Osteomel Once Weekly 70 mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALENDRONIC ACID

Available from:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

ATC code:

M05BA04

INN (International Name):

ALENDRONIC ACID 70 mg

Pharmaceutical form:

TABLET

Composition:

ALENDRONIC ACID 70 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR TREATMENT OF BONE DISEASES

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-09-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OSTEOMEL ONCE WEEKLY 70MG TABLETS
Alendronic acid
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 Osteomel Once Weekly is and what it is used for
2.
What you need to know before you take Osteomel Once Weekly
3.
How to take Osteomel Once Weekly
4.
Possible side effects
5.
How to store Osteomel Once Weekly
6.
Contents of the pack and other information
1. WHAT OSTEOMEL ONCE WEEKLY IS AND WHAT IT IS USED FOR
Alendronate belongs to a group of medicines called bisphosphonates.
Alendronate prevents the loss
of bone, and reduces the risk of spine and hip fractures.
OSTEOMEL ONCE WEEKLY IS USED
•
to treat
OSTEOPOROSIS
. Osteomel Once Weekly has been shown to reduce the risk of spine and
hip fractures in
WOMEN
.
OSTEOMEL ONCE WEEKLY IS A ONCE WEEKLY TREATMENT.
Osteoporosis is a thinning and weakening of the bones. Early on,
osteoporosis usually has no
symptoms, but if left untreated it can cause fractured bones. Although
these usually hurt, fractures
in the spine may go unnoticed until they cause height loss. Fractures
can happen during normal,
everyday activity, such as lifting, or from minor injury that would
not damage healthy bone.
Fractures usually occur at the hip, spine, or wrist and can lead not
only to pain but also to
considerable problems like stooped posture (‘dowager’s hump’)
and loss of mobility.
As well as your treatment with Osteomel Once Weekly, your doctor may
suggest you make changes
to your lifestyle (e.g. exercise an

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Osteomel Once Weekly 70 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as sodium alendronate
trihydrate).
Excipient with known effect
Each tablet contains 135.51 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Length: 12.90 mm, width: 7.25 mm. White to off-white, oval tablet.
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
Posology
The recommended dose is one 70 mg tablet per week.
_Duration of use _
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.
Patients should be given a calcium and vitamin D supplement if the
diet is inadequate (see
section 4.4).
_Special populations _
Elderly population
In clinical trials there was no age-related difference with regard to
efficacy or safety profiles of
alendronate. Therefore no adjustment of the dose is necessary for
elderly patients.
_ _
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Renal impairmentNo dose adjustment is necessary in patients with a
glomerular filtration rate
(GFR) greater than 35 ml/min. Alendronate is not recommended for
patients with impaired
renal function if the GFR is less than 35 ml/min, as there is no
experience of this.
Hepatic impairmentNo dose adjustment is necessary.
_Paediatric population _
Alendronate sodium is not recommended for use in children under the
age of 18 years due to
insufficient data on safety and efficacy in conditions associated with
paediatric osteoporosis
(also see section 5.1).
Alendronic acid 70 mg tablets have not been investigated in the
treatment of glucocorticoid-
induced osteoporosis.
Me