Yointy 625 Mg Hard Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Yointy 625 mg, hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 625 mg of glucosamine (equivalent to 750 mg of glucosamine hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Brown coloured hard gelatine capsules of size n°0EL.
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 (including the elderly):
The recommended dose is 2 capsules to be taken once a day (1,250 mg/day glucosamine).
Glucosamine is not indicated for the treatment of acute pain. The relief of the pain may occur after several weeks of treatment, and sometimes after a longer time. If no relief of pain occurs after 2-3 months, the continuation of the treatment should be reevaluated.
Paediatric population:
Yointy is not recommended for use in children below 18 years of age, due to a lack of data on safety and efficacy.
Impaired liver and/or renal Junction:
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 capsules can be taken before, during or after meals.
The capsules should be swallowed whole without chewing, and with a sufficient amount of water.
4.3 Contraindications
Known hypersensitivity to glucosamine or to any of the excipients.
Yointy 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 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.
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 no adequate data from 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 are no data available on the excretion of glucosamine in human milk. The use of glucosamine during breastfeeding is therefore not recommended as there are no data on the safety of 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 are not recommended.
4.8 Undesirable effects
The most common adverse reactions associated with treatment with glucosamine are described below with the frequencies “common” (defined as >1/100 to <1/10), “uncommon” (defined as >1/1,000 to <1/100) and “not known” (defined as cannot be estimated from the available data) and are listed by body system organ class. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The reported adverse reactions are usually mild and transitory.
Nervous system disorders Common: Headache, tiredness.
Not known: Dizziness
Respiratory, thoracic and mediastinal disorders Not known: Asthma / asthma aggravated
Gastrointestinal disorders
Common: Nausea, abdominal pain, indigestion, diarrhoea, constipation. Not known: Vomiting.
Skin and subcutaneous tissue disorders Uncommon: Rash, itching, flushing.
Not known: Angioedema, urticaria.
Metabolism and nutrition disorders
Not known: Diabetes mellitus inadequate control, hypercholesterolaemia.
General disorders and administration site conditions Not known: Oedema / peripheral oedema.
4.9 Overdose
No case of overdose has been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other antiinflammatory and antirheumatic agents, nonsteroids. 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 in man has not been completely elucidated.
5.3 Preclinical safety data
Non-clinical data from glucosamine reveal no special hazard for humans based on studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Magnesium stearate.
Capsule composition:
Gelatin
Red iron oxide (E172)
Titanium dioxide (E171)
Black iron oxide (E172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
6.5 Nature and contents of container
PVC/PVDC/aluminium-blister packed in cardboard carton.
Pack-sizes of 60 hard capsules (6 blisters of ten capsules each) and 180 hard capsules (3 packs of 60 hard capsules).
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
BIOIBERICA S.A.
Ctra. Nacional II, Km. 680,6 08389 Palafolls (Barcelona)
Spain.
8 MARKETING AUTHORISATION NUMBER(S)
PL 05517/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28/02/2012
10 DATE OF REVISION OF THE TEXT
28/02/2012