Instructions for Piascledin 300 capsules No. 30
Composition
active ingredients: avocado oil unsaponifiables; soybean oil unsaponifiables;
1 capsule contains a mixture of avocado and soybean oils of unsaponifiable compounds 300 mg, which corresponds to avocado oil of unsaponifiable compounds 100 mg, soybean oil of unsaponifiable compounds 200 mg;
excipients: colloidal anhydrous silicon dioxide, butylhydroxytoluene (E 321), polysorbate 80;
capsule shell: gelatin, titanium dioxide (E 171).
Dosage form
Capsules.
Main physicochemical properties: translucent sealed capsules with a white cap marked "P" if the white body of the capsule is marked "300" or a white cap marked "300" if the white body of the capsule is marked "P", containing a brown paste.
Pharmacotherapeutic group
Other non-steroidal anti-inflammatory and antirheumatic drugs. Avocado and soybean oils, unsaponifiables. ATX code M01A X26.
Pharmacological properties
The mechanism of action of avocado and soybean oil unsaponifiables was evaluated in in vitro and in vivo studies in a group of osteoarthritis patients, in which the following main pharmacological properties were demonstrated:
Avocado and soybean oil unsaponifiable compounds enhance collagen synthesis by articular chondrocytes and reduce IL-1 (interleukin 1) synthesis by chondrocytes; increase the expression of PAI-1 (plasminogen activator inhibitor, a fraction that inhibits plasminogen activator, which causes joint damage in osteoarthritis); increase the expression of transforming growth factor β (TGF β) in chondrocytes, which was later recognized as exhibiting anabolic properties towards cartilage tissue.
All of the above properties of avocado and soybean oils of unsaponifiable compounds allow us to assume that the drug Piascledin® 300 stimulates transforming growth factor β (TGF β), which leads to the restoration of extracellular matrix components in articular cartilage tissue.
Pharmacodynamics
Piascledin® 300 belongs to a new class of drugs called “SYSADOA” (symptomatic slow-acting drugs for the treatment of osteoarthritis), the main property of which is their delayed action.
Pharmacokinetics
Piascledin® is a medicinal product that is a combination of a large number of substances derived from soy and avocado. The development and validation of analytical methods for such medicinal products are very complex. Such pharmacokinetic data will not have additional significance or change the benefit/risk ratio for patients using Piascledin® 300, therefore, preclinical pharmacokinetic studies have not been conducted.
Indication
Piascledin® 300 is used in rheumatology for the treatment of adults: symptomatic treatment of osteoarthritis of the knee joints.
Contraindication
Allergy to any of the active or auxiliary substances of the drug listed in the "Composition" section.
Interaction with other medicinal products and other types of interactions
It is necessary to warn the doctor or pharmacist about the simultaneous use of other medications.
Piascledin® 300 may affect or be affected by anticoagulants.
Application features
You should consult your doctor before using Piascledin® 300.
Piascledin® 300 belongs to a new class of drugs “SYSADOA” (symptomatic slow-acting drugs for the treatment of osteoarthritis), the main property of which is their delayed action. Therefore, the effect of the drug can be observed after several weeks and usually continues after discontinuation of treatment. For this reason, at the beginning of treatment with Piascledin® 300, the appointment of non-steroidal anti-inflammatory drugs and/or analgesics may be recommended, the dose of which should be gradually reduced in accordance with the increase in the effectiveness of Piascledin® 300.
You should inform your doctor if your condition worsens or if there is no improvement within 2-3 months.
Some patients have experienced symptoms suggestive of liver disorders while taking Piascledin®300. Before using Piascledin® 300, you should tell your doctor if you have or have had liver disorders such as liver damage or gallstones. You should have regular liver function tests before and during treatment with Piascledin® 300. If you experience symptoms of liver disorders such as nausea (feeling sick), vomiting, abdominal pain, fatigue, loss of appetite, yellowing of the skin and eyes, or dark urine, you should stop treatment immediately and consult a doctor.
During studies of the use of the drug Piascledin® 300, some patients experienced increased blood pressure with combined symptoms such as hearing impairment or headaches. Before using the drug Piascledin® 300, it is necessary to inform the doctor if the patient has a history of high blood pressure, and regularly check blood pressure while using the drug Piascledin® 300.
During studies of the use of the drug Piascledin® 300, one isolated case of a significant decrease in platelet count was reported. If symptoms of coagulation disorders occur, such as red or purple spots on the skin, spontaneous bruising or ecchymoses, as well as bleeding from the mucous membrane, you should consult a doctor to monitor the platelet count and discontinue the use of Piascledin® 300 if necessary.
Use during pregnancy or breastfeeding
Studies on the use of the drug in pregnant women have not been conducted, therefore the use of the drug during pregnancy is not recommended.
There is no information on the use of the drug during breastfeeding, so you should refrain from using the drug during this period.
Ability to influence reaction speed when driving vehicles or other mechanisms
Piascledin® 300 does not affect the ability to drive or operate other mechanisms.
Method of administration and doses
It is used internally by adults.
Take 1 capsule once a day with a meal, with a glass of water. The capsule should not be chewed.
If you miss a dose, take the usual daily dose the next day; do not double the dose. The duration of treatment with Piascledin® 300 is determined in accordance with the doctor's recommendations.
Children. Piascledin® 300 is for use in adults only. Do not use this medicine in children (under 18 years of age).
Overdose
Taking a higher dose of Piascledin® 300 than prescribed may increase the risk of gastroenterological or liver disorders. If you take a higher dose of Piascledin® 300 than prescribed, you should immediately consult a doctor or pharmacist.
Side effects
Criteria for assessing the frequency of adverse reactions: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000), unknown (cannot be determined from the available data).
The most common adverse reactions to the use of Piascledin® 300 are diarrhea, abdominal pain, upper abdominal discomfort, and nausea.
The following effects were also noted:
Common (may affect up to 1 in 10 people):
diarrhea.
Uncommon (may affect up to 1 in 100 people):
allergic reactions such as itching, rash, redness, hives and eczema; headache; upper abdominal discomfort, heartburn, nausea, bad taste in the mouth, abdominal pain, change in stool color; dark urine; weakness, fatigue.
Rare (may affect up to 1 in 1,000 people):
Gastroenterological disorders such as intestinal inflammation, vomiting, dry mouth, belching; urolithiasis; decreased platelet count; increased blood pressure.
In addition, severe liver disorders such as liver damage or biliary obstruction, as well as increased levels of liver enzymes in the blood (such as transaminase, alkaline phosphatase, bilirubin and gamma-glutamyl transpeptidase) may occur with an unknown frequency.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
15 capsules in a PVC/aluminum blister; 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Laboratoire Expansiens, France
Location of the manufacturer and address of its place of business/location of the applicant
Rue de Quatre Fils 28230 Épernon, France / 1 Place des Sessons 92048 Paris la Défense Cedex, France.
