SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glucosine 400 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains glucosamine sulphate - sodium chloride complex corresponding to 400 mg
glucosamine or 509 mg glucosamine sulphate.
Excipient: 1 tablet contains sodium 50 mg.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
White to beige tablet, round, biconvex, diameter 12 mm.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Relief of symptoms in mild to moderate osteoarthritis.
4.2
Posology and method of administration
1 tablet 3 times daily. Alternatively, the total daily dose may be administered on one occasion.
Glucosine is not indicated for the treatment of acute painful symptoms.
The clinical effect is usually seen within 4 weeks after the start of treatment.
The lowest effective dose should be used.
Elderly
No dosage adjustment is required when treating elderly patients.
Impaired renal and/or liver function
Since no studies have been performed on patients with impaired renal and/or liver function,
no dose recommendations can be given.
Children and adolescents
Glucosine should not be given to children and adolescents under the age of 18 years.
4.3
Contraindications
Hypersensitivity to glucosamine or to any of the excipients.
Glucosine should 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’s consultation is recommended to rule out the presence of joint diseases for which
other treatment should be considered.
Caution is recommended in treatment of patients with diabetes mellitus. Closer monitoring of
the blood glucose level may be required at the beginning of treatment.
Glucosine must not be given to children and adolescents under the age of 18 years since
efficacy and safety have not been shown.
Caution is recommended if glucosamine is combined with other medicinal products, since
interaction data are missing (see 4.5 Interaction with other medicinal products and other forms
of interaction).
Glucosine contains 50 mg sodium per tablet and this is to be considered in patients on a
controlled sodium diet.
4.5
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Data on possible drug interactions with
glucosamine is limited.
Increased effect of coumarin anticoagulants (e.g. warfarin) during concomitant treatment with
glucosamine has been reported in the post–marketing experience. Patients treated with
coumarin anticoagulants should therefore be monitored closely when initiating or ending
glucosamine therapy.
It is not known whether glucosamine has any effects on the pharmacokinetics of other drugs.
As possible interactions can not be ruled out, care should be taken when combining
glucosamine with other medicinal products.
4.6
Pregnancy and lactation
There are no adequate data from the use of glucosamine in pregnant women. No studies on
animals have been carried out with respect to the effect on pregnancy, embryonal/foetal
development and postnatal development. Glucosine must therefore not be used during
pregnancy or lactation.
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.
Glucosine is not expected to have any effects on the ability to drive and use machines.
4.8
Undesirable effects
The most frequently reported undesirable effects with the glucosamine therapy include
stomach ache and discomfort, dyspepsia, constipation, diarrhoea and nausea. Headache,
fatigue, pruritus and erythema have also been reported. The reported undesirable effects were
mild and usually transient.
The following adverse reactions have been reported in the post-marketing experience of
glucosamine: angioedema/urticaria, oedema/peripheral oedema, dizziness, blood glucose
control worsened in patients with diabetes mellitus, hepatic enzyme elevation, jaundice.
The following side effects have been reported:
Investigations
Not known (cannot be estimated from the available data)
Blood glucose control worsened in patients with diabetes mellitus, hepatic enzyme elevation.
Nervous system disorders
Common (≥1/100 to <1/10)
Headache, drowsiness.
Not known (cannot be estimated from the available data)
Dizziness.
Gastrointestinal disorders
Common (≥1/100 to <1/10)
Dyspepsia, stomach ache, diarrhoea, constipation, nausea.
Not known (cannot be estimated from the available data)
Vomiting.
Skin and subcutaneous tissue disorders
Uncommon (>1/1000, <1/100)
Skin rash, pruritus, erythema.
Not known (cannot be estimated from the available data)
Angioedema, urticaria.
General disorders and administration site conditions
Not known (cannot be estimated from the available data)
Oedema/peripheral oedema.
Hepatobiliary disorders
Not known (cannot be estimated from the available data)
Jaundice.
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.
One case of overdose has been reported. A 12-year old female took 28 g of glucosamine
hydrochloride. She developed arthralgia, vomiting and disorientation. The patient recovered
without sequele.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: Other anti-inflammatory and anti-rheumatic agents, non-steroids
ATC-code: M01AX05
Glucosamine is an endogenous substance. Exogenous administration of glucosamine to
animals may increase the proteoglucan synthesis in cartilage and thereby inhibit the
degradation of cartilage. Long-term studies indicate that glucosamine may have a positive
effect on the metabolism of cartilage.
In published clinical studies, glucosamine has been shown to alleviate pain within 4 weeks as
well as improve motility of the affected joints in patients with mild to moderate osteoarthritis.
5.2
Pharmacokinetic properties
Glucosamine is a relatively small molecule (molecular mass 179), which is easily dissolved in
water and soluble in hydrophilic organic solvents.
The information available regarding the pharmacokinetics of glucosamine is limited. The
absolute bioavailablility is unknown. The distribution volume is approx. 5 litres and the halflife 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
Glucosamine has low acute toxicity. Animal experimental data regarding general toxicity
during long-term administration, reproduction toxicity, mutagenicity and carcinogenicity for
glucosamine have not been provided.
Results from in vitro and in vivo studies in animals have shown that glucosamine reduces
insulin secretion, probably via inhibition of glucokinase in the beta cells, and induces insulin
resistance in peripheral tissues. The clinical relevance is unknown.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Tablet core:
Povidone, citric acid anhydrous, colloidal anhydrous silica, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate (type A).
Film coating:
Macrogol 6000, hypromellose, paraffin, synthetic.
6.2
Incompatibilities
Not applicable.
6.3
Shelf-life
2 years.
6.4
Special precautions for storage
Do not store above 25 ºC.
6.5
Nature and content of container
60, 90, 180, 270 and 360 tablets in white plastic bottles with screw caps of HDPE
(polyethylene). Especially adjusted packing with an accessibility cap for people with reduced
function of the hands.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal
No special requirements.
7
MARKETING AUTHORISATION HOLDER
Recip AB
Box 906
S-170 09 Solna,
Sweden
8
MARKETING AUTHORISATION NUMBER(S)
18628
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23 May 2003/23 May 2008
10
DATE OF REVISION OF THE TEXT
2009-06-21