Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: IBSA Farmaceutici Italia S.r.l, Via Martiri di Cefalonia 2, 26900 Lodi (LO), Italy
Chondromel is indicated for the symptomatic treatment of osteoarthritis.
The recommended dose of Chondromel is 800 mg/day as a single-dose (2 capsules at a time) for 3 months at least.
For symptoms of severe inflammation, the recommend starting dose is 1200 mg/day as a single (3 capsules at a time) or divided dose (1 capsule 3 times a day) for 4-6 weeks, followed by 800 mg for up to 3 months. Therapy comprises repeatable courses of treatment; each course comprises 3 months intake at least, followed by a 2 month treatment-free interval.
The clinical effect will usually be seen in 4 weeks.
Clinical trials have only assessed the efficacy of the product over a two year treatment period.
The use of Chondromel is not recommended for children.
There is little experience available on the use of Chondromel by patients suffering from kidney failure. Therefore, these patients must be treated with special attention (see section 4.4).
There is no experience available on the use of Chondromel by patients suffering from liver failure. Therefore, it is not recommended for use in this group (see section 4.4).
Chondromel can be taken before, during or after a meal. Patients with a history of gastric intolerance to medicines are recommended to take it after a meal.
The capsules must be swallowed, not chewed, with sufficient liquid.
During post marketing surveillance one case of intentioned overdose to commit suicide was observed. After a dose of 64g, the patient did not experience any adverse reactions and laboratory data showed electrolyte values in the normal range.
3 years.
Store in the original package in order to protect from moisture.
PVC/Al blister strips in an outer carton: each pack contains either 60 or 180 capsules.
No special requirements.
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