Cartisorb®

Cartisorb®

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.

Cartisorb®

Cartisorb® is indicated for the symptomatic treatment of osteoarthritis.

Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chain of cartilage matrix and synovial fluid glycosaminoglycans. In vitro and in vivo studies have shown that glucosamine stimulates the physiological synthesis of glycosaminoglycans and proteoglycans through the chondrocytes and of hyaluronic acid through synoviocytes. 


1.       NAME OF THE MEDICINAL PRODUCT 

CARTISORB 1500 mg powder for oral solution 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each sachet contains 1,500 mg of glucosamine sulfate as 1,884 mg of glucosamine sulfate sodium chloride, equivalent to 1,178 mg of glucosamine. 

Excipients with known effect:

Each sachet contains 2028.5 mg of sorbitol (E420) and 151 mg (6.57 mmol) of sodium as sodium chloride. 

For the full list of excipients, see section 6.1. 

3.       PHARMACEUTICAL FORM 

Powder for oral solution. 

The sachet contains white powder. 

4.       CLINICAL PARTICULARS 

4.1     Therapeutic indications 

Cartisorb is indicated in adults for the relief of the symptoms of mild to moderate osteoarthritis of the knee. 

4.2     Posology and method of administration 

Posology 

Adults 

Cartisorb is administered orally. 

Glucosamine is not indicated for the treatment of acute pain. The relief of symptoms (especially pain relief) normally appears within 4 weeks following treatment start. If you do not experience pain relief after 2-3 months, continued treatment with glucosamine should be reconsidered. 

Children and adolescents 

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

Elderly: 

No specific studies have been performed in the elderly, though clinical experience indicates that no dose adjustment is necessary in otherwise-healthy elderly patients. 

Kidney and liver failure 

Since no studies have been conducted in patients with kidney and/or liver failure, the dose cannot be established in those cases. 

Method of administration:

Dissolve the contents of a sachet in a glass of water and take it once daily, preferably with meals.

Appearance after reconstitution: clear, colorless solution. 

4.3     Contraindications 

-        Hypersensitivity to glucosamine or to any of the excipients included in section 6.1.

-        It must not be administered to patients who are allergic to shellfish, since glucosamine is obtained from shellfish.

4.4     Special warnings and precautions for use

A doctor must be consulted to rule out the presence of joint diseases for which other treatment should be considered.

In patients with impaired glucose tolerance, monitoring of the blood glucose levels and, where relevant, insulin requirements is recommended before start of treatment and periodically during treatment.

In patients with a known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended, since hypercholesterolemia has been observed in a few cases in patients treated with glucosamine.

Exacerbated asthma symptoms triggered after initiation of glucosamine therapy have been described (symptoms resolved after withdrawal of glucosamine). Therefore, asthmatic patients should be warned of the potential exacerbation of their asthma symptoms when starting treatment with glucosamine.

This medicinal product contains 6.57 mmol (151 mg) of sodium per sachet, which should be taken into consideration in the treatment of patients with low-sodium diets. 

This medicinal product contains sorbitol. Patients with hereditary fructose intolerance must not take this medicinal product.

4.5     Interaction with other medicinal products and other forms of interaction

Limited data is available on drug interactions with glucosamine, but increases in the INR parameter have been reported with coumarin anticoagulants (warfarin and acenocoumarol). Patients treated with coumarin anticoagulants should therefore be monitored closely when initiating or ending glucosamine therapy.

Concurrent treatment with glucosamine and tetracyclines may increase the absorption and serum concentration of the tetracyclines, but the clinical relevance of this interaction is probably limited.

Due to limited documentation on potential drug interactions with glucosamine, one should generally be aware of an altered response or concentration of concurrently used medicinal products.

4.6     Fertility, pregnancy and lactation

Pregnancy

There is no adequate data from the use of glucosamine in pregnant women. The animal studies conducted are insufficient in terms of reproductive toxicity. Glucosamine should not be used during pregnancy.

Breast Feeding

It is unknown whether glucosamine is excreted through breast milk. Therefore, and due to the lack of safety information for the newborn, the use of glucosamine 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. If dizziness or drowsiness is experienced, driving vehicles and operating machinery is not recommended.

4.8     Undesirable effects 

The adverse reactions most commonly associated with treatment with glucosamine are described below as “common” (defined as ≥1/100 and <1/10), “uncommon” (defined as ≥1/1000 and ≤1/100) and “not known” (defined as not possible to be estimated from the available data) and by System Organ Class. Within each frequency group, the adverse reactions are presented in decreasing order of seriousness.

The reported adverse reactions are generally mild and transitory.

Common:
Nervous system disorders: Headache, Tiredness
Gastrointestinal disorders: Nausea, Abdominal Pain, Indigestion. Diarrhea, Constipation

Uncommon:
Gastrointestinal disorders: Vomiting
Skin and subcutaneous tissue disorders: Rash, Itching, Flushing

Not known: 
Nervous system disorders: Dizziness
Respiratory, chest and mediastinal disorders: Asthma, Aggravated asthma
Skin and subcutaneous tissue disorders: Angioedema, Urticaria
Metabolism and nutrition disorders: Inadequate control of diabetes mellitus, Hypercholesterolemia
General disorders and administration site conditions: Edema, Peripheral edema

Suspected adverse reaction reporting

It is important to report suspected adverse reactions to the medicinal product after its authorization. This enables the medicinal product's risk/benefit ratio to be continuously monitored. Healthcare professionals are asked to report suspected adverse reactions through the national reporting system in Spain “Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: [the Spanish Pharmacovigilance System for Medicinal Products for Human Use] www.notificaRAM.es”.

4.9     Overdose

Signs and symptoms of accidental or intentional overdose with glucosamine might include headache, dizziness, disorientation, arthralgia, nausea, vomiting, diarrhea or constipation.

In cases of overdose, treatment with glucosamine should be discontinued and standard supportive measures should be adopted as required.

5.       PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

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

ATC: code M01AX05

Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chain of cartilage matrix and synovial fluid glycosaminoglycans. In vitro and in vivo studies have shown that glucosamine stimulates the physiological synthesis of glycosaminoglycans and proteoglycans through the chondrocytes and of hyaluronic acid through synoviocytes.

The mechanism of action of glucosamine in humans is unknown. The period to onset of response cannot be assessed. 

5.2     Pharmacokinetic properties

Glucosamine is a relatively small molecule (molecular weight 179), which is easily dissolved in water and soluble in hydrophilic organic solvents.

The available information on the pharmacokinetics of glucosamine is limited. The absolute bioavailability is unknown. The volume of distribution is approximately 5 liters and the half-life after intravenous administration is approximately 2 hours. Approximately 38% of an intravenous dose is excreted in the urine as unchanged substance.

The ADME (absorption, distribution, metabolism and excretion) of glucosamine has not been completely elucidated.

5.3     Preclinical safety data

D-glucosamine has low acute toxicity.

Animal experimental data relating to repeated dose toxicity, reproductive toxicity, mutagenicity and carcinogenicity is lacking for glucosamine.

Results from in vitro studies and in vivo studies in animals have shown that glucosamine reduces insulin secretion and increases insulin resistance, probably via glucokinase inhibition in the beta cells. The clinical relevance is unknown.

6.       PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Sucralose

Sorbitol (E420)

Sodium chloride

Citric acid

Macrogol 4000

Lemon aroma

6.2     Incompatibilities

Not applicable.

6.3     Shelf life

21 months

6.4     Special precautions for storage

Do not store above 30ºC. Store in the original package in order to protect from moisture.

 

6.5     Nature and contents of container <and of the special equipment for its use, administration or implantation>

Polyethylene-aluminum-paper sachets in cardboard case. Each case contains 30 single-dose sachets.

6.6     Special precautions for disposal <and other handling>

No special requirements.

The disposal of unused medicinal product and of all of the materials that have been in contact with it shall be carried out in accordance with local regulations.

7.       MARKETING AUTHORIZATION HOLDER

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

8.       MARKETING AUTHORIZATION NUMBER(S)

64.546

9.       DATE FOR FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

Date of first authorization: 4 February 2002

Date of last renewal: 30 October 2006

10.     DATE OF REVISION OF THE TEXT

September 2013

 

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices http://www.aemps.gob.es

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Joint Health

E-mail address:
humanhealth@bioiberica.com
Telephone number:
+34 93 490 49 08
Fax:
+34 93 490 97 11