NOTICE
ANSM - Updated on: 31/07/2013
Name of the medicinal product
STRUCTUM 500 mg capsule
Chondroitin sodium sulphate
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS STRUCTUM 500 mg, hard capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE STRUCTUM 500 mg, capsule?
3. HOW TO TAKE STRUCTUM 500 mg capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE STRUCTUM 500 mg capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS STRUCTUM 500 mg, hard capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medicine contains chondroitin sulfate. STRUCTUM is an anti-arthritis. Osteoarthritis is a disease caused by cartilage wear.
Therapeutic indications
STRUCTUM is used in adults (over 15 years) in the treatment of pain and functional discomfort during osteoarthritis of the knee and hip. This drug has a slow, delayed action of about 2 months and its effect may persist after discontinuation of treatment.
2. BEFORE YOU TAKE STRUCTUM 500 mg, capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use STRUCTUM:
· if you are allergic (hypersensitive) to the active substance (chondroitin) or to any of the ingredients of this medication. You will find the list of components in section 6 .
· In a child under 15 years of age.
Precautions for use; special warnings
Not applicable.
Interaction with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if you have recently taken any other medicines, even those not prescribed.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
The use of this medication is not recommended unless your doctor tells you otherwise during pregnancy and lactation.
If you discover that you are pregnant during treatment, consult your doctor promptly: he alone will be able to adapt the treatment to your condition.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE STRUCTUM 500 mg capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Reserved for adults (over 15 years).
Oral use.
The capsules are to be swallowed as they are with a large glass of water.
1 x 500 mg capsule twice daily ie 1 g per day.
Symptoms and Instructions for Overdose
If you take more STRUCTUM 500 mg capsule than you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take STRUCTUM 500 mg capsule:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, STRUCTUM 500 mg capsule is likely to have side effects, although not everyone is.
· May cause allergic skin reactions such as redness, urticaria, eczema, rash, associated or not with itching and / or edema.
In this case, stop treatment immediately and notify your doctor .
· During treatment, it is possible that also occur digestive disorders such as nausea, vomiting.
In all these cases, you should tell your doctor .
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE STRUCTUM 500 mg capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Do not use STRUCTUM 500 mg capsule if you notice any visible signs of deterioration of the product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does STRUCTUM 500 mg, capsule contain?
The active substance is :
Chondroitin Sulfate Sodium .............................................. .................................................. ....... 500 mg
For 1 capsule.
The other components are :
The talc.
Composition of the capsule shell : gelatin, titanium dioxide, indigotine.
Pharmaceutical form and content
What is STRUCTUM 500 mg capsule and contents of the pack?
STRUCTUM 500 mg capsule is in the form of a capsule.
Box of 40, 60, 120 or 180 capsules.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92654 BOULOGNE CEDEX
exploiting
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92654 BOULOGNE CEDEX
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
45 PLACE ABEL GANCE
92654 BOULOGNE CEDEX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.
