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Ostine
COMPOSITION
One tablet contains:
Calcium carbonate...............................…………………………………….............
1250 mg
(equivalent to 500 mg or 12.5 mmol of calcium element)
Cholecalcipherol (INN) or vitamin D3 ....……………………………………..........
400 IU
(corresponding to 0.01 mg of vitamin D3)
Excipients: xylitol, sorbitol, polyvidone, lemon flavour and magnesium
stearate.
PHARMACEUTICAL
FORM AND CONTENT OF THE CONTAINER
30 and 60 chewable tablets for oral administration.
ACTIVITY
Ostine is a fixed combination of calcium and vitamin D. The high concentration
of calcium and vitamin D in each dosage unit facilitates the absorption
of a sufficient quantity of calcium, with a limited number of doses. This
is why the product is useful as a vitamin and calcium supplement, combined
with other treatments, for osteoporosis and as a correction of the deficit
of vitamin D and calcium in the elderly.
MARKETING
AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation Holder:
Farma-Lepori, S.A.
Osi, 7 - 08034 Barcelona (Spain)
Manufacturer:
Innothera Chouzy
L’Isle Vert. - Rue René Chantereau.
41150 Chouzy-Sur-Cisse (France)
THERAPEUTIC INDICATIONS
Correction of deficit of vitamin D and calcium, particularly in the elderly.
Vitamin D and calcium supplement associated with certain treatments of
osteoporosis.
CONTRAINDICATIONS
Ostine comprimidos is contraindicated in: hypersensitivity to
any of its ingredients, hypercalcaemia, hypercalciuria, calcium lithiasis
and tissue calcifications (nephrocalcinosis).
Ostine comprimidos is also contraindicated in patients with prolonged
immobilization accompanied by hypercalcaemia and/or hypercalciuria. In
these cases, the treatment may only be given when the patient recovers
mobility.
PRECAUTIONS
The total daily intake of vitamin D must be calculated when concomitant
treatments containing this vitamin are being given.
Regular monitoring is important during the treatment of the following
parameters: plasma calcium and urinary calcium determination.
In patients with renal impairment, the dose must be adapted according
to the creatinine clearance values obtained.
In the case of prolonged treatments, the urine excretion of calcium must
be monitored and treatment reduced or suspended if this excretion surpasses
7.5 to 9 mmol/24 h (300 to 360 mg/24 h).
INTERACTIONS
AND INCOMPATIBILITIES
In case of treatment with digital glycosides: risk of cardiac arrhythmias.
Clinical supervision is required, and electrocardiographic and calcium
plasma monitoring is recommended.
Associations to be taken into account in case of treatment with thiazide
diuretics: risk of hypercalcaemia through reduction of urine excretion
of calcium.
In case of concomitant use of oral tetracyclines, the administration of
Ostine should be spaced out as far as possible (3 hours): Ostine may reduce
the intestinal absorption of tetracyclines.
WARNINGS
Pregnancy and lactation:
If you are pregnant or think that you might be, see your doctor before
taking this medicine. Taking medicines during pregnancy may be harmful
for the embryo or unborn child, and should be monitored by your doctor.
In case of pregnancy, the maximum dose of 1 tablet a day should not be
surpassed, since an overdose of vitamin D and hypercalcaemia may be harmful
to the unborn child.
The Vitamin D and its metabolites are eliminated in the mother's milk,
whereby the possibility of hypercalcaemia in the newborn child should
be taken into account.
Effects
on the capacity to drive:
None described.
Use
in the elderly:
Regular monitoring of renal function is recommended.
Warnings
on the excipients:
As it contains xylitol as an excipient, this medicine may cause diarrhoea.
POSOLOGY
Oral. Only for adults.
One tablet twice daily.
INSTRUCTIONS
FOR THE CORRECT ADMINISTRATION OF THE PREPARATION
The tablets can be dissolved in the mouth or chewed.
OVERDOSE
Clinical signs: anorexia, intense thirst, nausea, vomiting, polyuria,
polydipsia, dehydration, hypertension, vasomotor disorders, constipation.
Laboratory signs: hypercalcaemia, hypercalciuria, deterioration
of renal function tests.
Emergency treatment:
- Discontinue all calcium and vitamin D supplements.
- Rehydration and, according to the seriousness of the intoxication, use
of diuretics alone or in combination, corticosteroids, calcitonin or peritoneal
dialysis.
In case of intoxication or accidental intake call the Toxicological Information
Service. Phone number 91 562 04 20.
UNDESIRABLE
EFFECTS
In case of prolonged treatments at high doses, hypercalciuria, and exceptionally
hypercalcaemia, may present.
Hypophosphatemia may also occur.
If you notice any side effects not mentioned in this leaflet, please inform
your doctor or pharmacist.
STORAGE
This medicine does not need special storage conditions.
EXPIRY
This medicine should not be used after the expiry date indicated on the
container.
KEEP
MEDICINES OUT OF THE REACH OF CHILDREN.
Revised
text: June 2000.
Farma-Lepori,
S.A.
C. Osi, 7- 08034 Barcelona
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