Alendronic acid 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alendronate sodium

Available from:

Dowelhurst Ltd

ATC code:

M05BA04

INN (International Name):

Alendronate sodium

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200

Patient Information leaflet

Top of page cut-off to middle of registration mark: 44 mm.
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 540
A dental examination should be considered
before you start treatment with Alendronic
Acid if you have any of the conditions below:
• You have cancer
• You are undergoing chemotherapy or
radiotherapy
• You are taking steroids
• You don’t receive routine dental care
• You have gum disease
• You smoke.
Appropriate preventive dental care, as
recommended by the dentist, should be
followed during treatment.
If you do develop difficulty or pain when
swallowing, pain behind the breastbone
(centre of the chest), or new or worsening
heartburn, stop taking your tablets and
contact your doctor.
OTHER MEDICINES AND ALENDRONIC ACID
Do NOT take any other oral medication at
exactly the same time as taking Alendronic
Acid Tablets. If you are taking any other
medicines, you should take your dose of
Alendronic Acid at least 30 minutes before
you take your other medication.
Talk to your doctor before you take
non-steroidal anti-inflammatory drugs
(NSAID’s) while taking Alendronic Acid.
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.
ALENDRONIC ACID WITH FOOD AND DRINK
These tablets should be taken on an empty
stomach, as food and drink can greatly
reduce the effectiveness of the medicine.
Take the tablets at least 30 minutes before
your first meal of the day.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
DRIVING AND USING MACHINES
In some cases Alendronic Acid 10 mg Tablets
may cause adverse reactions that may affect
your ability to drive or operate machinery
(like problems with sight). Do NOT drive or
operate machinery if you are affected.
HOW TO TAKE ALENDRONIC ACID
Always take this medicine exactly as your
doctor has told you. Check with your doctor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alendronic Acid 10mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg alendronic acid (as sodium alendronate
trihydrate).
Excipients: Each tablet contains 103.95 mg lactose monohydrate.
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, capsule-shaped, stamped "AN 10" on one side and
"Arrow
logo" on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of post-menopausal osteoporosis. Alendronate Sodium 10 mg
tablets reduces the risk of vertebral and hip fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
The recommended dosage is 10 mg once daily.
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 on an
individual patient basis, particularly after 5 or more years of use.
_To permit adequate absorption of alendronate: _
Alendronic Acid 10 mg Tablets must be taken at least 30 minutes before
the
first food, beverage, or medicinal product of the day with plain water
only.
Other beverages (including mineral water), food and some medicinal
products
are likely to reduce the absorption of alendronate (see section 4.5).
_To facilitate delivery to the stomach and thus reduce the potential
for local _
_and oesophageal irritation/adverse experiences (see _section _4.4)_:
•
Alendronic Acid 10 mg Tablets should only be swallowed upon arising
for the day with a full glass of water (not less than 200 ml or 7
fl.oz.).
•
Patients should only swallow Alendronic Acid 10 mg Tablets whole.
Patients should not crush or chew the tablet or allow the tablet to
dissolve in their mouths because of a potential for oropharyngeal
ulceration.
•
Patients should not lie down until after their first food of the day
which
should be at least 30 minutes after taking the tablet.
•
Patients should not