ARTHRYL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLUCOSAMINE SULFATE (CRYSTALLINE)

Available from:

DEXCEL LTD, ISRAEL

ATC code:

M01AX05

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

GLUCOSAMINE SULFATE (CRYSTALLINE) 1500 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ROTTAPHARM LTD, IRELAND

Therapeutic area:

GLUCOSAMINE

Therapeutic indications:

Treatment of osteoarthritis symptoms ( i.e. pain and function limitation).

Authorization date:

2021-06-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Arthryl
Powder for Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Crystalline glucosamine sulfate 1884 mg
equivalent to:
glucosamine sulfate
1500 mg
sodium chloride
384 mg
Excipients with known effect:
One sachet contains 2.5 mg aspartame, 151 mg sodium and 2028.5 mg
sorbitol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for oral solution.
A white, crystalline, odourless powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoarthritis symptoms (i.e. pain and function
limitation).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The contents of one sachet (dissolved in a glass of water) should be
taken once daily, preferably at meals.
Pivotal proof of efficacy has been demonstrated for periods of up to
three months, with a residual effect
evident for two months after drug withdrawal. The safety and efficacy
of the product were also confirmed
in pivotal clinical trials for treatment up to three years. Continuous
treatment beyond 3 years cannot be
recommended as the safety has not been established beyond this period.
Glucosamine is not indicated for the treatment of acute painful
symptoms. Relief of symptoms (especially
pain relief) may not be experienced until after some 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
by the patient’s healthcare practitioner.
2
Patients should seek medical advice if their symptoms deteriorate
after commencing treatment with
glucosamine.
_ _
_OLDER PEOPLE: _
No specific studies have been performed in older people, but according
to clinical experience dosage
adjustment is not required when treating otherwise healthy, older
patients.
_ _
_PATIENT WITH 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 performe