Fosamax Once Weekly 70mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Alendronate sodium

Verfügbar ab:

Sigma Pharmaceuticals Plc

ATC-Code:

M05BA04

INN (Internationale Bezeichnung):

Alendronate sodium

Dosierung:

70mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 06060200

Gebrauchsinformation

FOSAMAX
® ONCE WEEKLY 70MG
TABLETS
(alendronate sodium)
PATIENT INFORMATION LEAFLET
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.
-
It is particularly important to understand the information in section
3 before
taking this medicine.
The name of your medicine is Fosamax Once Weekly 70mg Tablets but will
be referred to as Fosamax throughout the following leaflet.
WHAT IS IN THIS LEAFLET:
1. What Fosamax is and what it is used for
2. What you need to know before you take Fosamax
3. How to take Fosamax
4. Possible side effects
5. How to store Fosamax
6. Contents of the pack and other information
1. WHAT FOSAMAX IS AND WHAT IT IS USED FOR
WHAT IS FOSAMAX?
Fosamax is a tablet containing the active substance alendronic acid
(commonly called alendronate) and belongs to a group of non-hormonal
medicines called bisphosphonates. Fosamax prevents the loss of bone
that
occurs in women after they have been through the menopause, and helps
to
rebuild bone. It reduces the risk of spine and hip fractures.
WHAT IS FOSAMAX USED FOR?
Your doctor has prescribed Fosamax to treat your osteoporosis. It
reduces
the risk of spine and hip fractures.
FOSAMAX IS A ONCE WEEKLY TREATMENT.
WHAT IS OSTEOPOROSIS?
Osteoporosis is a thinning and weakening of the bones. It is common in
women after the menopause. At the menopause, the ovaries stop
producing
the female hormone, oestrogen, which helps to keep a woman’s
skeleton
healthy. As a result, bone loss occurs and bones become weaker. The
earlier a woman reaches the menopause, the greater the risk of
oste

Fachinformation

1.
NAME OF THE MEDICINAL PRODUCT
FOSAMAX® Once Weekly 70 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as sodium trihydrate).
Excipients with known effect
Each tablet contains 113.4 mg lactose (as lactose anhydrous).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Oval white tablets, marked with an outline of a bone image on one
side, and ‘31’ on
the other.
4.1
THERAPEUTIC INDICATIONS
FOSAMAX is indicated in adults for the treatment of postmenopausal
osteoporosis. It reduces the risk
of vertebral and hip fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one 70 mg tablet once weekly.
Patients should be instructed that if they miss a dose of FOSAMAX Once
Weekly, they should take
one tablet on the morning after they remember. They should not take
two tablets on the same day but
should return to taking one tablet once a week, as originally
scheduled on their chosen day.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need
for continued treatment should be re-evaluated periodically based on
the benefits and potential risks
of ‘Fosamax’ on an individual patient basis, particularly after 5
or more years of use.
_Elderly _
In clinical studies there was no age-related difference in the
efficacy or safety profiles of alendronate.
Therefore no dosage adjustment is necessary for the elderly.
_ _
_Renal impairment _
No dosage adjustment is necessary for patients with creatinine
clearance greater than 35 ml/min.
Alendronate is not recommended for patients with renal impairment
where creatinine clearance is less
than 35 ml/min, due to lack of experience.
_ _
_Paediatric population_
The safety and efficacy of FOSAMAX in children less than 18 years of
age has not been established.
This medicinal product should not be used in children less than 18
years of age. Currently available
data for alendronic acid in the paediatric population is described in
sect