Actonel Once a Week 35mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Risedronate sodium

Inapatikana kutoka:

Accord-UK Ltd

ATC kanuni:

M05BA07

INN (Jina la Kimataifa):

Risedronate sodium

Kipimo:

35mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 06060200; GTIN: 05052667000218

Taarifa za kipeperushi

_S0973 LEAFLET Actonel 20190902 _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL
® ONCE A WEEK 35MG TABLETS
(RISEDRONATE SODIUM)
Your medicine is known as Actonel

once a week 35mg tablets but
will be referred to as Actonel once a week throughout the following
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 Actonel Once a Week is and what it is used for
2.
What you need to know before you take Actonel Once a Week
3.
How to take Actonel Once a Week
4.
Possible side effects
5.
How to store Actonel Once a Week
6.
Contents of the pack and other information
1.
WHAT ACTONEL ONCE A WEEK IS AND WHAT IT IS USED
FOR
WHAT ACTONEL ONCE A WEEK IS
Actonel Once a Week 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 can also occur in men due to a number of causes
including ageing and/or a low level of the male hormone,
testosterone.
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 os

Tabia za bidhaa

OBJECT 1
ACTONEL ONCE A WEEK 35 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 Once a Week 35 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 35 mg risedronate sodium (equivalent
to 32.5 mg risedronic acid).
Excipient with known effect:
Each film-coated tablet contains 126.0 mg lactose monohydrate
(equivalent to 119.7 mg lactose).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Oval light-orange 11.7 x 5.8mm film-coated tablet with RSN on one side
and 35 mg on the other.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of postmenopausal osteoporosis, to reduce the risk of
vertebral fractures. Treatment of
established postmenopausal osteoporosis, to reduce the risk of hip
fractures (see section 5.1).
Treatment of osteoporosis in men at high risk of fractures (see
section 5.1).
4.2 Posology and method of administration
Posology
The recommended dose in adults is one 35 mg tablet orally once a week.
The tablet should be taken on
the same day each week.
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.
This has also been shown in the very elderly, 75 years old and above
postmenopausal population.
_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 risedronate sodium is affected by food, thus to
ensure adequate absorption