Clasteon 400mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Sodium clodronate

Mevcut itibaren:

Kent Pharma (UK) Ltd

ATC kodu:

M05BA02

INN (International Adı):

Sodium clodronate

Doz:

400mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 06060200; GTIN: 5060061160360 5060061160384

Bilgilendirme broşürü

CCRF21179-9 #0011
Patient Information Leaflet:
CLASTEON 400MG CAPSULES
(SODIUM CLODRONATE)
Please read this leaflet carefully before taking Clasteon Capsules.
Keep the leaflet in case you need
to
refer to it again. If you want to know more about Clasteon Capsules or
have any questions, you should
ask your doctor or pharmacist.
1.
WHAT CLASTEON CAPSULES ARE AND WHAT THEY ARE USED FOR
Clasteon Capsules contain sodium clodronate, which is one of a group
of medicines known as
bisphosphonates.
Clasteon Capsules 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 CAPSULES
You must NOT take Clasteon Capsules 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 already taking a similar medicine (containing bisphosphonates)
Tell your doctor if:
•
you have kidney problems
•
you have ever had pain or swelling of your jaw
•
you are having or planning to have dental treatment or surgery. If you
are having dental
treatment tell your dentist that you are being treated with a
bisphosphonate (Clasteon).
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-inflammatory medicines such as ibuprofen or
diclofenac
•
antacid indigestion tablets
•
mineral supplements
•
estamustine, used to treat prostate cancer.
PREGNANCY AND BREASTFEEDING
Clasteon Capsules are not normally given to people during pregnancy.
If you think you might be
pregnant or if you are planning a family, tell your doctor before
taking this medicine. Do not BREASTFEED
while you are taking Clasteon Capsules.
CLASTEON CAPSULES CONTAINS SODIUM
This medicine con

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CLASTEON
®
400mg capsules
Sodium Clodronate 400mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400mg sodium clodronate (as the tetrahydrate).
For
excipients, see 6.1.
3
PHARMACEUTICAL FORM
Hard capsules for oral administration.
The capsules are oblong, white and blue, marked “CLASTEON
®
”.
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
capsules are also indicated for the maintenance of clinically
acceptable serum
calcium levels in patients with hypercalcaemia of malignancy initially
treated
with an intravenous infusion of sodium Clodronate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose is 4 capsules (1600mg sodium clodronate) daily.
If
necessary, the dosage may be increased but should not exceed a maximum
of
8 capsules (3200mg sodium clodronate) daily.
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 after and one hour before eating, drinking (other than
plain
water), or taking any other oral drugs.
Clodronate should in no case be taken with milk, food or drugs
containing
calcium or other divalent cations because they impair the absorption
of
clodronate.
_Elderly _
No special dosage recommendations.