Glucosamine sulfate 1500mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glucosamine sulfate

Available from:

FMC Pharma Ltd

ATC code:

M01AX; M01AX05

INN (International Name):

Glucosamine sulfate

Dosage:

1500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

Authorization status:

Not marketed

Authorization date:

2011-08-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOSAMINE SULFATE 1500 MG FILM-COATED TABLETS
GLUCOSAMINE SULFATE
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 Glucosamine sulfate is and what it is used for
2.
What you need to know before you take Glucosamine sulfate
3.
How to take Glucosamine sulfate
4.
Possible side effects
5.
How to store Glucosamine sulfate
6.
Contents of the pack and other information
1.
WHAT GLUCOSAMINE SULFATE IS AND WHAT IT IS USED FOR
Glucosamine sulfate belongs to a group of medicines called other
anti-inflammatory and anti-
rheumatic agents, non steroids.
Glucosamine sulfate is used for the relief of symptoms of mild to
moderate osteoarthritis of
the knee.
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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUCOSAMINE SULFATE
DO NOT TAKE GLUCOSAMINE SULFATE
-
If you are allergic to:
-
Glucosamine or to any of the other ingredients of Glucosamine sulfate
(listed in
section 6)
-
Shellfish, since Glucosamine sulfate is manufactured from shellfish.
-
Peanut or soya, since contains soya lecithin.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH GLUCOSAMINE SULFATE IF YOU
-
Suffer from impaired glucose tolerance. More frequent controls of your
blood glucose
levels may be necessary when starting treatment with Glucosamine
sulfate
-
Have kidney or liver dysfuncti

Summary of Product characteristics

Health Products Regulatory Authority
02 February 2021
CRN009ZP8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucosamine sulfate 1500mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1884mg glucosamine sulfate sodium
chloride equivalent to 1500 mg glucosamine sulfate or
1178mg glucosamine.
Excipient(s) with known effect
Each tablet contains 151.8 mg (6.6mmol) of sodium, 6.0 mg Lactose
monohydrate and 0.72 mg Lecithin soya (E322)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Off-white oblong shaped film-coated tablet, 9.5x21mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glucosamine sulfate tablets are indicated for relief of symptoms in
mild to moderate osteoarthritis of the knee.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Method of _administration
Glucosamine sulfate tablets should be swallowed whole.
Tablets can be taken with or without food.
_Adults and the elderly_:
One Glucosamine sulfate tablet should 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.
Additional information on special populations:
_Paediatric population_
Safety and efficacy has not been established in children and
adolescents, therefore, Glucosamine sulfate 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 clinicalexperience 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.
4.3 CONTRAINDICATIONS
Health Products Regulato