Symptomatic treatment of osteoarthritis

This drug (with this brand and datasheet) is registered in Spain, but is also approved in other countries. For more information please contact us.


Condrosan, base treatment for osteoarthritis1, is a chondroprotector drug, slow-acting on symptoms, indicated for the symptomatic treatment of osteoarthritis. 

Chondroitin sulfate is one of the main elements that form cartilage and combines with a central protein, forming proteoglycan, which gives cartilage its mechanical and elastic properties.

The clinical trials on patients with osteoarthritis show that treatment with chondroitin sulfate leads to a reduction or the disappearance of osteoarthritis symptoms, such as pain and functional disability, improving the movement of the affected joints, with an effect that will last 2 or 3 months after stopping the treatment.


CONDROSAN 400 mg hard capsules. 

CONDROSAN 400 mg granules for oral solution. 


Each capsule or sachet contains: Chondroitin sulfate, 400 mg

Each sachet contains: Sorbitol (E-420), 1,335 mg, sodium saccharin (1.34 mg of sodium) and Orange Yellow S (E-110), 1 mg 

For the full list of excipients, see section 6.1. 


Hard capsule.

Granules for oral solution.


4.1     Therapeutic indications 

CONDROSAN is indicated in the symptomatic treatment of osteoarthritis. 

4.2     Posology and method of administration 

Adults (including the elderly):

The recommended dose of CONDROSAN is 800 mg/day; therefore, 2 capsules or sachets will be taken per day, preferably together (2 sachets or 2 capsules at a time) for at least 3 months. However, in patients with significant inflammatory symptoms, treatment can be started with a dose of 1,200 mg (3 capsules or sachets daily in a single dose or in two doses) for the first 4 or 6 weeks, and then continuing with 800 mg until completing the administration period of at least 3 months.

CONDROSAN will be administered for at least 3 months, followed by, depending on the patient's symptoms, a 2-month rest period, given the product's carry-over effect, to then restart the treatment following the same cycle. 

Children and adolescents:

Condrosan is not recommended for use in children or adolescents under 18 years of age, due to the absence of safety and efficacy data. 

Kidney failure:

There is little experience available on the use of CONDROSAN in patients suffering from kidney failure. Therefore, these patients must be treated with special attention (See section 4.4). 

Liver failure:

There is no experience available on the use of CONDROSAN in patients suffering from liver failure. Therefore, these patients must be treated with special attention (See section 4.4). 

CONDROSAN can be taken before, during or after a meal. Patients with a history of gastric intolerance to medicinal products in general are recommended to take it after a meal.

The capsules must be swallowed, not chewed, with sufficient liquid.

In terms of the sachet doses, the contents of the sachet should be poured into a glass and dissolved in a small amount of water prior to its administration. 

4.3     Contraindications 

Hypersensitivity to the active ingredient or to any of the excipients. 

The CONDROSAN sachet formulation contains sorbitol (E-420). Patients with hereditary fructose intolerance must not take CONDROSAN in sachets. 

4.4     Special warnings and precautions for use 

Heart and/or kidney failure:

In very rare occasions (<1/10,000) such patients have experienced cases of edema and/or water retention. This phenomenon can be attributed to the osmotic effect of chondroitin sulfate. 

Liver failure:

There is no experience available on the use of CONDROSAN in patients suffering from liver failure. Therefore, these patients must be treated with special attention. 

No effect at the platelet level has been detected in either clinical research or through pharmacovigilance at the recommended dose. However, in rats at doses much higher than those recommended, 50 mg/kg/day (which would be the equivalent of 4,000 mg in humans/day), a possible slight platelet antiaggregant activity has been observed; therefore, this will be taken into account in cases of concomitant use with platelet antiaggregants (acetylsalicylic acid, dipyridamole, clopidrogrel, ditazole, triflusal and ticlopidine). 

The CONDROSAN sachet formulation may cause allergic reactions due to its orange yellow S (E-110) content. It may cause asthma, especially in patients who are allergic to acetylsalicylic acid. 

The CONDROSAN sachet formulation may have a laxative effect because it contains 1.335 g of sorbitol per sachet. Calorie content: 2.6 kcal/g sorbitol. 

The CONDROSAN sachet formulation contains 58.5 mmol (1.34 mg) of sodium per sachet. This should be taken into account in the treatment of patients with low-sodium diets. 

4.5     Interaction with other medicinal products and other forms of interaction 

No interaction studies have been conducted. 

For use in conjunction with platelet antiaggregants see section 4.4. 

4.6     Fertility, pregnancy and lactation 


There is insufficient data on the use of chondroitin sulfate in pregnant women. The animal studies are insufficient to determine the reactions in pregnancy and/or embryonic, fetal and postnatal development. Therefore, CONDROSAN must not be used during pregnancy. 

Breast Feeding

There is no information available on the excretion of chondroitin sulfate through breast milk. Therefore, and due to the lack of safety information for the newborn, the use of CONDROSAN during lactation is not recommended. 

4.7     Effects on ability to drive and use machines 

No studies have been conducted on the effects on the ability to drive vehicles or operate machinery. 

4.8     Undesirable effects 

Below are the adverse reactions experienced with CONDROSAN by System Organ Class and classified as “rare” (>1/10,000, to <1/1,000), which generally do not require treatment discontinuation, or “very rare” (<1/10,000).

The adverse reactions are listed in order of decreasing seriousness within each frequency interval. 

Gastrointestinal disorders

Rare: Nausea, gastrointestinal alterations. 

General disorders and administration site conditions

Very rare: Edema, water retention (see section 4.4). 

Immune system disorders

Very rare: Allergic reaction. 

4.9     Overdose 

No cases of overdose have been reported. 

Based on the acute and chronic toxicity results obtained, toxic symptoms are not expected, even after an elevated dose. 


5.1     Pharmacodynamic properties 

Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non-steroids. ATC code: M01AX. 

Chondroitin sulfate, the active ingredient of CONDROSAN, belongs to the polysaccharide class, included in the glycosaminoglycan group. 

Chondroitin sulfate is one of the main components of cartilage. It binds to a core protein and conforms what is known as proteoglycan, which is responsible for the mechanical and elastic properties of cartilage.

The therapeutic effect of chondroitin sulfate in patients suffering from osteoarthritis, is due to an anti-inflammatory activity at the level of the cellular components of the inflammation (in vivo), to the stimulation of the synthesis of endogenous proteoglycans (in vitro) and hyaluronic acid (in vivo), and to a decrease in the catabolic activity of chondrocytes (in vivo), inhibiting some proteolytic enzymes (collagenase, elastase, proteoglycanase, phospholipase A2, N-acetylglucosaminidase, etc.) (in vitro, in vivo) and the formation of other substances that damage the cartilage (in vitro). Chondroitin sulfate is also capable of modulating NF-kB activation, thereby inhibiting the nuclear translocation of this protein, involved in certain chronic inflammatory processes. 

Clinical trials in osteoarthritic patients show that treatment with chondroitin sulfate reduces or eliminates osteoarthritic disease symptoms, such as pain and functional impotence, and improves the movement of the affected joints, with an effect that lasts for 2 or 3 months after treatment suppression. 

In a double-blind, randomized, multicenter clinical trial on a total of 1583 patients with osteoarthritis of the knee, (NIH, USA; N Engl J Med 354;8;2006) the effect of 5 treatments was studied: 500 mg glucosamine 3 times daily; 400 mg chondroitin sulfate 3 times daily; 200 mg celecoxib daily; 500 mg glucosamine + 400 mg chondroitin sulfate 3 times daily; placebo) on the reduction of pain during 6 months. The results showed that glucosamine (64.0%), chondroitin sulfate (65.4%) or the combination of both (66.6%), did not produce a significant reduction of pain with respect to the placebo (60%) in the entire study population. The investigators demonstrated that this lack of response could be due to the fact that the majority of patients presented mild pain (therefore, there was little capacity to discern improvement of pain) and to a higher response (60%) to the placebo than expected (35%). However, an exploratory analysis in the subgroup of patients with moderate to severe pain could suggest that the combined treatment of chondroitin sulfate + glucosamine significantly reduces pain with respect to placebo (79.2% vs. 54.3%, p=0.002) in patients suffering from osteoarthritis of the knee.

In this same clinical trial, a significant decrease of swelling was observed, accompanied or not by joint effusion (synovitis), in the group treated with chondroitin sulfate, compared with placebo (p=0.01). 

In a placebo-controlled, double-blind, randomized, multicenter clinical trial, the efficacy and safety of CONDROSAN (800 mg/day of chondroitin sulfate) was studied in 129 patients of whom 116 (60 Chondroitin sulfate + 56 placebo) were included in the intention-to-treat (ITT) analysis, affected by uni- and/or bilateral femoral-tibial osteoarthritis of the knee of grades I to III according the Kellgren-Lawrence scale and vulgar psoriasis with cutaneous involvement in the form of persistent small or large disseminated plaques. The primary efficacy endpoint was to determine the reduction of pain using the Huskisson Visual Analog Scale, while the primary efficacy endpoint for psoriasis was to determine the Psoriasis Area and Severity Index.

In terms of the osteoarthitis of the knee, CONDROSAN caused a significant reduction of pain versus placebo at the end of the study (31.35 mm versus 43.15 mm CI 95% 25.75-36.95 vs. 37.35-48.95).

In terms of the Psoriasis Area and Severity Index (primary co-endpoint), CONDROSAN did not cause a significant reduction versus the placebo group. In one subgroup of patients (n=30, 15 patients treated with chondroitin sulfate and 15 patients treated with placebo), CONDROSAN presented improvement in plantar psoriasis versus placebo (p=0.0147). This result must be taken with caution, due to its exploratory nature.

In this clinical trial, the treatment with CONDROSAN did not increase the incidence of psoriasis flare-ups. 

5.2       Pharmacokinetic properties 

Absorption: Several studies suggest that chondroitin sulfate bioavailability ranges from 15% to 24% of the orally administered dose. Of the absorbed fraction of chondroitin sulfate, 10% is found as chondroitin sulfate and 90% as depolymerized derivatives with a lower molecular weight, suggesting that it undergoes a first-pass effect. After oral administration of chondroitin sulfate, the maximum concentration of chondroitin sulfate in blood is reached in about 4 hours.

Distribution: In blood, 85% of the concentration of chondroitin sulfate and depolymerized derivatives is bound to various plasma proteins. The volume of distribution of chondroitin sulfate is relatively small, approximately 0.3 l/kg. In humans, chondroitin sulfate shows an affinity for joint tissue. In rats, as well as joint tissue, chondroitin sulfate also shows affinity for the wall of the small intestine, liver, brain and kidneys.

Metabolism: At least 90% of the dose of chondroitin sulfate is first metabolized by lysosomal sulfatases, and then depolymerized by hyaluronidases, b-glucuronidases and b-n-acetylhexosaminidases. The liver, kidneys, and other organs participate in the depolymerization of chondroitin sulfate. No interactions have been reported with other drugs at the metabolism level. Chondroitin sulfate is not metabolized by cytochrome P450 enzymes. 

Elimination: Systemic clearance of chondroitin sulfate is 30.5 ml/min or 0.43 ml/min/kg. The half-life ranges from 5 to 15 hours depending on the experimental protocol. The most important route of elimination of chondroitin sulfate and depolymerized derivatives is the kidney.

Linearity: The kinetics of chondroitin sulfate are of first order up to single doses of 3,000 mg. Multiple doses of 800 mg in patients suffering from osteoarthritis do not alter the order of the kinetics of chondroitin sulfate. 

5.3     Preclinical safety data

Non-clinical study data does not show special risks for humans according to the conventional pharmacology studies on safety, repeated dose toxicity, mutagenicity, genotoxicity or reproductive toxicity. 


6.1     List of excipients 

a)         Per capsule: magnesium stearate. Composition of the capsule: gelatin, titanium dioxide, quinoline yellow (E-104), indigo carmine (E-132). 

b)        Per sachet: citric acid, orange aroma, sodium saccharin, Orange Yellow S (E-110), colloidal anhydrous silica, sorbitol (E-420) 

6.2     Incompatibilities 

Not applicable. 

6.3     Shelf life 

4 years. 

6.4     Special precautions for storage 

Store in the original package in order to protect from moisture. 

6.5     Nature and contents of container 

a)         capsules: PVDC-Aluminum blisters packed in cases containing 60 capsules. 

b)        sachets: thermosealed paper-aluminum-polyethylene sachets packed in cases containing 60 sachets. 

6.6     Special precautions for disposal and other handling 

No special requirements. 


BIOIBERICA S.A. Ctra. Nacional II, Km. 680,6 - 08389 Palafolls. Barcelona. Spain. 


CONDROSAN 400 mg hard capsules, Register No.: 64,549

CONDROSAN 400 mg granules for oral solution, Register No.: 64,550 



04.02.02/ 30.11.06 





Detailed, updated information on this medicinal product is available on the website for the Spanish Agency for Medicinal Products and Medical Devices (AEMPS).

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