Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Blue Bio Pharmaceuticals Ltd., 5<sup>th</sup> Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland
Relief of symptoms in mild to moderate osteoarthritis of the knee.
The recommended dose is 1178 mg of Glucosamine (1500 mg Glucosamine sulphate) to be taken once daily with a glass of water.
This quantity corresponds to: 3 tablets of Dolenio 500 mg to be taken together, once daily.
Other strengths can be available and the corresponding dosages is: 1 tablet of Dolenio 1500 mg or 2 tablets of Dolenio 750 mg to be taken together, 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 re-evaluated.
Tablets can be taken with or without food.
Dolenio is not recommended for use in children and adolescents below the age of 18 years, due to lack of data on safety and efficacy.
No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not required when treating otherwise healthy, elderly patients.
In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed with this group.
For oral use.
Signs and symptoms of accidental or intentional overdose with glucosamine might include headache, dizziness, disorientation, arthralgia, nausea, vomiting, diarrhoea or constipation.
In case of overdose, treatment with glucosamine should be discontinued and standard supportive measures should be adopted as required.
In clinical trials one of five healthy young subjects experienced headache following infusion of glucosamine up to 30 g.
In addition, one case of overdose has been reported in a 12-year old female who took orally 28 g of glucosamine hydrochloride. She developed arthralgia, vomiting and disorientation. The patient fully recovered.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
Alu/PVC/PVDC Blister packs.
Pack-sizes: 90, 180, 270 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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