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PIASCLEDINE 30'S


    RM 90.00

TAB

Contents
Soybean, avocado, vegetable extracts.

Indications/Uses
PIASCLEDINE capsule is indicated for the symptomatic slow-acting treatment of hip and knee osteoarthritis.

Dosage/Direction for Use
Adult patients: One capsule daily. An increase in daily dosage to 2 capsules daily did not evidence any increase in efficacy. The usual treatment duration is between 3 and 6 months. At the end of this treatment duration, the practitioner may consider the need for a new course if required. No special action is needed if one or more dose(s) are missed.
Paediatric population: The safety and efficacy of PIASCLEDINE capsule in children has not been established, while there is no relevant use of PIASCLEDINE capsule in the paediatric population. Therefore PIASCLEDINE is not to be used in children and adolescents below the age of 18.
Other special populations: Elderly patients: There was no specific clinical study of PIASCLEDINE in elderly patient population. However, the overall clinical experience with PIASCLEDINE was observed in patient population with an actual mean age around 60 years old, with a significant proportion of patients over 65 years old. Therefore, no dosage adjustment is to be made in elderly, otherwise healthy, patients.
Method of administration: Oral use. Capsule is to be swallowed as a whole, without chewing, with a glass of water, generally in the middle of a meal.

Overdosage
No overdose related to relevant and/or significant clinical symptoms was evidenced from clinical studies and/or post-marketing experience (pharmacovigilance data).

Contraindications
Hypersensitivity to the active substances or to any of the excipients of the medicine.

Special Precautions
PIASCLEDINE is not to be used in children and adolescents below the age of 18. In adults, no special warning and/or precaution for use were evidenced from clinical studies and/or post-marketing experience (pharmacovigilance data).
Effects on Ability to Drive and Use Machines: PIASCLEDINE has no known influence on the ability to drive and use machines.

Use In Pregnancy & Lactation
There are no data from the use of PIASCLEDINE in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive or fertility toxicity. As a precautionary measure, it is preferable to avoid the use of PIASCLEDINE during pregnancy. There is no information about the excretion of PIASCLEDINE/metabolites in human milk. As a precautionary measure, it is preferable to avoid the use of
PIASCLEDINE during breastfeeding.

Adverse Reactions
Summary of the safety profile: Safety data obtained from clinical studies revealed that PIASCLEDINE safety profile did not differ from that of a placebo. For both treatments, the body system with the higher incidence of adverse events is digestive system. Safety data obtained from pharmacovigilance evidenced a very low incidence of adverse events, that is lower than 0.08 cases per million treatment-days. Out of the whole events reported, digestive events were the most frequent (around 20% of all events). Other events with relative proportions >5% included those in the body systems: skin and subcutaneous tissue disorders, investigations, general disorders and administration site conditions, vascular disorders and nervous system disorders.
Tabulated list of adverse reactions: The frequency of undesirable effects is consistent with the MedDRA frequency convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1 000 to <1/100); Rare (≥1/10 000 to <1/1 000); Very rare (<1/10 000), not known (cannot be estimated from the available data). (See table.)

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