Dolenio 500 Mg Film-Coated Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolenio 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 628.2 mg of Glucosamine sulphate sodium chloride equivalent to 500 mg Glucosamine sulphate or 393 mg glucosamine.
Excipient with known effect: One tablet contains Sodium 51.538 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, oval shaped, bi-convex film-coated tablets.
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
Adults:
The recommended dose is 1178 mg of Glucosamine (1500 mg Glucosamine sulphate) to be taken once daily with a glass of water.
This quantity corresponds to:
3 tablets of Dolenio 500 mg to be taken together, once daily Other strengths can be available and the corresponding dosages is: 1 tablet of Dolenio 1500 mg or 2 tablets of Dolenio 750 mg to be taken together, once daily.
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.
Tablets can be taken with or without food.
Children and adolescents:
Dolenio is not recommended for use in children and adolescents below the age of 18 years, due to lack of data on safety and efficacy.
Older people
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 with this group.
Method of administration For oral use.
4.3 Contraindications
Hypersensitivity to shellfish as the active ingredient is obtained from shellfish.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Children under 2 years of age.
4.4 Special warnings and precautions for use
A doctor should be consulted to rule out the presence of joint disease 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 known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended, since hypercholesterolemia has been reported 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 asthma symptoms.
This medicinal product contains 2.240mmol (51.538 mg) of sodium per dose. 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 concentrations 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 medical products.
4.6 Fertility, pregnancy and lactation
Pregnancy:
There are inadequate data concerning 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 is no data available on the excretion of glucosamine in breastmilk. The use of glucosamine during breast feeding is therefore not recommended as there is no data on the safety of the child.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed.
If dizziness or drowsiness is experienced, car driving and the operating of machinery are 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.
In the table below, all causality adverse events are listed by system organ class and frequency (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)).
|
MedDRA System Organ Class |
Common (>1/100 to <1/10) |
Uncommon (>1/1000 to <1/100) |
Not known (cannot be estimated from the available data) | |
|
Nervous system disorders |
Headache Tiredness |
- |
Dizziness | |
|
Respiratory, thoracic and mediastinal disorders |
- |
- |
Asthma / Asthma aggravated | |
|
Gastrointestinal disorders |
Nausea Abdominal pain Indigestion Diarrhoea Constipation |
- |
Vomiting | |
|
Skin and subcutaneous tissue disorders |
- |
Rash Itching Flushing |
Angioedema Urticaria | |
|
Metabolism and nutrition disorders |
- |
- |
Diabetes mellitus inadequate control Hypercholesterolaemia | |
|
General disorders and administration site conditions |
- |
- |
Oedema / Peripheral oedema |
Cases of Hypercholesterolemia, Asthma, aggravated and Diabetes mellitus inadequate control have been reported, but causality has not been established.
Dolenio may cause Hepatic enzyme elevation and rarely jaundice.
Patients with Diabetes mellitus
Blood glucose control worsened in patients with diabetes mellitus. Frequency not known.
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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.
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 glucosamine 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 anti-inflammatory 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 glucosamine stimulates the synthesis of physiological glycosaminoglycans and proteoglycans by chondrocytes and of hyaluronic acid by synoviocytes. The mechanism of action of glucosamine is unknown.
The period to onset of response cannot 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 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 unchanged in the urine.
The ADME (absorption, distribution, metabolism and excretion) profile for Glucosamine sulphate in man has not been completely elucidated.
5.3 Preclinical safety data
D-glucosamine has low acute toxicity.
Animal experimental data relating to toxicity during repeated administration, reproduction toxicity or carcinogenicity is lacking for glucosamine. Glucosamine is not mutagenic. Equivocal results concerning the clastogenic effects of glucosamine have been observed in vivo. However, these findings are not deemed clinical relevant for human safety assessment considering that glucosamine is an endogenous substance.
Results from in vitro or 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 tablet
Povidone K30 Macrogol 4000 Magnesium Stearate Film-Coating Hypromellose Titanium Dioxide (E171) Talc
Propylene glycol Polysorbate 80
6.2
Incompatibilities
Not applicable.
Shelf life
6.3
2 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions
6.5 Nature and contents of container
Alu/PVC/PVDC Blister packs
Pack-sizes:
90, 180, 270 film-coated tablets Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Blue Bio Pharmaceuticals Ltd.,
5th Floor, Beaux Lane House Mercer Street Lower Dublin2, Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 33831/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/03/2012
10 DATE OF REVISION OF THE TEXT
07/08/2015