NOTICE
ANSM - Updated on : 14/02/2025
Product name
CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened
Chondroitin sulfate sodium
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened, and what is it used for?
2. What do I need to know before taking CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened?
3. How to take CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened?
4. What are the possible side effects?
5. How to store CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, sweetened with xylitol?
6. Package contents and other information.
1. WHAT IS CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, sweetened with xylitol AND WHAT IS IT USED FOR?
Pharmacotherapeutic class Other non-steroidal anti-rheumatic anti-inflammatories,
ATC code: M01AX25.
This medicine contains chondroitin sulfate. It is recommended for adults (over 18) in the treatment of pain and functional discomfort in osteoarthritis of the knee and hip.
It has a slow onset of action, with a delay of around 2 months, and its effect may persist after treatment has been discontinued.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened?
Never take CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, sweetened with xylitol:
- if you are allergic to the active substance or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking CHONDROITINE SULFATE IBSA SUGAR-FREE 1200mg oral gel, xylitol-sweetened.
This medicine is not recommended during pregnancy or when breast-feeding (see "Pregnancy and breast-feeding").
Patients with cardiac and/or renal insufficiency:
In very rare cases (<1/10,000), this category of patients has experienced edema and/or water retention. This may be attributed to the osmotic effect of chondroitin sulfate sodium (see section 4).
If in doubt, ask your doctor or pharmacist.
Children and adolescents
Contraindicated in children and adolescents under 18 years of age.
Other drugs and CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened
No interaction studies have been conducted.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened with food and drink
Not applicable.
Pregnancy, breast-feeding, fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
In the absence of data, this drug is not recommended during pregnancy or lactation.
Pregnancy
There are no clinical data on the use of this product during pregnancy. Studies in animals are not sufficient to determine the effects on pregnancy, embryonic, fetal and postnatal development. As a precautionary measure, the use of CHONDROITINE SULFATE IBSA SUGAR-FREE 1200mg oral gel, xylitol-sweetened, should be avoided during pregnancy.
Breast-feeding
In the absence of data on excretion into breast milk, the use of CHONDROITINE SULFATE IBSA SANS SUGRE 1200mg oral gel, sweetened with xylitol is not recommended in breast-feeding women.
Fertility
Animal studies are insufficient to determine effects on male and female fertility.
Driving and use of machinery
The effects on the ability to drive vehicles and use machines have not been studied. However, chondroitin sulfate may have a minor effect on the ability to drive and use machines. Dizziness may occur after taking the drug (see section 4).
CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol sweetened, contains 6 mg sodium benzoate (E211) in each sachet. It also contains 110 mg sodium (the main component of table salt) in each sachet. This is equivalent to 5.5% of the maximum daily sodium intake recommended for an adult.
3. HOW TO TAKE CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
This medicine is for adults only (over 18 years of age).
The recommended dose is 1 sachet (1200 mg) to be taken once a day.
Tear open the sachet and squeeze out the gel.
Oral use.
The contents of the sachet may be swallowed whole or diluted in half a glass of water, preferably after a meal.
The duration of treatment will depend on clinical results, bearing in mind that the effect is delayed by around 2 months and may persist after treatment has been discontinued.
Pediatric population
In the absence of data, the use of CHONDROITINE SULFATE IBSA SANS SUCRE 1200 mg oral gel, sweetened with xylitol in children and adolescents up to 18 years of age is not recommended.
Patients with renal, hepatic or cardiac insufficiency
There are few data available on the use of chondroitin sulfate sodium in patients with renal, hepatic or cardiac insufficiency. These patients should therefore be treated with particular care (see Warnings and Precautions).
If you have taken more CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol-sweetened, than you should have
In case of overdose or accidental intoxication, tell your doctor or pharmacist immediately.
If you forget to take CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, sweetened with xylitol
Not applicable.
If you stop taking CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, sweetened with xylitol
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause undesirable effects, but they do not occur systematically in everyone.
Adverse reactions have been classified within each organ system class and in order of frequency using the following convention (very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10000).
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Organ system class
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Rare
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Very rare
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Nervous system disorders
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Dizziness
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Gastrointestinal disorders
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Gastrointestinal disorders
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Epigastralgia
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Nausea
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Diarrhea
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Skin and subcutaneous tissue disorders
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Erythema
Rash
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Urticaria
Eczema
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Maculopapular rash
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Pruritus
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Allergic reaction1
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General disorders and administration site conditions
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edema2
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1Allergicreactions (such as angioneurotic edema) have been observed rarely.
2SeeWarning and precautions
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, sweetened with xylitol?
Keep out of sight and reach of children.
Do not use CHONDROITINE SULFATE IBSA SANS SUCRE 1200 mg oral gel, sweetened with xylitol after the expiration date stated on the box.
No special storage precautions.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CHONDROITINE SULFATE IBSA SUGAR-FREE 1200 mg oral gel, xylitol sweetened, contains
- The active substance is :
Chondroitin sulfate sodium......................................................................................... 1200 mg
- The other components are : Xylitol, sodium benzoate, potassium sorbate, microcrystalline cellulose, vanilla flavor*, caramel flavor**, purified water.
*Vanilla flavor composition: dacacia gum (E414), maltodextrin, heliotropin, vanillin, vanilla tincture.
**Caramel flavour composition: 2,3-pentanedione, 4- methylacetophenone, 6-methylcoumarin, acetanisole, acetoin, benzyl cinnamate, butyl-butyryl lactate, butyric acid, decanoic acid, ethyl maltol, ethyl vanillin, gamma-octalactone, gamma-valerolactone, guaiacol, heliotropin, lauryl acetate, meta-dimethoxybenzene, methylpara-ter-butylphenylacetate, modified waxy corn starch (E1450), octanoic acid, para-methoxybenzaldehyde, propylene glycol (E1520), tolualdehydes (ortho, meta, para mixture), vanilla extract, waxy corn maltodextrin.
What is CHONDROITINE SULFATE IBSA SANS SUCRE 1200 mg oral gel, xylitol-sweetened, and what does it contain?
Each sachet contains a viscous, opalescent amber gel with a characteristic flavour of aromas for oral use.
Box of 30 sachets
Box of 60 sachets
Marketing authorization holder
IBSA PHARMA SAS
PARC DE SOPHIA-ANTIPOLIS
LES TROIS MOULINS, 280 RUE DE GOA
06600 ANTIBES
FRANCE
Marketing authorization holder
IBSA PHARMA SAS
PARC DE SOPHIA-ANTIPOLIS
LES TROIS MOULINS, 280 RUE DE GOA
06600 ANTIBES
FRANCE
Manufacturer
IBSA FARMACEUTICI ITALIA SRL
VIA MARTIRI DI CEFALONIA 2
26900 LODI / ITALY
Drug names in member states of the European Economic Area
Not applicable
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.