FOSAMAX Once Weekly 70 mg tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Alendronic acid

Доступна з:

Organon Pharma (Ireland) Limited

Код атс:

M05BA; M05BA04

ІПН (Міжнародна Ім'я):

Alendronic acid

Дозування:

70 milligram(s)

Фармацевтична форма:

Tablet

Терапевтична области:

Bisphosphonates; alendronic acid

Статус Авторизація:

Marketed

Дата Авторизація:

2001-05-17

інформаційний буклет

TIN10GR/V
4
240119
282mm x 335mm
Folding size 48x85
403535863-0020
N/A
N/A
N/A
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Black
Profile
Technical Info
N/A
SGK IS A MATTHEWS INTERNATIONAL CORPORATION
PROPRIETARY
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSAMAX® ONCE WEEKLY 70 MG
TABLETS
ALENDRONIC 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.
-
It is particularly important to understand the
information in section 3 before taking this medicine.
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 w

Характеристики продукта

Health Products Regulatory Authority
06 February 2024
CRN00DJ12
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
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 CLINICAL PARTICULARS
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