NOTICE
ANSM - Updated: 08/09/2016
Description of the Medicine
PIASCLEDINE 300 mg tablet
Unsaponified avocado and soya
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Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed by your doctor, pharmacist or nurse.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any of the side effects, talk to your doctor, pharmacist or nurse. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should talk to your doctor if you feel uncomfortable or feel uncomfortable.
Do not allow this medication to reach children.
What is in this leaflet?
1. What is PIASCLEDINE 300 mg, Gel and in which cases is it used?
2. What information should I take before taking PIASCLEDINE 300 mg, GEL?
3. How to take PIASCLEDINE 300 mg, GEL?
4. What are the possible undesirable effects?
5. How to store PIASCLEDINE 300 mg, GEL?
6. Contents of the package and other information.
1. WHAT PIASCLEDINE 300 MG, GEL AND WHAT IS IT USED FOR?
This medicinal product 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 antirheumatic agents, non-steroidal).
This medication also works on the gums.
This medication is indicated for symptomatic treatment (pain and functional discomfort) with a different effect from osteoarthritis of the hip and knee.
This medication is indicated as an adjunct in some gum disease.
2. BEFORE YOU TAKE PIASCLEDINE 300 mg, GEL?
Do not take PIASCLEDINE 300 mg :
AT· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking PIASCLEDINE 300 mg .
Children and Youth
Not applicable.
Other medicines and PIASCLEDINE 300 mg
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
PIASCLEDINE 300 mg with food and beverages
Not applicable.
Pregnancy and breast feeding
As a precautionary measure, it is preferable to avoid the use of PIASCLEDINE 300 mg during pregnancy.
PIASCLEDINE 300 mg should not be used during breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medication.
Sport
Not applicable.
Driving and using machines
Not applicable.
PIASCLEDINE 300 mg contains:
Not applicable.
3. HOW TO TAKE PIASCLEDINE 300 mg, GEL?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor or pharmacist or nurse if you have any doubts.
Dosage
The recommended dose is 1 glucose per day in the middle of a meal.
Administration mode
Oral use.
The gel is swallowed as it is, with a large glass of water.
Frequency of administration
Daily and in the middle of a meal.
For proper use of this medication, regular medical monitoring is essential.
If you take more PIASCLEDINE 300 mg than you should have:
Immediately consult your doctor or pharmacist.
If you forget to take PIASCLEDINE 300 mg:
Do not take a double dose to make up for the missed dose.
If you stop taking PIASCLEDINE 300 mg:
Not applicable.
If you have any further questions about the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
AT· Regurgitations that can be avoided by taking the griddle in the middle of the meal.
AT· Rare allergic reactions.
AT· Exceptional hepatic impairment with hepatic changes.
AT· Diarrhea and stomach pains.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist or your nurse. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Pharmacovigilance Regional Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE PIASCLEDINE 300 mg, GEL?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the package. The redemption date refers to the last day of that month.
No special precautions for storage.
Do not throw any medicines into the sewer or with the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What PIASCLEDINE 300 mg contains
AT· The active substance is:
Total extract of unsaponifiables avocado-soya .......................................... .................................. 300.00 mg
Corresponding to :
Unsaponifiable of avocado oil ........................................... ................................................ 100, 00 mg
Unsaponifiable soybean oil ............................................ ................................................ 200, 00 mg
For a gall.
AT· The other components are:
Colloidal anhydrous silica, butylhydroxytoluene
Gel envelope : geranium, polysorbate 80, titanium dioxide, erythrosine, yellow iron oxide.
What is PIASCLEDINE 300 mg, capsule and contents of the outer packaging
This medication is in the form of an orange and beige-gray colored gel. Box of 15, 30, 60 or 90 gules.
Holder of the marketing authorization
EXPANSCIENCE LABORATORIES
10 AVENUE DE L'ARCHE
92419 COURBEVOIE CEDEX
Operator of the marketing authorization
EXPANSCIENCE LABORATORIES
10 AVENUE DE L'ARCHE
92419 COURBEVOIE CEDEX
Maker
EXPANSCIENCE LABORATORIES
RUE DES QUATRE FILLES
28230 EPERNON
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last date on which this notice was revised is as follows:
[To be subsequently completed by the Contractor]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicinal product is available on the website of the ANSM (France).
