Chondrosulf Chondroitin 800mg – 90 Tablets

Product Description:
Chondrosulf 800mg is an over-the-counter medicine containing chondroitin sulfate. It is used as a delayed-action symptomatic treatment for osteoarthritis in adults, including osteoarthritis of the hip, knee, and small joints of the hand.

Chondroitin helps support joint comfort and mobility over time. The effect is not immediate and may take up to 2 months to become noticeable. Benefits may continue after stopping treatment.

Benefits:
Supports joint comfort in osteoarthritis
Helps improve mobility over time
Suitable for osteoarthritis of the hip, knee, and small joints of the hand
Once-daily tablet format
Non-prescription medicine in France

Recommended Use:
Adults over 18 years: Take 1 tablet per day with a glass of water.
May be taken before, during, or after meals.

Important Information:
Not recommended for children or adolescents under 18 years old.
Not recommended during pregnancy or breastfeeding.
May cause side effects in some people, including skin rash or digestive discomfort. Consult your doctor if you have any concerns.
Contains sodium: 73mg per tablet.

Active Ingredient:
Chondroitin sulfate sodium 800mg per tablet

Package Size:
90 tablets

Brand:
IBSA

EAN / Reference:
3400930281185

Product Type:
Osteoarthritis treatment / joint comfort medicine

Summary of Product Characteristics

ANSM – Updated: 10/26/2023

1. Name of the Medicinal Product

CHONDROSULF 800 mg, tablet

2. Qualitative and Quantitative Composition

Chondroitin sulfate sodium: 800 mg
Per tablet

Excipient with known effect: sodium 73 mg per tablet.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

White to almost white, oblong, biconvex tablet.

4. Clinical Information

4.1 Therapeutic Indications

Delayed-action symptomatic treatment of osteoarthritis of the hip, knee, and small joints of the hand in adult patients.

4.2 Dosage and Method of Administration

For adults only, over 18 years old.

Dosage
1 tablet of 800 mg per day.

Pediatric Population
Due to the absence of clinical data, the use of chondroitin sulfate sodium in children and adolescents under 18 years old is not recommended.

Method of Administration
Oral use.

The tablet should be swallowed with a glass of water.

Frequency of Administration
CHONDROSULF 800 mg tablets may be taken before, during, or after meals.

Duration of Administration
The duration of treatment should be adjusted according to clinical results, keeping in mind that the effect is delayed by 2 months and may persist after treatment is stopped.

4.3 Contraindications

This medicine is contraindicated in the following situation:

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special Warnings and Precautions for Use

This medicine is not intended for children or adolescents under 18 years old. See section 4.2.

This medicine is not recommended during pregnancy or breastfeeding. See section 4.6.

Patients with heart and/or kidney failure:
In very rare cases, less than 1 in 10,000, edema and/or water retention have been reported in patients treated with chondroitin sulfate sodium. This may be attributed to the osmotic effect of chondroitin sulfate sodium. In patients with kidney and/or heart failure, this medicine should be used with caution and monitored regularly.

Patients with liver failure:
No data are available on the use of chondroitin sulfate sodium in patients with liver failure. Therefore, the medicine should be used with caution and monitored regularly.

This medicine contains 73 mg of sodium per tablet, equivalent to 3.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

4.5 Interactions with Other Medicines and Other Forms of Interaction

No interaction studies have been performed.

4.6 Fertility, Pregnancy, and Breastfeeding

Pregnancy
There are no clinical data on the administration of this product during pregnancy. Animal studies are insufficient to determine effects on reproduction and embryonic, fetal, and postnatal development. See section 5.3. The use of CHONDROSULF 800 mg tablets is not recommended during pregnancy.

Breastfeeding
Due to the absence of data on excretion into breast milk, the use of CHONDROSULF 800 mg tablets is not recommended in breastfeeding women.

Fertility
Animal studies are insufficient to determine effects on male and female fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects on the ability to drive vehicles and use machines have not been studied.

Chondroitin sulfate has no or negligible effect on the ability to drive vehicles or use machines.

4.8 Undesirable Effects

Undesirable effects are classified within each system organ class and by frequency using the following convention: very common, more than 1 in 10; common, at least 1 in 100 and less than 1 in 10; uncommon, at least 1 in 1,000 and less than 1 in 100; rare, at least 1 in 10,000 and less than 1 in 1,000; very rare, less than 1 in 10,000.

Nervous system disorders
Very rare: dizziness

Gastrointestinal disorders
Rare: gastrointestinal disorders, epigastric pain, nausea, diarrhea

Skin and subcutaneous tissue disorders
Rare: erythema, rash, maculopapular rash, urticaria, eczema, itching, allergic reaction¹

General disorders and administration site conditions
Very rare: edema²

¹ Cases of allergic reactions, such as angioedema, have been rarely observed.
² See section 4.4.

4.9 Overdose

No clinical or biological signs are expected in the event of massive ingestion of CHONDROSULF 800 mg tablets. However, if adverse effects related to overdose occur, symptomatic treatment should be initiated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic class: Other anti-inflammatory and antirheumatic products, non-steroidal
ATC code: M01AX25

Mechanism of Action
Chondroitin sulfate sodium, the active ingredient in CHONDROSULF 800 mg tablets, belongs to the subgroup of polysaccharides included in the glycosaminoglycan group.

Chondroitin sulfate sodium is one of the main components of cartilage. It binds to a central protein, forming what is known as a proteoglycan, which gives cartilage its mechanical and elastic properties.

Pharmacodynamic Effects
The therapeutic effect of chondroitin sulfate sodium in patients with osteoarthritis is due to anti-inflammatory activity at the level of the cellular components of inflammation in vivo, stimulation of the synthesis of endogenous proteoglycans in vitro and hyaluronic acid in vivo, and a decrease in the catabolic activity of chondrocytes in vivo. It inhibits certain proteolytic enzymes, including collagenase, elastase, proteoglycanases, phospholipase A2, N-acetyl-glucosaminidase, etc., in vitro and in vivo, as well as the formation of other substances that damage cartilage in vitro.

In vitro, chondroitin sulfate inhibits elastase, a mediator of cartilage degradation. It stimulates proteoglycan synthesis by cultured chondrocytes.

Clinical Efficacy and Safety
CHONDROSULF 800 mg tablets were studied in two pivotal clinical trials in osteoarthritis of the knee and hand, including a total of 766 patients.

The pivotal knee osteoarthritis study was conducted to evaluate the efficacy and safety of CHONDROSULF 800 mg tablets versus celecoxib 200 mg and placebo in patients with knee osteoarthritis over a 6-month treatment period.

The results of this study showed that at 800 mg/day, chondroitin sulfate was superior to placebo in reducing pain and improving mobility over 6 months in patients with symptomatic knee osteoarthritis.

The pivotal hand osteoarthritis study was conducted to evaluate the efficacy and safety of CHONDROSULF 800 mg tablets versus placebo in patients with radiologically confirmed finger joint osteoarthritis over a 6-month treatment period. The results showed that chondroitin sulfate was superior to placebo in improving overall pain and hand mobility.

Safety results from clinical studies showed that CHONDROSULF 800 mg tablets have a safety profile similar to placebo.

Other studies also confirm safety over a longer period.

Two additional randomized phase 3 clinical studies conducted over two years showed no differences between chondroitin sulfate 800 mg/day and placebo groups in the frequency of adverse effects among 922 patients with knee osteoarthritis. Both studies demonstrated maintenance of joint space after 2 years of treatment with chondroitin sulfate 800 mg compared with placebo. There is not enough information on the long-term effect of chondroitin on radiographic progression, but based on these two studies, chondroitin sulfate may have an effect on maintaining joint space in patients with knee osteoarthritis after two years of treatment.

In both studies, pain reduction was evaluated as a secondary endpoint. In one study, there was no appreciable change in pain, measured using the WOMAC pain scale, over two years. The most likely reason for this result was the relatively low average pain score of subjects at study entry, which left little room for improvement. In the second study, no significant difference in pain between chondroitin sulfate and placebo was observed during the second year of the study. However, differences in reduced pain scores using the VAS scale between the two groups, in favor of chondroitin sulfate, were significant between months 1 and 9, confirming results from other shorter published studies of 3 to 6 months on the symptomatic effects of chondroitin sulfate.

5.2 Pharmacokinetic Properties

Absorption
Several studies indicate that the bioavailability of chondroitin sulfate sodium ranges from 15% to 20% of the orally administered dose. Ten percent of the absorbed portion of chondroitin sulfate sodium appears as chondroitin sulfate and 90% as depolymerized derivatives of lower molecular weight, suggesting a first-pass hepatic effect. After oral administration of chondroitin sulfate sodium, the maximum blood concentration is reached in approximately 2 to 4 hours, with a slightly shorter time to maximum concentration when taken on an empty stomach. Steady state is reached after 3 to 4 hours.

Distribution
The volume of distribution of chondroitin sulfate sodium is relatively low, around 0.4 L/kg. In humans, 24 hours after oral administration, a high concentration of the substance may be found in the wall of the small intestine, liver, brain, and kidneys compared with other tissues. Chondroitin sulfate has been shown to be elevated not only in these organs involved in the breakdown and excretion of oligo- and polysaccharides, but also in synovial fluid and cartilage, where the molecule tends to accumulate. Reports have shown a very low percentage of protein binding, only 0.23% of total proteins. Reports have shown significant accumulation of the compound in synovial fluids, where chondroitin sulfate sodium exerts its chondroprotective and anti-inflammatory activities.

Biotransformation
Absorbed concentrations of chondroitin sulfate sodium reach the blood compartment as chondroitin sulfate 10% and depolymerized low-molecular-weight derivatives 90%. Chondroitin sulfate is not metabolized by cytochrome P450.

Elimination
Chondroitin sulfate sodium, both as an intact polymer and as depolymerized derivatives, is mainly eliminated by the kidneys. After oral administration, approximately 15% of the administered dose is excreted in the urine during the first 48 hours. The average elimination half-life after oral administration of chondroitin sulfate sodium is approximately 5 hours, varying from 5 to 10 hours depending on the experimental protocol. The systemic clearance of chondroitin sulfate sodium is 20 mL/min.

5.3 Preclinical Safety Data

Non-clinical data reveal no particular hazard for humans based on repeated-dose toxicity, genotoxicity, and carcinogenic potential studies.

The animal data available to date do not allow assessment of the effect of CHONDROSULF 800 mg tablets on fertility and reproduction.

6. Pharmaceutical Information

6.1 List of Excipients

Magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

No special storage precautions.

6.5 Nature and Contents of Container

Polyamide-Aluminum-PVC / thermolacquer-Aluminum blister packs.

Box of 30 or 90 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal and Other Handling

No special requirements.

7. Marketing Authorization Holder

IBSA PHARMA SAS
Parc de Sophia-Antipolis
Les Trois Moulins, 280 Rue de Goa
06600 Antibes
France

8. Marketing Authorization Number(s)

34009 302 811 7 8: box of 30 tablets
34009 302 811 8 5: box of 90 tablets

9. Date of First Authorization / Renewal of Authorization

To be completed later by the holder.

10. Date of Revision of the Text

To be completed later by the holder.

11. Dosimetry

Not applicable.

12. Instructions for Preparation of Radiopharmaceuticals

Not applicable.

Prescription and Dispensing Conditions

Medicine not subject to medical prescription.