FOSAMAX Once Weekly 70 mg tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Alendronate sodium

可用日期:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC代码:

M05BA; M05BA04

INN（国际名称）:

Alendronate sodium

剂量:

70 milligram(s)

药物剂型:

Tablet

给药途径:

Oral use

每包单位数:

Blister containing 2, 4, 8 , 12 or 40 tablets

处方类型:

Product subject to prescription which may be renewed (B)

厂商:

Merck Sharp & Dohme B.V

治疗组:

Bisphosphonate, for the treatment of bone diseases

治疗领域:

Bisphosphonates; alendronic acid

疗效迹象:

It is indicated in adults for the treatment of postmenopausal osteoporosis. FOSAMAX reduces the risk of vertebral and hip fractures.

授权状态:

Marketed

授权日期:

2001-05-17

资料单张

1
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 woman
reaches the menopause, the greater the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms. If left untreated,
however, it can result in broken bones.
A

产品特点

Health Products Regulatory Authority
18 September 2020
CRN009SN9
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