ALENDRO 10 alendronic acid 10 mg (as sodium alendronate monohydrate) tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

alendronate sodium monohydrate, Quantity: 11.1 mg (Equivalent: alendronic acid, Qty 10 mg)

Pieejams no:

Arrotex Pharmaceuticals Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

alendronate sodium monohydrate

Zāļu forma:

Tablet, uncoated

Kompozīcija:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; magnesium stearate

Ievadīšanas:

Oral

Vienības iepakojumā:

30 tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Treatment of osteoporosis, including glucocorticoid induced 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 history of osteoporotic fracture. Paget's disease of bone.

Produktu pārskats:

Visual Identification: white to off-white capsule shaped tablet marked 'AN10' on one side and the Arrow logo on the other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

2005-05-27

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION – ALENDRO (ALENDRONIC
ACID) TABLETS
1
NAME OF THE MEDICINE
Alendronic acid (as alendronate sodium monohydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alendro tablets come in three strengths and contain 10 mg, 40 mg or 70
mg of alendronic acid as
alendronate sodium monohydrate.
Alendro tablets contains lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Alendro 10
White to off-white capsule-shaped tablet embossed with “AN 10” on
one
side and the Arrow logo on the other.
Alendro 40
White to off-white triangle shaped tablet embossed with “AN” over
“40” on
one side and the Arrow logo on the other.
Alendro Once Weekly
White to off-white oval-shaped tablet embossed with “AN 70” on one
side
and plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
(See SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION)
Treatment of osteoporosis, including glucocorticoid induced
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.
Paget's disease of bone.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
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).
To facilitate delivery to the stomach and thus reduce the potential
for oesophageal irritation,
alendronate should only be swallowed upon arising for the day with a
full glass of water and 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 expe