Loron 520mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Sodium clodronate

Dostupno od:

Mawdsley-Brooks & Company Ltd

ATC koda:

M05BA02

INN (International ime):

Sodium clodronate

Doziranje:

520mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 06060200

Uputa o lijeku

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to
read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them even if
their signs of illness are the same
as yours.
•
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 Loron is and what it is used
for
2. What you need to know before
you take Loron
3. How to take Loron
4. Possible side effects
5. How to store Loron
6. Contents of the pack and other
information
1.
WHAT LORON IS AND
WHAT IT IS USED FOR
Loron contains a medicine called
clodronate disodium. This medicine
is a non-amino-bisphosphonate.
Loron is used to treat bone problems
in people with certain types of cancer.
These problems include:
•
Loss of calcium (a mineral) from
the bones and bone pain.
•
High levels of calcium in the blood
caused by loss of calcium from the
bones.
Loron works by binding to the bones.
This helps to stop the bones from
losing calcium which helps to keep
the bones strong.
2.
WHAT YOU NEED TO
KNOW BEFORE YOU TAKE
LORON
DO NOT TAKE LORON:
•
if you are allergic to clodronate
disodium or any of the other
ingredients of this medicine (listed
in section 6).
•
if you have pain or discomfort in
your stomach or bowel that is
severe.
•
if you are pregnant, might become
pregnant, or are breast-feeding
(see the section on 'Pregnancy and
breast-feeding').
•
if you have problems with your
kidneys (renal failure with creatinine
clearance below 10 ml/min).
•
if you are taking any other bisphos-
phonate medicines. These include
amongst others alendronate sodium,
ibandronic acid and risedronate
sodium. For details see the section
on 'Other medicines and Loron'.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before t

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loron 520
520 mg, film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 649.7 mg clodronate disodium
tetrahydrate, equivalent
to 520 mg clodronate disodium.
Excipients with known effect: lactose monohydrate; sodium (3.6 mmol
per film-
coated tablet)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet for oral administration.
Oblong, white, film-coated tablets, imprinted with “E9” on one
side and with a break
line on both sides.
The film-coated tablets can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Loron 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. Loron is also indicated for the maintenance of
clinically
acceptable serum calcium levels in patients with hypercalcaemia of
malignancy
initially treated with an intravenous infusion of clodronate disodium
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Clodronate is mainly eliminated via the kidneys. Therefore, adequate
fluid intake
must be maintained during clodronate treatment.
AFTER TAKING LORON THE PATIENT SHOULD NOT LAY DOWN, BUT REMAIN IN AN
UPRIGHT
POSITION TO PREVENT UPPER ABDOMINAL PAIN.
Posology
_Adults _
The recommended dose is 2 film-coated tablets (1040 mg clodronate
disodium) daily.
If necessary, the dosage may be increased but should not exceed a
maximum of 4
film-coated tablets (2080 mg clodronate disodium) daily.
_Elderly _
No special dosage recommendations.
_Children _
Safety and efficacy in children has not been established.
_Use in renal impairment _
In
patients
with
renal
insufficiency
with
creatinine
clearance
between
10
and
30 ml/min, the daily dose should be reduced to one half of the
recommended adult
dose. Serum creatinine should be monitored during therapy. Clodronate
disodium is
contra-indicated in patients with creatinine clearan