Dolenio 1500mg Film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Glucosamine sulfate

Tilgjengelig fra:

Blue Bio Pharmaceuticals Ltd

ATC-kode:

M01AX; M01AX05

INN (International Name):

Glucosamine sulfate

Dosering :

1500 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

Autorisasjon status:

Marketed

Autorisasjon dato:

2009-03-20

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
Dolenio 1500mg Film-coated tablets
Glucosamine sulphate
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. 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 Dolenio is and what it is used for
2. What you need to do before you take Dolenio
3. How to take Dolenio
4. Possible side effects
5. How to store Dolenio
6. Contents of the pack and other information
1. WHAT DOLENIO IS AND WHAT IT IS USED FOR
Dolenio belongs to the group of other anti-inflammatory and ant
rheumatic agents, non-
steroids.
Glucosamine is a substance naturally occurring in the human body and
necessary for joint
fluid and cartilage in adults.
Dolenio tablets is a medical product used for the relief of symptoms
in mild to
moderate osteoarthritis of the knee.
Osteoarthritis is a type of joint degeneration which symptoms are
: Stiffness (after sleep or long rest), pain at motion (e.g. when
climbing the stairs or walking
along uneven surfaces), which relieves at a rest.
2. BEFORE YOU TAKE DOLENIO
DO NOT TAKE DOLENIO
-
if you are allergic to glucosamine or any of the other ingredients of
Dolenio.
-
if you are allergic to shellfish, as the active ingredient,
glucosamine, is extracted
from shellfish.
- if you are pregnant of breast-feeding.
Dolenio must not be used in children and adolescents under 18 years of
age.
WARNINGS AND PRECAUTIONS
Glucosamine is not indicated for the treatment of acute pain.
Talk to your doctor or pharmacist before
taking
Dolenio.
Particularly,
tell
your
doctor:
• if you suffer of diabetes mellitus or have impaired glucose

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolenio 1500mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 1884.60 mg of Glucosamine sulphate
sodium chloride equivalent to 1500 mg
Glucosamine sulphate or 1178 mg glucosamine.
Excipient with known effect: Sodium 151 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped, bi-convex film coated tablets with
breakline on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms in mild to moderate osteoarthritis of the knee.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
One tablet daily
Glucosamine is not indicated for the treatment of acute painful
symptoms. Relief of symptoms (especially pain relief)
may not be experienced until after several weeks of treatment and in
some cases even longer. If no relief of symptoms
is experienced after 2-3 months, continued treatment with glucosamine
should be re-evaluated.
_Paediatric population:_
Doenio is not recommended for use in children and adolescents below
the age of 18 years, due to lack of data on safety
and efficacy.
_Older people:_
No specific studies have been performed in the elderly, but according
to clinical experience dosage adjustment is not
required when treating otherwise healthy, elderly patients.
_Impaired renal and/or liver function:_
In patients with impaired renal and/or liver function no dose
recommendations can be given, since no studies have been
performed with this group.
Method of administration
For oral use. Tablets can be taken with or without food.
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