ACECLOFENAC Film-coated tablet (2015)
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Περιεχόμενα
Name of the medicinal product
Aceclofenac 100 mg film-coated Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 100 mg of Aceclofenac. For a full list of excipients, see section 6.1.
Pharmaceutical form
<u>100 mg:</u> Film-coated tablet. White to off-white, round shaped, biconvex, film-coated tablet debossed with 100 on one side and plain on the other side.
Therapeutic indications
Aceclofenac film-coated tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Posology and method of administration
Aceclofenac film-coated tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. To be taken preferably with or after food. When Aceclofenac was ...
Contraindications
Hypersensitivity to Aceclofenac or to any of the excipients. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of 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 Aceclofenac ...
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) as this may increase the risk of adverse effects (see section 4.4). Anti-hypertensives: ...
Fertility, pregnancy and lactation
Pregnancy There is no information on the use of aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological ...
Effects on ability to drive and use machines
Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
Undesirable effects
Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment. Aceclofenac is both structurally related ...
Overdose
There is insufficient data available on the consequences of Aceclofenac in humans. a) Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal ...
Pharmacodynamic properties
ATC code: M01AB16 Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. ...
Pharmacokinetic properties
After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates ...
Preclinical safety data
The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs. The principal target organ was the gastro-intestinal tract. No unexpected findings were recorded. ...
List of excipients
Core Tablet: Cellulose microcrystalline Croscarmellose sodium Povidone K-30 Glyceryl palmitostearate Tablet coating: Hypromellose 15 cps Macrogol 400 Titanium dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Aceclofenac Tablets 100 mg are packed in aluminium -aluminium blister packs. The aluminium blister foil is soft temper, plain, one side bright, dull side lacquer laminated to 25 μm OPA, bright side lacquer ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4 HF, United Kingdom
Marketing authorization number(s)
PL 20075/0350
Date of first authorization / renewal of the authorization
14/09/2011
Date of revision of the text
29/06/2015
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