CHONDROMEL Hard capsule Ref.[8646] Active ingredients: Chondroitin sulfate

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

Therapeutic indications

Chondromel is indicated for the symptomatic treatment of osteoarthritis.

Posology and method of administration

Adults (including the elderly)

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.

Children

The use of Chondromel is not recommended for children.

Kidney failure

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).

Liver failure

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.

Overdose

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.

Shelf life

3 years.

Special precautions for storage

Store in the original package in order to protect from moisture.

Nature and contents of container

PVC/Al blister strips in an outer carton: each pack contains either 60 or 180 capsules.

Special precautions for disposal and other handling

No special requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.