Piascledine

Leaflet attached to the packaging: patient information

Piascledine,100 mg + 200 mg, hard capsules
Non-saponifiable fractions of avocado oil and soybean oil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after a few weeks there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Piascledine and what is it used for
• 2. Important information before taking Piascledine
• 3. How to take Piascledine
• 4. Possible side effects
• 5. How to store Piascledine
• 6. Package contents and other information

1. What is Piascledine and what is it used for

Piascledine contains non-saponifiable fractions of avocado oil and soybean oil. Piascledine belongs to a group of medicines called other non-steroidal anti-inflammatory and anti-rheumatic medicines, also known as symptomatic slow-acting drugs in osteoarthritis (SYSADOA).
Piascledine is used in adults to relieve symptoms of osteoarthritis of the knee, such as pain and difficulty moving.
The full effectiveness of Piascledine may be delayed for several weeks and usually persists after treatment is discontinued.
If after a few weeks there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Piascledine

When not to take Piascledine:

• if the patient is allergic to non-saponifiable fractions of avocado oil and/or soybean oil or to any of the other ingredients of this medicine (listed in section 6),

Warnings and precautions

Before taking Piascledine, the patient should discuss it with their doctor or pharmacist.
If the patient has or has had liver or biliary disease, they should inform their doctor or pharmacist before taking Piascledine. If symptoms related to liver or biliary problems occur, such as unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine, treatment should be discontinued and the doctor should be consulted immediately.
Treatment should be discontinued and the doctor should be consulted immediately if any symptoms of an allergic reaction occur, such as hives, itching, and/or skin rash, redness of the skin, facial swelling, and/or difficulty breathing.
If the patient is taking anticoagulants, they should inform their doctor or pharmacist before taking Piascledine (see "Piascledine and other medicines").
Treatment should be discontinued and the doctor should be consulted immediately if any symptoms of bleeding disorders occur, such as red or purple spots on the skin, spontaneous bruising, or bleeding from mucous membranes.

Children and adolescents

Piascledine is a medicine intended only for adults. It should not be used in children and adolescents under 18 years of age.

Piascledine and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Caution should be exercised when taking Piascledine in patients who are also taking anticoagulants, due to the potential risk of bleeding disorders.
The patient should inform their doctor if they are taking Piascledine with other medicines used to treat osteoarthritis.

Piascledine with food, drink, or alcohol

While taking this medicine, the patient can eat and drink as usual.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be used during pregnancy and breastfeeding.
Piascledine is not recommended for women of childbearing age who are not using effective contraception. There is insufficient information on the effect of the medicine on fertility.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

3. How to take Piascledine

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adults

The recommended dose is one capsule per day, taken during a meal.
The capsule should be swallowed whole, with a glass of water. It should not be chewed or crushed.
The recommended treatment duration is 3 to 6 months.
The effect of Piascledine may be delayed for several weeks.
If the patient thinks that the improvement is not occurring quickly enough, they should not stop treatment without consulting their doctor or pharmacist.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Piascledine than recommended

Overdose of Piascledine (taking more than 1 capsule per day) may cause or worsen gastrointestinal disorders and/or liver function disorders.
In case of overdose, the patient should consult their doctor or pharmacist immediately.

Missing a dose of Piascledine

The patient should not take a double dose to make up for a missed capsule.
The next dose should be taken at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Piascledine can cause side effects, although not everybody gets them.
The most common side effects associated with Piascledine are: diarrhea, abdominal pain, discomfort in the upper abdomen, and nausea.

Serious side effects:

The patient should immediately inform their doctor and stop taking the medicine if they experience any of the following serious side effects, which may require urgent medical attention:

Symptoms that may be a sign of severe allergic reactions (occurring not very often):

itching, hives, skin rash, redness of the skin, facial swelling, difficulty breathing, changes in mucous membranes, persistent gastrointestinal symptoms, low blood pressure.

Intensive skin eruptions (occurring rarely).

Liver function disorders (occurring not very often):

liver or biliary damage, sometimes in combination with abdominal pain, nausea, stool discoloration, dark urine, yellowing of the skin, and elevated liver enzyme activity in the blood (i.e., transaminases, alkaline phosphatase, bilirubin, and gamma-glutamyltranspeptidase) may occur not very often (see "Warnings and precautions" in section 2).

Other reported side effects:

Common (may occur in up to 1 in 10 patients)

• Diarrhea

Uncommon (may occur in up to 1 in 100 patients)

• Discomfort in the upper abdomen, heartburn, nausea, unpleasant taste in the mouth, abdominal pain, stool color change,
• Headache,
• Dark urine,
• Weakness, fatigue,
• Chest pain, breast swelling, and bleeding from the genital tract.

Rare (may occur in up to 1 in 1000 patients)

• Gastrointestinal disorders such as enteritis, vomiting, dry mouth, belching,
• Eczema,
• Kidney stones,
• Bleeding disorders such as decreased platelet count (see "Warnings and precautions" in section 2),
• Increased blood pressure.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Piascledine

This medicine does not require special storage conditions.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Do not use this medicine if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Piascledine contains

The active substances of Piascledine are non-saponifiable fractions of avocado oil and soybean oil. Each capsule contains 100 mg of non-saponifiable avocado oil fraction and 200 mg of non-saponifiable soybean oil fraction.
The other ingredients are: butylhydroxytoluene, colloidal silica anhydrous, titanium dioxide (E 171), gelatin, erythrosine (E 127), yellow iron oxide (E 172), bovine gelatin (Type B), polysorbate 80.

What Piascledine looks like and contents of the pack

Piascledine is a capsule with an orange cap and a non-transparent gray body with the imprint "P 300".
The capsules are packaged in a cardboard box containing 2 blisters of 15 capsules (30 capsules).

Marketing authorization holder and manufacturer:

Marketing authorization holder

Laboratoires Expanscience
1 place des Saisons, 92048 Paris La Défense Cedex, France

Manufacturer

Laboratoires Expanscience
Rue des Quatre Filles, 28230 Epernon, France

To obtain information about this medicinal product, please contact the local representative of the marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70-28-200
e-mail: angelini@angelini.pl
Date of last revision of the leaflet: September 2024