Piascledine 300 (Capsules) Instructions for Use

Marketing Authorization Holder

Laboratoires Expanscience (France)

ATC Code

M01AX26 (Avocado and soybean oils unsaponifiable)

Dosage Form

Piascledine 300

Capsules 300 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules (size I) with semi-transparent white cap and body marked “P 300”; the cap is marked “P” and “300”, the body is marked “300” and “P” respectively; containing a brown paste.

Excipients: colloidal silicon dioxide – 7 mg, butylhydroxytoluene – 0.03 mg.

Capsule body composition titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 2%, gelatin – up to 100%.
Sealing solution composition (capsule sealing composition) polysorbate 80 – 0.25 mg, gelatin – 5.75 mg.
Composition of “TekPrint^® SW-9008 Black Ink” for capsule marking shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, black iron oxide dye.

15 pcs. – blisters (2) – cardboard packs.
15 pcs. – blisters (4) – cardboard packs.
15 pcs. – blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating metabolism in cartilage tissue

Pharmacotherapeutic Group

Other nonsteroidal anti-inflammatory and antirheumatic agents

Pharmacological Action

A herbal medicine. It has a symptomatic anti-inflammatory and analgesic effect on the joints.

It causes direct and indirect effects that promote the synthesis of macromolecules of the cartilage extracellular matrix (anabolic pathway): increased synthesis of proteoglycans (especially high molecular weight ones) by normal articular chondrocytes, as well as by chondrocytes in osteoarthritis, which are similar in properties to physiological proteoglycans; stimulation of the synthesis and accumulation of aggrecan (one of the main proteoglycans in cartilage) in chondrocytes in osteoarthritis; stimulation of type II collagen production by synoviocytes and articular chondrocytes; prevention of the inhibitory effect of osteoarthritic subchondral osteoblasts on the synthesis of aggrecan and type II collagen by chondrocytes in a co-culture model; stimulation of the biosynthesis of factors such as transforming growth factor β1 and β2 (TGF-β1 and TGF-β2).

It causes effects that limit the degradation of components of the cartilage extracellular matrix (catabolic pathway): inhibition of proteoglycan degradation; blockade of the inhibitory effect of interleukin-1β (IL-1β) on the production of collagen and aggrecan; inhibition of the stimulating effect of IL-1β on the collagenolytic activity of synovial cells and chondrocytes; inhibition of IL-1β-induced synthesis and activity of collagenase (MMP-13) and stromelysin (MMP-3) in chondrocytes; reduction in the production of pro-inflammatory cytokines IL-6 and IL-8, as well as IL-1β-induced excessive production of PGE2; stimulation of the biosynthesis of plasminogen activator inhibitor-1.

It is characterized by a delayed action.

Indications

Symptomatic treatment of knee osteoarthritis.

ICD codes

Dosage Regimen

Take one capsule orally once daily.

Administer the capsule with a full glass of water during a meal to improve gastrointestinal tolerance.

Adhere strictly to the recommended daily dose; do not exceed one capsule per day.

Initiate treatment for a minimum duration of three to six months to achieve the full therapeutic effect.

Be aware that the onset of action is delayed; symptomatic relief typically begins after approximately two months of continuous use.

Continue the full course of treatment as prescribed, even if symptoms improve earlier.

Note that the therapeutic effect may persist for one to two months following treatment discontinuation.

If a dose is missed, take it as soon as remembered on the same day. If the day has passed, resume the usual schedule of one capsule the next day; do not double the dose.

This regimen is indicated for the symptomatic treatment of knee osteoarthritis.

Adverse Reactions

Blood and lymphatic system disorders rarely – thrombocytopenia.

Immune system disorders uncommon – hypersensitivity.

Gastrointestinal disorders common – diarrhea; uncommon – dyspepsia, dysgeusia, nausea, abdominal pain, discolored feces.

Hepatobiliary disorders uncommon – hepatic cytolysis, cholestasis, jaundice, increased transaminase activity, ALP, GGT, increased bilirubin concentration.

Skin and subcutaneous tissue disorders common – toxicoderma, eczema.

Renal and urinary disorders uncommon – chromaturia; rarely – nephrolithiasis.

Reproductive system and breast disorders: uncommon – breast pain, breast swelling, metrorrhagia.

Cardiovascular disorders rarely – increased blood pressure.

General disorders uncommon – asthenic syndrome.

Contraindications

Hypersensitivity to this agent, age under 18 years, pregnancy, breastfeeding.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Contraindicated for use in women of childbearing potential who are not using reliable methods of contraception.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

If symptoms of liver or biliary tract damage occur during treatment (such as unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellowing of the skin and sclera, dark urine), the patient should discontinue use of this agent and immediately consult a doctor.

If symptoms of allergic reactions occur during treatment (such as itching, hives, skin rash/redness, facial swelling, difficulty breathing) the patient should discontinue treatment and immediately consult a doctor.

In case of concomitant anticoagulant therapy, consultation with a doctor is necessary before starting the use of this agent. If symptoms of blood clotting disorders occur (such as red or purple spots on the skin, spontaneous bruising or ecchymoses, as well as bleeding from mucous membranes), treatment should be discontinued and a doctor should be consulted immediately.

Effect on ability to drive vehicles and operate machinery

Has no or negligible influence on the ability to drive vehicles and operate machinery.

Drug Interactions

When using this agent against the background of anticoagulant therapy, there is a potential risk of bleeding.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.