Alendronic acid 70mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alendronate sodium

Available from:

Viatris UK Healthcare 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: 5016695000077

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONIC ACID
70 MG TABLETS
SODIUM ALENDRONATE
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. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Alendronic Acid is and what it is used
for
2. What you need to know before you take
Alendronic Acid
3. How to take Alendronic Acid
4. Possible side effects
5. How to store Alendronic Acid
6. Contents of the pack and other information
1.
WHAT ALENDRONIC ACID IS AND WHAT
IT IS USED FOR
Alendronic Acid contains the active substance
alendronic acid (as sodium alendronate
trihydrate).
Your medicine is in the form of a tablet.
Alendronic Acid belongs to a group of non-
hormonal medicines called bisphosphonates.
Bisphosphonates can be used to help bone
disease such as osteoporosis. Alendronic
Acid can treat and prevent osteoporosis in
post-menopausal women, by stopping bones
becoming thinner and weaker.
HOW CAN OSTEOPOROSIS BE TREATED?
As well as your treatment with Alendronic Acid,
your doctor may suggest you make changes
to your lifestyle to help your condition, such as:
_Stopping smoking_
Smoking appears to increase the rate at which
you lose bone and, therefore, may increase
your risk of broken bones.
_Exercise_
Like muscles, bones need exercise to stay
strong and healthy. Consult your doctor
before you begin any exercise programme.
_Eating a balanced diet_
Your doctor can advise you about your diet
or whether you should take any dietary
supplements (especially calcium and Vitamin D).
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ALENDRONIC ACID
DO NOT TA

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 70 mg alendronic acid (as sodium trihydrate)
Excipient with known effect: Each tablet contains 158.88 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White biconvex tablet 9.5mm in diameter, embossed ‘AD70’ on one
side and ‘G’ on
the reverse.
SUMMARY OF PRODUCT CHARACTERISTICS
4.1.
THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. Alendronic Acid reduces the
risk of
vertebral and hip fractures.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one 70 mg tablet once weekly.
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.
_Special populations _
_ _
_Elderly patients_:
In clinical studies there was no age-related difference in the
efficacy or safety profiles
of alendronate. Therefore, no dosage adjustment is necessary for
elderly people.
_Paediatric population: _
The safety and efficacy of alendronic acid in children less than18
years of age has not
been established. This medicinal product should not be used in
children less than
18 years of age. Currently available data for alendronic acid in the
paediatric
population is described in section 5.1.
_ _
_Patients with renal impairment_:
No dosage adjustment is necessary for patients with creatinine
clearance greater than
35 ml/min. Alendronate is not recommended for patients with renal
impairment
where creatinine clearance is less than 35 ml/min, due to lack of
experience.
Method of administration
For oral administration.
_To permit adequate absorption of Alendronic Acid. _
Alendronic Acid must be taken at least 30 minutes before the first
food, beverage, or