Summary of Product Characteristics (SmPC) - Dolenio 750 mg film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Dolenio 750 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 942.3 mg of Glucosamine sulphate sodium chloride equivalent to 750 mg Glucosamine sulphate or 589 mg glucosamine.
Excipient(s) with known effect: Each tablet contains Sodium 75.5 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
Dolenio Tablets is indicated for relief of symptoms in mild to moderate osteoarthritis of
the knee as diagnosed by a doctor.
Glucosamine is not indicated for the treatment of acute painful symptoms.
4.2 Posology and method of administration
Administration:
For oral use.
Tablets can be taken with or without food.
Adults and the elderly:
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.
Additional information on special populations:
Children / adolescents:
Safety and efficacy has not been established in children and adolescents, therefore, Dolenio tablets should not be used in persons under the age of 18 years.
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:
No studies have been performed in patients with impaired renal and/or liver function.
4.3 Contraindications
Known sensitivity to glucosamine (or any of its derivatives), sulfates or any of the other ingredients in Dolenio tablets (listed in section 6.1).
Dolenio tablets must not be used in patients who are allergic to shellfish as the active ingredient is obtained from shellfish.
Dolenio tablets should not be used in patients taking warfarin (or other coumarin anticoagulants) as increased effect during concomitant treatment with glucosamine has been reported (see section 4.5).
Dolenio tablets should not be used in patients with impaired renal and/or liver function, as no dose recommendations can be given since no studies have been performed.
Patients taking oral tetracycline should not take glucosamine at the same time, as concurrent treatment with glucosamine may increase the absorption and serum concentrations of tetracyclines (see section 4.5).
Glucosamine should not be used during pregnancy or breast-feeding as there are inadequate data concerning the use of glucosamine in pregnant or breast-feeding women (see section 4.6).
4.4 Special warnings and precautions for use
A doctor must be consulted to rule out the presence of joint disease for which other
treatment should be considered.
A doctor must be consulted if this medicine is intended for long term use.
Continuous treatment beyond 3 years cannot currently be recommended as safety has not been established beyond this period.
As the risk of diabetogenic effects is unknown and until further evidence becomes available, caution should be exercised in patients with Diabetes or a predisposition for Diabetes. Therefore in patients with impaired glucose tolerance, pre-diabetics and diagnosed diabetics (Type I and II) monitoring of the blood glucose levels should be increased, as deemed necessary, before start of treatment, periodically during treatment and at the end of the treatment, as determined by the primary Healthcare Professional.
Where relevant, monitoring of insulin requirements is also recommended before start of treatment, periodically during treatment and at the end of the treatment, under medical supervision.
In patients with a known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended during treatment with Dolenio tablets since hypercholesterolemia has been observed in a few patients treated with glucosamine. The results should be a factor in determining whether treatment is continued after 2-3 months.
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 3.26 mmol (75.5 mg) of sodium per dose, equivalent to 3.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.
The label will state:
Read the package leaflet before use.
Information for the Patient:
Dolenio tablets are to be used only for the relief of symptoms of mild to moderate
osteoarthritis of the knee that has previously been diagnosed by your doctor.
Please make sure that you have been diagnosed with osteoarthritis of the knee before taking this product.
Do not take this product if you:
- are allergic to shellfish, glucosamine, sulfates, or any other ingredient of this medicine
- are pregnant or breast-feeding
- have liver or kidney problems
- are under the age of 18 years
- are taking warfarin (or other coumarin anticoagulants)
- are taking oral tetracycline (an antibiotic effective against a wide range of bacterial infections), do not take glucosamine at the same time.
Speak to a doctor or pharmacist before taking this product if you:
- have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke or heart problems as your doctor may need to monitor you more regularly
- are on a controlled sodium diet.
Do not exceed the stated dose.
4.5 Interaction with other medicinal products and other forms of interaction
Dolenio should be used with caution in combination with:
Hypoglycaemic agents:
Close monitoring of blood sugar levels is recommended for diabetics on hypoglycaemic agents (see section 4.4).
Tetracyclines:
Concurrent treatment with glucosamine may increase the absorption and serum concentrations of tetracyclines, but the clinical relevance of this interaction is probably limited. If the patient is taking oral tetracycline they should not take glucosamine at the same time.
Wafarin:
There are limited data on possible drug interactions with glucosamine, but increments in the INR parameter have been reported with oral vitamin K antagonists. Patients treated
with oral vitamin K antagonists should therefore be closely monitored at the time of initiation or termination of glucosamine therapy
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 breast milk.
Glucosamine should not be used during breast feeding 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 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.
MedDRA System Organ Class | Common (≥1/100 to <1/10) | Uncommon (≥1/1000 to <1/100) | Rare (≥1/10,000 to <1/1000) | Not known (cannot be estimated from the available data) |
Metabolism and nutrition disorders | Diabetes mellitus inadequate control Hypercholesterolaemia | |||
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 |
General disorders and administration site conditions | Oedema / Peripheral oedema |
Cases of Hypercholesterolemia, Asthma, (or 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.
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 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-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 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 in the urine as unchanged substance.
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.
6.3 Shelf life
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:
60, 120, 180 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 Pharma (UK) Limited
167-169 Great Portland Street,
Fifth Floor, London W1W 5PF
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 53594/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/03/2012
10 DATE OF REVISION OF THE TEXT
20/05/2024