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Document: Glucosine 625 mg film-coated tablet ENG SmPC change

• Glucosine 625 mg film-coated tablet SmPC
• Glucosine 625 mg film-coated tablet ENG SmPC

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summary of the product characteristics

Glucosine 625 mg film-coated tablets

1 tablet contains glucosamine sulphate - sodium chloride complex corresponding to 625 mg glucosamine or 795 mg glucosamine sulphate.

Excipient: 1 tablet contains sodium 78 mg

For a full list of excipients, see section 6.1.

Film-coated tablet

White to beige tablet, oblong, 8,5 x 19 mm.

Relief of symptoms in mild to moderate osteoarthritis.

Start dosage: 1 tablet 2 times daily, preferable at meals. 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.

Hypersensitivity to the active ingredient 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.

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).

In asthmatic patients the product should be used with caution as these patients could be more susceptible to develop an allergic reaction to glucosamine with possible exacerbation of their symptoms.

Glucosine contains 78 mg sodium per tablet and this is to be considered in patients on a controlled sodium diet.

No specific drug interaction studies have been performed. However the physical-chemical pharmacokinetic properties of glucosamine sulphate suggest a low potential for interactions. In addition glucosamine sulphate was found not to inhibit or to induce any of the major human CYP450 enzymes. In fact, the compound does not compete for absorption mechanisms and, after absorption, does not bind to plasma proteins, while its metabolic fate as an andogenous substance incorporated in proteoglycans or degraded independently of the cytochrome enzyme system, is unlikely to give rise or to drug interactions.

The oral administration of glucosamine sulphate can enhance the gastrointestinal absorption of tetracyclines but the clinical relevance of this interaction is probably limited.

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.

Non-steroidal anti-inflammatory drugs (NSAIDs) can be administered together with glucosamine sulphate.

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.

Pregnancy

Studies in animals did not show reproductive toxicity. There isno adequate data from the use of glucosamine in pregnant women. Glucosine shouldtherefore not be used during pregnancy.

Breastfeeding

There is no data available on the excretion of glucosamine in human milk. Glucosine should therefore not be used during breastfeeding.

Fertility

In the rat, no adverse effects on fertility have been observed.

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. If dizziness or drowsiness is experienced, car driving and the operating of machinery are not recommended.

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.

Adverse drug reactions are ranked by frequency, the most frequent first, using the following convention: 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), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

The following side effects have been reported:

System Organ Class	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)	Not known (cannot be estimated from the available data)
Immune system disorders					Allergic reaction (Hypersensitivity)
Metabolism and nutrition disorders					Diabetes inadequate control
Nervous system disorders	Headache Somnolence				Dizziness
Vascular disorders		Flushing
Respiratory, thoracic and mediastinal					Asthma/ Asthma aggravated
Gastrointestinal disorders	Diarrhoea Constipation Nausea Flatulence Abdominal pain Dyspepsia				Vomiting
Hepatobiliary disorders					Jaundice
Skin and subcutaneous tissue disorders		Erythema Pruritus Rash			Angioedema Urticaria
General disorders and administration site conditions	Tiredness (Fatigue)				Oedema/ peripheral oedema
Investigations					Hepatic enzyme elevation International normalized ratio fluctuation

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.*

Signs and symptoms of 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.

One case of overdose has been reported. A 12-year old female who took orally 28g of glucosamine hydrochloride. She developed arthralgia, vomiting and disorientation. The patient fully recovered.

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

ATC-code: M01AX05

Mechanism of action

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.

However, the mechanism of action of glucosamine in humans is unknown. Clinical studies have shown that pain relief is expected to occur after some weeks of treatment with glucosamine.

I

Clinical efficacy and tolerability

Glucosamine sulphate has demonstrated a good tolerability over both short-term and long-term treatment courses.

Absorption.

After oral administration of 14C-labelled glucosamine, the radioactivity is rapidly and almost completely (about 90%) absorbed systemically in healthy volunteers. The absolute bioavailability of glucosamine in man after administration of oral glucosamine sulphate was 44%, due to first-pass effect of the liver. After oral administration of daily repeated doses of 1500 mg of glucosamine sulphate in healthy volunteers under fasting conditions, the maximum plasma concentrations at steady-state (C_max,ss) averaged 1602±426 ng/mml between 1.5-4 h (median; 3 h, t_max). At steady-state, AUC of the plasma concentrations vs time curve was 14564±4138 ng.h/ml. It is unknown if meals significantly affect the drug oral bioavailability. The pharmacokinetics of glucosamine are linear after once daily repeated administrations in the dose interval 750-1500 mg with deviation from linearity at the dose of 3000 mg due to lower bioavailability. No gender differences were found in man with regard to the absorption and to the bioavailability of glucosamine. The pharmacokinetics of glucosamine was similar between healthy volunteers and patients with osteoarthritis of the knee.

DistributionThe distribution volume is approximately5 litres. Glucosamine does not bind to plasma protein.

Metabolism.

The metabolic profile of glucosamine has not been studied because being an endogenous substance; it is used as a building block for the biosynthesis of articular cartilage components. Glucosamine is mainly metabolized through the hexosamine pathway and independently of the cytochrome enzyme system.

Crystalline glucosamine sulphate does not act as an inhibitor nor as an inducer of the human CYP450 isoenzymes including CYP 3A4, 1A2, 2E1, 2C9 and 2D6 even when tested at concentrations of glucosamine 300-fold higher than the peak plasma concentrations observed in man after therapeutic doses of crystalline glucosamine sulphate. No clinically relevant metabolic inhibition and/or induction interactions are expected between crystalline glucosamine sulphate and co-administered drugs that are substrates of the human CYP 450 isoforms.

Excretion.

In man, the terminal elimination half-life of glucosamine from plasma is estimated at 15 h. After oral administration of 14C-labelled glucosamine to humans, the urinary excretion of radioactivity was 10±9% of the administered dose while fecal excretion was 11.3±0.1%. The mean urinary excretion of unchanged glucosamine after oral administration in man was about 1% of the administered dose suggesting that the kidney and the liver do not significantly contribute to the elimination of glucosamine and/or of its metabolites and/or its degradation products.

Patients with renal or hepatic impairment.

The pharmacokinetics of glucosamine were not investigated in patients with renal or hepatic insufficiency(See section 4.2).

Children and adolescents.

The pharmacokinetics of glucosamine was not investigated in children and adolescents.

Elderly patients.

No specific pharmacokinetic studies were performed in elderly however in the clinical efficacy and safety studies mainly elderly patients were include. Dose adjustment is not required.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dosetoxicity, genotoxicity,toxicity toreproduction and development.Carcinogenicity studies are not available.

Results from in vitro and in vivo studies in animals have shown that i.v. infusion of glucosamine in suprapharmacological concentrations reduces insulin secretion, probably via inhibition of glucokinase in the beta cells, and induces insulin resistance in peripheral tissues. The relevance in humans is inconclusive.

Tablet core:

Povidone,

Citric acid anhydrous

Colloidal anhydrous silica

Magnesium stearate

Microcrystalline cellulose

Sodium starch glycolate (type A)

Film coating:

Macrogol 6000

Hypromellose

Paraffin.

Not applicable.

2 years.

Do not store above 25 ºC.

60, 90 and 180 tablets in white plastic bottles with screw caps of HDPE (polyethylene).

Not all pack sizes may be marketed.

No special requirements.

Recip AB, Box 906, 170 09 Solna, Sweden

21339

2005-05-20 / 2009-12-30