Alendronate Sandoz 70mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Sodium Alendronate

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Sodium Alendronate

Unit dalam pakej:

4 Tablets

Dikeluarkan oleh:

LEK PHARMACEUTICALS D.D.

Risalah maklumat

ALENDRONATE SANDOZ TABLET _ _
Alendronic acid (70 mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
WHAT IS IN THIS LEAFLET:
1.
What Alendronate Sandoz is used
for
2.
How Alendronate Sandoz works
3.
Before you use Alendronate Sandoz
4.
How to use Alendronate Sandoz
5.
While you are using Alendronate
Sandoz
6.
Side effects
7.
Storage and disposal Alendronate
Sandoz
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ALENDRONATE SANDOZ IS USED FOR
Your doctor has prescribed Alendronate
Sandoz to treat your osteoporosis.
Osteoporosis is a thinning and
weakening of the bones. It is common in
women after the menopause. At
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. Although
these usually hurt, breaks in the bones of
the spine may go unnoticed until they
cause height loss. Broken bones can
happen during normal, everyday activity,
such as lifting or from minor injury that
would not generally break normal bone.
Broken bones usually occur at the hip,
spine, or wrist and can lead not only to
pain but also to considerable problems
like stooped posture (‘dowager’s hump’)
and loss of mobility.
.
HOW ALENDRONATE SANDOZ WORKS
Alendronate belongs to a group of non-
hormonal medicines called
bisphosphonates. Alendronate prevents the
loss of bones 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.
BEFORE YOU USE ALENDRONATE SANDOZ
_- When you must not use it _
Do not take Alendronate Sandoz:
_ _
•
If you are hypersensitive (allergic) to
alendronate sodium trihydrate, other
bisphosphates or any of the other
ingredients of Alendronate Sandoz
(see section
PRODUCT DESCRIPTION

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Alendronate Sandoz 70 mg Film-coated Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 70 mg alendronic acid (as sodium
alendronate).
_ _
_For a full list of excipients, see section 6.1. _
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film coated tablet, debossed with "ALN 70" on
one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of post-menopausal osteoporosis.
Alendronate reduces the risk of vertebral and hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 70 mg tablet once weekly.
_ _
_Use in elderly patients:_
In clinical trials, there was no age-related difference with regard to
efficacy or safety profiles of
alendronate. Therefore no adjustment of the dose is necessary for
elderly patients.
_ _
_Use in impaired renal function:_
No dose adjustment is necessary in patients with a glomerular
filtration rate (GFR) greater than 35 ml/min.
Alendronate is not recommended for patients with impaired renal
function if the GFR is less than 35
ml/min, as there is no experience of this.
_ _
_Use in impaired hepatic function:_
No dose adjustment is necessary.
_ _
_Use in children:_
Alendronate has not been studied in children and should not be given
to them.
Method of administration
For oral use.
_ _
_TO OBTAIN SATISFACTORY ABSORPTION OF ALENDRONATE_
Alendronate Sandoz 70 mg Film-coated tablets must be taken on an empty
stomach immediately on
rising in the morning, with plain water only, at least 30 minutes
before the first food, drink or other
medication of the day. Other drinks (including mineral water), food
and some medicines are likely to
reduce the absorption of alendronate (see section 4.5).
_ _
_To assist delivery to the stomach and thus reduce the risk of
irritation/side effects locally and in the _
_oesophagus (see section 4.4)._
•
Alendronate Sandoz 70 mg Film-coated tablets should only be swallowed
on arising for the day
with a whole glass of water (not less