Alendronic Acid Bluefish Once weekly 70 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium alendronate

Available from:

Bluefish Pharmaceuticals AB

ATC code:

M05BA; M05BA04

INN (International Name):

Sodium alendronate

Dosage:

70 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bisphosphonates; alendronic acid

Authorization status:

Marketed

Authorization date:

2009-04-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID BLUEFISH ONCE WEEKLY 70 MG TABLETS
(ALENDRONIC ACID AS 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 further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms 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 Bluefish Once weekly 70 mg Tablets are and what
it is used for
2.
What you need to know before you take Alendronic Acid Bluefish Once
weekly 70 mg Tablets
3.
How to take Alendronic Acid Bluefish Once weekly 70 mg Tablets
4.
Possible side effects
5.
How to store Alendronic Acid Bluefish Once weekly 70 mg Tablets
6.
Contents of the pack and other information 1.
WHAT ALENDRONIC ACID BLUEFISH ONCE WEEKLY 70 MG TABLET IS AND WHAT IT
IS USED FOR
The active ingredient, alendronate monosodium trihydrate, belongs to a
group of non-hormonal
medicines called “bisphosphonates”. It works by preventing the
loss of bone that occurs in women
after they have been through the menopause, and helps to rebuild bone.
It reduces the risk of spine and
hip fractures.
Alendronic Acid Bluefish Once weekly is used to treat the following
condition:
- Postmenopausal osteoporosis.
Osteoporosis is a thinning and weakening of the bones. It is common in
women after the menopause.
At the menopause, the ovaries stop producing the female hormone,
oestrogen, which helps to keep a
woman’s skeleton healthy. As a result, bone loss occurs and bones
become weaker. The earlier a
woman reaches the menopause, the greater the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms. If left untreated,
however, it can result in fractures

Summary of Product characteristics

Health Products Regulatory Authority
11 May 2023
CRN00DFXM
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alendronic Acid Bluefish Once weekly 70 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the equivalent of 70 mg of alendronic acid as
91.37 mg sodium alendronate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White oval flat tablets, with dimensions of 14 x 8 mm and marked on
one face with “70”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. Alendronic Acid Bluefish
Once weekly 70 mg tablets 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.
_To permit adequate absorption of alendronate:_
Alendronic Acid Bluefish Once weekly 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 Bluefish Once weekly 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 Bluefish Once weekly
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 least 30 minutes after taking
Alendronic Acid Bluefish Once weekly 70 mg tablets.
• Alendronic Acid Bluefish Once weekly 70 mg tablets should not be
t