Bondronat 50mg tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Ibandronic sodium monohydrate

Disponibbli minn:

Atnahs Pharma UK Ltd

Kodiċi ATC:

M05BA06

INN (Isem Internazzjonali):

Ibandronic sodium monohydrate

Dożaġġ:

50mg

Għamla farmaċewtika:

Tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 06060200; GTIN: 5000471006193

Fuljett ta 'informazzjoni

1
uk-mt-pil-bondronat-clean-160425-50mg-fct.doc
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BONDRONAT 50 MG FILM-COATED TABLETS
ibandronic acid
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 Bondronat is and what it is used for
2.
What you need to know before you take Bondronat
3.
How to take Bondronat
4.
Possible side effects
5
How to store Bondronat
6.
Contents of the pack and other information
1.
WHAT BONDRONAT IS AND WHAT IT IS USED FOR
Bondronat contains the active substance ibandronic acid. This belongs
to a group of medicines called
bisphosphonates.
Bondronat is used in adults and prescribed to you if you have breast
cancer that has spread to your
bones (called ‘bone metastases’).
•
It helps to prevent your bones from breaking (fractures)
•
It also helps to prevent other bone problems that may need surgery or
radiotherapy
Bondronat works by reducing the amount of calcium that is lost from
your bones. This helps to stop
your bones from getting weaker.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BONDRONAT
DO NOT TAKE BONDRONAT:
•
if you are allergic to ibandronic acid or any of the other ingredients
of this medicine that are
listed in section 6
•
if you have problems with your food pipe/gullet (oesophagus) such as
narrowing or difficulty
swallowing
•
if you cannot stand or sit upright for at least one hour (60 minutes)
at a time
•
if you have or ever had low calcium in your blood
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to yo

Karatteristiċi tal-prodott

BONDRONAT 50MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-May-2016 | Roche
Products Limited
1. Name of the medicinal product
Bondronat 50 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 50 mg of ibandronic acid (as sodium
monohydrate).
Excipients with known effect:
Contains 88.1 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets.
White to off-white film-coated tablets, of oblong shape engraved
“L2“ on one side and “IT“ on the
other side.
4. Clinical particulars
4.1 Therapeutic indications
Bondronat is indicated in adults for the prevention of skeletal events
(pathological fractures, bone
complications requiring radiotherapy or surgery) in patients with
breast cancer and bone metastases.
4.2 Posology and method of administration
Bondronat therapy should only be initiated by physicians experienced
in the treatment of cancer.
Posology
The recommended dose is one 50 mg film-coated tablet daily.
_Special populations_
_Patients with hepatic impairment_
No dose adjustment is required (see section 5.2).
_Patients with renal impairment _
No dose adjustment is necessary for patients with mild renal
impairment (CLcr ≥50 and <80 mL/min).
For patients with moderate renal impairment (CLcr ≥30 and <50
mL/min) a dosage adjustment to one 50
mg film-coated tablet every second day is recommended (see section
5.2).
For patients with severe renal impairment (CLcr <30 mL/min) the
recommended dose is one 50 mg film-
coated tablet once weekly. See dosing instructions, above.
_Elderly population (> 65 years)_
No dose adjustment is necessary (see section 5.2).
_Paediatric population_
The safety and efficacy of Bondronat in children and adolescents below
the age of 18 years have not been
established. No data are available. (see section 5.1 and 5.2).
Method of administration
For oral use.
Bondronat tablets should be taken after an overnight fast (at least 6
hours) and before the f