1. Name Of The Medicinal Product
Avosoya 300 mg capsules
2. Qualitative And Quantitative Composition
Total extract of unsaponifiable Avocado/Soyabean oils 300.00 mg Equivalent To: Unsaponifiable Avocado oil Unsaponifiable Soyabean oil 100.00 mg 200.00 mg Per capsule.
3. Pharmaceutical Form
Hard gelatinous capsule
4. CLINICAL DATA
4.1. Therapeutic Indications
- In rheumatology: symptomatic treatment for delayed effect of arthrosis of the hip and knee.
- In stomatology: adjuvant treatment for periodontal diseases.
4.2. Posology And Method Of Administration
Method of administration
- Oral Route.
- The capsule is to be swallowed whole, with a large glass of water.
Posology
1 capsule per day, taken with meals.
4.3. Contraindications
History of allergic reactions to one of the components of the product.
4.4. Special Warnings And Precautions For Use
Not applicable.
4.5. Interactions With Other Drugs And Other Forms Of Interaction
Not applicable.
4.6. Pregnancy and lactation
Pregnancy
Clinical data: In clinical practice, there are currently no sufficient relevant data to evaluate possible teratogenic or fetotoxic effect of Avosoya when administered during pregnancy. Accordingly, the use of Avosoya is not recommended during pregnancy
Lactation
Not applicable.
4.7. Effects On The Ability To Drive And Use Machines
Not applicable.
4.8. Undesirable Effects
- Rare regurgitations with lipid odor that can be avoided by taking the capsule during meals.
- Rare hypersensitivity reactions.
- Exceptional liver disorder with increased levels of transaminases, alkaline phosphatases, bilirubin and gamma GT.
- Gastrointestinal disorders: diarrhea and epigastric pain (unknown frequency).
4.9. Overdose
Not applicable.
5. Pharmacological Properties
5.1. Pharmacodynamics
- Arthrosis
- Periodontal Diseases
- With trophic intentions/indications.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
6. Excipient
Avecil PH 101, Dibasic calcium phosphate Anhydrous, Colloidal Silicon dioxide (aerocil), Magnesium Stearate, Quinoline yellow, Gelatine, Titanium dioxide, Green color.
7. Storage
- Store at Temp. not exceeding 30° C in dry place.
- Keep away from reach of children
8. Package
Carton box containing (1, 2 or 3 Al transparent PVC) each strip contains 15 hard gelatine capsules with insert leaflet
