Flexove 625 mg tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Glucosamine

Saadav alates:

Laboratoires Expanscience

ATC kood:

M01AX; M01AX05

INN (Rahvusvaheline Nimetus):

Glucosamine

Annus:

625 milligram(s)

Ravimvorm:

Tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2007-10-05

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLEXOVE 625 MG TABLETS
Glucosamine
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 further questions, please 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.
IN THIS LEAFLET
:
1.
What Flexove is and what it is used for
2.
What you need to know before you take Flexove
3.
How to take Flexove
4.
Possible side effects
5.
How to store Flexove
6.
Contents of the pack and other information
1.
WHAT FLEXOVE IS AND WHAT IT IS USED FOR
Flexove belongs to the group of medicines called anti-inflammatory and
anti-rheumatic
agents, non-steroids.
Flexove is used for the relief of symptoms in mild to moderate
osteoarthritis of the knee.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLEXOVE
DO NOT TAKE FLEXOVE IF YOU:

are
ALLERGIC
to
GLUCOSAMINE
or to
ANY OF THE OTHER INGREDIENTS
of Flexovethis medicine
(listed in section 6).

are
ALLERGIC
(hypersensitive)
to
SHELLFISH
,
since
glucosamine
is
manufactured
from
shellfish. WARNINGS AND PRECAUTIONS.
Glucosamine is not indicated for the treatment of acute painful
symptoms.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING FLEXOVE

suffer from
IMPAIRED GLUCOSE TOLERANCE
. More frequent controls of your blood glucose
levels may be necessary when starting treatment with Flexove.

have a
KNOWN RISK FACTOR FOR CARDIOVASCULAR (HEART) DISEASE
, since an abnormally high
level of cholesterol in the blood has been observed in a few patients
treated with Flexove.

suffer
from
ASTHMA
.
When
starting
on
Flexove,
you
should
be
aware
of
potential
worsening of symptoms.
CHILDREN AND ADOLESCENTS
-
Flexove should not be used in c

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flexove 625 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 750 mg of glucosamine hydrochloride equivalent to
625 mg of glucosamine
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to light beige, oval tablet of 10 mm x 18.75 mm marked with
“G” on one side and a score line on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flexove is indicated in adults for the relief of symptoms in mild to
moderate osteoarthritis of the knee.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1250 mg glucosamine once daily for relief of symptoms.
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.
Additional information
on special populations.
_Paediatric population_
Flexove should not be used in children and adolescents below the age
of 18 (see 4.4).
_Elderly_
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.
_Method of administration_
Tablets can be taken with or without food.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Flexove must not be given to patients who are allergic to shellfish as
the active substance is obtained from shellfish.
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