GLUCOSAMINE SULPHATE 1500 MG POWDER FOR ORAL SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Glucosamine sulphate 1500mg powder for oral solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains:

Glucosamine sulphate sodium chloride 1884 mg, equivalent to glucosamine sulphate 1500 mg or 1178 mg glucosamine.

Excipients with known effect:

Each sachet contains 2.5 mg of aspartame and 2028.5 mg of sorbitol.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for oral solution

White to slightly yellowish powder in single dose sachets.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Relief of symptoms in mild to moderate osteoarthritis of the knee, as diagnosed by a doctor.

4.2 Posology and method of administration

Posology

Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after some weeks of treatment or sometimes 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

Paediatric population:

Glucosamine sulphate should not be used in children and adolescents below the age of 18 years, since safety and efficacy have not been established.

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.

Use in renal and liver impairment patients:

In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed.

Method of administration

The contents of one sachet (1500 mg glucosamine sulphate) should be taken once daily. The entire contents of one sachet should be fully dissolved in at least 250 ml of water (one glass of water) before drinking.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Glucosamine sulphate must not be used in patients who are allergic to shellfish as the active ingredient is obtained from shellfish.

Glucosamine sulphate must not be given to patients who suffer from phenylketonuria, since it contains aspartame, a source of phenylalanine.

Glucosamine sulphate 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).

Glucosamine sulphate 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 diseases 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 Glucosamine sulphate 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 symptoms.

Glucosamine sulphate must not be given to patients who suffer from phenylketonuria, since it contains aspartame, which is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine

Glucosamine sulphate contains sorbitol. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

Glucosamine sulphate contains 151 mg)(6,6 mmol) sodium per sachet, equivalent to 7.55% of the WHO recommended maximum daily intake of 2 g sodium for an adult..

The label will state:

Read the package leaflet before use.

Information for the Patient:

Glucosamine sulphate sachets 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, sulphates, or any other ingredient of this medicine

suffer from phenylketonuria

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

Glucosamine sulphate 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).

Warfarin:

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.

Tetracyclines:

Concurrent treatment with glucosamine may increase the absorption and serum concentration 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.

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 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of glucosamine in pregnant women.

From animal studies only insufficient data are available. Glucosamine sulphate should not be used during pregnancy.

Breast-feeding

There are no data available on the excretion of glucosamine into human milk. The use of glucosamine sulphate 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, diarrhoea and constipation. In addition, headache, tiredness, rash, pruritus and erythema have been reported.

frequency cannot be estimated from the available data

Sporadic, spontaneous cases of hypercholeste­rolemia, asthma (or asthma aggravated) and Diabetes mellitus inadequate control have been reported, but causality has not been established.

Glucosamine 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 at:

www.mhra.gov.uk/y­ellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 cases 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: Anti-inflammatory and anti-rheumatic products/Other anti-inflammatory and anti-rheumatic 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 in humans 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.

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

Citric acid, anhydrous (E330)

Macrogol 4000

Aspartame (E951)

Sorbitol (E420)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions.

6.5 Nature and contents of container

One sachet made of a three layered material comprising white Kraft paper, aluminium and low density polyethylene.

Pack sizes of 30, 60 or 90 sachets.

Not all pack-sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Crescent Pharma Limited,

Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton,

Hants RG25 3ED

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 20416/0280

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/03/2016