1 name of the medicinal product osaflex 1178 mg powder for oral solution, sachet. 2 Qualitative and quantitative composition



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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT


Osaflex 1178 mg powder for oral solution, sachet.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION


Each sachet contains: 1884 mg mixture of glucosamine hydrochloride and anhydrous sodium sulphate, corresponding to 1500 mg glucosamine sulphate or 1178 mg glucosamine.

Excipients: aspartame (E951), sorbitol (E420).

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM


Powder for oral solution, sachet.

White, crystalline powder.


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


One sachet daily. The powder should be dissolved in a glass of water (250ml) and drunk.

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.

Osaflex can be taken with or without food.

Additional information on special populations

Children and Adolescents

Osaflex is not recommended for use in children and adolescents below the age of 18, due to lack of data on safety and efficacy.

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.


4.3 Contraindications


Hypersensitivity to the active substance or to any of the excipients.

Osaflex must not be given to patients who are allergic to shellfish as the active substance 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.

A report on exacerbated asthma symptoms triggered after initiation of glucosamine therapy has been described (symptoms resolved after withdrawal of glucosamine). Asthmatic patients starting on glucosamine should therefore be aware of potential worsening of symptoms.

Osaflex contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.

Osaflex contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.


One sachet contains 6,6 mmol (151 mg) sodium. To be taken into consideration by patients on a controlled sodium diet.

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 is no adequate data from the use of glucosamine in pregnant women. From animal studies only insufficient data are available. Osaflex should not be used during pregnancy.  
Breast Feeding

There is no data available on the excretion of glucosamine in human milk. The use of glucosamine during breastfeeding is therefore not recommended as there is no data on the safety for 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.

4.8 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.


System Organ Class

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Not known (cannot be estimated from the available data)

Nervous system disorders

Headache
Tiredness







Dizziness

Gastrointestinal disorders

Nausea

Abdominal pain

Indigestion

Diarrhoea

Constipation








Vomiting

Skin and subcutaneous tissue disorders




Rash

Itching


Flushing




Angioedema

Urticaria



General Disorders and Administration Site Conditions










Oedema, peripheral oedema

Hepatobiliary disorders










Hepatic enzyme increased and jaundice

Sporadic, spontaneous cases of hypercholesterolemia have been reported, but causality has not been established.

Patients with diabetes mellitus

Blood glucose control worsened in patients with diabetes mellitus. Frequency not known.


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.

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 anti-inflammatory and anti-rheumatic agents, non-steroidal anti-inflammatory drugs. 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 glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes.  The mechanism of action of glucosamine in humans is unknown. The period to onset of response cannot be assessed.


    1. Pharmacokinetic properties


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 approximately 5 litres 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.

5.3 Preclinical safety data


D-glucosamine has low acute toxicity. Animal experimental data relating to toxicity during repeated 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


Aspartame (E951)

Sorbitol (E420)

Citric acid anhydrous

Macrogol 4000


    1. Incompatibilities


Not applicable.

6.3 Shelf life


3 years

6.4 Special precautions for storage


Do not store above 30°C.

6.5 Nature and contents of container


One sachet made of a three-layered material comprising paper, aluminium and polyethylene.

Pack-sizes of 30 and 90 sachets. Not all pack-sizes may be marketed.


6.6 Special precautions for disposal


No special requirements.

7 MARKETING AUTHORISATION HOLDER


To be completed nationally

For SE:

ROTTAPHARM Ltd

Damastown Industrial Park

Mulhuddart, Dublin 15



Irland

8 MARKETING AUTHORISATION NUMBER(S)


To be completed nationally

For SE: 27809

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION


2009-07-16

10 DATE OF REVISION OF THE TEXT


2011-03-17



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