Piascledine 300 Symptomatic Treatment for Osteoarthritis for Hip and Knee

Description:

Piascledine Herbal Capsules helps to restore the normal cartilage structure by stimulating the synthesis of proteoglycans, and collagen. Slow acting treatment for the symptoms of rheumatic pain, osteoarthritis, periodontitis. Piascledine 300 is recommended for the treatment of pain and functional discomfort in cases of osteoarthritis of the hip and knee. It can also help with gum pain.

Piascledine 300 is available in 3 sizes:  30, 60, or 90 Capsules.

Indications:

N/A

Composition:

Avocado-soya unsaponifiables.

Directions:

The recommended dose of Piascledine 300 is one capsule per day with a meal to be taken Orally. The capsule should be swallowed whole, with a full glass of water. Do not chew. The duration of the treatment will be modulated according to the clinical results, knowing that the effect is delayed by approximately 2 months and that it may persist after stopping the treatment. For the correct use of Piascledine, it is essential to submit to regular medical supervision.

Please read the following full disclosure before purchasing this item.

NOTICE - Updated on: 11/10/2020

Medication Name

PIASCLEDINE 300 mg, capsule

Unsaponifiables of avocado and soybean

Boxed Warning

Please read this notice carefully before taking this medicine as it contains important information for you.

You should always take this medicine strictly following the information provided in this notice or by your doctor, pharmacist, or nurse.

· Keep this notice. You might need to read it again.

· Consult your pharmacist for any advice or information.

· If you experience any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this notice. See section 4.

· You should consult your doctor if you don't feel any improvement or if you feel worse.

What does this notice contain?

1. What is PIASCLEDINE 300 mg, capsule, and in what cases is it used?

2. What information should you know before taking PIASCLEDINE 300 mg, capsule?

3. How to take PIASCLEDINE 300 mg, capsule?

4. What are the possible side effects?

5. How to store PIASCLEDINE 300 mg, capsule?

6. Packaging content and other information.

7. WHAT IS PIASCLEDINE 300 mg, CAPSULE, AND IN WHAT CASES IS IT USED?

This medicine contains an active substance extracted from avocado and soybean oils.

This medication acts on the joints (it belongs to the group of medicines called other anti-inflammatory and anti-rheumatic agents, non-steroidal).

This medication is indicated for adults for symptomatic treatment (pain and discomfort during movements) with delayed effect for knee osteoarthritis.

This medication has a slow action, delayed by about 2 months, and its effect may persist after stopping the treatment.

2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING PIASCLEDINE 300 mg, CAPSULE?

Never take PIASCLEDINE 300 mg:

· if you are allergic to the active ingredient or any other components contained in this medication, mentioned in section 6.

Warnings and Precautions

Speak to your doctor, pharmacist, or nurse before taking PIASCLEDINE 300 mg.

If you have or have had a liver or gallbladder disease, inform your doctor or pharmacist before taking PIASCLEDINE. If symptoms or signs of liver or gallbladder problems occur, such as unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, skin and eyes yellowing (jaundice), and dark urine, stop the treatment and contact your doctor immediately.

Stop the treatment and immediately contact your doctor if signs and symptoms of allergic reactions occur, such as itching, hives, skin rash/redness, facial swelling, and breathing difficulties.

Before taking PIASCLEDINE, inform your doctor or pharmacist if you are treated with anticoagulants (see "Other medications and PIASCLEDINE 300 mg").

Stop the treatment and contact your doctor immediately if signs and symptoms of blood clotting disorders occur, like red or purple spots on the skin, spontaneous bruises or hemorrhages, and mucous membrane bleeding.

Children and Adolescents

PIASCLEDINE is for adults only. Do not give this medication to children and adolescents under 18.

Other medications and PIASCLEDINE 300 mg

Inform your doctor or pharmacist if you take, have recently taken, or might take any other medicine.

PIASCLEDINE should be used cautiously when combined with anticoagulant treatment due to the potential risk of clotting disorders.

PIASCLEDINE 300 mg with food and drink

You can eat and drink normally while using this medication.

Pregnancy, breastfeeding, and fertility

The use of PIASCLEDINE 300 mg is not recommended during pregnancy and in women of childbearing age not using contraception.

PIASCLEDINE 300 mg should not be used during breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, seek advice from your doctor or pharmacist before taking this medicine.

Driving and using machines

PIASCLEDINE does not affect the ability to drive or operate machinery.

PIASCLEDINE 300 mg contains:

Not applicable.

3. HOW TO TAKE PIASCLEDINE 300 mg, capsule?

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are unsure.

Adults:

The recommended dose is one capsule per day, taken in the middle of a meal.

Oral use.

Swallow the capsule whole with a large glass of water. Do not chew.

The duration of treatment will be adjusted based on clinical outcomes, knowing that the effect is delayed by about 2 months and may persist after stopping the treatment.

For the proper use of this medicine, it is essential to undergo regular medical check-ups.

If you take more PIASCLEDINE 300 mg than you should

Overdosing on PIASCLEDINE can cause or exacerbate gastrointestinal and/or liver disorders. If you take more PIASCLEDINE than the recommended dose, consult your doctor or pharmacist immediately.

If you forget to take PIASCLEDINE 300 mg

Do not take a double dose to make up for a forgotten dose.

Take the next dose of the medicine as planned.

If you stop taking PIASCLEDINE 300 mg

Not applicable.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most commonly reported side effects with PIASCLEDINE are diarrhea, abdominal pain, upper abdominal discomfort, and nausea.

Serious possible side effects:

Contact your doctor immediately and stop the treatment if you experience any of the following side effects, which could be serious and may require urgent medical treatment:

Signs and symptoms that may indicate severe allergic reactions (infrequent):

• Itching, hives, skin rash/redness, facial swelling, breathing difficulties.

• Intense skin rash (rare)

Liver disorders (infrequent):

Liver damage or blockage of bile ducts may occasionally occur and may be associated with yellowing of the skin and elevated liver enzymes in the blood (such as transaminases, alkaline phosphatase, bilirubin, and gamma-glutamyl transferase) (see "Warnings and precautions" in section 2).

Other reported side effects include:

Common (may affect up to 1 in 10 patients):

• Diarrhea.

Infrequent (may affect up to 1 in 100 patients):

• Upper abdominal discomfort, heartburn, nausea, an unpleasant taste in the mouth which may be avoided by taking the capsule in the middle of a meal (see section 3), abdominal pain, stool discoloration,

• Headache,

• Dark urine,

• Weakness, fatigue,

• Breast pain, breast swelling, and gynecological bleeding.

Rare (may affect up to 1 in 1,000 patients):

• Gastrointestinal disorders such as: inflammation of the intestines, vomiting, dry mouth, belching,

• Eczema,

• Kidney stones,

• Blood clotting disorders such as a reduced number of blood platelets (see "Warnings and precautions" in section 2),

• High blood pressure.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Product Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr

By reporting side effects, you can help provide more information on the safety of the medicine.

Here's the English translation of the provided text:

5. HOW TO STORE PIASCLEDINE 300 mg, capsule?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiration date refers to the last day of that month.

No special storage precautions are necessary.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist to dispose of medicines you no longer use. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What PIASCLEDINE 300 mg contains

· The active substance is:

Total extract of unsaponifiables avocado-soy.......... 300.00 mg

Equivalent to:

Avocado oil unsaponifiable................................. 100.00 mg

Soybean oil unsaponifiable................................ 200.00 mg

Per capsule.

· The other components are:

Anhydrous colloidal silica, butylhydroxytoluene.

Capsule shell: gelatin, polysorbate 80, titanium dioxide, erythrosine, yellow iron oxide.

What PIASCLEDINE 300 mg, capsule looks like and contents of the outer packaging

This medicine comes in the form of an orange and beige-gray capsule. Box of 15, 30, 60, or 90 capsules.

Marketing Authorization Holder

LABORATOIRES EXPANSCIENCE

1 PLACE DES SAISONS

92048 PARIS LA DEFENSE CEDEX

Marketing Authorization Operator

LABORATOIRES EXPANSCIENCE

1 PLACE DES SAISONS

92048 PARIS LA DEFENSE CEDEX

Manufacturer

LABORATOIRES EXPANSCIENCE

RUE DES QUATRE FILLES

28230 EPERNON

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 10/11/2020

1. NAME OF THE MEDICINE

   PIASCLEDINE 300 mg, capsule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

   Total extract of avocado-soybean unsaponifiables .......................................... 300.00 mg

   Corresponding to:

   Unsaponifiable of avocado oil .................................................................. 100.00 mg

   Unsaponifiable of soybean oil .................................................................. 200.00 mg

   Per capsule.

   For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

   Capsule in orange and beige-gray color.

4. CLINICAL DATA

   4.1. Therapeutic indications

   PIASCLEDINE is indicated as a symptomatic treatment with delayed effect for knee osteoarthritis.

   PIASCLEDINE is indicated for adults.

   4.2. Dosage and administration

   Dosage

   Adult patients

   One capsule per day.

   The duration of treatment will be adjusted based on clinical results, noting that the effect is delayed by about 2 months and may persist after treatment discontinuation.

   Pediatric population

   In the absence of efficacy and safety data in children under 18 years of age, the use of PIASCLEDINE is not recommended in this population.

   Liver insufficiency

   There is no available data for patients with severe liver insufficiency; therefore, no recommendation can be made.

   Elderly patients

   No dosage adjustment is necessary for elderly patients. In clinical studies with PIASCLEDINE, the average age of the population was over 60 years, and a significant proportion of patients were over 65 years old.

   Administration method

   Oral route.

   The capsule must be swallowed whole, without being chewed, with a large glass of water, in the middle of a meal.

   4.3. Contraindications

   Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

   4.4. Special warnings and precautions for use

   Post-marketing, infrequent adverse reactions such as hepatic cytolysis, cholestasis, jaundice, and elevated transaminases have been reported. Special attention should be paid to patients with a medical history or suffering from hepatic or biliary disorders, or those with a disease that may increase the risk of gallstones or liver lesions. PIASCLEDINE treatment should be discontinued in case of biological signs or clinical symptoms of hepatic or biliary lesions.

   Hypersensitivity reactions, as well as skin rashes, urticaria, and dermatitis, have been infrequently reported during clinical development of the product. Patients should be informed of the signs and/or symptoms suggestive of an allergic reaction, and they should stop treatment and consult their doctor at the first appearance of a skin reaction or signs of hypersensitivity (see section 4.8).

   A few cases of thrombocytopenia have been reported with PIASCLEDINE, one of which occurred during clinical development. PIASCLEDINE treatment should be discontinued if symptoms suggestive of coagulation disorders occur (e.g., petechiae, purpura).

   4.5. Interactions with other medicines and other forms of interactions

   PIASCLEDINE should be used with caution in patients on concurrent anticoagulant therapy (see section 4.4).

   4.6. Fertility, pregnancy, and breastfeeding

   Pregnancy

   Data in animals have shown reproductive toxicity at systemic exposure levels much higher than human therapeutic doses (see section 5.3).

   In clinical practice, there are currently insufficient data to assess a potential teratogenic or fetotoxic effect of PIASCLEDINE 300 mg when administered during pregnancy.

   Therefore, the use of this medicine is not recommended during pregnancy and in women of childbearing age not using contraception.

5. Breastfeeding (Allaitement):

   • There's no available data on the excretion of PIASCLEDINE 300 mg or its metabolites in breast milk.
   • There's a potential risk for newborns/infants.
   • This drug should not be used during breastfeeding.

   Fertility:

   • Animal data showed, at high doses, early pre-implantation and post-implantation losses.
   • The relevance of this data to humans is unknown.

   Effects on Ability to Drive and Use Machines (4.7. Effets sur l'aptitude à conduire des véhicules et à utiliser des machines):

   • PIASCLEDINE has little to no effect on the ability to drive vehicles and operate machines.

   Adverse Effects (4.8. Effets indésirables):

   • Most commonly reported side effects relate to the gastrointestinal system, occurring in about 3% of patients.
   • Diarrhea, abdominal pain, dyspepsia, abdominal distention, and nausea can occur in 0.4% to 1.1% of patients. These side effects are mild to moderate in intensity.

   Summary of Adverse Effects by Organ System:

   • Hematologic & Lymphatic System:
     • Rare: Thrombocytopenia
   • Immune System:
     • Infrequent: Hypersensitivity
   • Nervous System:
     • Infrequent: Headaches
   • Gastrointestinal:
     • Frequent: Not specified
     • Infrequent: Diarrhea
     • Rare: Dyspepsia, dysgeusia, nausea, abdominal pain, stool discoloration, enteritis, vomiting, belching, dry mouth
   • Liver & Biliary System:
     • Infrequent: Liver cell damage, cholestasis, jaundice, increased levels of transaminases, alkaline phosphatase, bilirubin, and gamma-glutamyl transpeptidase
   • Skin & Subcutaneous Tissue:
     • Rare: Toxic skin rash, eczema
   • Kidney & Urinary Tract:
     • Infrequent: Chromaturia
     • Rare: Nephrolithiasis (kidney stones)
   • Reproductive System & Breast:
     • Infrequent: Breast pain, breast swelling, metrorrhagia (uterine bleeding)
   • General Disorders:
     • Infrequent: Asthenia (weakness)
   • Investigations:
     • Rare: Increased blood pressure

   ---

   Issues/Improvements:

   1. The "Frequent" side effects under "Gastrointestinal" are not specified. For a comprehensive understanding, the full list of frequent side effects should be provided.
   2. Some side effects have annotations like (*), (**), etc., but the meanings or explanations of these annotations are not provided.

   Recommendations:

   1. If this is for a patient or consumer, it's important to consult with a healthcare professional about any potential side effects or interactions.
   2. The annotations might be crucial for a deeper understanding, so referencing the original document or source for these would be helpful.

   3. §) The capsule should be taken in the middle of a meal to avoid taste disturbances. See section 4.2.

      (#) These side effects have been reported after marketing. Since these effects were not reported during clinical trials involving 1,310 patients exposed to PIASCLEDINE, they are estimated to be infrequent.

      Description of certain side effects:

      (*) Taking PIASCLEDINE can sometimes cause hypersensitivity, such as systemic allergic reactions, meaning the sudden onset of a condition with skin involvement (itching, hives, redness, rash), mucous membrane involvement or both, cough, persistent gastrointestinal symptoms or a decrease in blood pressure and/or associated symptoms. See section 4.4.

      (**) Signs of liver problems, such as abdominal pain associated with nausea, stool discoloration, dark urine, and/or jaundice, can occur during treatment with PIASCLEDINE. See section 4.4.

      (***) Signs and symptoms suggestive of increased blood pressure (namely headaches, hearing problems, hot flushes) can occur with PIASCLEDINE treatment.

      Reporting suspected side effects:

      Reporting suspected side effects after drug approval is important. It allows continuous monitoring of the drug's benefit/risk ratio. Health professionals report any suspected side effects through the national reporting system: National Agency for Drug and Health Product Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

      4.9. Overdose:

      During clinical trials, administering doses of up to 900 mg/day for several months was associated with dose-dependent gastrointestinal disorders.

      Overdoses can cause or exacerbate gastrointestinal disorders and/or liver problems.

      5. PHARMACOLOGICAL PROPERTIES:

      5.1. Pharmacodynamic properties:

      Therapeutic class: Other anti-inflammatory and anti-rheumatic agents, non-steroidal, ATC code: M01AX26.

      Pharmacodynamic effects:

      Targeted at tissue growth.

      Clinical efficacy and safety:

      The effects of Piascledine 300 mg in osteoarthritis have been evaluated in clinical studies and have shown positive results on symptom onset. The results of five randomized controlled studies (three studies versus placebo and two studies versus active comparator) are presented below.

      In a multicenter, randomized, double-blind study versus placebo on 86 patients with knee osteoarthritis, NSAID consumption was significantly reduced by 70% compared to 33% for the placebo (p<0.01) after 3 months. Rest pain and functional discomfort were also significantly improved with Piascledine 300 mg compared to placebo.

      In another multicenter, randomized, double-blind study versus placebo, in a subgroup of 101 patients with knee osteoarthritis, the primary criterion was the resumption of NSAIDs after discontinuation. The number of patients who resumed NSAID after 3 months of treatment was 54.2% with Piascledine 300 mg, compared to 73% with the placebo (p=0.05). A significant reduction in functional discomfort was observed, while the decrease in rest pain was not significant.

      In a multicenter, randomized, double-blind study over 6 months versus placebo, Piascledine 300 mg did not significantly improve the main criterion (Lequesne index, p=0.07) or rest pain in the subgroup of patients with knee osteoarthritis (N=55), possibly due to the low number of patients, but it significantly reduced NSAID consumption.

      Two non-inferiority studies compared Piascledine 300 mg to chondroitin sulfate 400 mg, three times a day for 6 months, and diacerein 50 mg, twice a day for 3 months in 184 and 64 patients, respectively. These studies showed the non-inferiority of Piascledine 300 mg versus the two comparators on the total WOMAC score and on NSAID consumption, which was the main criterion for each study, respectively. No difference was observed between these comparators and Piascledine 300 mg on secondary criteria (Lequesne index and rest pain).

      Moreover, Piascledine 300 mg has a slow action, delayed by about 2 months, and its effect can persist after treatment discontinuation.

      5.2. Pharmacokinetic properties:

      PIASCLEDINE is an extract composed of multiple entities derived from soy and avocado, for which no validated analytical method is available. Therefore, no pharmacokinetic study has been conducted.

   4. 5.3. Preclinical safety data

      The general toxicological properties of PIASCLEDINE have been studied in various animal species, including rodents, rabbits, and dogs, under single dose and repeated dose conditions.

      Single-dose toxicity studies have shown low toxicity of PIASCLEDINE, as no LD50 could be calculated due to the absence of mortality at doses up to 8,000 mg/kg in mice.

      In repeated dose toxicity studies (6 months) in rats and dogs, the general tolerance of PIASCLEDINE was satisfactory; however, the liver and thyroid were identified as target organs.

      Liver

      PIASCLEDINE 300 mg is not an enzyme inducer in rats.

      Thyroid

      In a toxicity study in rats (28 days), at autopsy, the thyroid weight was higher in animals treated with the high dose of 750 mg/kg/day compared to control animals.

      Histopathology revealed minor abnormalities (hypertrophy of epithelial cells) in males.

      In a 26-week repeated dose study in rats, PIASCLEDINE 300 mg induced reversible thyroid follicular hypertrophy at the high dose of 750 mg/kg/day.

      Reproductive toxicology

      A fertility study in rats showed that PIASCLEDINE 300 mg at a high dose (750 mg/kg/day) could slightly decrease uterine implantation and early embryo survival. No effect was reported in male rats.

      No teratogenic or embryotoxic effect was demonstrated up to doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits (corresponding to 7 times and 10 times the recommended dose in humans). An increase in post-implantation losses, minor skeletal modifications (rat), and changes in the abdominal wall (rabbit) were reported at maternotoxic doses of 750 mg/kg/day in rats and 500 mg/kg/day in rabbits (corresponding to 24 and 32 times the recommended dose in humans).

      No effect on the peri- and postnatal development of the F1 generation was observed in a dedicated study conducted in rats.

      Studies with PIASCLEDINE showed no mutagenic or genotoxic effects.

      6. PHARMACEUTICAL DATA

      6.1. List of excipients

      Anhydrous colloidal silica, butylated hydroxytoluene

      Capsule shell: gelatin, polysorbate 80, titanium dioxide, erythrosine, yellow iron oxide.

      6.2. Incompatibilities

      Not applicable.

      6.3. Shelf life

      3 years.

      6.4. Special storage precautions

      No special storage precautions.

      6.5. Nature and content of the outer packaging

      15, 30, 60, or 90 capsules in blister packs (PVC/Aluminum).

   5. 6.6. Special precautions for disposal and handling

      No special requirements.

      Any unused medicine or waste must be disposed of in accordance with current regulations.

      7. MARKETING AUTHORIZATION HOLDER

      EXPANSCIENCE LABORATORIES

      1 PLACE DES SAISONS

      92048 PARIS LA DEFENSE CEDEX

      8. MARKETING AUTHORIZATION NUMBER(S)

      · 34009 321 495 4 4: 15 capsules in blister packs (PVC/Aluminum)

      · 34009 359 413 5 0: 30 capsules in blister packs (PVC/Aluminum)

      · 34009 300 729 2 9: 60 capsules in blister packs (PVC/Aluminum)

      · 34009 300 729 3 6: 90 capsules in blister packs (PVC/Aluminum)

      9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

      [to be filled in later by the holder]

      10. DATE OF UPDATE OF THE TEXT

      [to be filled in later by the holder]

      11. DOSIMETRY

      Not applicable.

      12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

      Not applicable.

      PRESCRIPTION AND SUPPLY CONDITIONS

      Medicine not subject to a medical prescription.

Details:

EAN/UPC: 03577056004698

Contents: N/A

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