Arthrimel 500 mg Film-Coated Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Glucosamine sulfate

Tillgänglig från:

Phoenix Labs

ATC-kod:

M01AX; M01AX05

INN (International namn):

Glucosamine sulfate

Dos:

500 milligram(s)

Läkemedelsform:

Film-coated tablet

Receptbelagda typ:

Product not subject to medical prescription

Terapiområde:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

Bemyndigande status:

Not marketed

Tillstånd datum:

2005-07-22

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARTHRIMEL® 500 MG FILM-COATED TABLETS
GLUCOSAMINE SULFATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 1 month.
IN THIS LEAFLET:
1.
What Arthrimel® is and what it is used for
2.
Before you take Arthrimel®
3.
How to take Arthrimel®
4.
Possible side effects
5.
How to store Arthrimel®
6.
Further information
1.
WHAT ARTHRIMEL® IS AND WHAT IT IS USED FOR
Arthrimel® belongs to a group of medicines called other
anti-inflammatory and anti-
rheumatic agents, non-steroids.
Arthrimel ® is used for the relief of symptoms of mild to moderate
osteoarthritis of the knee
that has previously been diagnosed by your doctor.
Osteoarthritis is a type of joint degeneration that generates symptoms
such as stiffness (after
sleep or long rest) and pain at motion (e.g. when climbing the stairs
or walking along uneven
surfaces).
2.
BEFORE YOU TAKE ARTHRIMEL®
DO NOT TAKE ARTHRIMEL®
-
If you are allergic (hypersensitive) to:
-
Glucosamine or to any of the other ingredients of Arthrimel® (see
Section 6 “Further
Information”)
-
Shellfish, since Arthrimel® is manufactured from shellfish.
TAKE SPECIAL CARE WITH ARTHRIMEL® IF YOU
-
Suffer from impaired glucose tolerance. More frequent controls of your
blood glucose
levels may be necessary when starting treatment with Arthrimel®
-
Have kidney or liver dysfunction, since no studies have been performed
in such patient’s
dose recommendations cannot be given.
-
Have a known risk factor for heart (cardiovascular) disease, since
high cholesterol
(hypercholesterolemia)
has
been
observ

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arthrimel 500 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains glucosamine sulfate sodium chloride
equivalent to 500 mg glucosamine sulfate.
Excipients:
Each tablet contains 50.6 mg (2.2 mmol) of sodium and 60 mg of lactose
monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oblong, off-white, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arthrimel tablets are indicated for relief of symptoms in mild to
moderate osteoarthritis of the knee as diagnosed by a
doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Administration:_
Arthrimel tablets should be swallowed whole.
Tablets can be taken with or without food.
_Adults and the elderly:_
One Arthrimel tablet should be taken 3 times daily.
Or
Three Arthrimel tablets to be taken once 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 reevaluated by your healthcare
practitioner.
Patients should seek medical advice if their symptoms deteriorate
after commencing treatment with glucosamine.
Additional information on special populations:
_Children/adolescents:_
Safety and efficacy has not been established in children and
adolescents, therefore, Arthrimel tablets should not be used
in persons under the age of 18 years.
_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.
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