Piascledine 300 - Symptomatic Treatment of Osteoarthritis - Avocado and Soya Oils - 60 Capsules

1. NAME OF THE MEDICINAL PRODUCT

PIASCLEDINE 300 mg, capsule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Total extract of unsaponifiable avocado-soya ................................ 300,00 mg 

CORRESPONDING TO

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

Unsaponifiable soybean oil ................................................ 200,00 mg

For one capsule.

3. PHARMACEUTICAL FORM

Orange and beige/grey capsule.

4. CLINICAL DATA

4.1 Therapeutic indications In rheumatology: symptomatic treatment with delayed effect of osteoarthritis of the hip and knee. In stomatology: adjunctive treatment of periodontal disease.

4.2. Dosage and method of administration Method of administration Oral use. The capsule should be swallowed as it is, with a large glass of water. Dosage 1 capsule per day in the middle of a meal.

4.3. Contraindications History of allergic reactions with any of the components of the product.

4.4. Special warnings and precautions for use Not applicable.

4.5. Interactions with other medicinal products and other forms of interaction Not applicable.

4.6. Pregnancy and lactation Pregnancy Animal data: There are no reliable data on teratogenesis in animals. Clinical data: There are currently no clinically relevant data to evaluate a possible malformative or fetotoxic effect of Piascledine when administered during pregnancy. Therefore, the use of Piascedin is not recommended during pregnancy. Breastfeeding Not applicable.

4.7. Effects on ability to drive and use machines Not applicable.

4.8. Undesirable effects - Rare regurgitation with a fatty odour which can be avoided by taking the capsule in the middle of the meal. - Rare hypersensitivity reactions. - Exceptional liver damage with elevated transaminases, alkaline phosphatases, bilirubin and gamma GT. - Gastrointestinal disorders: diarrhoea and epigastralgia (frequency unknown).

4.9. Overdosage Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties ARTHROSIS (M: musculoskeletal system) PERIODONTAL DISEASE (A: digestive system and metabolism) For trophic purposes. 5.2. Pharmacokinetic properties Not applicable. 5.3. Preclinical safety data Not applicable.

6. PHARMACEUTICAL DATA

6.1. List of excipients Colloidal anhydrous silica (Aerosil 200), butylhydroxytoluene Composition of the 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 precautions for storage No special precautions for storage. 6.5. Nature and contents of container 60 capsules in blister packs (PVC/Aluminium) 6.6. Special precautions for disposal and other handling No special requirements.

7. MARKETING AUTHORIZATION HOLDER

EXPANSCIENCE Laboratories 10, avenue de l'Arche 92419 Courbevoie Cedex

8. MARKETING AUTHORIZATION NUMBER(S)

359 413-5: 60 capsules in blister pack (PVC/Aluminium)

9.DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[to be completed by the holder] 10. DATE OF UPDATE OF THE TEXT [to be completed by the holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable.