Alendronic acid 70mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alendronate sodium

Available from:

Actavis UK Ltd

ATC code:

M05BA04

INN (International Name):

Alendronate sodium

Dosage:

70mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200; GTIN: 5012617016195

Patient Information leaflet

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 signs of illness 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.
WHAT IS IN THIS LEAFLET:
1. What Alendronic Acid 70mg Tablets are and what they are
used for
2. What you need to know before you take Alendronic Acid
70mg Tablets
3. How to take Alendronic Acid 70mg Tablets
4. Possible side effects
5. How to store Alendronic Acid 70mg Tablets
6. Contents of the pack and other information
_ 1. WHAT ALENDRONIC ACID 70MG TABLETS ARE AND WHAT THEY ARE _
_USED FOR_
Alendronic acid belongs to a group of non-hormonal medicines
known as bisphosphonates, which prevent bone loss from the
body.
Alendronic acid is used to treat a condition called osteoporosis
(brittle bones). This condition is common in women after the
menopause. The earlier a woman reaches the menopause, the
greater the risk of her developing osteoporosis.
Without treatment, osteoporosis can cause thinning and
weakening of the bones in the skeleton which can then lead
to fractures, usually of the hip, backbone and wrists. Fractures
can occur easily in people suffering from osteoporosis including
during normal everyday activities such as heavy lifting or from a
minor injury or fall.
Alendronic acid helps to prevent bone loss and to build up bone
which may have been lost due to osteoporosis. It can therefore
reduce the risk of back and hip fractures.
_ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID _
_ 70MG TABLETS_
DO NOT TAKE ALENDRONIC ACID 70MG TABLETS:
• If you are allergic to alendronic acid or any of the other
ingredients of this medicine (listed in section 6)
• If you have certain diso

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alendronic Acid 70 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70mg alendronic acid (as sodium alendronate
trihydrate)
Excipients: Each tablet contains 142.64 mg lactose monohydrate
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, oval tablet, embossed "AN 70" on one side and the
Arrow logo on
the other.
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
For oral use.
The recommended dose is one 70 mg tablet per week.
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 70 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 70 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 70 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 lie down for at le