Viartril 1500 mg Powder for Oral Solution

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Glucosamine sulphate sodium chloride

제공처:

Rottapharm Ltd

ATC 코드:

M01AX; M01AX05

INN (International Name):

Glucosamine sulphate sodium chloride

복용량:

1500 milligram(s)

약제 형태:

Powder for oral solution

처방전 유형:

Product not subject to medical prescription

치료 영역:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

승인 상태:

Not marketed

승인 날짜:

2005-07-08

환자 정보 전단

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIARTRIL
® 1500 MG POWDER FOR ORAL SOLUTION
glucosamine sulfate
_READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT _
_CONTAINS IMPORTANT INFORMATION FOR YOU. _
_Always take this medicine exactly as described in this leaflet or as
your pharmacist has _
_told you. _
o
_Keep this leaflet. You may need to read it again. _
o
_Ask your pharmacist if you need more information or advice. _
o
_If you get any side effects, talk to your pharmacist. This includes
any possible side _
_effects not listed in this leaflet. See section 4. _
o
_You must contact a doctor if your symptoms worsen or do not improve
after 30 _
_days. _
_ _
_ _
_What is in this leaflet: _
_1. _
_What Viartril is and what it is used for _
_2. _
_What you need to know before you take Viartril _
_3. _
_How to take Viartril _
_4. _
_Possible side effects _
_5. _
_How to store Viartril _
_6. _
_Contents of the pack and other information _
1.
WHAT VIARTRIL IS AND WHAT IT IS USED FOR
Viartril contains glucosamine sulfate which belongs to a group of
medicines called non-
steroidal anti-inflammatory and anti-rheumatic agents.
Viartril is used for the relief of symptoms in mild to moderate
osteoarthritis of the knee, as
diagnosed by your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIARTRIL
DO NOT TAKE VIARTRIL:

If you are allergic (hypersensitive) to glucosamine or any of the
other ingredients of
Viartril.

If you suffer from a genetic metabolic disorder (phenylketonuria).

If you are allergic to shellfish, as glucosamine is obtained from
shellfish.
WARNINGS AND PRECAUTIONS:
Consult your doctor before taking Viartril:
2

If you have diabetes; in this case closer monitoring of blood sugar
levels and where
relevant insulin requirements may be necessary at the beginning of the
treatment
and periodically during treatment with Viartril.

If you suffer from asthma; when starting on glucosamine, you should be
aware of
potential worsening of symptoms.

If you have sev

제품 특성 요약

Health Products Regulatory Authority
16 December 2020
CRN009ZWN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Viartril 1500 mg Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 1884 mg glucosamine sulfate sodium chloride,
equivalent to 1500 mg glucosamine sulfate and 384 mg
sodium chloride.
Excipients: Each sachet contains 2.5 mg aspartame (E951), 2028.5 mg
sorbitol (E420) and 151 mg sodium.
For a 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
Relief of symptoms in mild to moderate osteoarthritis of the knee, as
diagnosed by a doctor.
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.
Patients should seek medical advice if their symptoms deteriorate
after commencing treatment with glucosamine.
_OLDER PEOPLE:_
No specific studies have been performed in elderly, 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 live