Risebon tablets film-coated

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

risedronic acid (risedronate sodium)

Disponible des:

Adamed Pharma S.A.

Codi ATC:

M05BA07

Designació comuna internacional (DCI):

risedronic acid (risedronate sodium)

Dosis:

35mg

formulario farmacéutico:

tablets film-coated

Unidades en paquete:

(4/1x4/) in blister

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2023-03-21

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISEBON, 35 MG, 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.
WHAT IS IN THIS LEAFLET
1.
What Risebon is and what it is used for
2.
What you need to know before you take Risebon
3.
How to take Risebon
4.
Possible side effects
5.
How to store Risebon
6.
Contents of the pack and other information
1. WHAT RISEBON IS AND WHAT IT IS USED FOR
Risebon 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 osteoporosis have no symptoms and you may not even
have known that you had it.
The treatment of osteoporosis in POSTMENOPAUSAL WOMEN, even if
osteoporosis is severe.
It reduces the risk of spinal and hip fractures.
Treatment of osteoporosis in men at high risk of fractures.
2. WHAT YOU N

Fitxa tècnica

1.
NAME OF THE MEDICINAL PRODUCT
Risebon, 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: lactose monohydrate.
Each film-coated tablet contains 133.58 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated, biconvex, pale orange coloured round tablet.
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.
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption
patients should take Risebon, 35 mg:
• Before breakfast: At least 30 minutes before the first food, other
medicinal product or drink
(other than plain water) of the day.
Patients should be instructed that if a dose is missed, one Risebon,
35 mg tablet should be taken
on the day that the tablet is remembered. Patients should then return
to taking one tablet once a
week on the day the tablet is normally taken. Two tablets should not
be taken on the same day.
The tablet must be swallowed whole and not sucked or chewed. To aid
delivery of the tablet to
the stomach Risebon, 35 mg is to be taken while in an upright position
with a glass of plain water
(≥120 ml). Patients should not lie down for 30 minutes after taking
the tablet (see section 4.4).
Supplemental calcium and vitamin D should be considered if the dietary
intake is inadequate.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The
need for continued treatment shoul