Piascledine

Piascledine

Manufacturer:

Hyphens

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Soybean, avocado, vegetable extracts.
Description
Composition in active substances, per capsule: Avocado oil unsaponifiable: 100.00 mg, soybean oil unsaponifiable: 200.00 mg. i.e. total extract of avocado and Soybean unsaponifiable fractions: 300.00 mg. Qs one capsule No 1: 307 mg.
Excipients/Inactive Ingredients: Capsule content: Anhydrous colloidal silica (Aerosil 200), Butylhydroxytoluene (E321).
Capsule shell: Polysorbate 80, Gelatine, Titanium dioxide (E171), Erythrosin (E127), Yellow oxide of iron (E172).
Action
Pharmacotherapeutic group: Other anti-inflammatory and anti-rheumatic agents, non steroids. ATC code: M01AX26.
Pharmacology: Pharmacodynamics: PIASCLEDINE belongs to the new class of "SYSADOA" (symptomatic slow-acting drugs in osteoarthritis), which are notably characterized by their delayed action. For this reason, it may be necessary to prescribe, at the beginning of treatment with PIASCLEDINE, a combined NSAID and/or analgesics, the dosage of which being likely to be reduced, as the PIASCLEDINE efficacy is increasing. Clinical studies have shown that there was a significant carry-over effect of an additional 2 months after the discontinuation of PIASCLEDINE at 6 months. The mode of action of Avocado/Soya Unsaponifiables (ASU) has been assessed through in vitro and in vivo studies in osteoarthritis (OA) which evidenced the following main pharmacological properties. The main targets of the PIASCLEDINE mechanism of action include: An increase in the proteoglycans (PG) synthesis, especially those of high molecular weight, with a quality similar to the nature PG.
A complementary effect of the two components of Piascledine: acute inhibition of PG degradation and chronic stimulation of PG synthesis.
A stimulation of collagen synthesis by synoviocytes and articular chondrocytes. The effects on collagen are supported by a decrease in the IL-1 inhibitory effect and in the synthesis of PGE2 by chondrocytes.
Piascledine also inhibits articular type II collagenase.
Finally, Piascledine was shown to stimulate the expression of TGFβ1 and TGFβ2 and plasminogen activator inhibitor 1 (PAI-1), these effects accounting for a potential beneficial effect on the repair and protection of the extracellular matrix components.
Pharmacokinetics: No assay method, specific and precise enough for pharmacokinetic studies, was available for assay of ASU in biological fluids. Therefore, no data is available about PIASCLEDINE pharmacokinetics.
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.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Not applicable.
Safety in paediatric population: Not applicable.
Safety in other special populations: There was no specific assessment of safety in special populations such as elderly or patients with renal/liver function impairment.
Drug Interactions
No specific interaction studies have been performed with PIASCLEDINE. According to the pharmacodynamic profile of the drug and to the extended post-marketing experience, no clinically relevant interaction with other medicinal products is to be expected.
Caution For Usage
Special precautions for disposal: No special requirements.
Incompatibilities: Not applicable.
Storage
Store below 30°C.
Shelf-Life: 3 years.
MIMS Class
Other Drugs Acting on Musculo-Skeletal System
ATC Classification
M01AX26 - avocado and soyabean oil, unsaponifiables ; Belongs to the class of other non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Cap (hard capsule, size No.1, orange body and opaque greyish cap containing a soft brown paste and marked "P 300") 2 x 15's. 4 x 15's.
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