Document: Glufan film-coated tablet ENG SmPC change

• Glufan film-coated tablet SmPC
• Glufan film-coated tablet ENG SmPC

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Glufan 625 mg film-coated tablet

One tablet contains 750 mg glucosamine hydrochloride, corresponding to 625 mg glucosamine.

Excipient: sunset yellow FCF aluminium lake (E 110)

For thefull list of excipients, see section 6.1.

Film-coated tablet

The tablet is yellow and plain on both sides.

Relief of symptoms in mild to moderate osteoarthritisof the knee.

Posology

Starting dose: 1 tablet twice daily.

Clinical effect is usually seen within 4 weeks after the start of treatment. Once the symptoms have been relieved, the dose may be reduced to 1 tablet daily.

Elderly

No dosage adjustment is required when treating elderly patients.

Impaired renal and/or liver function

As no studies have been carried out in patients with impaired renal and/or liver function no dose recommendations can be given.

Paediatric population

Glufan should not be given to children or adolescents under the age of 18 years.

Hypersensitivity to the active substanceor to any of the excipientslisted in section 6.1.

Glufan must not be given to patients who are allergic to shellfish as the active ingredient is obtained from shellfish.

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

Caution is urged in the treatment of patients with diabetes mellitus. Closer monitoring of the blood glucose levels may be required at the start of treatment.

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.

Caution is recommended if glucosamine is combined with other medicinal products as there are no data available relating to interactions (see 4.5 Interactions with other medicinal products and other interactions).

Paediatric population

Glufan must not be given to children and adolescents under the age of 18 years as the efficacy and safety have not been proven.

No interaction studies have been performed.

It is not known whether glucosamine has any effects on the pharmacokinetics of other drugs. As possible interactions cannot be ruled out, care should be taken when combining glucosamine with other medicinal products.

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.

Pregnancy

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.

Glufan should therefore not be used during pregnancy.

Lactation

Glufan should not be used during lactation.

No studies have been performed. Glufan is not expected to have any effects on the ability to drive and operate machinery.

The following side effects have been reported during clinical trials: headache, drowsiness, dyspepsia, skin rash, pruritus and erythema. The reported adverse reactions are usually mild and transitory:

System Organ Class	Very common (>1/10)	Common (≥1/100 to <1/10)	Uncommon (≥1/1,000 to ≤1/100)	Rare (> 1/10,000 to < 1/1000)	Not known (cannot be estimated from the available data)
Nervous system disorders	-	Headache, Drowsiness	-		Dizziness
Respiratory, thoracic and mediastinal disorders					Asthma or asthma deteriorated
Gastrointestinal disorders	-	Dyspepsia	-		Stomach ache, Diarrhoea, Nausea/ Vomiting
Skin and subcutaneous tissue disorders	-	-	Skin rash, Pruritus, Erythema		Angioedema, Urticaria
Metabolism and nutrition disorders					Blood glucose control worsened in patients with diabetes mellitus.
General disorders and administration site conditions					Oedema/peripheral oedema
Hepatobiliary disorders					Hepatic enzyme elevation, Jaundice

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 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.

Paediatric population

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 recovered without sequele.

Pharmacotherapeutic group: Non-steroidal, anti-inflammatory and anti-rheumatic drugs, ATC code: M01AX05

Glucosamine is an endogenous substance. The exogenous administration of glucosamine to animals can increase proteoglucan synthesis and thereby inhibit the breakdown of cartilage. Long-term studies indicate that glucosamine can 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 mobility in the affected joints in patients with mild to moderate osteoarthritis.

Glucosamine is a relatively small molecule (molecular mass 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 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.

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.

Tablet core:

Povidone

calcium phosphate

microcrystalline cellulose

crospovidone

magnesium stearate

Tablet coating:

polyvinyl alcohol

talc

lecithin

macrogol

titanium dioxide (E171)

sunset yellow FCF aluminium lake (E 110)

quinoline yellow (E 104)

yellow iron oxide (E 172)

Not applicable.

2 years

Do not store above 30^oC. Store in the original container.

PVC/PVDC/Aluminium blister packs: Package size: 20, 60 and 180 tablets

HDPE tablet container: Package size: 90 tablets

Not all pack sizes may be marketed.

No special requirements.

< To be completed nationally >

< To be completed nationally >

< To be completed nationally >

13 March 2015