APO-ALENDRONATE alendronate sodium trihydrate (equivalent to 70 mg alendronic acid) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium trihydrate, Quantity: 91.35 mg (Equivalent: alendronic acid, Qty 70 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

alendronate sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; mannitol

Administration route:

Oral

Units in package:

4 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of osteoporosis. Osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults, or by the presence of osteoporotic fracture.

Product summary:

Visual Identification: White, oval biconvex tablet engraved "APO" on one side and "ALE 70" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2006-08-28

Patient Information leaflet

APO-ALENDRONATE ONCE
WEEKLY
_Alendronate sodium_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about alendronate. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Alendronate is used to treat
osteoporosis. It belongs to a group of
medicines called bisphosphonates.
Osteoporosis is a disease which
causes bones to become more porous,
gradually making them weaker, more
brittle and likely to break.
_UNDERSTANDING BONE_
Bone is living, growing tissue.
Throughout life, our bodies are
breaking down old bone and
rebuilding new bone in a continuous
cycle.
_HOW IT WORKS_
Alendronate works by slowing down
the process of old bone being
removed, which allows the bone-
forming cells time to rebuild normal
bone. Alendronate helps prevent the
loss of bone and helps to rebuild
bone, making bone less likely to
break. This helps to prevent or
reverse the progression of
osteoporosis.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
alendronate for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of alendronate in
children.
BEFORE YOU TAKE THIS
MEDICINE
ALENDRONATE CAN IRRITATE OR BURN
YOUR MOUTH OR FOOD PIPE (ALSO
CALLED THE OESOPHAGUS).
The chances of this happening should
be reduced if you follow the
instructions for taking alendronate in
this leaflet.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
al

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- ALENDRONATE (ALENDRONATE SODIUM) TABLETS
1
NAME OF THE MEDICINE
Alendronate sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains alendronate sodium equivalent to 70 mg alendronic
acid.
3
PHARMACEUTICAL FORM
Tablets.
APO- Alendronate _ONCE WEEKLY_ 70 mg Tablets: white, oval, biconvex
tablets, engraved APO
on one side and ALE 70 on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis. Osteoporosis must be confirmed by the
finding of low bone mass
of at least two standard deviations below the gender specific mean for
young adults, or by the
presence of osteoporotic fracture.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Alendronate _ONCE WEEKLY_ 70 mg Tablets are intended for oral
administration.
DOSAGE
TREATMENT OF OSTEOPOROSIS
The recommended dosage is one Alendronate Once Weekly (70 mg) tablet
once weekly.
Alendronate must be taken at least 30 minutes before the first food,
beverage or medication
of the day with plain water only. Other beverages (including mineral
water), food and some
medications are likely to reduce the absorption of alendronate (see
section 4.5 INTERACTIONS
WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS).
Alendronate should only be taken upon arising for the day. To
facilitate delivery to the stomach
and thus reduce the potential for oesophageal irritation, an
alendronate tablet should be
swallowed with a full glass of water. Patients should not crush, chew
or suck on the tablet
because of a potential for stomatitis or oropharyngeal ulceration.
Patients should not lie down for at least 30 minutes and until after
their first food of the day.
Alendronate should not be taken at bedtime or before arising for the
day. Failure to follow these
instructions may increase the risk of oesophageal adverse experiences
(see section 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
2
SEVERE OESOPHAGEAL ULCERATION HAS BEEN REPORTED IN PATIENTS TAKING
THIS DRUG (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE