EMFLEX Capsule (2016)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Emflex Capsules.
Qualitative and quantitative composition
Each capsule contains acemetacin 60mg. Excipients: Each capsule contains 73.9mg lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Gelatine capsule.
Therapeutic indications
Rheumatoid arthritis, osteoarthritis, low back pain, and post-operative pain and inflammation.
Posology and method of administration
Method of administration For oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary ...
Contraindications
Hypersensitivity to the active substance, indomethacin or to any of the excipients listed in section 6.1. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ...
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 Emflex ...
Interaction with other medicinal products and other forms of interaction
Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin, other salicylates, diflusinal) as this may increase the risk of adverse ...
Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery. These effects will be enhanced ...
Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) ...
Overdose
Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally ...
Pharmacodynamic properties
Acemetacin is a glycolic acid ester of indomethacin and the pharmacological activity resulting from acemetacin administration in man is derived from the presence of both acemetacin and indomethacin. The ...
Pharmacokinetic properties
Acemetacin is well absorbed after oral administration. Its major metabolite is indomethacin which, after repeated administration, is present at levels in excess of those of acemetacin. Acemetacin is bound ...
Preclinical safety data
Emflex Capsules show similar toxicity to other non-steroidal anti-inflammatory drugs.
List of excipients
Gelatine capsule (colourings: Ferric oxide red E172, Ferric oxide yellow E172 and titanium dioxide E171) Lactose Magnesium stearate Silicon dioxide Talc sodium dodecylsulphate
Incompatibilities
None known.
Shelf life
5 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
White polypropylene bottles with polypropylene screw caps. Pack sizes: 90, 56, 60 and 30 capsules. PVC/PVDC foil blister packs in cartons: Pack sizes: 90, 60, 56, 30, 10, and 6 capsules. Not all pack sizes ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Marketing authorization number(s)
PL 11648/0083
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 November 1990 Date of latest renewal: 25 March 1996
Date of revision of the text
19 May 2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
