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SPC, UK: Emflex Capsules (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Serono
Διεύθυνση :
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
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Name of the medicinal product

Emflex Capsules.

Qualitative and quantitative composition

Each capsule contains Acemetacin 60mg Excipients: Each capsule contains 73.9mg lactose. For a 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

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 to control symptoms (see ...

Contraindications

Hypersensitivity to acemetacin, indomethacin or to any of the excipients. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). NSAIDS ...

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 ...

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.

Undesirable effects

Gastro-intestinal: The most commonly observed adverse events are gastro-intestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section ...

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

Five years

Special precautions for storage

Store below 25 degree 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

Special precautions for disposal and other handling

To be taken with food.

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

26 November 1990/25 March 1996

Date of revision of the text

21 February 2012
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