CLASTEON 800 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLODRONIC ACID AS DISODIUM TETRATHYDRATE

Available from:

BIOAVENIR LTD, ISRAEL

ATC code:

M05BA02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

CLODRONIC ACID AS DISODIUM TETRATHYDRATE 800 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ABOIGEN PHARMA S.P.A, ITALY

Therapeutic area:

CLODRONIC ACID

Therapeutic indications:

Treatment of hypercalcemia due to malignancy. Palliative treatment of osteolysis due to malignancy.

Authorization date:

2022-01-31

Patient Information leaflet

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
CLASTEON 800 MG, FILM-COATED TABLETS
Active ingredient and its quantity in each film-coated tablet:
800 mg disodium clodronate (as tetrahydrate)
For the list of inactive ingredients and allergens, please see section
2 sub-section
"Important information about some of this medicine’s ingredients"
and section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
The medicine is intended for adults above the age of 18.
1. WHAT IS THIS MEDICINE INTENDED FOR?
•
For treatment of bone lysis or destruction (osteolysis) in patients
suffering from
enhanced bone breakdown as a result of tumors.
•
For treatment of hypercalcemia (excess calcium in blood) in case of
malignancy
(cancer).
THERAPEUTIC GROUP: bisphosphonates.
2. BEFORE USING THIS MEDICINE: DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient (sodium
clodronate), similar
medicines or any of the other ingredients contained in the medicine
(listed in section
6)
•
you have severe kidney dysfunction
•
you are taking other medicines of the bisphosphonates group
SPECIAL WARNINGS ABOUT USING THIS MEDICINE:
BEFORE TREATMENT WITH CLASTEON 800 MG, TELL YOUR DOCTOR IF:
•
you have kidney problems
•
you have or have previously had pain, swelling or numbness of the jaw
or a
heavy jaw feeling or loosening of a tooth.
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If you are undergoing DENTAL TREATMENT or are expected to undergo
DENTAL SURGERY, tell
your dentist that you are being treated with a bisphosphonate. Certain
dental treatments
are not recommended while taking bisphosphonates.
DRUG INTE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CLASTEON
®
800 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 800 mg disodium clodronate.
In the preparation, the active ingredient is in the form of disodium
clodronate
tetrahydrate.
Each tablet contains 128.24 mg sodium. For a full list of excipients,
see 6.1.
3
PHARMACEUTICAL FORM
Film coated tablets.
White, oval, convex tablet with breakline. The scoreline is only to
facilitate breaking for ease of
swallowing and not to divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypercalcemia due to malignancy.
Palliative treatment of osteolysis due to malignancy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Clodronate is mainly eliminated via the kidneys. Therefore, adequate
fluid intake must
be maintained during clodronate treatment.
_Pediatric patients: _Safety and efficacy in children have not been
established.
Elderly _patients: _
There are no special dosage recommendations for the elderly. Clinical
trials have
included patients over 65 years and no adverse effects specific to
this age group have
been reported.
CLASTEON
®
800 mg tablets should be swallowed whole. A CLASTEON
®
800 mg tablet may
be divided into two to ease swallowing, but the halves have to be
taken at the same time of
administration. CLASTEON
®
800 mg tablets must not be crushed or dissolved before intake.
A daily dose of 1600 mg should be taken as a single dose. When higher
daily doses are
used, the part of the dose exceeding 1600 mg should be taken
separately (as a second
dose) as recommended below.
The single daily dose and the first dose of two, should preferably be
taken in the morning
on an empty stomach together with a glass of water. The patient should
then refrain from
eating, drinking (other than plain water), and taking any other oral
drugs for one hour.
When twice daily dosing is used the first dose should be taken as
recommended above.
The second dose should be taken between meals, more than two hours
aft