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SPC, UK: DOLENIO Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Dolenio 500 mg film-coated tablets.

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 ...

Pharmaceutical form

Film-coated tablet. White to off white, oval shaped, bi-convex film-coated tablets.

Therapeutic indications

Relief of symptoms in mild to moderate osteoarthritis of the knee.

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 ...

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 ...

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 ...

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 ...

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 ...

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.

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 ...

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, ...

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 ...

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 ...

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 ...

List of excipients

Core tablet: Povidone K30 Macrogol 4000 Magnesium Stearate Film-Coating: Hypromellose Titanium Dioxide (E171) Talc Propylene glycol Polysorbate 80

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

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.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Blue Bio Pharmaceuticals Ltd., 5<sup>th</sup> Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

Marketing authorization number(s)

PL 33831/0002

Date of first authorization / renewal of the authorization

01/03/2012

Date of revision of the text

04/05/2018

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