CLASTEON 800mg film-coated Tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

CLODRONATE SODIUM, ANHYDROUS

Tilgjengelig fra:

Athlone Pharmaceuticals Limited Ballymurray Co. Roscommon F42 EW02 , Ireland

ATC-kode:

M05BA02

INN (International Name):

CLODRONATE SODIUM, ANHYDROUS 800 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

CLODRONATE SODIUM, ANHYDROUS 800 mg

Resept typen:

POM

Terapeutisk område:

DRUGS FOR TREATMENT OF BONE DISEASES

Autorisasjon status:

Authorised

Autorisasjon dato:

2011-09-09

Informasjon til brukeren

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT/USER
CLASTEON 800MG FILM-COATED TABLETS
(SODIUM CLODRONATE)
Please read this leaflet carefully before taking Clasteon tablets.
Keep the leaflet in case you need to refer to it again. If you want to
know more about Clasteon tablets
or have any questions, you should ask your doctor or pharmacist.
What is in this leaflet
1.
What Clasteon tablets are used for
2.
What you need to know before taking Clasteon tablets
3.
How to take Clasteon tablets
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT CLASTEON TABLETS ARE USED FOR
Clasteon tablets contain sodium clodronate, which is one of a group of
medicines known as
bisphosphonates. These medicines help prevent loss of calcium from
bones.
Clasteon tablets are used to manage bone diseases, particularly those
associated with cancer. They
also help to maintain normal levels of calcium in your blood.
2.
WHAT YOU NEED TO KNOW BEFORE TAKING CLASTEON TABLETS
YOU MUST NOT TAKE CLASTEON TABLETS AND SHOULD TALK TO YOUR DOCTOR IF:
●
you are allergic to sodium clodronate, similar medicines or any of the
ingredients (listed in section 6)
●
you have very poor kidney function
●
you are pregnant or breast feeding
●
you are already taking a similar medicine (containing
bisphosphonates).
TELL YOUR DOCTOR IF:
●
you have ever had/have pain, numbness or swelling of your jaw or a
heavy jaw feeling or loosening
of a tooth
●
you are having dental treatment or will undergo dental surgery, tell
your dentist that you are being
treated with a bisphosphonate (Sodium clodronate). Certain types of
dental treatment are not
recommended while taking bisphosphonates
●
you have problems with your kidneys.
OTHER MEDICINES AND CLASTEON
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicine including
those obtained without a prescription.
This is particularly important if you are taking any of the following:
●
antibiotics
●
non-steroidal anti

Preparatomtale

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CLASTEON
®
800mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1000mg of disodium clodronate tetrahydrate,
equivalent
to 800mg of anhydrous sodium clodronate. 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
Sodium clodronate is indicated for the management of osteolytic
lesions,
hypercalcaemia and bone pain associated with skeletal metastases in
patients
with carcinoma of the breast or multiple myeloma. Sodium clodronate
tablets
are also indicated for the maintenance of clinically acceptable serum
calcium
levels in patients with hypercalcaemia of malignancy initially treated
with an
intravenous bisphosphonate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
: The recommended daily dose is 2 tablets (1600mg sodium clodronate)
taken as a single dose. If clinically necessary, the dose may be
increased, but is
not recommended to exceed 3200 mg daily.
Intravenous clodronate is recommended for the treatment of
hypercalcaemia
due to malignancy. However, if oral therapy is used, a high starting
dose of
2400 or 3200 mg daily should be used and, depending on the individual
response, this can be reduced gradually to 1600 mg daily in order to
maintain
normocalcaemia.
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.
Page 2 of 12
When twice daily dosing is used, the first dose s