercalcaemia: Up to 3 tablets daily (adjustment being made according
to
requirements).
Vitamin D resistant rickets: 2-3 tablets daily.
Method of administration
PHOSPHATE SANDOZ should be dissolved in 1/3 to 1/2 a tumblerful of
water (50-
70ml) and taken orally.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to sodium acid phosphate anhydrous or to any of the
excipients listed in section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In cases of impaired renal function associated with hypercalcaemia and
in cases
where restricted sodium intake is required, e.g. congestive cardiac
failure,
hypertension or pre-eclamptic toxaemia, the sodium (20.4mmol / 469mg
per tablet)
and potassium (3.1mmol / 123mg_ _per tablet) content of PHOSPHATE
SANDOZ
should be taken into considerati