Viartril-S

País: Malta

Idioma: inglés

Fuente: Medicines Authority

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Ficha técnica Ficha técnica (SPC)
17-05-2024

Ingredientes activos:

GLUCOSAMINE SULFATE, SODIUM CHLORIDE

Disponible desde:

Rottapharm S.p.A Galleria Unione, 5-20122 Milan, Italy

Código ATC:

M01AX05

Designación común internacional (DCI):

GLUCOSAMINE SULFATE 250 mg SODIUM CHLORIDE 64 mg

formulario farmacéutico:

HARD CAPSULE

Composición:

GLUCOSAMINE SULFATE 250 mg SODIUM CHLORIDE 64 mg

tipo de receta:

POM

Área terapéutica:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2007-03-02

Información para el usuario

                                _AF121006AF09 _
 
VIARTRIL
®
-S 
_GLUCOSAMINE SULFATE _
 
 
COMPOSITION 
 
Each capsule contains: 
_ACTIVE INGREDIENT _
 
Crystalline glucosamine sulfate 
314.0  mg 
_ _
_equivalent to:  glucosamine sulfate _
_250.0  mg _
_  _
_sodium _
_chloride _
_64.0 mg _
_EXCIPIENTS _
 
Maize starch, Lactose, Magnesium stearate, Talc. 
_Shell of the hard-gelatine capsule _
Titanium dioxide (E 171), Iron oxides (E 172), Erythrosine (E
127), Gelatin. 
 
 
PHARMACEUTICAL FORM AND PRESENTATION 
Package of 80 capsules of 250 mg. 
 
PHARMACO-THERAPEUTIC GROUP 
_M01AX05_: Other antiinflammatory/antirheumatic, non
steroidal drugs – 
_Glucosamine sulfate_.  
 
MARKETING AUTHORIZATION HOLDER  AND MANUFACTURER 
 
_Marketing Authorisation Holder_: 
ROTTAPHARM – S.p.A. - Galleria Unione 5 - 20122 Milan - Italy. 
 
_Manufacturer responsible for batch release_: 
ROTTAPHARM Ltd. - Damastown Industrial Park, Mulhuddart, Dublin 15 -
Ireland 
or ROTTAPHARM S.p.A. - Via Valosa di Sopra 9 - 20052 Monza (MI)
– Italy.   
THERAPEUTIC INDICATIONS 
Relief of symptoms in mild to moderate osteoarthritis.  
 
CONTRA-INDICATIONS 
Assessed individual hypersensitivity to glucosamine. 
 
PRECAUTIONS FOR USE 
The administration of VIARTRIL
®
-S should be withdrawn in women with fertility 
problems or in women who are undergoing fertility tests. 
The use of VIARTRIL
®
-S is not advised in women who intend to have pregnancy. 
No unfavourable effects on the reproductive functions or
on lactation are known. 
Nevertheless, the use of the product should be limited to cases of
acknowledged 
necessity and under medical control. 
 
- 2 - 
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF 
INTERACTION 
The oral administration of glucosamine sulfate can enhance the
gastrointestinal 
absorption of tetracyclines and decrease that of penicillines
or chloramphenicol 
contemporaneously administered by oral route. 
Steroidal or non-stero
                                
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Ficha técnica

                                Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 
1.  
NAME OF THE MEDICINAL PRODUCT 
 VIARTRIL-S 
 
 
2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
 
Each hard-gelatin capsule contains: 
 
_ACTIVE INGREDIENT_: 
 
Crystalline glucosamine sulfate 
314.0  mg 
_ equivalent _
_to: _
_glucosamine _
_sulfate _
_250.0 _
_mg _
_ _
_ _
_sodium chloride _
_64.0   mg _
 
 
3.  
PHARMACEUTICAL FORM 
 Hard-gelatine 
capsules. 
 
 
4.  
CLINICAL PARTICULARS 
 
4.1. THERAPEUTIC 
INDICATIONS 
Relief of symptoms in mild to moderate osteoarthritis.  
 
4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 
 If not differently prescribed by the physician, 2 hard-gelatin
capsules three 
times daily (in the morning and at meals) are recommended for 6
weeks or 
more if necessary.  
 The therapeutic cycle can be repeated at 2-month intervals. 
 
4.3. CONTRAINDICATIONS 
 Assessed individual hypersensitivity to glucosamine.  
 
4.4. 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
  
Although VIARTRIL-S has not an inhibitory activity on the synthesis
of 
prostaglandins and cycloxygenase, its use is not advised in
women who intend 
to have pregnancy. 
 The administration of VIARTRIL®-S should be withdrawn in women
with 
fertility problems or in women who are
undergoing fertility tests. 
 
4.5. 
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION 
 The oral administration of glucosamine sulfate can enhance the
gastrointestinal 
absorption of tetracyclines and decrease that of penicillines or
chloramphenicol 
contemporaneously administered by oral route. 
 
Steroidal or non-steroidal analgesic or antiinflammatory
agents can be 
administered contemporaneously. 
 
 
4.6. 
PREGNANCY AND LACTATION 
Page 2 of 5 
 
The animal studies did not evidence any unfavourable effects on
the 
reproductive functions or on lactation. Nevertheless, the use of
the drug should 
be limited to ca
                                
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