ALENDRONIC ACID ONCE WEEKLY

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

ALENDRONIC ACID

から入手可能:

Accord Healthcare Limited

ATCコード:

M05BA04

INN（国際名）:

ALENDRONIC ACID

投薬量:

70 Milligram

医薬品形態:

Tablets

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

alendronic acid

認証ステータス:

Marketed

承認日:

2011-02-18

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 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
symptoms 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. How to take Alendronic acid, before taking
this medicine.
WHAT IS IN THIS LEAFLET
1. What Alendronic Acid Tablets are and what they are used for
2. What you need to know before you take Alendronic Acid Tablets
3. How to take Alendronic Acid Tablets
4. Possible side effects
5. How to store Alendronic Acid Tablets
6. Contents of the pack and other information
1. WHAT ALENDRONIC ACID TABLETS ARE AND WHAT THEY ARE USED FOR
WHAT IS Alendronic acid?
Alendronic acid tablet is a tablet containing the active substance
alendronic acid (commonly called alendronate) and belongs
to a group of non-hormonal medicines called bisphosphonates.
Alendronic acid 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 ARE ALENDRONIC ACID TABLETS USED FOR?
Your doctor has prescribed alendronic acid tablets to treat your
osteoporosis. Alendronic acid reduces the risk of spine and
hip fractures.
ALENDRONIC ACID 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 bo

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alendronic Acid Once Weekly 70 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70mg alendronic acid (as alendronate sodium)
Excipients: Each tablet contains 272.070 mg of Lactose Anhydrous
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to off- white, oval, biconvex, tablet, debossed with ‘AHI’
on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of post-menopausal osteoporosis. Alendronic acid 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.
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 Alendronic acid Once Weekly 70 mg
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 alendronic acid. Therefore no
dosage adjustment is necessary for the elderly.
_Renal impairment_
No dosage adjustment
is necessary for
patients with GFR greater
than 35 ml/min.
Alendronic acid Tablet is not
recommended for patients with renal impairment where GFR is less than
35 ml/min, due to lack of experience.
_Paediatric population_
Alendronate Sodium is not recommended for use in children under the
age of 18 years due to insufficient data on safety
and efficacy in conditions associated with paediatric osteoporosis
(See also section 5.1).
Alendronic acid Once Weekly 70 mg has not been investigated in the
treatment of glucocorticoid-induced osteoporosis.
Method of administration
Oral use.
_To permit adequate absorption of alendrnic acid:_
Alendronic acid Tablet must be taken at least 30 minutes before the
first food,
beverage,
or medicinal product of the
day with plain water only. Ot