Risedronate sodium 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Risedronate sodium

Available from:

A A H Pharmaceuticals Ltd

ATC code:

M05BA07

INN (International Name):

Risedronate sodium

Dosage:

30mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200; GTIN: 5025903009580

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.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Risedronate is and what it is used for
2. What you need to know before you take Risedronate
3. How to take Risedronate
4. Possible side effects
5. How to store Risedronate
6. Contents of the pack and other information
1. WHAT RISEDRONATE IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE IS
Risedronate 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.
Paget’s disease occurs when this process, called remodeling,
happens too quickly and in a disordered way. The new bone that
is produced is weaker than normal and the affected bones may
become enlarged, painful and may fracture. Risedronate changes
the bone remodeling process back to normal, returning the
strength to the bone structure.
WHAT RISEDRONATE IS USED FOR
Treatment of Paget´s disease of the bone (osteitis deformans).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISEDRONATE
DO NOT TAKE RISEDRONATE
• if you are ALLERGIC to risedronate sodium or any of the other
ingredients of this medicine (listed in section 6).
• if your doctor has told you that you have a condition called
HYPOCALCAEMIA (a low blood calcium level).
• if you may be PREGNANT, are pregnant or are planning to
become pregnant.
• if you are BREAST-FEEDING.
• if you have SEVERE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risedronate sodium 30 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
30 mg
risedronate
sodium
(amorphous),
equivalent to 27.84 mg risedronic acid.
Excipient:
Each film-coated tablet contains 131.3 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White 8.5 mm round, biconvex, film-coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Paget’s disease of the bone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended daily dose in adults is one 30 mg tablet orally for 2
months. If re-
treatment is considered necessary (at least two months
post-treatment), a new
treatment with the same dose and duration of therapy could be given.
SPECIAL POPULATIONS
_Elderly_: No dosage adjustment is necessary since bioavailability,
distribution and
elimination were similar in elderly (> 60 years of age) compared to
younger subjects.
_Renal Impairment_: No dosage adjustment is required for those
patients with mild to
moderate renal impairment. The use of risedronate sodium is
contraindicated in
patients with severe renal impairment (creatinine clearance lower than
30 ml/min)
(see sections 4.3 and 5.2).
_Paediatric population:_ Risedronate sodium is not recommended for use
in children
below 18 years of age due to insufficient data on safety and efficacy
(see also section
5.1).
METHOD OF ADMINISTRATION
The absorption of Risedronate sodium is affected by food, thus to
ensure adequate
absorption patients should take Risedronate sodium:
•
Before breakfast: At least 30 minutes before the first food, other
medicinal
product or drink (other than plain water), of the day.
In the particular instance that before breakfast dosing is not
practical, Risedronate
sodium can be taken between meals or in the evening at the same time
everyday, with
strict adherence to the following instructions, to ensure Risedronate
sodium is ta