Osteoeze
summary of product characteristics
1. NAME OF THE MEDICINAL PRODUCT
OsteoEze 625 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 625 mg of glucosamine (as 750 mg glucosamine hydrochloride).
Excipients with known effect: Sunset yellow FCF aluminium lake (E110) 0.1 mg
Lecithin (soya) (E322) 1.1 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL form
Film-coated tablet.
The tablet is yellow, oblong and embossed with V.
4. Clinical particulars
4.1 Therapeutic indications
Relief of symptoms in mild to moderate osteoarthritis of the knee.
4.2 Posology and method of administration
Posology
1250 mg glucosamine once daily for relief of symptoms.
Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated.
Elderly:
No specific studies
have been performed in the elderly, but according to clinical
experience dosage adjustment is not required when treating
otherwise healthy, elderly patients.
Impaired renal and/or liver
function:
In patients with impaired renal and/or liver
function no dose recommendations can be given, since no studies have been performed.
Paediatric
population:
OsteoEze should not be given to children and
adolescents under the age of 18 years, due to lack of data on
safety and efficacy.
Method of administration
Tablets can be taken with or without food.
4.3 Contraindications
Known hypersensitivity to glucosamine or to any of the excipients
(in particular peanut or soya as this medicinal product contains
soya derivative).
OsteoEze must not be given to patients who are allergic to shellfish as the active ingredient 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.
Cases of exacerbated asthma symptoms triggered after initiation of glucosamine therapy have been described (symptoms resolved after withdrawal of glucosamine). Asthmatic patients starting on glucosamine should therefore be aware of potential worsening of symptoms.
Information concerning excipients
This product contains “Sunset yellow FCF aluminium lake (E110)” that may cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
Increased effect of coumarin anticoagulants (e.g. warfarin) during concomitant treatment with glucosamine has been reported. Patients treated with coumarin anticoagulants should therefore be monitored closely when initiating or ending glucosamine therapy.
Concurrent treatment with glucosamine may increase the absorption and serum concentration of 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 altered response or concentration of concurrently used medicinal products.
4.6 Pregnancy and lactation
Pregnancy
There are no adequate data from the use of glucosamine in pregnant
women. From animal studies only insufficient data are available.
Glucosamine should not be used during pregnancy.
Breast-feeding
There are no data available on
the excretion of glucosamine in human milk. The use of glucosamine
during breast-feeding is therefore not recommended as there are no
data on the safety of the newborn.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. If dizziness or drowsiness is experienced, car driving and the operating of machinery is not recommended.
Undesirable effects
The most common adverse reactions associated with treatment with glucosamine are nausea, abdominal pain, indigestion, constipation, and diarrhoea. In addition, headache, tiredness, rash, itching, and flushing have been reported. The reported adverse reactions are usually mild and transitory.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), or not known (can not be estimated from the available data).
|
MedDRA System Organ Class |
Common |
Uncommon |
Very rare |
Not known (cannot be estimated from the available data) |
|
Metabolism and nutrition disorders |
|
|
|
Diabetes mellitus inadequate control, hypercholesterolaemia |
|
Nervous system disorders |
Headache Tiredness |
|
|
Dizziness |
|
Respiratory, thoracic and mediastinal disorders |
|
|
|
Asthma aggravated |
|
Gastrointestinal disorders |
Nausea Abdominal pain Indigestion Diarrhoea Constipation |
|
|
Vomiting |
|
Hepatobiliary Disorder |
|
|
|
Hepatic enzyme Elevation, jaundice |
|
Skin and subcutaneous tissue disorders |
|
Rash Itching Flushing |
|
Angioedema Urticaria |
|
|
|
|
|
|
|
General disorders and administration site conditions |
|
|
|
Oedema Peripheral oedema |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9 Overdose
Signs and symptoms of accidental or intentional overdose with glucosamine might include headache, dizziness, disorientation, arthralgia, nausea, vomiting, diarrhoea or constipation.
In case of overdose treatment with glucosamine should be discontinued and standard supportive measures should be adopted as required.
In clinical trials one of five healthy young subjects experienced headache following infusion of glucosamin up to 30 g.
In addition, one case of overdose has been reported in a 12-year old female who took orally 28 g of glucosamine hydrochloride. She developed arthralgia, vomiting and disorientation. The patient fully recovered.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other
antiinflammatory and antirheumatic agents, non-steroids.
ATC code: M01AX05
Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. In vitro and in vivo studies have shown that glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes.
Mechanism of
action
The mechanism of action of glucosamine in humans
is unknown.
The period of onset can not be assessed.
5.2 Pharmacokinetic properties
Glucosamine is a relatively small molecule (molecular mass 179), which is easily dissolved in water and soluble in hydrophilic organic solvent.
The available information on the pharmacokinetics of glucosamine is limited. The absolute bioavailability is unknown. The distribution volume is approx. 5 litres and the half-life after intravenous administration is approx. 2 hours. Approx. 38% of an intravenous dose is excreted in the urine as unchanged substance.
5.3 Preclinical safety data
D-Glucosamine has low acute toxicity.
Animal experimental data relating to general toxicity during chronic administration, reproduction 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 induces insulin resistance, probably via glucokinase inhibition in the beta cells. The clinical relevance is unknown.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core
Povidone K30,
calcium phosphate tribasic,
microcrystalline cellulose,
crospovidone,
magnesium stearate.
Coating
polyvinyl alcohol,
talc,
lecithin (E322),
macrogol 4000/-macrogol 3000,
titanium dioxide (E171),
sunset yellow FCF aluminium lake (E110),
quinoline yellow aluminium lake (E104),
yellow iron oxide (E 172).
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC/PVDC/Aluminium blister packs: Pack sizes: 30, 60 and 180 tablets.
Not all packages sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Novartis Sverige AB
Box 1150
SE-183 11 Täby
Sweden
8. MARKETING AUTHORISATION NUMBER(S)
19028
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 10 January 2003
Date of last renewal: 10 January 2008
10. DATE OF REVISION OF THE TEXT
2015-03-30
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