Actonel 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Risedronate sodium

Available from:

Waymade Healthcare Plc

ATC code:

M05BA07

INN (International Name):

Risedronate sodium

Dosage:

5mg

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

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL® 5MG FILM-COATED TABLETS
(risedronate sodium)
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.
The name of your medicine is Actonel 5mg film-coated tablets but will
be
referred to as Actonel throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Actonel is and what it is used for
2.
What you need to know before you take Actonel
3.
How to take Actonel
4.
Possible side effects
5.
How to store Actonel
6.
Contents of the pack and other information
1.
WHAT ACTONEL IS AND WHAT IT IS USED FOR
WHAT ACTONEL IS
Actonel belongs to a group of
non-hormonal medicines called
bisphosphonates which are used to treat bone
diseases. It works directly on your bones to
make them stronger and therefore less likely to
break.
Bone is a living tissue. Old bone is constantly removed from your
skeleton and replaced with new bone.
Postmenopausal osteoporosis is a condition occurring in women after
the
menopause where the bones become weaker, more fragile and more
likely to break after a fall or strain.
Osteoporosis is more likely to occur in women who have reached the
menopause early and also in patients treated long-term with steroids.
The spine, hip and wrist are the most likely bones to break, although
this
can happen to any bone in your body. Osteoporosis - related fractures
can also cause back pain, height loss and a curved back. Many patients
with osteoporosis have no symptoms and you may not even have known
that you had it.
WHAT ACTONEL IS USED FOR
The treatment of ost

Summary of Product characteristics

PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Not applicable
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable
3.
PHARMACEUTICAL FORM
Not applicable
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Not applicable
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Not applicable
4.3.
CONTRAINDICATIONS
Not applicable
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not applicable
4.6.
PREGNANCY AND LACTATION
Not applicable
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable
4.8.
UNDESIRABLE EFFECTS
Not applicable
4.9.
OVERDOSE
Not applicable
5.
PHARMACOLOGICAL PROPERTIES
5.1.
PHARMACODYNAMIC PROPERTIES
Not applicable
5.2.
PHARMACOKINETIC PROPERTIES
Not applicable
5.3.
PRECLINICAL SAFETY DATA
Not applicable
6.
PHARMACEUTICAL PARTICULARS
6.1.
LIST OF EXCIPIENTS
Not applicable
6.2.
INCOMPATIBILITIES
Not applicable
6.3.
SHELF LIFE
Not applicable
6.4.
SPECIAL PRECAUTIONS FOR STORAGE
Not applicable
6.5.
NATURE AND CONTENTS OF CONTAINER
Not applicable
6.6.
INSTRUCTION FOR USE AND HANDLING (, AND DISPOSAL)
Not applicable
No Data Held
ADMINISTRATIVE DATA
7.
Marketing Authorisation Holder
Not applicable
8.
MARKETING AUTHORISATION NUMBER
Not applicable
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Not applicable
10.
DATE OF (PARTIAL) REVISION OF TEXT
Not applicable