Actonel 30mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Risedronate sodium

Dostępny od:

Warner Chilcott UK Ltd

Kod ATC:

M05BA07

INN (International Nazwa):

Risedronate sodium

Dawkowanie:

30mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 06060200; GTIN: 04015600005177

Ulotka dla pacjenta

Risedronic Acid (Actonel) 30mg PIL - UK (Warner Chilcott)
item no: AAAI5654
print proof no: 02
origination date: 01-12-2015
originated by: NM
revision date: 02-12-2015
revised by: NM
dimensions: 210 x 320
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 01-12-2015
supplier: Warner Chilcott
approved: 02-12-2015
min pt size: 9 pts
TECHNICAL APPROVAL
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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.
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. Actonel changes the
bone remodeling process back to normal, returning the strength to
the bone structure.
WHAT ACTONEL IS USED FOR
Treatment of Paget’s disease of the bone (osteitis deformans).
2. WHA

Charakterystyka produktu

OBJECT 1
ACTONEL 30 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 03-Mar-2016 | Warner
Chilcott UK Limited (a subsidiary of
Actavis PLC)
1. Name of the medicinal product
Actonel 30 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 30 mg risedronate sodium (equivalent
to 27.8 mg risedronic acid).
Excipient with known effect
Each film-coated tablet contains 131.0 mg lactose monohydrate
(equivalent to 124.45 mg lactose).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets.
Oval white film-coated tablet with RSN on one side and 30 mg on the
other.
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 age 18
due to insufficient data on
safety and efficacy (also see section 5.1).
METHOD OF ADMINISTRATION
The absorption of Actonel is affected by food, thus to ensure adequate
absorption patients should take
Actonel:
• 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, Actonel can be taken between me