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 contraindicated in individuals with known or suspected hypersensitivity to chondroitin sulfate or any of its excipients.
Heart and/or kidney failure: In very rare occasions (<1/10.000) such patients have experienced cases of edema and/or water retention. This can be attributed to the osmotic effect of Chondroitin sulfate.
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.
No effect at platelet level has been observed within the recommended dose rates. However, with rats and doses greatly in excess of the recommended 50 mg/kg/day (which would correspond to 4,000 mg in humans/day), a slight platelet antiaggregant activity has been observed. This reaction will have to be taken into account when Chondromel is used in conjunction with platelet antiaggregants (acetylsalicylic acid, dipyridamole, clopidrogel, ditazol, trifusal or ticlopidine).
This medicinal product contains 36.5 mg sodium per capsule, equivalent to 1.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For use in conjunction with platelet antiaggregants see section 4.4.
There is no research on the use of Chondromel by pregnant or lactating women. Therefore, its use should be avoided during these periods.
There is no evidence that Chondromel interferes with the ability to drive vehicles or operate machinery.
In the following table adverse reactions observed in clinical trials* (on a total of 1826 patients, out of which 1264 were treated with Chondromel) and during post marketing surveillance are listed. Adverse reactions are grouped by System Organ Class.
Within each System Organ Class, the adverse reactions are classified according to frequency of observation, using the following convention: very common (>1/10); common (>1/100, <1/10), uncommon (>1/1,.000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).
| Gastro-intestinal disorders | Rare | Gastrointestinal disorder* Epigastralgia* Nausea* Diarrhoea* |
| Skin and subcutaneous tissue disorders | Rare | Erythema Rash* Rash maculo-papular |
| Very rare | Urticaria Eczema Pruritus Allergic reaction** | |
| General disorders and administration site conditions | Very rare | Oedema |
* Adverse reactions observed in clinical trials
** Cases of allergic reactions (such as angioneurotic edema) have rarely been reported
Not applicable.
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