CHONDROMEL Hard capsule (2021)
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Περιεχόμενα
Name of the medicinal product
Chondromel 400 mg Capsules.
Qualitative and quantitative composition
<u>Each hard capsule contains:</u> chondroitin sulfate 400 mg as chondroitin sulfate sodium. <u>Excipient with known effects:</u> sodium. For a full list of excipients see section 6.1.
Pharmaceutical form
Hard capsule. Transparent green and blue gelatin capsule.
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 ...
Contraindications
Chondromel is contraindicated in individuals with known or suspected hypersensitivity to chondroitin sulfate or any of its excipients.
Special warnings and precautions for use
<u>Heart and/or kidney failure:</u> 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 ...
Interaction with other medicinal products and other forms of interaction
For use in conjunction with platelet antiaggregants see section 4.4.
Pregnancy and lactation
There is no research on the use of Chondromel by pregnant or lactating women. Therefore, its use should be avoided during these periods.
Effects on ability to drive and use machines
There is no evidence that Chondromel interferes with the ability to drive vehicles or operate machinery.
Undesirable effects
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 ...
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 ...
Pharmacodynamic properties
<b>M01AX:</b> Other non-steroidal anti-inflammatories and anti-rheumatics Chondroitin sulfate, the active ingredient of Chondromel, belongs to the polysaccharide subgroup of glycosaminoglycans. Chondroitin ...
Pharmacokinetic properties
Absorption Several studies indicate that the bioavailability of chondroitin sulfate fluctuates between 15 and 24% of the dose by oral administration. 10% of the absorbed portion of chondroitin sulfate ...
Preclinical safety data
Toxicity (severe, sub severe and chronic), mutagenicity, genotoxicity, carcinogenicity and reproductive toxicity studies, have given negative results in all cases.
List of excipients
Magnesium stearate <u>The capsule shells contain:</u> Gelatin Titanium dioxide (E171) Quinoline yellow (E104) Indigo carmine (E132)
Incompatibilities
Not applicable.
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.
Marketing authorization holder
IBSA Farmaceutici Italia S.r.l, Via Martiri di Cefalonia 2, 26900 Lodi (LO), Italy
Marketing authorization number(s)
PA1104/003/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 December 2005 Date of last renewal: 22 December 2010
Date of revision of the text
September 2021
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