LODINE SR Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Lodine 600 mg SR Tablets.
Qualitative and quantitative composition
Each tablet contains 600 mg of etodolac. Excipients with known effect: Each tablet contains 109 mg lactose and 34 mg of sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Lodine SR Tablets are for oral administration. Each tablet is capsular, oval shaped light grey film coated, impressed on one side with Lodine SR600 and contains etodolac 600mg in a sustained release formulation. ...
Therapeutic indications
Lodine (etodolac) is indicated for acute or long-term use in rheumatoid arthritis and osteoarthritis.
Posology and method of administration
Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4) Adults One tablet daily. If a lower dose is sufficient, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Lodine should not be used in patients with severe heart failure. Lodine should not be used in patients with active ...
Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). The use of Lodine ...
Interaction with other medicinal products and other forms of interaction
Since Lodine is extensively protein-bound, it may be necessary to modify the dosage of other highly protein-bound drugs. Other analgesics including cyclooxygenase-2 selective inhibitor: Avoid concomitant ...
Fertility, pregnancy and lactation
Fertility The use of Lodine may impair female fertility and is not recommended in woman attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, ...
Effects on ability to drive and use machines
Lodine can cause dizziness, drowsiness, fatigue or abnormal vision. Patients need to be aware of how they react to this medicine before driving or operating machines.
Undesirable effects
Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and ...
Overdose
(a) Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointaestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally ...
Pharmacodynamic properties
Inhibition of prostaglandin synthesis and COX-2 selectivity All non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to inhibit the formation of prostaglandins. It is this action which is responsible ...
Pharmacokinetic properties
In man, etodolac is well absorbed following oral administration. Etodolac is highly bound to serum proteins. The elimination half-life averages seven hours in man. The primary route of excretion is in ...
Preclinical safety data
Nothing of note to the prescriber.
List of excipients
Hydroxypropyl methylcellulose Dibasic sodium phosphate Ethylcellulose Lactose Magnesium stearate Hydroxypropyl cellulose Macrogol 400 Macrogol 6000 Colourings titanium dioxide (E171), iron oxide (E172) ...
Incompatibilities
None.
Shelf life
Shelf life: Lodine SR Tablets may be stored for up to 3 years.
Special precautions for storage
Store at room temperature, below 25°C.
Nature and contents of container
Vinyl Aclar or PVdC/PVC/Aluminium foil blister packs of 2, 28 or 30 tablets. HDPE bottle with child resistant closures of 28 or 30 tablets. Polypropylene securitainers with polyethylene caps of 28 or 30 ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Almirall, S.A., Ronda General Mitre 151, 08022, Barcelona, Spain
Marketing authorization number(s)
PL 16973/0021
Date of first authorization / renewal of the authorization
02/03/2009
Date of revision of the text
10/10/2018
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