|
Viartril-S
Glucosamine Sulfate
Powder for oral solution
Name of the medicinal product
Viartril-S
Composition
Each sachet contains :
Active ingredient
Crystalline glucosamine sulfate
1884.0mg equivalent to : glucosamine sulfate 1500.0 mg, sodium chloride
384.0mg
EXCIPIENTS
Aspartame, sorbitol, macrogol 4000, citric acid
Pharmaceutical form and presentation
Powder for oral solution ( sachet ). Package of 14 and 30 sachets.
Pharmaco-therapeutic group
Product for the treatment of osteoarthritis.
( Product for the musculoskeletal system – ATC code : M01AX05 )
Therapeutic indications
Treatment of the symptoms of osteoarthritis, i.e. pain and function
limitation.
Contraindications
Hypersensitivity to glucosamine.
The powder for oral solution
contains aspartame and is therefore contraindicated in patients with
phenylketonuria.
As the active ingredient is
obtained from seafood ( shellfish ), the product should not be given to
patients who are allergic to shellfish.
Precautions for use
The administration in patients with severe hepatic or renal insufficiency
should be made under medical supervision.
Special warnings
The animal studies did not
evidence any unfavorable effects on the reproductive functions or on
lactation. In the absence of such studies in humans, the product during
pregnancy and lactation should be used only under medical control.
Administration during the first three months of pregnancy must be avoided.
No effects on the ability to
drive or to operate machines is expected.
Posology and method of
administration
The content of one sachet
( dissolved in a glass of water ) should be taken once daily, preferably at
meals.
Overdose
No cases of accidental or intentional overdose are known. The animal acute
and chronic toxicological studies indicate that toxic effects and symptoms
of toxicity are not likely to occur, even after high overdoses.
Undesirable effects
The clinical trials have shown the good tolerability of the product.
Undesirable effects have been observed in a low proportion of patients. They
were transient, of minor entity, and included :
Cardiovascular :
Peripheral oedema, tachycardia were reported in a few patients following
larger clinical trials investigating oral administraton in osteoarthritis.
Causal relationship has not been established.
Central nervous system :
Drowsiness, headache, somnolence, insomnia have been observed rarely during
therapy.
Gastrointestinal : Nausea,
vomiting, diarrhoea, dyspepsia or epigastric pain, flatulence, constipation,
heartburn and anorexia have been described rarely during oral therapy with
glucosamine.
Skin : Skin reactions such
as cutaneous rash, erythema, pruritus, have been reported with therapeutic
administration of glucosamine. Occasionally contact dermatitis, rash papular,
urticaria and eczema may occur.
Isolated cases of hair loss,
allergic reactions, visual disturbances and oedema were observed.
The patient should inform his
doctor of any any other undesirable effect during the treatment.
Special precautions for storage and expiry date
Do not use the product after the expiry date indicated on the label.
Avoid exposure to excessive heat.
The expiry date applies to the
correctly stored product in the intact package.
Keep out of reach of children
|
